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News and Views that Matter to Rheumatologists
gambling
compulsive behaviors
ammunition
assault rifle
black jack
Boko Haram
bondage
child abuse
cocaine
Daech
drug paraphernalia
explosion
gun
human trafficking
ISIL
ISIS
Islamic caliphate
Islamic state
mixed martial arts
MMA
molestation
national rifle association
NRA
nsfw
pedophile
pedophilia
poker
porn
pornography
psychedelic drug
recreational drug
sex slave rings
slot machine
terrorism
terrorist
Texas hold 'em
UFC
substance abuse
abuseed
abuseer
abusees
abuseing
abusely
abuses
aeolus
aeolused
aeoluser
aeoluses
aeolusing
aeolusly
aeoluss
ahole
aholeed
aholeer
aholees
aholeing
aholely
aholes
alcohol
alcoholed
alcoholer
alcoholes
alcoholing
alcoholly
alcohols
allman
allmaned
allmaner
allmanes
allmaning
allmanly
allmans
alted
altes
alting
altly
alts
analed
analer
anales
analing
anally
analprobe
analprobeed
analprobeer
analprobees
analprobeing
analprobely
analprobes
anals
anilingus
anilingused
anilinguser
anilinguses
anilingusing
anilingusly
anilinguss
anus
anused
anuser
anuses
anusing
anusly
anuss
areola
areolaed
areolaer
areolaes
areolaing
areolaly
areolas
areole
areoleed
areoleer
areolees
areoleing
areolely
areoles
arian
arianed
arianer
arianes
arianing
arianly
arians
aryan
aryaned
aryaner
aryanes
aryaning
aryanly
aryans
asiaed
asiaer
asiaes
asiaing
asialy
asias
ass
ass hole
ass lick
ass licked
ass licker
ass lickes
ass licking
ass lickly
ass licks
assbang
assbanged
assbangeded
assbangeder
assbangedes
assbangeding
assbangedly
assbangeds
assbanger
assbanges
assbanging
assbangly
assbangs
assbangsed
assbangser
assbangses
assbangsing
assbangsly
assbangss
assed
asser
asses
assesed
asseser
asseses
assesing
assesly
assess
assfuck
assfucked
assfucker
assfuckered
assfuckerer
assfuckeres
assfuckering
assfuckerly
assfuckers
assfuckes
assfucking
assfuckly
assfucks
asshat
asshated
asshater
asshates
asshating
asshatly
asshats
assholeed
assholeer
assholees
assholeing
assholely
assholes
assholesed
assholeser
assholeses
assholesing
assholesly
assholess
assing
assly
assmaster
assmastered
assmasterer
assmasteres
assmastering
assmasterly
assmasters
assmunch
assmunched
assmuncher
assmunches
assmunching
assmunchly
assmunchs
asss
asswipe
asswipeed
asswipeer
asswipees
asswipeing
asswipely
asswipes
asswipesed
asswipeser
asswipeses
asswipesing
asswipesly
asswipess
azz
azzed
azzer
azzes
azzing
azzly
azzs
babeed
babeer
babees
babeing
babely
babes
babesed
babeser
babeses
babesing
babesly
babess
ballsac
ballsaced
ballsacer
ballsaces
ballsacing
ballsack
ballsacked
ballsacker
ballsackes
ballsacking
ballsackly
ballsacks
ballsacly
ballsacs
ballsed
ballser
ballses
ballsing
ballsly
ballss
barf
barfed
barfer
barfes
barfing
barfly
barfs
bastard
bastarded
bastarder
bastardes
bastarding
bastardly
bastards
bastardsed
bastardser
bastardses
bastardsing
bastardsly
bastardss
bawdy
bawdyed
bawdyer
bawdyes
bawdying
bawdyly
bawdys
beaner
beanered
beanerer
beaneres
beanering
beanerly
beaners
beardedclam
beardedclamed
beardedclamer
beardedclames
beardedclaming
beardedclamly
beardedclams
beastiality
beastialityed
beastialityer
beastialityes
beastialitying
beastialityly
beastialitys
beatch
beatched
beatcher
beatches
beatching
beatchly
beatchs
beater
beatered
beaterer
beateres
beatering
beaterly
beaters
beered
beerer
beeres
beering
beerly
beeyotch
beeyotched
beeyotcher
beeyotches
beeyotching
beeyotchly
beeyotchs
beotch
beotched
beotcher
beotches
beotching
beotchly
beotchs
biatch
biatched
biatcher
biatches
biatching
biatchly
biatchs
big tits
big titsed
big titser
big titses
big titsing
big titsly
big titss
bigtits
bigtitsed
bigtitser
bigtitses
bigtitsing
bigtitsly
bigtitss
bimbo
bimboed
bimboer
bimboes
bimboing
bimboly
bimbos
bisexualed
bisexualer
bisexuales
bisexualing
bisexually
bisexuals
bitch
bitched
bitcheded
bitcheder
bitchedes
bitcheding
bitchedly
bitcheds
bitcher
bitches
bitchesed
bitcheser
bitcheses
bitchesing
bitchesly
bitchess
bitching
bitchly
bitchs
bitchy
bitchyed
bitchyer
bitchyes
bitchying
bitchyly
bitchys
bleached
bleacher
bleaches
bleaching
bleachly
bleachs
blow job
blow jobed
blow jober
blow jobes
blow jobing
blow jobly
blow jobs
blowed
blower
blowes
blowing
blowjob
blowjobed
blowjober
blowjobes
blowjobing
blowjobly
blowjobs
blowjobsed
blowjobser
blowjobses
blowjobsing
blowjobsly
blowjobss
blowly
blows
boink
boinked
boinker
boinkes
boinking
boinkly
boinks
bollock
bollocked
bollocker
bollockes
bollocking
bollockly
bollocks
bollocksed
bollockser
bollockses
bollocksing
bollocksly
bollockss
bollok
bolloked
bolloker
bollokes
bolloking
bollokly
bolloks
boner
bonered
bonerer
boneres
bonering
bonerly
boners
bonersed
bonerser
bonerses
bonersing
bonersly
bonerss
bong
bonged
bonger
bonges
bonging
bongly
bongs
boob
boobed
boober
boobes
boobies
boobiesed
boobieser
boobieses
boobiesing
boobiesly
boobiess
boobing
boobly
boobs
boobsed
boobser
boobses
boobsing
boobsly
boobss
booby
boobyed
boobyer
boobyes
boobying
boobyly
boobys
booger
boogered
boogerer
boogeres
boogering
boogerly
boogers
bookie
bookieed
bookieer
bookiees
bookieing
bookiely
bookies
bootee
booteeed
booteeer
booteees
booteeing
booteely
bootees
bootie
bootieed
bootieer
bootiees
bootieing
bootiely
booties
booty
bootyed
bootyer
bootyes
bootying
bootyly
bootys
boozeed
boozeer
boozees
boozeing
boozely
boozer
boozered
boozerer
boozeres
boozering
boozerly
boozers
boozes
boozy
boozyed
boozyer
boozyes
boozying
boozyly
boozys
bosomed
bosomer
bosomes
bosoming
bosomly
bosoms
bosomy
bosomyed
bosomyer
bosomyes
bosomying
bosomyly
bosomys
bugger
buggered
buggerer
buggeres
buggering
buggerly
buggers
bukkake
bukkakeed
bukkakeer
bukkakees
bukkakeing
bukkakely
bukkakes
bull shit
bull shited
bull shiter
bull shites
bull shiting
bull shitly
bull shits
bullshit
bullshited
bullshiter
bullshites
bullshiting
bullshitly
bullshits
bullshitsed
bullshitser
bullshitses
bullshitsing
bullshitsly
bullshitss
bullshitted
bullshitteded
bullshitteder
bullshittedes
bullshitteding
bullshittedly
bullshitteds
bullturds
bullturdsed
bullturdser
bullturdses
bullturdsing
bullturdsly
bullturdss
bung
bunged
bunger
bunges
bunging
bungly
bungs
busty
bustyed
bustyer
bustyes
bustying
bustyly
bustys
butt
butt fuck
butt fucked
butt fucker
butt fuckes
butt fucking
butt fuckly
butt fucks
butted
buttes
buttfuck
buttfucked
buttfucker
buttfuckered
buttfuckerer
buttfuckeres
buttfuckering
buttfuckerly
buttfuckers
buttfuckes
buttfucking
buttfuckly
buttfucks
butting
buttly
buttplug
buttpluged
buttpluger
buttpluges
buttpluging
buttplugly
buttplugs
butts
caca
cacaed
cacaer
cacaes
cacaing
cacaly
cacas
cahone
cahoneed
cahoneer
cahonees
cahoneing
cahonely
cahones
cameltoe
cameltoeed
cameltoeer
cameltoees
cameltoeing
cameltoely
cameltoes
carpetmuncher
carpetmunchered
carpetmuncherer
carpetmuncheres
carpetmunchering
carpetmuncherly
carpetmunchers
cawk
cawked
cawker
cawkes
cawking
cawkly
cawks
chinc
chinced
chincer
chinces
chincing
chincly
chincs
chincsed
chincser
chincses
chincsing
chincsly
chincss
chink
chinked
chinker
chinkes
chinking
chinkly
chinks
chode
chodeed
chodeer
chodees
chodeing
chodely
chodes
chodesed
chodeser
chodeses
chodesing
chodesly
chodess
clit
clited
cliter
clites
cliting
clitly
clitoris
clitorised
clitoriser
clitorises
clitorising
clitorisly
clitoriss
clitorus
clitorused
clitoruser
clitoruses
clitorusing
clitorusly
clitoruss
clits
clitsed
clitser
clitses
clitsing
clitsly
clitss
clitty
clittyed
clittyer
clittyes
clittying
clittyly
clittys
cocain
cocaine
cocained
cocaineed
cocaineer
cocainees
cocaineing
cocainely
cocainer
cocaines
cocaining
cocainly
cocains
cock
cock sucker
cock suckered
cock suckerer
cock suckeres
cock suckering
cock suckerly
cock suckers
cockblock
cockblocked
cockblocker
cockblockes
cockblocking
cockblockly
cockblocks
cocked
cocker
cockes
cockholster
cockholstered
cockholsterer
cockholsteres
cockholstering
cockholsterly
cockholsters
cocking
cockknocker
cockknockered
cockknockerer
cockknockeres
cockknockering
cockknockerly
cockknockers
cockly
cocks
cocksed
cockser
cockses
cocksing
cocksly
cocksmoker
cocksmokered
cocksmokerer
cocksmokeres
cocksmokering
cocksmokerly
cocksmokers
cockss
cocksucker
cocksuckered
cocksuckerer
cocksuckeres
cocksuckering
cocksuckerly
cocksuckers
coital
coitaled
coitaler
coitales
coitaling
coitally
coitals
commie
commieed
commieer
commiees
commieing
commiely
commies
condomed
condomer
condomes
condoming
condomly
condoms
coon
cooned
cooner
coones
cooning
coonly
coons
coonsed
coonser
coonses
coonsing
coonsly
coonss
corksucker
corksuckered
corksuckerer
corksuckeres
corksuckering
corksuckerly
corksuckers
cracked
crackwhore
crackwhoreed
crackwhoreer
crackwhorees
crackwhoreing
crackwhorely
crackwhores
crap
craped
craper
crapes
craping
craply
crappy
crappyed
crappyer
crappyes
crappying
crappyly
crappys
cum
cumed
cumer
cumes
cuming
cumly
cummin
cummined
cumminer
cummines
cumming
cumminged
cumminger
cumminges
cumminging
cummingly
cummings
cummining
cumminly
cummins
cums
cumshot
cumshoted
cumshoter
cumshotes
cumshoting
cumshotly
cumshots
cumshotsed
cumshotser
cumshotses
cumshotsing
cumshotsly
cumshotss
cumslut
cumsluted
cumsluter
cumslutes
cumsluting
cumslutly
cumsluts
cumstain
cumstained
cumstainer
cumstaines
cumstaining
cumstainly
cumstains
cunilingus
cunilingused
cunilinguser
cunilinguses
cunilingusing
cunilingusly
cunilinguss
cunnilingus
cunnilingused
cunnilinguser
cunnilinguses
cunnilingusing
cunnilingusly
cunnilinguss
cunny
cunnyed
cunnyer
cunnyes
cunnying
cunnyly
cunnys
cunt
cunted
cunter
cuntes
cuntface
cuntfaceed
cuntfaceer
cuntfacees
cuntfaceing
cuntfacely
cuntfaces
cunthunter
cunthuntered
cunthunterer
cunthunteres
cunthuntering
cunthunterly
cunthunters
cunting
cuntlick
cuntlicked
cuntlicker
cuntlickered
cuntlickerer
cuntlickeres
cuntlickering
cuntlickerly
cuntlickers
cuntlickes
cuntlicking
cuntlickly
cuntlicks
cuntly
cunts
cuntsed
cuntser
cuntses
cuntsing
cuntsly
cuntss
dago
dagoed
dagoer
dagoes
dagoing
dagoly
dagos
dagosed
dagoser
dagoses
dagosing
dagosly
dagoss
dammit
dammited
dammiter
dammites
dammiting
dammitly
dammits
damn
damned
damneded
damneder
damnedes
damneding
damnedly
damneds
damner
damnes
damning
damnit
damnited
damniter
damnites
damniting
damnitly
damnits
damnly
damns
dick
dickbag
dickbaged
dickbager
dickbages
dickbaging
dickbagly
dickbags
dickdipper
dickdippered
dickdipperer
dickdipperes
dickdippering
dickdipperly
dickdippers
dicked
dicker
dickes
dickface
dickfaceed
dickfaceer
dickfacees
dickfaceing
dickfacely
dickfaces
dickflipper
dickflippered
dickflipperer
dickflipperes
dickflippering
dickflipperly
dickflippers
dickhead
dickheaded
dickheader
dickheades
dickheading
dickheadly
dickheads
dickheadsed
dickheadser
dickheadses
dickheadsing
dickheadsly
dickheadss
dicking
dickish
dickished
dickisher
dickishes
dickishing
dickishly
dickishs
dickly
dickripper
dickrippered
dickripperer
dickripperes
dickrippering
dickripperly
dickrippers
dicks
dicksipper
dicksippered
dicksipperer
dicksipperes
dicksippering
dicksipperly
dicksippers
dickweed
dickweeded
dickweeder
dickweedes
dickweeding
dickweedly
dickweeds
dickwhipper
dickwhippered
dickwhipperer
dickwhipperes
dickwhippering
dickwhipperly
dickwhippers
dickzipper
dickzippered
dickzipperer
dickzipperes
dickzippering
dickzipperly
dickzippers
diddle
diddleed
diddleer
diddlees
diddleing
diddlely
diddles
dike
dikeed
dikeer
dikees
dikeing
dikely
dikes
dildo
dildoed
dildoer
dildoes
dildoing
dildoly
dildos
dildosed
dildoser
dildoses
dildosing
dildosly
dildoss
diligaf
diligafed
diligafer
diligafes
diligafing
diligafly
diligafs
dillweed
dillweeded
dillweeder
dillweedes
dillweeding
dillweedly
dillweeds
dimwit
dimwited
dimwiter
dimwites
dimwiting
dimwitly
dimwits
dingle
dingleed
dingleer
dinglees
dingleing
dinglely
dingles
dipship
dipshiped
dipshiper
dipshipes
dipshiping
dipshiply
dipships
dizzyed
dizzyer
dizzyes
dizzying
dizzyly
dizzys
doggiestyleed
doggiestyleer
doggiestylees
doggiestyleing
doggiestylely
doggiestyles
doggystyleed
doggystyleer
doggystylees
doggystyleing
doggystylely
doggystyles
dong
donged
donger
donges
donging
dongly
dongs
doofus
doofused
doofuser
doofuses
doofusing
doofusly
doofuss
doosh
dooshed
doosher
dooshes
dooshing
dooshly
dooshs
dopeyed
dopeyer
dopeyes
dopeying
dopeyly
dopeys
douchebag
douchebaged
douchebager
douchebages
douchebaging
douchebagly
douchebags
douchebagsed
douchebagser
douchebagses
douchebagsing
douchebagsly
douchebagss
doucheed
doucheer
douchees
doucheing
douchely
douches
douchey
doucheyed
doucheyer
doucheyes
doucheying
doucheyly
doucheys
drunk
drunked
drunker
drunkes
drunking
drunkly
drunks
dumass
dumassed
dumasser
dumasses
dumassing
dumassly
dumasss
dumbass
dumbassed
dumbasser
dumbasses
dumbassesed
dumbasseser
dumbasseses
dumbassesing
dumbassesly
dumbassess
dumbassing
dumbassly
dumbasss
dummy
dummyed
dummyer
dummyes
dummying
dummyly
dummys
dyke
dykeed
dykeer
dykees
dykeing
dykely
dykes
dykesed
dykeser
dykeses
dykesing
dykesly
dykess
erotic
eroticed
eroticer
erotices
eroticing
eroticly
erotics
extacy
extacyed
extacyer
extacyes
extacying
extacyly
extacys
extasy
extasyed
extasyer
extasyes
extasying
extasyly
extasys
fack
facked
facker
fackes
facking
fackly
facks
fag
faged
fager
fages
fagg
fagged
faggeded
faggeder
faggedes
faggeding
faggedly
faggeds
fagger
