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Multimodal imaging of DIP-joint and SEC can help distinguish PsA from psoriasis or OA
Key clinical point: Ultrasound (US), magnetic resonance imaging (MRI), and X-ray could differentiate psoriatic arthritis (PsA) from psoriasis and hand osteoarthritis (OA) based on the degree of structural involvement in the distal interphalangeal (DIP)-joint and synovio-entheseal complex (SEC).
Major finding: US-detected new bone formation (NBF; risk ratio [RR] 0.52; P < .001) and DIP-joint synovial hypertrophy (RR 0.66; P = .005) along with PsA MRI scores (all P < .001) were associated with a lower risk for PsA vs. OA. Patients with PsA vs. psoriasis had a higher prevalence of X-ray entheseal change (mean difference 0.42; P = .024) and a higher trend toward US-detected NBF and erosions.
Study details: This prospective, cross-sectional study included 50 patients with DIP-joint PsA and nail involvement, 12 patients with psoriasis and nail involvement, and 13 patients with erosive and nonerosive OA.
Disclosures: The study was funded by Novartis, The Oak Foundation, and others. Some authors declared receiving speaker/consulting fees, research grants, or honoraria or serving as members of advisory board or consultants for several sources.
Source: Guldberg-Møller J et al. Multimodal imaging of the distal interphalangeal-joint synovio-entheseal complex in psoriatic arthritis (MIDAS): A cross-sectional study on the diagnostic accuracy of different imaging modalities comparing psoriatic arthritis to psoriasis and osteoarthritis. RMD Open. 2022;8:e002109 (Mar 28). Doi: 10.1136/rmdopen-2021-002109
Key clinical point: Ultrasound (US), magnetic resonance imaging (MRI), and X-ray could differentiate psoriatic arthritis (PsA) from psoriasis and hand osteoarthritis (OA) based on the degree of structural involvement in the distal interphalangeal (DIP)-joint and synovio-entheseal complex (SEC).
Major finding: US-detected new bone formation (NBF; risk ratio [RR] 0.52; P < .001) and DIP-joint synovial hypertrophy (RR 0.66; P = .005) along with PsA MRI scores (all P < .001) were associated with a lower risk for PsA vs. OA. Patients with PsA vs. psoriasis had a higher prevalence of X-ray entheseal change (mean difference 0.42; P = .024) and a higher trend toward US-detected NBF and erosions.
Study details: This prospective, cross-sectional study included 50 patients with DIP-joint PsA and nail involvement, 12 patients with psoriasis and nail involvement, and 13 patients with erosive and nonerosive OA.
Disclosures: The study was funded by Novartis, The Oak Foundation, and others. Some authors declared receiving speaker/consulting fees, research grants, or honoraria or serving as members of advisory board or consultants for several sources.
Source: Guldberg-Møller J et al. Multimodal imaging of the distal interphalangeal-joint synovio-entheseal complex in psoriatic arthritis (MIDAS): A cross-sectional study on the diagnostic accuracy of different imaging modalities comparing psoriatic arthritis to psoriasis and osteoarthritis. RMD Open. 2022;8:e002109 (Mar 28). Doi: 10.1136/rmdopen-2021-002109
Key clinical point: Ultrasound (US), magnetic resonance imaging (MRI), and X-ray could differentiate psoriatic arthritis (PsA) from psoriasis and hand osteoarthritis (OA) based on the degree of structural involvement in the distal interphalangeal (DIP)-joint and synovio-entheseal complex (SEC).
Major finding: US-detected new bone formation (NBF; risk ratio [RR] 0.52; P < .001) and DIP-joint synovial hypertrophy (RR 0.66; P = .005) along with PsA MRI scores (all P < .001) were associated with a lower risk for PsA vs. OA. Patients with PsA vs. psoriasis had a higher prevalence of X-ray entheseal change (mean difference 0.42; P = .024) and a higher trend toward US-detected NBF and erosions.