fagges
fagging
faggit
faggited
faggiter
faggites
faggiting
faggitly
faggits
faggly
faggot
faggoted
faggoter
faggotes
faggoting
faggotly
faggots
faggs
faging
fagly
fagot
fagoted
fagoter
fagotes
fagoting
fagotly
fagots
fags
fagsed
fagser
fagses
fagsing
fagsly
fagss
faig
faiged
faiger
faiges
faiging
faigly
faigs
faigt
faigted
faigter
faigtes
faigting
faigtly
faigts
fannybandit
fannybandited
fannybanditer
fannybandites
fannybanditing
fannybanditly
fannybandits
farted
farter
fartes
farting
fartknocker
fartknockered
fartknockerer
fartknockeres
fartknockering
fartknockerly
fartknockers
fartly
farts
felch
felched
felcher
felchered
felcherer
felcheres
felchering
felcherly
felchers
felches
felching
felchinged
felchinger
felchinges
felchinging
felchingly
felchings
felchly
felchs
fellate
fellateed
fellateer
fellatees
fellateing
fellately
fellates
fellatio
fellatioed
fellatioer
fellatioes
fellatioing
fellatioly
fellatios
feltch
feltched
feltcher
feltchered
feltcherer
feltcheres
feltchering
feltcherly
feltchers
feltches
feltching
feltchly
feltchs
feom
feomed
feomer
feomes
feoming
feomly
feoms
fisted
fisteded
fisteder
fistedes
fisteding
fistedly
fisteds
fisting
fistinged
fistinger
fistinges
fistinging
fistingly
fistings
fisty
fistyed
fistyer
fistyes
fistying
fistyly
fistys
floozy
floozyed
floozyer
floozyes
floozying
floozyly
floozys
foad
foaded
foader
foades
foading
foadly
foads
fondleed
fondleer
fondlees
fondleing
fondlely
fondles
foobar
foobared
foobarer
foobares
foobaring
foobarly
foobars
freex
freexed
freexer
freexes
freexing
freexly
freexs
frigg
frigga
friggaed
friggaer
friggaes
friggaing
friggaly
friggas
frigged
frigger
frigges
frigging
friggly
friggs
fubar
fubared
fubarer
fubares
fubaring
fubarly
fubars
fuck
fuckass
fuckassed
fuckasser
fuckasses
fuckassing
fuckassly
fuckasss
fucked
fuckeded
fuckeder
fuckedes
fuckeding
fuckedly
fuckeds
fucker
fuckered
fuckerer
fuckeres
fuckering
fuckerly
fuckers
fuckes
fuckface
fuckfaceed
fuckfaceer
fuckfacees
fuckfaceing
fuckfacely
fuckfaces
fuckin
fuckined
fuckiner
fuckines
fucking
fuckinged
fuckinger
fuckinges
fuckinging
fuckingly
fuckings
fuckining
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The leading independent newspaper covering rheumatology news and commentary.
After Remission Failure in Early RA, Adding Etanercept No Better Than Adding Leflunomide
TOPLINE:
Treatment with etanercept led to faster disease control initially in patients with early rheumatoid arthritis (RA) who had an insufficient early response to methotrexate and bridging glucocorticoids therapy, but more patients achieved disease control with leflunomide at 104 weeks.
METHODOLOGY:
- Researchers conducted CareRA2020, a randomized controlled trial including 276 patients with early RA who were initially treated with oral methotrexate 15 mg/wk and a step-down prednisone scheme, with early insufficient responders (n = 110) randomized to add etanercept 50 mg/wk or leflunomide 10 mg/d for 24 weeks.
- Patients were classified as early insufficient responders if they did not achieve a 28-joint Disease Activity Score with C-reactive protein (DAS28-CRP) < 3.2 between weeks 8 and 32 or < 2.6 at week 32, despite an increase in methotrexate dose to 20 mg/wk.
- The primary outcome was the longitudinal disease activity measured by DAS28-CRP over 104 weeks.
- The secondary outcomes included disease control at 28 weeks post randomization and the use of biologic or targeted synthetic disease-modifying antirheumatic drugs at week 104.
TAKEAWAY:
- Early introduction of etanercept in patients with RA did not show long-term superiority over leflunomide in disease control over 2 years (P = .157).
- At 28 weeks post randomization, the percentage of patients who achieved a DAS28-CRP < 2.6 was higher in the etanercept group than in the leflunomide group (59% vs 44%).
- After stopping etanercept, disease activity scores worsened, and a lower proportion of patients achieved DAS28-CRP < 2.6 in the etanercept group than in the leflunomide group (55% vs 69%) at week 104.
- Even after treatment with etanercept or leflunomide, the 110 early insufficient responders never reached the same level of disease control as the 142 patients who responded to methotrexate and bridging glucocorticoids within weeks 8-32.
IN PRACTICE:
“The CareRA2020 trial did not completely solve the unmet need of patients responding insufficiently to conventional initial therapy for early RA, but it provides opportunities to further optimize the treatment approach in this population, for instance, by focusing on the identification of potential subgroups with different disease activity trajectories within the early insufficient responder group,” wrote the authors.
SOURCE:
The study was led by Delphine Bertrand of the Skeletal Biology and Engineering Research Center in the Department of Development and Regeneration at KU Leuven in Belgium, and was published online on August 7, 2024, in RMD Open.
LIMITATIONS:
The open-label design of the study may have introduced bias, as patients and investigators were aware of the treatment. The temporary administration of etanercept may not have reflected its long-term effects. The study was conducted in Belgium, which limited the generalizability of the findings to other populations.
DISCLOSURES:
The study was supported by the Belgian Health Care Knowledge Centre. Some authors reported serving as speakers or receiving grants, consulting fees, honoraria, or meeting or travel support from financial ties with Novartis, Pfizer, Amgen, and other pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Treatment with etanercept led to faster disease control initially in patients with early rheumatoid arthritis (RA) who had an insufficient early response to methotrexate and bridging glucocorticoids therapy, but more patients achieved disease control with leflunomide at 104 weeks.
METHODOLOGY:
- Researchers conducted CareRA2020, a randomized controlled trial including 276 patients with early RA who were initially treated with oral methotrexate 15 mg/wk and a step-down prednisone scheme, with early insufficient responders (n = 110) randomized to add etanercept 50 mg/wk or leflunomide 10 mg/d for 24 weeks.
- Patients were classified as early insufficient responders if they did not achieve a 28-joint Disease Activity Score with C-reactive protein (DAS28-CRP) < 3.2 between weeks 8 and 32 or < 2.6 at week 32, despite an increase in methotrexate dose to 20 mg/wk.
- The primary outcome was the longitudinal disease activity measured by DAS28-CRP over 104 weeks.
- The secondary outcomes included disease control at 28 weeks post randomization and the use of biologic or targeted synthetic disease-modifying antirheumatic drugs at week 104.
TAKEAWAY:
- Early introduction of etanercept in patients with RA did not show long-term superiority over leflunomide in disease control over 2 years (P = .157).
- At 28 weeks post randomization, the percentage of patients who achieved a DAS28-CRP < 2.6 was higher in the etanercept group than in the leflunomide group (59% vs 44%).
- After stopping etanercept, disease activity scores worsened, and a lower proportion of patients achieved DAS28-CRP < 2.6 in the etanercept group than in the leflunomide group (55% vs 69%) at week 104.
- Even after treatment with etanercept or leflunomide, the 110 early insufficient responders never reached the same level of disease control as the 142 patients who responded to methotrexate and bridging glucocorticoids within weeks 8-32.
IN PRACTICE:
“The CareRA2020 trial did not completely solve the unmet need of patients responding insufficiently to conventional initial therapy for early RA, but it provides opportunities to further optimize the treatment approach in this population, for instance, by focusing on the identification of potential subgroups with different disease activity trajectories within the early insufficient responder group,” wrote the authors.
SOURCE:
The study was led by Delphine Bertrand of the Skeletal Biology and Engineering Research Center in the Department of Development and Regeneration at KU Leuven in Belgium, and was published online on August 7, 2024, in RMD Open.
LIMITATIONS:
The open-label design of the study may have introduced bias, as patients and investigators were aware of the treatment. The temporary administration of etanercept may not have reflected its long-term effects. The study was conducted in Belgium, which limited the generalizability of the findings to other populations.
DISCLOSURES:
The study was supported by the Belgian Health Care Knowledge Centre. Some authors reported serving as speakers or receiving grants, consulting fees, honoraria, or meeting or travel support from financial ties with Novartis, Pfizer, Amgen, and other pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Treatment with etanercept led to faster disease control initially in patients with early rheumatoid arthritis (RA) who had an insufficient early response to methotrexate and bridging glucocorticoids therapy, but more patients achieved disease control with leflunomide at 104 weeks.
METHODOLOGY:
- Researchers conducted CareRA2020, a randomized controlled trial including 276 patients with early RA who were initially treated with oral methotrexate 15 mg/wk and a step-down prednisone scheme, with early insufficient responders (n = 110) randomized to add etanercept 50 mg/wk or leflunomide 10 mg/d for 24 weeks.
- Patients were classified as early insufficient responders if they did not achieve a 28-joint Disease Activity Score with C-reactive protein (DAS28-CRP) < 3.2 between weeks 8 and 32 or < 2.6 at week 32, despite an increase in methotrexate dose to 20 mg/wk.
- The primary outcome was the longitudinal disease activity measured by DAS28-CRP over 104 weeks.
- The secondary outcomes included disease control at 28 weeks post randomization and the use of biologic or targeted synthetic disease-modifying antirheumatic drugs at week 104.
TAKEAWAY:
- Early introduction of etanercept in patients with RA did not show long-term superiority over leflunomide in disease control over 2 years (P = .157).
- At 28 weeks post randomization, the percentage of patients who achieved a DAS28-CRP < 2.6 was higher in the etanercept group than in the leflunomide group (59% vs 44%).
- After stopping etanercept, disease activity scores worsened, and a lower proportion of patients achieved DAS28-CRP < 2.6 in the etanercept group than in the leflunomide group (55% vs 69%) at week 104.
- Even after treatment with etanercept or leflunomide, the 110 early insufficient responders never reached the same level of disease control as the 142 patients who responded to methotrexate and bridging glucocorticoids within weeks 8-32.
IN PRACTICE:
“The CareRA2020 trial did not completely solve the unmet need of patients responding insufficiently to conventional initial therapy for early RA, but it provides opportunities to further optimize the treatment approach in this population, for instance, by focusing on the identification of potential subgroups with different disease activity trajectories within the early insufficient responder group,” wrote the authors.
SOURCE:
The study was led by Delphine Bertrand of the Skeletal Biology and Engineering Research Center in the Department of Development and Regeneration at KU Leuven in Belgium, and was published online on August 7, 2024, in RMD Open.
LIMITATIONS:
The open-label design of the study may have introduced bias, as patients and investigators were aware of the treatment. The temporary administration of etanercept may not have reflected its long-term effects. The study was conducted in Belgium, which limited the generalizability of the findings to other populations.
DISCLOSURES:
The study was supported by the Belgian Health Care Knowledge Centre. Some authors reported serving as speakers or receiving grants, consulting fees, honoraria, or meeting or travel support from financial ties with Novartis, Pfizer, Amgen, and other pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
Patients With Immune-Mediated Inflammatory Diseases, Type 2 Diabetes Reap GLP-1 Receptor Agonist Benefits, Too
TOPLINE:
Compared with dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are associated with a lower risk for all-cause mortality and major adverse cardiovascular events (MACE) in patients with immune-mediated inflammatory diseases (IMIDs) and type 2 diabetes (T2D).
METHODOLOGY:
- GLP-1 RAs reduce the risk for all-cause mortality, cardiovascular mortality, and stroke in patients with diabetes. However, previous trials have excluded those with IMIDs, leaving a gap in understanding the cardioprotective effects of GLP-1 RAs in this population.
- Researchers conducted a population-based cohort study to assess if patients with an IMID derive greater benefits from GLP-1 RAs than DPP-4 inhibitors.
- They used administrative health data from British Columbia, Canada, to include 10,855 patients with IMIDs (rheumatoid arthritis, psoriatic disease, ankylosing spondylitis, inflammatory bowel disease, or systemic autoimmune rheumatic disease) and T2D who initiated either GLP-1 RA (n = 3570) or DPP-4 inhibitor (n = 7285).
- The mean follow-up was 1.46 and 1.88 years in the GLP-1 RA and DPP-4 inhibitor cohorts, respectively.
- The primary outcome was all-cause mortality, and the secondary outcome was MACE, including cardiovascular death, myocardial infarction, and ischemic stroke.
TAKEAWAY:
- The risk for all-cause mortality was 52% lower in patients who initiated GLP-1 RAs than in those who initiated DPP-4 inhibitors (weighted hazard ratio [HR], 0.48; 95% CI, 0.31-0.75).
- Additionally, patients initiating DPP-4 inhibitors.
- In the subgroup of patients with GLP-1 RAs had a significantly lower risk for MACE (weighted HR, 0.66; 95% CI, 0.50-0.88), particularly myocardial infarction (weighted HR, 0.62; 95% CI, 0.40-0.96), than those initiating rheumatoid arthritis and T2D, those who initiated GLP-1 RAs had a 55% lower risk for all-cause mortality and 61% lower risk for MACE than those who initiated DPP-4 inhibitors.
IN PRACTICE:
“This corresponds to nine fewer deaths and 11 fewer MACE per 1000 person-years, respectively, supporting the hypothesis that these agents have a cardioprotective effect in this high-risk population,” the authors wrote.
SOURCE:
This study was led by Derin Karacabeyli, MD, Division of Rheumatology, Department of Medicine, University of British Columbia, Vancouver, Canada, and was published online on August 8, 2024, in PLOS ONE.
LIMITATIONS:
The study’s dependence on administrative health data might have resulted in incomplete capture of comorbidities, particularly obesity. The mean follow-up period was relatively short, which might have limited the long-term applicability of these findings. The accuracy of the case definitions for IMIDs and T2D, according to International Classification of Diseases codes, could not be fully ascertained.
DISCLOSURES:
The study was supported by grants from the Canadian Institutes of Health Research. Two authors declared receiving research support, consulting fees, or participating in advisory boards outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Compared with dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are associated with a lower risk for all-cause mortality and major adverse cardiovascular events (MACE) in patients with immune-mediated inflammatory diseases (IMIDs) and type 2 diabetes (T2D).
METHODOLOGY:
- GLP-1 RAs reduce the risk for all-cause mortality, cardiovascular mortality, and stroke in patients with diabetes. However, previous trials have excluded those with IMIDs, leaving a gap in understanding the cardioprotective effects of GLP-1 RAs in this population.
- Researchers conducted a population-based cohort study to assess if patients with an IMID derive greater benefits from GLP-1 RAs than DPP-4 inhibitors.
- They used administrative health data from British Columbia, Canada, to include 10,855 patients with IMIDs (rheumatoid arthritis, psoriatic disease, ankylosing spondylitis, inflammatory bowel disease, or systemic autoimmune rheumatic disease) and T2D who initiated either GLP-1 RA (n = 3570) or DPP-4 inhibitor (n = 7285).
- The mean follow-up was 1.46 and 1.88 years in the GLP-1 RA and DPP-4 inhibitor cohorts, respectively.
- The primary outcome was all-cause mortality, and the secondary outcome was MACE, including cardiovascular death, myocardial infarction, and ischemic stroke.
TAKEAWAY:
- The risk for all-cause mortality was 52% lower in patients who initiated GLP-1 RAs than in those who initiated DPP-4 inhibitors (weighted hazard ratio [HR], 0.48; 95% CI, 0.31-0.75).
- Additionally, patients initiating DPP-4 inhibitors.
- In the subgroup of patients with GLP-1 RAs had a significantly lower risk for MACE (weighted HR, 0.66; 95% CI, 0.50-0.88), particularly myocardial infarction (weighted HR, 0.62; 95% CI, 0.40-0.96), than those initiating rheumatoid arthritis and T2D, those who initiated GLP-1 RAs had a 55% lower risk for all-cause mortality and 61% lower risk for MACE than those who initiated DPP-4 inhibitors.
IN PRACTICE:
“This corresponds to nine fewer deaths and 11 fewer MACE per 1000 person-years, respectively, supporting the hypothesis that these agents have a cardioprotective effect in this high-risk population,” the authors wrote.
SOURCE:
This study was led by Derin Karacabeyli, MD, Division of Rheumatology, Department of Medicine, University of British Columbia, Vancouver, Canada, and was published online on August 8, 2024, in PLOS ONE.
LIMITATIONS:
The study’s dependence on administrative health data might have resulted in incomplete capture of comorbidities, particularly obesity. The mean follow-up period was relatively short, which might have limited the long-term applicability of these findings. The accuracy of the case definitions for IMIDs and T2D, according to International Classification of Diseases codes, could not be fully ascertained.
DISCLOSURES:
The study was supported by grants from the Canadian Institutes of Health Research. Two authors declared receiving research support, consulting fees, or participating in advisory boards outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Compared with dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide 1 receptor agonists (GLP-1 RAs) are associated with a lower risk for all-cause mortality and major adverse cardiovascular events (MACE) in patients with immune-mediated inflammatory diseases (IMIDs) and type 2 diabetes (T2D).
METHODOLOGY:
- GLP-1 RAs reduce the risk for all-cause mortality, cardiovascular mortality, and stroke in patients with diabetes. However, previous trials have excluded those with IMIDs, leaving a gap in understanding the cardioprotective effects of GLP-1 RAs in this population.
- Researchers conducted a population-based cohort study to assess if patients with an IMID derive greater benefits from GLP-1 RAs than DPP-4 inhibitors.
- They used administrative health data from British Columbia, Canada, to include 10,855 patients with IMIDs (rheumatoid arthritis, psoriatic disease, ankylosing spondylitis, inflammatory bowel disease, or systemic autoimmune rheumatic disease) and T2D who initiated either GLP-1 RA (n = 3570) or DPP-4 inhibitor (n = 7285).
- The mean follow-up was 1.46 and 1.88 years in the GLP-1 RA and DPP-4 inhibitor cohorts, respectively.
- The primary outcome was all-cause mortality, and the secondary outcome was MACE, including cardiovascular death, myocardial infarction, and ischemic stroke.
TAKEAWAY:
- The risk for all-cause mortality was 52% lower in patients who initiated GLP-1 RAs than in those who initiated DPP-4 inhibitors (weighted hazard ratio [HR], 0.48; 95% CI, 0.31-0.75).
- Additionally, patients initiating DPP-4 inhibitors.
- In the subgroup of patients with GLP-1 RAs had a significantly lower risk for MACE (weighted HR, 0.66; 95% CI, 0.50-0.88), particularly myocardial infarction (weighted HR, 0.62; 95% CI, 0.40-0.96), than those initiating rheumatoid arthritis and T2D, those who initiated GLP-1 RAs had a 55% lower risk for all-cause mortality and 61% lower risk for MACE than those who initiated DPP-4 inhibitors.
IN PRACTICE:
“This corresponds to nine fewer deaths and 11 fewer MACE per 1000 person-years, respectively, supporting the hypothesis that these agents have a cardioprotective effect in this high-risk population,” the authors wrote.
SOURCE:
This study was led by Derin Karacabeyli, MD, Division of Rheumatology, Department of Medicine, University of British Columbia, Vancouver, Canada, and was published online on August 8, 2024, in PLOS ONE.
LIMITATIONS:
The study’s dependence on administrative health data might have resulted in incomplete capture of comorbidities, particularly obesity. The mean follow-up period was relatively short, which might have limited the long-term applicability of these findings. The accuracy of the case definitions for IMIDs and T2D, according to International Classification of Diseases codes, could not be fully ascertained.
DISCLOSURES:
The study was supported by grants from the Canadian Institutes of Health Research. Two authors declared receiving research support, consulting fees, or participating in advisory boards outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Tendon Damage, Tenosynovitis Common But Not Limiting or Painful in Hand Osteoarthritis
TOPLINE:
Ultrasonography reveals tendon involvement in nearly 70% of the patients with hand osteoarthritis (OA), with no significant impact on hand function or pain. Tendon damage was more frequent in the flexor tendons, while tenosynovitis was more common in the extensor tendons.
METHODOLOGY:
- Tendon damage is commonly associated with radiographic damage in rheumatoid arthritis and is a typical finding in psoriatic arthritis; however, data on tendon involvement in hand OA are scarce.
- Researchers assessed tendon involvement, its impact on pain and hand function, and its association with radiographic features in hand OA.
- They conducted a cross-sectional, monocenter observational study including 86 patients with hand OA (mean age, 65.9 years; 87.2% women) and 23 age- and sex-matched control individuals without bony enlargement and hand pain at a tertiary center of rheumatic and musculoskeletal disease in Vienna.
- Clinical examination and ultrasonography were used to assess the extensor and flexor tendons of both hands for tenosynovitis and tendon damage.
- Participants completed the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) questionnaire and the Moberg pickup test for the assessment of hand function, stiffness, and pain.
TAKEAWAY:
- Ultrasonography identified tendon involvement in a higher proportion of patients with hand OA than in control individuals (69.8% vs 8.7%; P < .01).
- In patients with hand OA, the flexor tendons were more commonly affected by tendon damage than the extensor tendons (2.1% vs 0.9%; P = .03), whereas tenosynovitis was more prevalent in the extensor tendons than in the flexor tendons (8.0% vs 0.6%; P < .001).
- No significant association was found between tendon involvement and hand function or self-reported pain.
- The sensitivity and specificity of clinical evaluation in identifying tendon involvement were 14.5% and 83.8%, respectively.
IN PRACTICE:
“Physicians treating patients with hand OA should keep the high prevalence of tendon involvement in mind,” the authors wrote. “In case of clinical suspicion, a sonographic examination should be performed. If tenosynovitis or tendon damage is detected, treatment may be tailored accordingly.”
SOURCE:
The study, led by Irina Gessl, MD, Department of Internal Medicine III, Medical University of Vienna in Austria, was published online on August 7, 2024, in Rheumatology.
LIMITATIONS:
The study lacked a standardized clinical examination and a preferred method for detecting tenosynovitis and tendon damage. The lack of a separate evaluation of clinical tenderness in individual joints may have hindered a more comprehensive assessment of pain. The M-SACRAH questionnaire is validated for assessing the overall hand function in patients with hand OA and rheumatoid arthritis but not tendon involvement.
DISCLOSURES:
The Medical Scientific Fund of the Mayor of the City of Vienna supported the study. Some authors reported receiving personal fees, grants, royalties, or licenses and being part of speakers bureau for various pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Ultrasonography reveals tendon involvement in nearly 70% of the patients with hand osteoarthritis (OA), with no significant impact on hand function or pain. Tendon damage was more frequent in the flexor tendons, while tenosynovitis was more common in the extensor tendons.
METHODOLOGY:
- Tendon damage is commonly associated with radiographic damage in rheumatoid arthritis and is a typical finding in psoriatic arthritis; however, data on tendon involvement in hand OA are scarce.
- Researchers assessed tendon involvement, its impact on pain and hand function, and its association with radiographic features in hand OA.
- They conducted a cross-sectional, monocenter observational study including 86 patients with hand OA (mean age, 65.9 years; 87.2% women) and 23 age- and sex-matched control individuals without bony enlargement and hand pain at a tertiary center of rheumatic and musculoskeletal disease in Vienna.
- Clinical examination and ultrasonography were used to assess the extensor and flexor tendons of both hands for tenosynovitis and tendon damage.
- Participants completed the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) questionnaire and the Moberg pickup test for the assessment of hand function, stiffness, and pain.
TAKEAWAY:
- Ultrasonography identified tendon involvement in a higher proportion of patients with hand OA than in control individuals (69.8% vs 8.7%; P < .01).
- In patients with hand OA, the flexor tendons were more commonly affected by tendon damage than the extensor tendons (2.1% vs 0.9%; P = .03), whereas tenosynovitis was more prevalent in the extensor tendons than in the flexor tendons (8.0% vs 0.6%; P < .001).
- No significant association was found between tendon involvement and hand function or self-reported pain.
- The sensitivity and specificity of clinical evaluation in identifying tendon involvement were 14.5% and 83.8%, respectively.
IN PRACTICE:
“Physicians treating patients with hand OA should keep the high prevalence of tendon involvement in mind,” the authors wrote. “In case of clinical suspicion, a sonographic examination should be performed. If tenosynovitis or tendon damage is detected, treatment may be tailored accordingly.”
SOURCE:
The study, led by Irina Gessl, MD, Department of Internal Medicine III, Medical University of Vienna in Austria, was published online on August 7, 2024, in Rheumatology.
LIMITATIONS:
The study lacked a standardized clinical examination and a preferred method for detecting tenosynovitis and tendon damage. The lack of a separate evaluation of clinical tenderness in individual joints may have hindered a more comprehensive assessment of pain. The M-SACRAH questionnaire is validated for assessing the overall hand function in patients with hand OA and rheumatoid arthritis but not tendon involvement.
DISCLOSURES:
The Medical Scientific Fund of the Mayor of the City of Vienna supported the study. Some authors reported receiving personal fees, grants, royalties, or licenses and being part of speakers bureau for various pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
TOPLINE:
Ultrasonography reveals tendon involvement in nearly 70% of the patients with hand osteoarthritis (OA), with no significant impact on hand function or pain. Tendon damage was more frequent in the flexor tendons, while tenosynovitis was more common in the extensor tendons.
METHODOLOGY:
- Tendon damage is commonly associated with radiographic damage in rheumatoid arthritis and is a typical finding in psoriatic arthritis; however, data on tendon involvement in hand OA are scarce.
- Researchers assessed tendon involvement, its impact on pain and hand function, and its association with radiographic features in hand OA.
- They conducted a cross-sectional, monocenter observational study including 86 patients with hand OA (mean age, 65.9 years; 87.2% women) and 23 age- and sex-matched control individuals without bony enlargement and hand pain at a tertiary center of rheumatic and musculoskeletal disease in Vienna.
- Clinical examination and ultrasonography were used to assess the extensor and flexor tendons of both hands for tenosynovitis and tendon damage.
- Participants completed the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) questionnaire and the Moberg pickup test for the assessment of hand function, stiffness, and pain.
TAKEAWAY:
- Ultrasonography identified tendon involvement in a higher proportion of patients with hand OA than in control individuals (69.8% vs 8.7%; P < .01).
- In patients with hand OA, the flexor tendons were more commonly affected by tendon damage than the extensor tendons (2.1% vs 0.9%; P = .03), whereas tenosynovitis was more prevalent in the extensor tendons than in the flexor tendons (8.0% vs 0.6%; P < .001).
- No significant association was found between tendon involvement and hand function or self-reported pain.