Study details: This prospective, cross-sectional study included 50 patients with DIP-joint PsA and nail involvement, 12 patients with psoriasis and nail involvement, and 13 patients with erosive and nonerosive OA.
Disclosures: The study was funded by Novartis, The Oak Foundation, and others. Some authors declared receiving speaker/consulting fees, research grants, or honoraria or serving as members of advisory board or consultants for several sources.
Source: Guldberg-Møller J et al. Multimodal imaging of the distal interphalangeal-joint synovio-entheseal complex in psoriatic arthritis (MIDAS): A cross-sectional study on the diagnostic accuracy of different imaging modalities comparing psoriatic arthritis to psoriasis and osteoarthritis. RMD Open. 2022;8:e002109 (Mar 28). Doi: 10.1136/rmdopen-2021-002109
Long-term efficacy, safety data for ixekizumab in pediatric psoriasis reported
with the interleukin (IL)-17 inhibitor, investigators reported.
In addition, findings of a substudy, which evaluated randomized withdrawal of treatment after 60 weeks, suggest patients were able to regain benefit after not being treated for a period.
Ixekizumab (Taltz) was approved by the U.S. Food and Drug Administration for treating pediatric psoriasis in March 2020 for patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The trial (IXORA-PEDS) involved 171 patients aged 6-17 years (mean age, 13.5 years; 99 females and 72 males), who were randomly assigned to receive ixekizumab via subcutaneous administration every 4 weeks (115) or placebo for 12 weeks (56). Thereafter, 166 patients continued in an open-label maintenance period in which they were treated every 4 weeks for 12-60 weeks. This was followed by an extension period of up to 108 weeks, which was completed by 139 patients (83.7%). At baseline, the patients’ Psoriasis Area and Severity Index (PASI) score was 12 or higher, the static Physician’s Global Assessment (sPGA) score was 3 or higher, and 10% or more of body surface area was affected.
In the study, at 12 weeks, treatment with ixekizumab was superior to placebo, with sustained responses through 48 weeks. In the follow-up phase, primary and secondary endpoints were sustained through week 108, with patients achieving or maintaining PASI 75 (91.7%), PASI 90 (79%), PASI 100 (55.1%), sPGA 0 or 1 (78.3%), and sPGA 0 (52.4%). Significant improvements in itch were seen at 12 weeks and were sustained with “meaningful improvements in itch for 78.5% of these patients at week 108,” the investigators report.
Among the patients who received ixekizumab, clearance rates in areas that are difficult to treat increased from week 12 to week 108 among those affected. During this time, clearance of nail psoriasis increased from 22.8% to 68.1%, clearance of palmoplantar psoriasis increased from 46.2% to 90%, clearance of scalp psoriasis increased from 70.7% to 76.2%, and clearance of genital psoriasis increased from 83.3% to 87.5%.
No new safety findings during weeks 48-108 of the trial were reported, including no new cases of inflammatory bowel disease (IBD) or Candida infections. The results were reported in JAMA Dermatology.
“Safety is really what we think of most when we are talking about pediatric patients, especially since they may be on these for decades and ... since they most commonly start these therapies in adolescence,” said Amy Paller, MD, the study’s lead author, in an interview. “To be able to take this out 108 weeks, 2 years, is starting to get to a point where we are getting more comfortable with safety. Clearly, no new signals arose.” Dr. Paller is chair of the department of dermatology and professor of dermatology and pediatrics, Northwestern University, Chicago.
One of the biggest concerns with using IL-17 inhibitors such as ixekizumab to manage psoriasis is the development of IBD, said Dr. Paller. She noted that four cases of IBD were reported before the extension phase of the trial but that no new IBD cases were reported after week 48.
“We would not start this as a treatment of choice in someone with Crohn’s disease, or perhaps we would think twice about using it in someone with a strong family history [of Crohn’s disease],” said Dr. Paller, who is also the director of the Skin Biology and Diseases Resource-Based Center at Northwestern. “Otherwise, it does not make me concerned about its use.”