- The sensitivity and specificity of clinical evaluation in identifying tendon involvement were 14.5% and 83.8%, respectively.
IN PRACTICE:
“Physicians treating patients with hand OA should keep the high prevalence of tendon involvement in mind,” the authors wrote. “In case of clinical suspicion, a sonographic examination should be performed. If tenosynovitis or tendon damage is detected, treatment may be tailored accordingly.”
SOURCE:
The study, led by Irina Gessl, MD, Department of Internal Medicine III, Medical University of Vienna in Austria, was published online on August 7, 2024, in Rheumatology.
LIMITATIONS:
The study lacked a standardized clinical examination and a preferred method for detecting tenosynovitis and tendon damage. The lack of a separate evaluation of clinical tenderness in individual joints may have hindered a more comprehensive assessment of pain. The M-SACRAH questionnaire is validated for assessing the overall hand function in patients with hand OA and rheumatoid arthritis but not tendon involvement.
DISCLOSURES:
The Medical Scientific Fund of the Mayor of the City of Vienna supported the study. Some authors reported receiving personal fees, grants, royalties, or licenses and being part of speakers bureau for various pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
A version of this article first appeared on Medscape.com.
Mobile App Shows Promise in Managing Fibromyalgia Symptoms
TOPLINE:
A smartphone app that delivers acceptance and commitment therapy (ACT), a type of cognitive behavioral therapy, improves overall well-being and reduces the severity of pain, fatigue, sleep issues, and depression to a greater extent than daily symptom tracking in patients with fibromyalgia.
METHODOLOGY:
- Researchers conducted the phase 3 PROSPER-FM trial at 25 community sites in the United States to assess the efficacy and safety of digital ACT for patients with fibromyalgia.
- A total of 275 adult patients aged 22-75 years with fibromyalgia were randomly assigned to either the digital ACT group (n = 140) or the active control group (n = 135) for 12 weeks.
- Patients in the digital ACT group received a self-guided, smartphone-delivered program in which they learned and practiced the core ACT skills of acceptance, values, mindfulness, defusion, self as context, and willingness and committed action to build psychological flexibility, while the control group underwent daily symptom tracking and received educational materials.
- The primary endpoint was the response rate on the Patient Global Impression of Change (PGIC) at week 12, which is an indicator of patient well-being.
- The secondary endpoints included changes in the Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score and pain intensity, pain interference, and sleep interference scores.
TAKEAWAY:
- At week 12, 71% of the patients in the digital ACT group responded with a minimally improved or better change in the PGIC response, compared with only 22% of the patients in the control group (P < .0001).
- The digital ACT group showed a significant reduction in the impact of fibromyalgia, with a between-group effect size of d = 0.65 (P < .0001) at week 12. The FIQ-R total score significantly improved within 3 weeks of using the self-guided digital ACT app.
- The use of digital ACT also demonstrated positive effects on the levels of weekly pain intensity (P = .001) and depression (P < .0001), compared with the control group.
- No serious adverse effects related to the app were reported, and both groups demonstrated high rates of adherence, with most (72%) participants in the digital ACT group completing at least 42 sessions.
IN PRACTICE:
“The results found in the study are essential for professionals who care for patients with fibromyalgia as they present a new viable treatment alternative,” Guilherme Torres Vilarino, PhD, Santa Catarina State University, Florianópolis, Brazil, wrote in an accompanying editorial.
SOURCE:
This study was led by R. Michael Gendreau, MD, PhD, Gendreau Consulting, Poway, California. It was published online in The Lancet.
LIMITATIONS:
The study population predominantly consisted of women and White individuals, which may limit the generalizability of the findings to more diverse populations. Additionally, the study was conducted in the United States, and the results may thus not be applicable to other countries with different racial, ethnic, educational, and economic characteristics. The study duration was 12 weeks, and the long-term benefits of digital ACT have not yet been shown.
DISCLOSURES:
This study was funded by Swing Therapeutics. Seven authors declared having stock options and/or receiving salary from Swing Therapeutics. Other authors reported having many ties with several sources, including Swing Therapeutics.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
A smartphone app that delivers acceptance and commitment therapy (ACT), a type of cognitive behavioral therapy, improves overall well-being and reduces the severity of pain, fatigue, sleep issues, and depression to a greater extent than daily symptom tracking in patients with fibromyalgia.
METHODOLOGY:
- Researchers conducted the phase 3 PROSPER-FM trial at 25 community sites in the United States to assess the efficacy and safety of digital ACT for patients with fibromyalgia.
- A total of 275 adult patients aged 22-75 years with fibromyalgia were randomly assigned to either the digital ACT group (n = 140) or the active control group (n = 135) for 12 weeks.
- Patients in the digital ACT group received a self-guided, smartphone-delivered program in which they learned and practiced the core ACT skills of acceptance, values, mindfulness, defusion, self as context, and willingness and committed action to build psychological flexibility, while the control group underwent daily symptom tracking and received educational materials.
- The primary endpoint was the response rate on the Patient Global Impression of Change (PGIC) at week 12, which is an indicator of patient well-being.
- The secondary endpoints included changes in the Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score and pain intensity, pain interference, and sleep interference scores.
TAKEAWAY:
- At week 12, 71% of the patients in the digital ACT group responded with a minimally improved or better change in the PGIC response, compared with only 22% of the patients in the control group (P < .0001).
- The digital ACT group showed a significant reduction in the impact of fibromyalgia, with a between-group effect size of d = 0.65 (P < .0001) at week 12. The FIQ-R total score significantly improved within 3 weeks of using the self-guided digital ACT app.
- The use of digital ACT also demonstrated positive effects on the levels of weekly pain intensity (P = .001) and depression (P < .0001), compared with the control group.
- No serious adverse effects related to the app were reported, and both groups demonstrated high rates of adherence, with most (72%) participants in the digital ACT group completing at least 42 sessions.
IN PRACTICE:
“The results found in the study are essential for professionals who care for patients with fibromyalgia as they present a new viable treatment alternative,” Guilherme Torres Vilarino, PhD, Santa Catarina State University, Florianópolis, Brazil, wrote in an accompanying editorial.
SOURCE:
This study was led by R. Michael Gendreau, MD, PhD, Gendreau Consulting, Poway, California. It was published online in The Lancet.
LIMITATIONS:
The study population predominantly consisted of women and White individuals, which may limit the generalizability of the findings to more diverse populations. Additionally, the study was conducted in the United States, and the results may thus not be applicable to other countries with different racial, ethnic, educational, and economic characteristics. The study duration was 12 weeks, and the long-term benefits of digital ACT have not yet been shown.
DISCLOSURES:
This study was funded by Swing Therapeutics. Seven authors declared having stock options and/or receiving salary from Swing Therapeutics. Other authors reported having many ties with several sources, including Swing Therapeutics.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
A smartphone app that delivers acceptance and commitment therapy (ACT), a type of cognitive behavioral therapy, improves overall well-being and reduces the severity of pain, fatigue, sleep issues, and depression to a greater extent than daily symptom tracking in patients with fibromyalgia.
METHODOLOGY:
- Researchers conducted the phase 3 PROSPER-FM trial at 25 community sites in the United States to assess the efficacy and safety of digital ACT for patients with fibromyalgia.
- A total of 275 adult patients aged 22-75 years with fibromyalgia were randomly assigned to either the digital ACT group (n = 140) or the active control group (n = 135) for 12 weeks.
- Patients in the digital ACT group received a self-guided, smartphone-delivered program in which they learned and practiced the core ACT skills of acceptance, values, mindfulness, defusion, self as context, and willingness and committed action to build psychological flexibility, while the control group underwent daily symptom tracking and received educational materials.
- The primary endpoint was the response rate on the Patient Global Impression of Change (PGIC) at week 12, which is an indicator of patient well-being.
- The secondary endpoints included changes in the Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score and pain intensity, pain interference, and sleep interference scores.
TAKEAWAY:
- At week 12, 71% of the patients in the digital ACT group responded with a minimally improved or better change in the PGIC response, compared with only 22% of the patients in the control group (P < .0001).
- The digital ACT group showed a significant reduction in the impact of fibromyalgia, with a between-group effect size of d = 0.65 (P < .0001) at week 12. The FIQ-R total score significantly improved within 3 weeks of using the self-guided digital ACT app.
- The use of digital ACT also demonstrated positive effects on the levels of weekly pain intensity (P = .001) and depression (P < .0001), compared with the control group.
- No serious adverse effects related to the app were reported, and both groups demonstrated high rates of adherence, with most (72%) participants in the digital ACT group completing at least 42 sessions.
IN PRACTICE:
“The results found in the study are essential for professionals who care for patients with fibromyalgia as they present a new viable treatment alternative,” Guilherme Torres Vilarino, PhD, Santa Catarina State University, Florianópolis, Brazil, wrote in an accompanying editorial.
SOURCE:
This study was led by R. Michael Gendreau, MD, PhD, Gendreau Consulting, Poway, California. It was published online in The Lancet.
LIMITATIONS:
The study population predominantly consisted of women and White individuals, which may limit the generalizability of the findings to more diverse populations. Additionally, the study was conducted in the United States, and the results may thus not be applicable to other countries with different racial, ethnic, educational, and economic characteristics. The study duration was 12 weeks, and the long-term benefits of digital ACT have not yet been shown.
DISCLOSURES:
This study was funded by Swing Therapeutics. Seven authors declared having stock options and/or receiving salary from Swing Therapeutics. Other authors reported having many ties with several sources, including Swing Therapeutics.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Do You Have Patients With JAKne — JAK Inhibitor–Associated Acne? Here’s What to Know
Since the first Food and Drug Administration approval of a Janus kinase (JAK) inhibitor in 2011, the number of these medications available — and their treatment indications — have continued to grow. Prescribing physicians are familiar with the benefits and risks for these drugs, including higher risk for cardiac events and malignancy; however, one adverse effect may be overlooked, especially by specialties outside of dermatology: acne. Though less serious than some other side effects, JAK inhibitor–associated acne — JAKne, for short — can be a concern for patients.
“Your physical appearance and how you present yourself to the world is an important part of your self-confidence and living life on your own terms,” said Arash Mostaghimi, MD, the director of inpatient dermatology at Brigham and Women’s Hospital in Boston, Massachusetts. “I think letting people know about [JAKne] and then addressing it when it occurs should be a normal part of managing these medications.”
What Is JAKne?
JAKne generally looks like other kinds of acne, explained Janelle Nassim, MD, director of laser and cosmetic dermatology at the Indiana University School of Medicine, Indianapolis. “It can affect the same areas that typical acne affects, including the face, chest, back, neck, and upper shoulders.”
Though it appears like typical forms of acne, it is not clear what drives these skin eruptions in patients taking JAK inhibitors.
“We don’t understand the underlying pathophysiology,” Dr. Mostaghimi said. “It looks like acne, but we don’t know if the exact underlying inflammatory process is the same or if it’s different.”
In a 2023 systematic review of clinical studies, Dr. Mostaghimi and colleagues found that patients on any JAK inhibitor were nearly four times more likely to experience acne than patients who received placebo, but risk varied between medications. Patients taking JAK inhibitors for skin conditions had higher risk for acne than those given the medications for other indications. However, Dr. Mostaghimi thinks this finding is the result of selection bias.
Participants may not mention side effects like acne in trials for rheumatologic or gastrointestinal conditions, he said, unlike in trials for skin conditions. “Clinically, I’ve seen it in patients across every indication.”
Patients with a history of acne seem to be more likely to develop this side effect, though formal studies looking into risk factors are lacking. In Dr. Mostaghimi’s own clinical experience, JAKne is also more common in younger patients, but it can happen to anyone. “I’ve seen 70-year-olds develop acne — patients who’ve never had an issue their whole life — when they’re taking a JAK inhibitor.”
This issue also appears to be more common earlier in treatment, he added, and may improve over time as a patient continues with the medication.
How Do You Treat It?
“I think in other specialties, you will often feel awkward addressing skin conditions or pointing out acne,” Dr. Mostaghimi said. The most important steps are being aware of this potential side effect, and if you see it practice, to bring it up.
“Say: I’m noticing there’s some changes in your skin. Some patients on JAK inhibitors develop more acne. Have you noticed this? And if so, is this bothering you?”
Generally, JAKne is mild to moderate, explained Dr. Nassim, and if non-dermatologists are comfortable, they can prescribe a first-line topical regimen for patients. Dr. Mostaghimi recommends prescribing a clindamycin 1% lotion or gel. In addition, patients can use a benzoyl peroxide wash (4% or 10%) combined with a gentle retinoid, such as adapalene. (Both of these treatments are now available over the counter.)
In patients with scalp or hairline involvement, he often prescribes a ketoconazole 2% shampoo, which patients can use to wash their scalp, face, chest, and back in the shower.
If they aren’t responding to these initial treatments, then refer to a dermatologist for further assessment.
“Ultimately, referring to a dermatologist is the best course of action,” Dr. Nassim said. “I have had patients on JAK inhibitors who improved with topical acne treatments, and some that required more aggressive treatment with oral medications.”
Dr. Mostaghimi reported consulting fees from AbbVie, Concert Pharmaceuticals, Pfizer, and 3Derm Systems; research funding from Incyte, Aclaris Therapeutics, Eli Lilly, and Concert Pharmaceuticals; personal fees from Equillium, ASLAN Pharmaceuticals, ACOM, and Boehringer Ingelheim; and advisory board fees from Fig.1 Beauty, Eli Lilly, Pfizer, and Hims & Hers Health. Dr. Nassim had no relevant disclosures.
A version of this article first appeared on Medscape.com.
Since the first Food and Drug Administration approval of a Janus kinase (JAK) inhibitor in 2011, the number of these medications available — and their treatment indications — have continued to grow. Prescribing physicians are familiar with the benefits and risks for these drugs, including higher risk for cardiac events and malignancy; however, one adverse effect may be overlooked, especially by specialties outside of dermatology: acne. Though less serious than some other side effects, JAK inhibitor–associated acne — JAKne, for short — can be a concern for patients.
“Your physical appearance and how you present yourself to the world is an important part of your self-confidence and living life on your own terms,” said Arash Mostaghimi, MD, the director of inpatient dermatology at Brigham and Women’s Hospital in Boston, Massachusetts. “I think letting people know about [JAKne] and then addressing it when it occurs should be a normal part of managing these medications.”
What Is JAKne?
JAKne generally looks like other kinds of acne, explained Janelle Nassim, MD, director of laser and cosmetic dermatology at the Indiana University School of Medicine, Indianapolis. “It can affect the same areas that typical acne affects, including the face, chest, back, neck, and upper shoulders.”
Though it appears like typical forms of acne, it is not clear what drives these skin eruptions in patients taking JAK inhibitors.
“We don’t understand the underlying pathophysiology,” Dr. Mostaghimi said. “It looks like acne, but we don’t know if the exact underlying inflammatory process is the same or if it’s different.”
In a 2023 systematic review of clinical studies, Dr. Mostaghimi and colleagues found that patients on any JAK inhibitor were nearly four times more likely to experience acne than patients who received placebo, but risk varied between medications. Patients taking JAK inhibitors for skin conditions had higher risk for acne than those given the medications for other indications. However, Dr. Mostaghimi thinks this finding is the result of selection bias.
Participants may not mention side effects like acne in trials for rheumatologic or gastrointestinal conditions, he said, unlike in trials for skin conditions. “Clinically, I’ve seen it in patients across every indication.”
Patients with a history of acne seem to be more likely to develop this side effect, though formal studies looking into risk factors are lacking. In Dr. Mostaghimi’s own clinical experience, JAKne is also more common in younger patients, but it can happen to anyone. “I’ve seen 70-year-olds develop acne — patients who’ve never had an issue their whole life — when they’re taking a JAK inhibitor.”
This issue also appears to be more common earlier in treatment, he added, and may improve over time as a patient continues with the medication.
How Do You Treat It?
“I think in other specialties, you will often feel awkward addressing skin conditions or pointing out acne,” Dr. Mostaghimi said. The most important steps are being aware of this potential side effect, and if you see it practice, to bring it up.
“Say: I’m noticing there’s some changes in your skin. Some patients on JAK inhibitors develop more acne. Have you noticed this? And if so, is this bothering you?”
Generally, JAKne is mild to moderate, explained Dr. Nassim, and if non-dermatologists are comfortable, they can prescribe a first-line topical regimen for patients. Dr. Mostaghimi recommends prescribing a clindamycin 1% lotion or gel. In addition, patients can use a benzoyl peroxide wash (4% or 10%) combined with a gentle retinoid, such as adapalene. (Both of these treatments are now available over the counter.)
In patients with scalp or hairline involvement, he often prescribes a ketoconazole 2% shampoo, which patients can use to wash their scalp, face, chest, and back in the shower.
If they aren’t responding to these initial treatments, then refer to a dermatologist for further assessment.
“Ultimately, referring to a dermatologist is the best course of action,” Dr. Nassim said. “I have had patients on JAK inhibitors who improved with topical acne treatments, and some that required more aggressive treatment with oral medications.”
Dr. Mostaghimi reported consulting fees from AbbVie, Concert Pharmaceuticals, Pfizer, and 3Derm Systems; research funding from Incyte, Aclaris Therapeutics, Eli Lilly, and Concert Pharmaceuticals; personal fees from Equillium, ASLAN Pharmaceuticals, ACOM, and Boehringer Ingelheim; and advisory board fees from Fig.1 Beauty, Eli Lilly, Pfizer, and Hims & Hers Health. Dr. Nassim had no relevant disclosures.
A version of this article first appeared on Medscape.com.
Since the first Food and Drug Administration approval of a Janus kinase (JAK) inhibitor in 2011, the number of these medications available — and their treatment indications — have continued to grow. Prescribing physicians are familiar with the benefits and risks for these drugs, including higher risk for cardiac events and malignancy; however, one adverse effect may be overlooked, especially by specialties outside of dermatology: acne. Though less serious than some other side effects, JAK inhibitor–associated acne — JAKne, for short — can be a concern for patients.
“Your physical appearance and how you present yourself to the world is an important part of your self-confidence and living life on your own terms,” said Arash Mostaghimi, MD, the director of inpatient dermatology at Brigham and Women’s Hospital in Boston, Massachusetts. “I think letting people know about [JAKne] and then addressing it when it occurs should be a normal part of managing these medications.”
What Is JAKne?
JAKne generally looks like other kinds of acne, explained Janelle Nassim, MD, director of laser and cosmetic dermatology at the Indiana University School of Medicine, Indianapolis. “It can affect the same areas that typical acne affects, including the face, chest, back, neck, and upper shoulders.”
Though it appears like typical forms of acne, it is not clear what drives these skin eruptions in patients taking JAK inhibitors.
“We don’t understand the underlying pathophysiology,” Dr. Mostaghimi said. “It looks like acne, but we don’t know if the exact underlying inflammatory process is the same or if it’s different.”
In a 2023 systematic review of clinical studies, Dr. Mostaghimi and colleagues found that patients on any JAK inhibitor were nearly four times more likely to experience acne than patients who received placebo, but risk varied between medications. Patients taking JAK inhibitors for skin conditions had higher risk for acne than those given the medications for other indications. However, Dr. Mostaghimi thinks this finding is the result of selection bias.
Participants may not mention side effects like acne in trials for rheumatologic or gastrointestinal conditions, he said, unlike in trials for skin conditions. “Clinically, I’ve seen it in patients across every indication.”
Patients with a history of acne seem to be more likely to develop this side effect, though formal studies looking into risk factors are lacking. In Dr. Mostaghimi’s own clinical experience, JAKne is also more common in younger patients, but it can happen to anyone. “I’ve seen 70-year-olds develop acne — patients who’ve never had an issue their whole life — when they’re taking a JAK inhibitor.”
This issue also appears to be more common earlier in treatment, he added, and may improve over time as a patient continues with the medication.
How Do You Treat It?
“I think in other specialties, you will often feel awkward addressing skin conditions or pointing out acne,” Dr. Mostaghimi said. The most important steps are being aware of this potential side effect, and if you see it practice, to bring it up.
“Say: I’m noticing there’s some changes in your skin. Some patients on JAK inhibitors develop more acne. Have you noticed this? And if so, is this bothering you?”
Generally, JAKne is mild to moderate, explained Dr. Nassim, and if non-dermatologists are comfortable, they can prescribe a first-line topical regimen for patients. Dr. Mostaghimi recommends prescribing a clindamycin 1% lotion or gel. In addition, patients can use a benzoyl peroxide wash (4% or 10%) combined with a gentle retinoid, such as adapalene. (Both of these treatments are now available over the counter.)
In patients with scalp or hairline involvement, he often prescribes a ketoconazole 2% shampoo, which patients can use to wash their scalp, face, chest, and back in the shower.
If they aren’t responding to these initial treatments, then refer to a dermatologist for further assessment.
“Ultimately, referring to a dermatologist is the best course of action,” Dr. Nassim said. “I have had patients on JAK inhibitors who improved with topical acne treatments, and some that required more aggressive treatment with oral medications.”
Dr. Mostaghimi reported consulting fees from AbbVie, Concert Pharmaceuticals, Pfizer, and 3Derm Systems; research funding from Incyte, Aclaris Therapeutics, Eli Lilly, and Concert Pharmaceuticals; personal fees from Equillium, ASLAN Pharmaceuticals, ACOM, and Boehringer Ingelheim; and advisory board fees from Fig.1 Beauty, Eli Lilly, Pfizer, and Hims & Hers Health. Dr. Nassim had no relevant disclosures.
A version of this article first appeared on Medscape.com.
A 62-year-old Black female presented with an epidermal inclusion cyst on her left upper back
This heterogeneous disorder can present with a wide range of clinical manifestations, including dermatological symptoms that may be the first or predominant feature. Systemic amyloidosis is characterized by macroglossia, periorbital purpura, and waxy skin plaques. Lateral scalloping of the tongue may be seen due to impingement of the teeth. Cutaneous amyloidosis occurs when amyloid is deposited in the skin, without internal organ involvement. Variants of cutaneous amyloidosis include macular, lichen, nodular and biphasic.
This condition requires a thorough diagnostic workup, including serum and urine protein electrophoresis and biopsy of the affected tissue. Biopsy of a cutaneous amyloidosis lesion will show fractured, amorphous, eosinophilic material in the dermis. Pigment and epidermal changes are often found with cutaneous amyloidosis, including hyperkeratosis, acanthosis, hypergranulosis, parakeratosis, and epidermal atrophy. Stains that may be used include Congo red showing apple-green birefringence, thioflavin T, and crystal violet.
If untreated, the prognosis is generally poor, related to the extent of organ involvement. Cardiac involvement, a common feature of systemic amyloidosis, can lead to restrictive cardiomyopathy, heart failure, and arrhythmias. Management strategies include steroids, chemotherapy, and stem cell transplantation. Medications include dexamethasone, cyclophosphamide, bortezomib, and melphalan.
This patient went undiagnosed for several years until she began experiencing cardiac issues, including syncope, angina, and restrictive cardiomyopathy with heart failure. A cardiac biopsy confirmed the diagnosis of systemic amyloidosis. This patient is currently awaiting a heart transplant. Early diagnosis of amyloidosis is vital, as it can help prevent severe complications such as heart involvement, significantly impacting the patient’s prognosis and quality of life. When amyloidosis is suspected based on dermatological findings, it is essential to distinguish it from other conditions, such as chronic cutaneous lupus erythematosus, dermatomyositis, scleromyxedema, and lipoid proteinosis. Early identification of characteristic skin lesions and systemic features can lead to timely interventions, more favorable outcomes, and reduction in the risk of advanced organ damage.
The case and photo were submitted by Ms. Cael Aoki and Mr. Shapiro of Nova Southeastern University College of Osteopathic Medicine, Davie, Florida, and Dr. Bartos, of Imperial Dermatology, Hollywood, Florida. The column was edited by Donna Bilu Martin, MD.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Florida. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
References
1. Brunt EM, Tiniakos DG. Clin Liver Dis. 2004 Nov;8(4):915-30, x. doi: 10.1016/j.cld.2004.06.009.
2. Bolognia JL et al. (2017). Dermatology E-Book. Elsevier Health Sciences.
3. Mehrotra K et al. J Clin Diagn Res. 2017 Aug;11(8):WC01-WC05. doi: 10.7860/JCDR/2017/24273.10334.
4. Banypersad SM et al. J Am Heart Assoc. 2012 Apr;1(2):e000364. doi: 10.1161/JAHA.111.000364.
5. Bustamante JG, Zaidi SRH. Amyloidosis. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.
This heterogeneous disorder can present with a wide range of clinical manifestations, including dermatological symptoms that may be the first or predominant feature. Systemic amyloidosis is characterized by macroglossia, periorbital purpura, and waxy skin plaques. Lateral scalloping of the tongue may be seen due to impingement of the teeth. Cutaneous amyloidosis occurs when amyloid is deposited in the skin, without internal organ involvement. Variants of cutaneous amyloidosis include macular, lichen, nodular and biphasic.
This condition requires a thorough diagnostic workup, including serum and urine protein electrophoresis and biopsy of the affected tissue. Biopsy of a cutaneous amyloidosis lesion will show fractured, amorphous, eosinophilic material in the dermis. Pigment and epidermal changes are often found with cutaneous amyloidosis, including hyperkeratosis, acanthosis, hypergranulosis, parakeratosis, and epidermal atrophy. Stains that may be used include Congo red showing apple-green birefringence, thioflavin T, and crystal violet.
If untreated, the prognosis is generally poor, related to the extent of organ involvement. Cardiac involvement, a common feature of systemic amyloidosis, can lead to restrictive cardiomyopathy, heart failure, and arrhythmias. Management strategies include steroids, chemotherapy, and stem cell transplantation. Medications include dexamethasone, cyclophosphamide, bortezomib, and melphalan.
This patient went undiagnosed for several years until she began experiencing cardiac issues, including syncope, angina, and restrictive cardiomyopathy with heart failure. A cardiac biopsy confirmed the diagnosis of systemic amyloidosis. This patient is currently awaiting a heart transplant. Early diagnosis of amyloidosis is vital, as it can help prevent severe complications such as heart involvement, significantly impacting the patient’s prognosis and quality of life. When amyloidosis is suspected based on dermatological findings, it is essential to distinguish it from other conditions, such as chronic cutaneous lupus erythematosus, dermatomyositis, scleromyxedema, and lipoid proteinosis. Early identification of characteristic skin lesions and systemic features can lead to timely interventions, more favorable outcomes, and reduction in the risk of advanced organ damage.
The case and photo were submitted by Ms. Cael Aoki and Mr. Shapiro of Nova Southeastern University College of Osteopathic Medicine, Davie, Florida, and Dr. Bartos, of Imperial Dermatology, Hollywood, Florida. The column was edited by Donna Bilu Martin, MD.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Florida. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
References
1. Brunt EM, Tiniakos DG. Clin Liver Dis. 2004 Nov;8(4):915-30, x. doi: 10.1016/j.cld.2004.06.009.
2. Bolognia JL et al. (2017). Dermatology E-Book. Elsevier Health Sciences.
3. Mehrotra K et al. J Clin Diagn Res. 2017 Aug;11(8):WC01-WC05. doi: 10.7860/JCDR/2017/24273.10334.
4. Banypersad SM et al. J Am Heart Assoc. 2012 Apr;1(2):e000364. doi: 10.1161/JAHA.111.000364.
5. Bustamante JG, Zaidi SRH. Amyloidosis. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.
This heterogeneous disorder can present with a wide range of clinical manifestations, including dermatological symptoms that may be the first or predominant feature. Systemic amyloidosis is characterized by macroglossia, periorbital purpura, and waxy skin plaques. Lateral scalloping of the tongue may be seen due to impingement of the teeth. Cutaneous amyloidosis occurs when amyloid is deposited in the skin, without internal organ involvement. Variants of cutaneous amyloidosis include macular, lichen, nodular and biphasic.
This condition requires a thorough diagnostic workup, including serum and urine protein electrophoresis and biopsy of the affected tissue. Biopsy of a cutaneous amyloidosis lesion will show fractured, amorphous, eosinophilic material in the dermis. Pigment and epidermal changes are often found with cutaneous amyloidosis, including hyperkeratosis, acanthosis, hypergranulosis, parakeratosis, and epidermal atrophy. Stains that may be used include Congo red showing apple-green birefringence, thioflavin T, and crystal violet.
If untreated, the prognosis is generally poor, related to the extent of organ involvement. Cardiac involvement, a common feature of systemic amyloidosis, can lead to restrictive cardiomyopathy, heart failure, and arrhythmias. Management strategies include steroids, chemotherapy, and stem cell transplantation. Medications include dexamethasone, cyclophosphamide, bortezomib, and melphalan.
This patient went undiagnosed for several years until she began experiencing cardiac issues, including syncope, angina, and restrictive cardiomyopathy with heart failure. A cardiac biopsy confirmed the diagnosis of systemic amyloidosis. This patient is currently awaiting a heart transplant. Early diagnosis of amyloidosis is vital, as it can help prevent severe complications such as heart involvement, significantly impacting the patient’s prognosis and quality of life. When amyloidosis is suspected based on dermatological findings, it is essential to distinguish it from other conditions, such as chronic cutaneous lupus erythematosus, dermatomyositis, scleromyxedema, and lipoid proteinosis. Early identification of characteristic skin lesions and systemic features can lead to timely interventions, more favorable outcomes, and reduction in the risk of advanced organ damage.
The case and photo were submitted by Ms. Cael Aoki and Mr. Shapiro of Nova Southeastern University College of Osteopathic Medicine, Davie, Florida, and Dr. Bartos, of Imperial Dermatology, Hollywood, Florida. The column was edited by Donna Bilu Martin, MD.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Florida. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
References
1. Brunt EM, Tiniakos DG. Clin Liver Dis. 2004 Nov;8(4):915-30, x. doi: 10.1016/j.cld.2004.06.009.
2. Bolognia JL et al. (2017). Dermatology E-Book. Elsevier Health Sciences.
3. Mehrotra K et al. J Clin Diagn Res. 2017 Aug;11(8):WC01-WC05. doi: 10.7860/JCDR/2017/24273.10334.
4. Banypersad SM et al. J Am Heart Assoc. 2012 Apr;1(2):e000364. doi: 10.1161/JAHA.111.000364.
5. Bustamante JG, Zaidi SRH. Amyloidosis. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.
Doctors Are Seeking Professional Coaches More Often. Here’s Why
When Andrea Austin, MD, an emergency medicine specialist, left the military in 2020, she knew the adjustment to civilian life and practice might be difficult. To help smooth the transition, she reached out to a physician mentor who also had a professional coaching certificate. After a conversation, Dr. Austin signed up for 6 months of career coaching.
It was time well spent, according to Dr. Austin, who today is a coach herself. “It was really the first time I had the ability to choose what I wanted to do, and that required a mindset shift,” she explains. “A big part of coaching is helping physicians discover their agency so that they can make the best career choices.”
Physicians have long lacked the coaching resources typically made available to corporate executives. But that’s changing. In today’s high-pressure environment, where doctors are burning out at a rapid pace, coaching can sometimes be an avenue to staying in the field, especially if that coach is a fellow physician who understands what you’re facing.
With a physician shortage that the Association of American Medical Colleges expects to hit 86,000 in the next decade or so, coaching could be a stone worth turning over. A 2024 report in JAMA Network Open found that coaching provided by physician peers led to a significant reduction in interpersonal disengagement and burnout.
“What I think is exciting about coaching is that it allows you to better understand yourself and know your strengths and weaknesses,” said Dr. Austin. “It might seem simple, but many ‘soft skills’ aren’t considered mainstream in medicine. Coaching allows us to understand them and ourselves better.”
Why Are Doctors Using Coaches?
Although it’s hard to put a number on how many physicians are turning to coaches, the number of coaches available for doctors is growing rapidly. The American Medical Women’s Association maintains a database of physician coaches. According to deputy director Jodi Godfrey, MS, RDN, the number of members who have added coaching to their skill set has tripled in the past 4 years. “Many cite burnout as the reason they sought coaching support, and then they decided to go on to get certified in coaching.”
The pandemic is one reason physician coaching has grown, said Elizabeth Esparaz, MD, an ophthalmologist and physician coach. “Since the pandemic, the word ‘burnout’ is thrown around a good deal.” And the causes are clear. “Doctors are facing longer hours, they must make split-second decisions, they’re multitasking, and they have less support staff.”
Among her coaching clients, Dr. Austin has noticed other common struggles: fears of litigation, time scarcity with patients, declining reimbursement that hasn’t kept up with inflation, and loss of autonomy because of the corporatization of healthcare.
Coaching, Dr. Esparaz believes, can be an antidote to many of these issues. “Coaches help doctors see their strengths and find better ways of applying them,” she said. “We help them move forward, and also see their blind spots.”
Clarity, Goals, and Making the Right Choices
Physician coaching comes in a variety of flavors — some one on one, and others in the form of group sessions. All, however, serve the purpose of helping physicians gain career clarity. “Sometimes clients realize their job may not be working for them, but that there are things they can do to change that without having to leave the field,” said Jattu Senesie, MD, a former ob.gyn. who is now a physician coach.
Dr. Esparaz works with doctors to establish SMART goals: specific, measurable, attainable, realistic, and time based. She gave the example of learning how to set boundaries. “If a physician is asked to create a presentation for work, I encourage them to ask for compensation or administrative time before committing to unpaid tasks.”
Another big issue: charting. It’s increasingly burdensome, and many doctors find it encroaching on their home lives. “If we can identify a problem like that, we can come up with a strategy for mitigating it,” Dr. Esparaz said. This might include setting a goal of getting 80% of charting completed immediately after the patient encounter on the busiest clinic day of the week. The client tests the experiment and then revisits it with the coach to discuss what worked and what didn’t, refining the process until it has freed up the physician’s home life.
The younger generation of doctors often struggles with career choices, too, because it’s the first time they are without structure, said Dr. Senesie. There’s med school and residency, which puts a framework around every move a doctor makes. But once they become attending physicians, the choices are endless. “Coaching can help them find a new structure and systems that will allow them to thrive.”
Although mentoring has been a well-embraced concept for decades, it “hits a wall,” at some point in terms of what it can offer, Dr. Austin said. That’s where coaching can take over. “There’s a point where a mentor cannot help someone self-actualize. As a coach, you don’t need to know everything about a doctor’s life, but you can help them learn to ask themselves the right questions to solve problems.”
Should You Stay or Should You Go?
Dr. Austin’s approach begins with the premise that healthcare today is challenging and dysfunctional — but doctors still have agency. She has worked with clients on the verge of leaving the field and helped them find their way back.
“They have a light bulb moment and open up to the idea that they have much to give still,” she said. “We take an inventory to help them better communicate their needs and make changes, and I help them connect to their values. Sometimes that exercise allows them to reframe their current work environment.”
Not every doctor who goes through coaching remains in the field. But “that’s the exception, not the rule,” Dr. Austin said. And that’s okay. “If that’s the outcome, coaching probably helped them get to that point faster, and with an informed decision.”
Dr. Senesie has been coaching for about a decade, and in that time, she’s seen a shift that goes beyond figuring out career goals. “Doctors are more aware of the need for well-being today. The pandemic made it impossible to ignore what doesn’t work for us. When I work with clients, we look for ways to make the job more tenable.”
According to Dr. Senesie, younger doctors are looking for that balance at the outset. “They want to be physicians, but they also want a life,” she said. “It’s a challenge for them because in addition to that mindset, they’re also coming out with more debt than older generations. They want out from underneath that.”
When It’s Time to Find a Physician Coach
Wondering whether coaching is right for you? Consider these symptoms:
- You need help setting boundaries at work.
- You feel like you’re sacrificing your own well-being for your job.
- You’re using maladaptive strategies to cope with the stress at work.
- You’ve reached a point where you are considering leaving the field.
If you’re interested in finding a physician coach, there are several places to begin your search, word of mouth being one of them. “Conferences and social media can also expose you to coaches,” suggested Dr. Esparaz. There are different methods and approaches to coaching. So, as you research, “make sure the coach you choose has techniques and a framework that fit what you’re after.”
Dr. Austin warned that it is an unregulated industry, so buyer beware. To ensure you’re getting an accredited physician coach, look for people who have obtained an International Coach Federation (ICF) accreditation. These coaches will hold an associate certified coach credential, which requires at least 60 hours of coaching-specific training approved by the ICF, in addition to other assessments and education.
Ensure that the coach you choose is within your budget. “There are some people charging astronomical rates out there,” Dr. Austin said. “If you’re burned out or struggling, it can be easy to reach for your credit card.”
Dr. Austin also cautioned doctors seeking a coach to avoid promises that sound too good to be true. Some coaching can have a gaslighting quality to it, she warned, “suggesting it can allow you to endure any environment.” But positive self-talk alone won’t cure an abusive or discriminatory situation. “If a client describes a toxic work environment,” the coach has an “ethical imperative” to help that person protect themselves.
A Side Gig or a New Career Path
After Dr. Austin’s experience with her coach, she made the choice to continue as an emergency physician part-time while starting her own coaching business. “It’s important for me personally to keep in touch with what’s happening on the ground, but I have no judgment for anyone who chooses to leave clinical practice to become a coach.”
When Dr. Senesie looks back on her own struggles as a clinician, she recognizes the state of burnout she was in 10 years ago. “I knew there was an issue, but I didn’t have the mindset to find a way to make it work,” she said. “I left the field when I was at my depths of burnout, which is generally not the best way to go about it.”
Guidance might have allowed her to take into account other avenues and helped her remain in the field, said Dr. Senesie. She has since learned that “there are many ways to practice medicine, and the way we’ve gone about it traditionally has worked for some, but not necessarily for everyone.”
There may be more possibilities than you think. By helping you assess your path and make meaningful changes, a physician coach might be the key to remaining in the field you love.
A version of this article first appeared on Medscape.com.
When Andrea Austin, MD, an emergency medicine specialist, left the military in 2020, she knew the adjustment to civilian life and practice might be difficult. To help smooth the transition, she reached out to a physician mentor who also had a professional coaching certificate. After a conversation, Dr. Austin signed up for 6 months of career coaching.
It was time well spent, according to Dr. Austin, who today is a coach herself. “It was really the first time I had the ability to choose what I wanted to do, and that required a mindset shift,” she explains. “A big part of coaching is helping physicians discover their agency so that they can make the best career choices.”
Physicians have long lacked the coaching resources typically made available to corporate executives. But that’s changing. In today’s high-pressure environment, where doctors are burning out at a rapid pace, coaching can sometimes be an avenue to staying in the field, especially if that coach is a fellow physician who understands what you’re facing.
With a physician shortage that the Association of American Medical Colleges expects to hit 86,000 in the next decade or so, coaching could be a stone worth turning over. A 2024 report in JAMA Network Open found that coaching provided by physician peers led to a significant reduction in interpersonal disengagement and burnout.
“What I think is exciting about coaching is that it allows you to better understand yourself and know your strengths and weaknesses,” said Dr. Austin. “It might seem simple, but many ‘soft skills’ aren’t considered mainstream in medicine. Coaching allows us to understand them and ourselves better.”
Why Are Doctors Using Coaches?
Although it’s hard to put a number on how many physicians are turning to coaches, the number of coaches available for doctors is growing rapidly. The American Medical Women’s Association maintains a database of physician coaches. According to deputy director Jodi Godfrey, MS, RDN, the number of members who have added coaching to their skill set has tripled in the past 4 years. “Many cite burnout as the reason they sought coaching support, and then they decided to go on to get certified in coaching.”
The pandemic is one reason physician coaching has grown, said Elizabeth Esparaz, MD, an ophthalmologist and physician coach. “Since the pandemic, the word ‘burnout’ is thrown around a good deal.” And the causes are clear. “Doctors are facing longer hours, they must make split-second decisions, they’re multitasking, and they have less support staff.”
Among her coaching clients, Dr. Austin has noticed other common struggles: fears of litigation, time scarcity with patients, declining reimbursement that hasn’t kept up with inflation, and loss of autonomy because of the corporatization of healthcare.
Coaching, Dr. Esparaz believes, can be an antidote to many of these issues. “Coaches help doctors see their strengths and find better ways of applying them,” she said. “We help them move forward, and also see their blind spots.”
Clarity, Goals, and Making the Right Choices
Physician coaching comes in a variety of flavors — some one on one, and others in the form of group sessions. All, however, serve the purpose of helping physicians gain career clarity. “Sometimes clients realize their job may not be working for them, but that there are things they can do to change that without having to leave the field,” said Jattu Senesie, MD, a former ob.gyn. who is now a physician coach.
Dr. Esparaz works with doctors to establish SMART goals: specific, measurable, attainable, realistic, and time based. She gave the example of learning how to set boundaries. “If a physician is asked to create a presentation for work, I encourage them to ask for compensation or administrative time before committing to unpaid tasks.”
Another big issue: charting. It’s increasingly burdensome, and many doctors find it encroaching on their home lives. “If we can identify a problem like that, we can come up with a strategy for mitigating it,” Dr. Esparaz said. This might include setting a goal of getting 80% of charting completed immediately after the patient encounter on the busiest clinic day of the week. The client tests the experiment and then revisits it with the coach to discuss what worked and what didn’t, refining the process until it has freed up the physician’s home life.
The younger generation of doctors often struggles with career choices, too, because it’s the first time they are without structure, said Dr. Senesie. There’s med school and residency, which puts a framework around every move a doctor makes. But once they become attending physicians, the choices are endless. “Coaching can help them find a new structure and systems that will allow them to thrive.”
Although mentoring has been a well-embraced concept for decades, it “hits a wall,” at some point in terms of what it can offer, Dr. Austin said. That’s where coaching can take over. “There’s a point where a mentor cannot help someone self-actualize. As a coach, you don’t need to know everything about a doctor’s life, but you can help them learn to ask themselves the right questions to solve problems.”
Should You Stay or Should You Go?
Dr. Austin’s approach begins with the premise that healthcare today is challenging and dysfunctional — but doctors still have agency. She has worked with clients on the verge of leaving the field and helped them find their way back.
“They have a light bulb moment and open up to the idea that they have much to give still,” she said. “We take an inventory to help them better communicate their needs and make changes, and I help them connect to their values. Sometimes that exercise allows them to reframe their current work environment.”
Not every doctor who goes through coaching remains in the field. But “that’s the exception, not the rule,” Dr. Austin said. And that’s okay. “If that’s the outcome, coaching probably helped them get to that point faster, and with an informed decision.”
Dr. Senesie has been coaching for about a decade, and in that time, she’s seen a shift that goes beyond figuring out career goals. “Doctors are more aware of the need for well-being today. The pandemic made it impossible to ignore what doesn’t work for us. When I work with clients, we look for ways to make the job more tenable.”
According to Dr. Senesie, younger doctors are looking for that balance at the outset. “They want to be physicians, but they also want a life,” she said. “It’s a challenge for them because in addition to that mindset, they’re also coming out with more debt than older generations. They want out from underneath that.”
When It’s Time to Find a Physician Coach
Wondering whether coaching is right for you? Consider these symptoms:
- You need help setting boundaries at work.
- You feel like you’re sacrificing your own well-being for your job.
- You’re using maladaptive strategies to cope with the stress at work.
- You’ve reached a point where you are considering leaving the field.
If you’re interested in finding a physician coach, there are several places to begin your search, word of mouth being one of them. “Conferences and social media can also expose you to coaches,” suggested Dr. Esparaz. There are different methods and approaches to coaching. So, as you research, “make sure the coach you choose has techniques and a framework that fit what you’re after.”
Dr. Austin warned that it is an unregulated industry, so buyer beware. To ensure you’re getting an accredited physician coach, look for people who have obtained an International Coach Federation (ICF) accreditation. These coaches will hold an associate certified coach credential, which requires at least 60 hours of coaching-specific training approved by the ICF, in addition to other assessments and education.
Ensure that the coach you choose is within your budget. “There are some people charging astronomical rates out there,” Dr. Austin said. “If you’re burned out or struggling, it can be easy to reach for your credit card.”
Dr. Austin also cautioned doctors seeking a coach to avoid promises that sound too good to be true. Some coaching can have a gaslighting quality to it, she warned, “suggesting it can allow you to endure any environment.” But positive self-talk alone won’t cure an abusive or discriminatory situation. “If a client describes a toxic work environment,” the coach has an “ethical imperative” to help that person protect themselves.
A Side Gig or a New Career Path
After Dr. Austin’s experience with her coach, she made the choice to continue as an emergency physician part-time while starting her own coaching business. “It’s important for me personally to keep in touch with what’s happening on the ground, but I have no judgment for anyone who chooses to leave clinical practice to become a coach.”
When Dr. Senesie looks back on her own struggles as a clinician, she recognizes the state of burnout she was in 10 years ago. “I knew there was an issue, but I didn’t have the mindset to find a way to make it work,” she said. “I left the field when I was at my depths of burnout, which is generally not the best way to go about it.”
Guidance might have allowed her to take into account other avenues and helped her remain in the field, said Dr. Senesie. She has since learned that “there are many ways to practice medicine, and the way we’ve gone about it traditionally has worked for some, but not necessarily for everyone.”
There may be more possibilities than you think. By helping you assess your path and make meaningful changes, a physician coach might be the key to remaining in the field you love.
A version of this article first appeared on Medscape.com.
When Andrea Austin, MD, an emergency medicine specialist, left the military in 2020, she knew the adjustment to civilian life and practice might be difficult. To help smooth the transition, she reached out to a physician mentor who also had a professional coaching certificate. After a conversation, Dr. Austin signed up for 6 months of career coaching.
It was time well spent, according to Dr. Austin, who today is a coach herself. “It was really the first time I had the ability to choose what I wanted to do, and that required a mindset shift,” she explains. “A big part of coaching is helping physicians discover their agency so that they can make the best career choices.”
Physicians have long lacked the coaching resources typically made available to corporate executives. But that’s changing. In today’s high-pressure environment, where doctors are burning out at a rapid pace, coaching can sometimes be an avenue to staying in the field, especially if that coach is a fellow physician who understands what you’re facing.
With a physician shortage that the Association of American Medical Colleges expects to hit 86,000 in the next decade or so, coaching could be a stone worth turning over. A 2024 report in JAMA Network Open found that coaching provided by physician peers led to a significant reduction in interpersonal disengagement and burnout.
“What I think is exciting about coaching is that it allows you to better understand yourself and know your strengths and weaknesses,” said Dr. Austin. “It might seem simple, but many ‘soft skills’ aren’t considered mainstream in medicine. Coaching allows us to understand them and ourselves better.”
Why Are Doctors Using Coaches?
Although it’s hard to put a number on how many physicians are turning to coaches, the number of coaches available for doctors is growing rapidly. The American Medical Women’s Association maintains a database of physician coaches. According to deputy director Jodi Godfrey, MS, RDN, the number of members who have added coaching to their skill set has tripled in the past 4 years. “Many cite burnout as the reason they sought coaching support, and then they decided to go on to get certified in coaching.”
The pandemic is one reason physician coaching has grown, said Elizabeth Esparaz, MD, an ophthalmologist and physician coach. “Since the pandemic, the word ‘burnout’ is thrown around a good deal.” And the causes are clear. “Doctors are facing longer hours, they must make split-second decisions, they’re multitasking, and they have less support staff.”
Among her coaching clients, Dr. Austin has noticed other common struggles: fears of litigation, time scarcity with patients, declining reimbursement that hasn’t kept up with inflation, and loss of autonomy because of the corporatization of healthcare.
Coaching, Dr. Esparaz believes, can be an antidote to many of these issues. “Coaches help doctors see their strengths and find better ways of applying them,” she said. “We help them move forward, and also see their blind spots.”
Clarity, Goals, and Making the Right Choices
Physician coaching comes in a variety of flavors — some one on one, and others in the form of group sessions. All, however, serve the purpose of helping physicians gain career clarity. “Sometimes clients realize their job may not be working for them, but that there are things they can do to change that without having to leave the field,” said Jattu Senesie, MD, a former ob.gyn. who is now a physician coach.
Dr. Esparaz works with doctors to establish SMART goals: specific, measurable, attainable, realistic, and time based. She gave the example of learning how to set boundaries. “If a physician is asked to create a presentation for work, I encourage them to ask for compensation or administrative time before committing to unpaid tasks.”
Another big issue: charting. It’s increasingly burdensome, and many doctors find it encroaching on their home lives. “If we can identify a problem like that, we can come up with a strategy for mitigating it,” Dr. Esparaz said. This might include setting a goal of getting 80% of charting completed immediately after the patient encounter on the busiest clinic day of the week. The client tests the experiment and then revisits it with the coach to discuss what worked and what didn’t, refining the process until it has freed up the physician’s home life.
The younger generation of doctors often struggles with career choices, too, because it’s the first time they are without structure, said Dr. Senesie. There’s med school and residency, which puts a framework around every move a doctor makes. But once they become attending physicians, the choices are endless. “Coaching can help them find a new structure and systems that will allow them to thrive.”
Although mentoring has been a well-embraced concept for decades, it “hits a wall,” at some point in terms of what it can offer, Dr. Austin said. That’s where coaching can take over. “There’s a point where a mentor cannot help someone self-actualize. As a coach, you don’t need to know everything about a doctor’s life, but you can help them learn to ask themselves the right questions to solve problems.”
Should You Stay or Should You Go?
Dr. Austin’s approach begins with the premise that healthcare today is challenging and dysfunctional — but doctors still have agency. She has worked with clients on the verge of leaving the field and helped them find their way back.
“They have a light bulb moment and open up to the idea that they have much to give still,” she said. “We take an inventory to help them better communicate their needs and make changes, and I help them connect to their values. Sometimes that exercise allows them to reframe their current work environment.”
Not every doctor who goes through coaching remains in the field. But “that’s the exception, not the rule,” Dr. Austin said. And that’s okay. “If that’s the outcome, coaching probably helped them get to that point faster, and with an informed decision.”
Dr. Senesie has been coaching for about a decade, and in that time, she’s seen a shift that goes beyond figuring out career goals. “Doctors are more aware of the need for well-being today. The pandemic made it impossible to ignore what doesn’t work for us. When I work with clients, we look for ways to make the job more tenable.”
According to Dr. Senesie, younger doctors are looking for that balance at the outset. “They want to be physicians, but they also want a life,” she said. “It’s a challenge for them because in addition to that mindset, they’re also coming out with more debt than older generations. They want out from underneath that.”
When It’s Time to Find a Physician Coach
Wondering whether coaching is right for you? Consider these symptoms:
- You need help setting boundaries at work.
- You feel like you’re sacrificing your own well-being for your job.
- You’re using maladaptive strategies to cope with the stress at work.
- You’ve reached a point where you are considering leaving the field.
If you’re interested in finding a physician coach, there are several places to begin your search, word of mouth being one of them. “Conferences and social media can also expose you to coaches,” suggested Dr. Esparaz. There are different methods and approaches to coaching. So, as you research, “make sure the coach you choose has techniques and a framework that fit what you’re after.”
Dr. Austin warned that it is an unregulated industry, so buyer beware. To ensure you’re getting an accredited physician coach, look for people who have obtained an International Coach Federation (ICF) accreditation. These coaches will hold an associate certified coach credential, which requires at least 60 hours of coaching-specific training approved by the ICF, in addition to other assessments and education.
Ensure that the coach you choose is within your budget. “There are some people charging astronomical rates out there,” Dr. Austin said. “If you’re burned out or struggling, it can be easy to reach for your credit card.”
Dr. Austin also cautioned doctors seeking a coach to avoid promises that sound too good to be true. Some coaching can have a gaslighting quality to it, she warned, “suggesting it can allow you to endure any environment.” But positive self-talk alone won’t cure an abusive or discriminatory situation. “If a client describes a toxic work environment,” the coach has an “ethical imperative” to help that person protect themselves.
A Side Gig or a New Career Path
After Dr. Austin’s experience with her coach, she made the choice to continue as an emergency physician part-time while starting her own coaching business. “It’s important for me personally to keep in touch with what’s happening on the ground, but I have no judgment for anyone who chooses to leave clinical practice to become a coach.”
When Dr. Senesie looks back on her own struggles as a clinician, she recognizes the state of burnout she was in 10 years ago. “I knew there was an issue, but I didn’t have the mindset to find a way to make it work,” she said. “I left the field when I was at my depths of burnout, which is generally not the best way to go about it.”
Guidance might have allowed her to take into account other avenues and helped her remain in the field, said Dr. Senesie. She has since learned that “there are many ways to practice medicine, and the way we’ve gone about it traditionally has worked for some, but not necessarily for everyone.”
There may be more possibilities than you think. By helping you assess your path and make meaningful changes, a physician coach might be the key to remaining in the field you love.
A version of this article first appeared on Medscape.com.
Fillers, Hyaluronidase Relieve Orofacial Changes in Patients with Scleroderma
CARLSBAD, CALIFORNIA — In 2003, researchers asked 303 patients with systemic sclerosis (scleroderma) what bothered them most about their disease from an aesthetic standpoint: Orofacial features, such as thin lips and mouth furrows, or non-facial features, such as fingertip ulceration and waxy changes to the skin.
Respondents expressed significant concern about specific orofacial features, including thin lips (73%), mouth furrows (80%), loss of facial lines (68%), and a smaller, tighter mouth (77%).
“Patients with systemic sclerosis may have loss of vermilion lip, microstomia, and perioral rhytids,” Kathleen Cook Suozzi, MD, who directs the Aesthetic Dermatology Program at Yale University School of Medicine, New Haven, Connecticut, said at the Controversies and Conversations in Laser and Cosmetic Surgery annual symposium. “How can we address these changes for our patients?”
Recent research has shown that hyaluronidase injections can help improve orofacial changes commonly experienced by patients with scleroderma. In 2019, researchers in Alabama reported the case of a 53-year-old woman treated with hyaluronidase for scleroderma-induced microstomia. After four visits over 7 months and a total hyaluronidase dose of 470 IU, the patient reported an improved Mouth Handicap in Systemic Sclerosis (MHISS) score (38 of 48); subjective improvement of symptoms, including greater ease in eating and undergoing dental treatment; and improved mouth closure.
In 2023, researchers published a cohort study of four women between the ages of 43 and 61 with autoimmune sclerosing conditions that resulted in oral microstomia. Following hyaluronidase injections, all improved in mouth opening capacity and MHISS, with change stabilizing between three and five treatments. More recently, in a study pending publication in JAAD Case Reports, Dr. Suozzi and colleagues retrospectively evaluated 12 women with scleroderma who received between 150 and 300 units of hyaluronic acid (HA) filler for microstomia between 2020 and 2023. Of the 12 women, 58% had diffuse disease, and 42% had limited disease. Overall, oral aperture width increased by 0.65 cm (P = .0027) and oral aperture height increased by 0.88 cm (P < .0001). “In general, patients needed three to four treatments to reach peak effect, and then they reached a plateau,” Dr. Suozzi said. “It wasn’t that the treatment wasn’t working anymore, but it was because their oral aperture had gotten to a size of around 5 cm, which is clinically normal. Interestingly, we found that if the patient’s disease flared and their microstomia started to return, when you rechallenged them, they continued to respond. So, patients can continue to use this treatment over time.”
In a separate case series of seven patients, Dr. Suozzi and colleagues prospectively evaluated the effect of HA soft tissue filler with Restylane Silk for lip augmentation. Study participants experienced statistically significant increases in the difference between pre- and postinjection fullness in both upper and lower lips. Also, the mean posttreatment score fell between “much improved” (2) and “improved” (3) on both the Investigator Global Aesthetic Improvement Scale and the Subject Global Aesthetic Improvement Scale.
Dr. Suozzi recommends using nerve blocks for injecting HA filler or hyaluronidase in patients with scleroderma and minimizing the injection points. “Initially, we were using 30% lidocaine preparations around the mouth for an hour before the procedure, and patients were still having pain, so now we use nerve blocks,” she said. “For hyaluronidase, we do perform a test dose of 75-100 units, usually in the commissure. It’s amazing how well it works; people will usually come back after their test dose and have improvements in their measurements. This is a really easy treatment to perform, and I think it can be done in the office of a general dermatologist. There is concern about cross-reactivity with bee venom, so you want to ask patients about that.”
Dr. Suozzi reported having no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CARLSBAD, CALIFORNIA — In 2003, researchers asked 303 patients with systemic sclerosis (scleroderma) what bothered them most about their disease from an aesthetic standpoint: Orofacial features, such as thin lips and mouth furrows, or non-facial features, such as fingertip ulceration and waxy changes to the skin.
Respondents expressed significant concern about specific orofacial features, including thin lips (73%), mouth furrows (80%), loss of facial lines (68%), and a smaller, tighter mouth (77%).
“Patients with systemic sclerosis may have loss of vermilion lip, microstomia, and perioral rhytids,” Kathleen Cook Suozzi, MD, who directs the Aesthetic Dermatology Program at Yale University School of Medicine, New Haven, Connecticut, said at the Controversies and Conversations in Laser and Cosmetic Surgery annual symposium. “How can we address these changes for our patients?”
Recent research has shown that hyaluronidase injections can help improve orofacial changes commonly experienced by patients with scleroderma. In 2019, researchers in Alabama reported the case of a 53-year-old woman treated with hyaluronidase for scleroderma-induced microstomia. After four visits over 7 months and a total hyaluronidase dose of 470 IU, the patient reported an improved Mouth Handicap in Systemic Sclerosis (MHISS) score (38 of 48); subjective improvement of symptoms, including greater ease in eating and undergoing dental treatment; and improved mouth closure.
In 2023, researchers published a cohort study of four women between the ages of 43 and 61 with autoimmune sclerosing conditions that resulted in oral microstomia. Following hyaluronidase injections, all improved in mouth opening capacity and MHISS, with change stabilizing between three and five treatments. More recently, in a study pending publication in JAAD Case Reports, Dr. Suozzi and colleagues retrospectively evaluated 12 women with scleroderma who received between 150 and 300 units of hyaluronic acid (HA) filler for microstomia between 2020 and 2023. Of the 12 women, 58% had diffuse disease, and 42% had limited disease. Overall, oral aperture width increased by 0.65 cm (P = .0027) and oral aperture height increased by 0.88 cm (P < .0001). “In general, patients needed three to four treatments to reach peak effect, and then they reached a plateau,” Dr. Suozzi said. “It wasn’t that the treatment wasn’t working anymore, but it was because their oral aperture had gotten to a size of around 5 cm, which is clinically normal. Interestingly, we found that if the patient’s disease flared and their microstomia started to return, when you rechallenged them, they continued to respond. So, patients can continue to use this treatment over time.”
In a separate case series of seven patients, Dr. Suozzi and colleagues prospectively evaluated the effect of HA soft tissue filler with Restylane Silk for lip augmentation. Study participants experienced statistically significant increases in the difference between pre- and postinjection fullness in both upper and lower lips. Also, the mean posttreatment score fell between “much improved” (2) and “improved” (3) on both the Investigator Global Aesthetic Improvement Scale and the Subject Global Aesthetic Improvement Scale.
Dr. Suozzi recommends using nerve blocks for injecting HA filler or hyaluronidase in patients with scleroderma and minimizing the injection points. “Initially, we were using 30% lidocaine preparations around the mouth for an hour before the procedure, and patients were still having pain, so now we use nerve blocks,” she said. “For hyaluronidase, we do perform a test dose of 75-100 units, usually in the commissure. It’s amazing how well it works; people will usually come back after their test dose and have improvements in their measurements. This is a really easy treatment to perform, and I think it can be done in the office of a general dermatologist. There is concern about cross-reactivity with bee venom, so you want to ask patients about that.”
Dr. Suozzi reported having no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CARLSBAD, CALIFORNIA — In 2003, researchers asked 303 patients with systemic sclerosis (scleroderma) what bothered them most about their disease from an aesthetic standpoint: Orofacial features, such as thin lips and mouth furrows, or non-facial features, such as fingertip ulceration and waxy changes to the skin.
Respondents expressed significant concern about specific orofacial features, including thin lips (73%), mouth furrows (80%), loss of facial lines (68%), and a smaller, tighter mouth (77%).
“Patients with systemic sclerosis may have loss of vermilion lip, microstomia, and perioral rhytids,” Kathleen Cook Suozzi, MD, who directs the Aesthetic Dermatology Program at Yale University School of Medicine, New Haven, Connecticut, said at the Controversies and Conversations in Laser and Cosmetic Surgery annual symposium. “How can we address these changes for our patients?”
Recent research has shown that hyaluronidase injections can help improve orofacial changes commonly experienced by patients with scleroderma. In 2019, researchers in Alabama reported the case of a 53-year-old woman treated with hyaluronidase for scleroderma-induced microstomia. After four visits over 7 months and a total hyaluronidase dose of 470 IU, the patient reported an improved Mouth Handicap in Systemic Sclerosis (MHISS) score (38 of 48); subjective improvement of symptoms, including greater ease in eating and undergoing dental treatment; and improved mouth closure.
In 2023, researchers published a cohort study of four women between the ages of 43 and 61 with autoimmune sclerosing conditions that resulted in oral microstomia. Following hyaluronidase injections, all improved in mouth opening capacity and MHISS, with change stabilizing between three and five treatments. More recently, in a study pending publication in JAAD Case Reports, Dr. Suozzi and colleagues retrospectively evaluated 12 women with scleroderma who received between 150 and 300 units of hyaluronic acid (HA) filler for microstomia between 2020 and 2023. Of the 12 women, 58% had diffuse disease, and 42% had limited disease. Overall, oral aperture width increased by 0.65 cm (P = .0027) and oral aperture height increased by 0.88 cm (P < .0001). “In general, patients needed three to four treatments to reach peak effect, and then they reached a plateau,” Dr. Suozzi said. “It wasn’t that the treatment wasn’t working anymore, but it was because their oral aperture had gotten to a size of around 5 cm, which is clinically normal. Interestingly, we found that if the patient’s disease flared and their microstomia started to return, when you rechallenged them, they continued to respond. So, patients can continue to use this treatment over time.”
In a separate case series of seven patients, Dr. Suozzi and colleagues prospectively evaluated the effect of HA soft tissue filler with Restylane Silk for lip augmentation. Study participants experienced statistically significant increases in the difference between pre- and postinjection fullness in both upper and lower lips. Also, the mean posttreatment score fell between “much improved” (2) and “improved” (3) on both the Investigator Global Aesthetic Improvement Scale and the Subject Global Aesthetic Improvement Scale.
Dr. Suozzi recommends using nerve blocks for injecting HA filler or hyaluronidase in patients with scleroderma and minimizing the injection points. “Initially, we were using 30% lidocaine preparations around the mouth for an hour before the procedure, and patients were still having pain, so now we use nerve blocks,” she said. “For hyaluronidase, we do perform a test dose of 75-100 units, usually in the commissure. It’s amazing how well it works; people will usually come back after their test dose and have improvements in their measurements. This is a really easy treatment to perform, and I think it can be done in the office of a general dermatologist. There is concern about cross-reactivity with bee venom, so you want to ask patients about that.”
Dr. Suozzi reported having no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Chronic Back Pain in Patients With Psoriasis, Uveitis, or Colitis: How Often Is It Axial Spondyloarthritis?
TOPLINE:
Patients with psoriasis, uveitis, or colitis who present with undiagnosed chronic back pain should be referred to a rheumatologist for the assessment of axial spondyloarthritis (axSpA), with MRI being a more accurate diagnostic method than clinical features.
METHODOLOGY:
- Researchers assessed the prevalence of axSpA according to the extra-articular presentation and human leukocyte antigen B27 (HLA-B27) status in two Canadian cohorts (SASPIC 1 and 2).
- Overall, 363 adult patients aged ≤ 45 years with psoriasis, uveitis, or colitis who presented with chronic undiagnosed back and/or buttock pain lasting 3 months or more were included.
- Participants were referred to rheumatologists with expertise in axSpA for structured diagnostic evaluations, including history, physical exam, levels of C-reactive protein, HLA-B27 status, and imaging studies.
- An MRI of the sacroiliac joints was conducted in all patients in the SASPIC-2 cohort and in 62.3% of those in the SASPIC-1 cohort.
- The primary outcome was the proportion of patients diagnosed with axSpA after final global evaluation, and the secondary outcome was the impact of MRI on diagnosis and classification.
TAKEAWAY:
- AxSpA diagnoses were made in 46.7% with psoriasis, 61.6% with uveitis, and 46.8% with colitis in the SASPIC-1 cohort and in 23.5%, 57.9%, and 23.3%, respectively, in the SASPIC-2 cohort.
- Being positive for HLA-B27 was linked to the presence of axSpA in 56%-88% of those in both the cohorts.
- Musculoskeletal clinical features were not helpful in differentiating between patients with and without axSpA.
- In both the cohorts, the MRI of the sacroiliac joints was indicative of axSpA in a significantly greater number of patients with psoriasis, uveitis, or colitis who were diagnosed with axSpA than in those not diagnosed with axSpA (P < .05 for all).
IN PRACTICE:
“Our data supports the benefit of recent referral recommendations that advocate referral to a rheumatologist of patients with chronic back pain and extra-articular features related to axSpA,” the authors wrote.
SOURCE:
The study was led by Walter P. Maksymowych, MB ChB, University of Alberta, Edmonton, Alberta, Canada. It was published online in Arthritis & Rheumatology.
LIMITATIONS:
MRI readers had to rely on their own expertise to decide if an MRI was indeed positive and thus indicative of axSpA. This study included only patients with undiagnosed back pain, and a longer follow-up duration could have led to a higher number of patients being diagnosed with axial inflammation. In SASPIC-1, local rheumatologists conducted MRI evaluations of the spinal lesions only when necessary, while in SASPIC-2, MRI of only the sacroiliac joints was required.
DISCLOSURES:
SASPIC-1 was supported by AbbVie Canada and Janssen Canada, and SASPIC-2 was supported by AbbVie Canada. The authors disclosed receiving grants, consulting fees, speaking fees, and/or honoraria and having other ties with AbbVie and several other pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Patients with psoriasis, uveitis, or colitis who present with undiagnosed chronic back pain should be referred to a rheumatologist for the assessment of axial spondyloarthritis (axSpA), with MRI being a more accurate diagnostic method than clinical features.
METHODOLOGY:
- Researchers assessed the prevalence of axSpA according to the extra-articular presentation and human leukocyte antigen B27 (HLA-B27) status in two Canadian cohorts (SASPIC 1 and 2).
- Overall, 363 adult patients aged ≤ 45 years with psoriasis, uveitis, or colitis who presented with chronic undiagnosed back and/or buttock pain lasting 3 months or more were included.
- Participants were referred to rheumatologists with expertise in axSpA for structured diagnostic evaluations, including history, physical exam, levels of C-reactive protein, HLA-B27 status, and imaging studies.
- An MRI of the sacroiliac joints was conducted in all patients in the SASPIC-2 cohort and in 62.3% of those in the SASPIC-1 cohort.
- The primary outcome was the proportion of patients diagnosed with axSpA after final global evaluation, and the secondary outcome was the impact of MRI on diagnosis and classification.
TAKEAWAY:
- AxSpA diagnoses were made in 46.7% with psoriasis, 61.6% with uveitis, and 46.8% with colitis in the SASPIC-1 cohort and in 23.5%, 57.9%, and 23.3%, respectively, in the SASPIC-2 cohort.
- Being positive for HLA-B27 was linked to the presence of axSpA in 56%-88% of those in both the cohorts.
- Musculoskeletal clinical features were not helpful in differentiating between patients with and without axSpA.
- In both the cohorts, the MRI of the sacroiliac joints was indicative of axSpA in a significantly greater number of patients with psoriasis, uveitis, or colitis who were diagnosed with axSpA than in those not diagnosed with axSpA (P < .05 for all).
IN PRACTICE:
“Our data supports the benefit of recent referral recommendations that advocate referral to a rheumatologist of patients with chronic back pain and extra-articular features related to axSpA,” the authors wrote.
SOURCE:
The study was led by Walter P. Maksymowych, MB ChB, University of Alberta, Edmonton, Alberta, Canada. It was published online in Arthritis & Rheumatology.
LIMITATIONS:
MRI readers had to rely on their own expertise to decide if an MRI was indeed positive and thus indicative of axSpA. This study included only patients with undiagnosed back pain, and a longer follow-up duration could have led to a higher number of patients being diagnosed with axial inflammation. In SASPIC-1, local rheumatologists conducted MRI evaluations of the spinal lesions only when necessary, while in SASPIC-2, MRI of only the sacroiliac joints was required.
DISCLOSURES:
SASPIC-1 was supported by AbbVie Canada and Janssen Canada, and SASPIC-2 was supported by AbbVie Canada. The authors disclosed receiving grants, consulting fees, speaking fees, and/or honoraria and having other ties with AbbVie and several other pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Patients with psoriasis, uveitis, or colitis who present with undiagnosed chronic back pain should be referred to a rheumatologist for the assessment of axial spondyloarthritis (axSpA), with MRI being a more accurate diagnostic method than clinical features.
METHODOLOGY:
- Researchers assessed the prevalence of axSpA according to the extra-articular presentation and human leukocyte antigen B27 (HLA-B27) status in two Canadian cohorts (SASPIC 1 and 2).
- Overall, 363 adult patients aged ≤ 45 years with psoriasis, uveitis, or colitis who presented with chronic undiagnosed back and/or buttock pain lasting 3 months or more were included.
- Participants were referred to rheumatologists with expertise in axSpA for structured diagnostic evaluations, including history, physical exam, levels of C-reactive protein, HLA-B27 status, and imaging studies.
- An MRI of the sacroiliac joints was conducted in all patients in the SASPIC-2 cohort and in 62.3% of those in the SASPIC-1 cohort.
- The primary outcome was the proportion of patients diagnosed with axSpA after final global evaluation, and the secondary outcome was the impact of MRI on diagnosis and classification.
TAKEAWAY:
- AxSpA diagnoses were made in 46.7% with psoriasis, 61.6% with uveitis, and 46.8% with colitis in the SASPIC-1 cohort and in 23.5%, 57.9%, and 23.3%, respectively, in the SASPIC-2 cohort.
- Being positive for HLA-B27 was linked to the presence of axSpA in 56%-88% of those in both the cohorts.
- Musculoskeletal clinical features were not helpful in differentiating between patients with and without axSpA.
- In both the cohorts, the MRI of the sacroiliac joints was indicative of axSpA in a significantly greater number of patients with psoriasis, uveitis, or colitis who were diagnosed with axSpA than in those not diagnosed with axSpA (P < .05 for all).
IN PRACTICE:
“Our data supports the benefit of recent referral recommendations that advocate referral to a rheumatologist of patients with chronic back pain and extra-articular features related to axSpA,” the authors wrote.
SOURCE:
The study was led by Walter P. Maksymowych, MB ChB, University of Alberta, Edmonton, Alberta, Canada. It was published online in Arthritis & Rheumatology.
LIMITATIONS:
MRI readers had to rely on their own expertise to decide if an MRI was indeed positive and thus indicative of axSpA. This study included only patients with undiagnosed back pain, and a longer follow-up duration could have led to a higher number of patients being diagnosed with axial inflammation. In SASPIC-1, local rheumatologists conducted MRI evaluations of the spinal lesions only when necessary, while in SASPIC-2, MRI of only the sacroiliac joints was required.
DISCLOSURES:
SASPIC-1 was supported by AbbVie Canada and Janssen Canada, and SASPIC-2 was supported by AbbVie Canada. The authors disclosed receiving grants, consulting fees, speaking fees, and/or honoraria and having other ties with AbbVie and several other pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
FTC Interim Report on Pharmacy Middlemen Is First Step of Many Needed in Addressing Drug Costs, Access
Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs.
Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.
PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.
The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.
Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana.
Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines.
For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said.
One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.
This Q&A has been edited for length and clarity.
What would you want federal and state policymakers to do in response to the FTC’s report?
I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.
Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies.
That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.
You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?
Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report.
Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.
What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies.
They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well.
I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.
In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed.
The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective?
Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.
The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?
Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.”
I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.
Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.”
That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.
Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response.
I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
A version of this article appeared on Medscape.com.
Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs.
Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.
PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.
The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.
Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana.
Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines.
For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said.
One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.
This Q&A has been edited for length and clarity.
What would you want federal and state policymakers to do in response to the FTC’s report?
I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.
Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies.
That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.
You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?
Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report.
Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.
What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies.
They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well.
I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.
In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed.
The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective?
Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.
The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?
Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.”
I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.
Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.”
That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.
Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response.
I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
A version of this article appeared on Medscape.com.
Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs.
Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.
PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.
The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.
Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana.
Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines.
For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said.
One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.
This Q&A has been edited for length and clarity.
What would you want federal and state policymakers to do in response to the FTC’s report?
I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.
Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies.
That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.
You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?
Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report.
Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.
What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies.
They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well.
I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.
In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed.
The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective?
Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.
The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?
Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.”
I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.
Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.”
That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.
Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response.
I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
A version of this article appeared on Medscape.com.