Commenting on the study, Kelly M. Cordoro, MD, professor of dermatology and pediatrics at the University of California, San Francisco, said that the trial’s results provide additional evidence regarding the optimal management of pediatric psoriasis.
“The landscape has shifted toward involving more pediatric patients in clinical trials, thereby providing dermatologists with data to select safe and effective therapies to manage children with psoriasis,” Dr. Cordoro said in an interview. “We have data showing that children with psoriasis have been undertreated, likely because of concerns about safety. The more evidence available from trials such as this, the more likely children are to receive necessary treatment.”
The efficacy data from the study on difficult-to-treat areas of psoriasis, in addition to improvements in BSA and PASI measures, are significant for clinicians deciding on a therapy for patients with psoriasis concentrated in specific body sites. “It was very valuable that the efficacy data was provided by site, such as scalp, palmoplantar, nails, and genital psoriasis, as these are low-BSA but high-impact areas for patients,” said Dr. Cordoro.
The trial data on Crohn’s disease buttress her decision to continue to refrain from initiating ixekizumab in a child with IBD or who is at high risk for IBD. “I was happy to see that there was not a signal for Candida infection,” she added.
Interestingly, in the substudy in the European population, in which there was a double-blind, randomized withdrawal period, fewer patients who were reassigned to receive ixekizumab experienced relapse, compared with those who were reassigned to receive placebo. A total of 90.9% of patients who received placebo experienced relapse, compared with 17.6% of patients treated with ixekizumab. The median time to relapse in the placebo group was 149 days.
“There are data in the adult population that suggest intermittent treatment does allow for recapture of clinical response,” said Dr. Cordoro. “While it is not a large enough dataset to know definitively, this substudy of patients suggests the possibility of intermittent treatment and the ability to regain control [of psoriasis] after a period off drug.”
The study was funded by Eli Lilly. Dr. Paller is an investigator and consultant for Eli Lilly. Several other authors have received grants, personal fees, and/or were a consultant to Eli Lilly, and two authors are Eli Lilly employees. Dr. Cordoro reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
with the interleukin (IL)-17 inhibitor, investigators reported.
In addition, findings of a substudy, which evaluated randomized withdrawal of treatment after 60 weeks, suggest patients were able to regain benefit after not being treated for a period.
Ixekizumab (Taltz) was approved by the U.S. Food and Drug Administration for treating pediatric psoriasis in March 2020 for patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The trial (IXORA-PEDS) involved 171 patients aged 6-17 years (mean age, 13.5 years; 99 females and 72 males), who were randomly assigned to receive ixekizumab via subcutaneous administration every 4 weeks (115) or placebo for 12 weeks (56). Thereafter, 166 patients continued in an open-label maintenance period in which they were treated every 4 weeks for 12-60 weeks. This was followed by an extension period of up to 108 weeks, which was completed by 139 patients (83.7%). At baseline, the patients’ Psoriasis Area and Severity Index (PASI) score was 12 or higher, the static Physician’s Global Assessment (sPGA) score was 3 or higher, and 10% or more of body surface area was affected.
In the study, at 12 weeks, treatment with ixekizumab was superior to placebo, with sustained responses through 48 weeks. In the follow-up phase, primary and secondary endpoints were sustained through week 108, with patients achieving or maintaining PASI 75 (91.7%), PASI 90 (79%), PASI 100 (55.1%), sPGA 0 or 1 (78.3%), and sPGA 0 (52.4%). Significant improvements in itch were seen at 12 weeks and were sustained with “meaningful improvements in itch for 78.5% of these patients at week 108,” the investigators report.
Among the patients who received ixekizumab, clearance rates in areas that are difficult to treat increased from week 12 to week 108 among those affected. During this time, clearance of nail psoriasis increased from 22.8% to 68.1%, clearance of palmoplantar psoriasis increased from 46.2% to 90%, clearance of scalp psoriasis increased from 70.7% to 76.2%, and clearance of genital psoriasis increased from 83.3% to 87.5%.
No new safety findings during weeks 48-108 of the trial were reported, including no new cases of inflammatory bowel disease (IBD) or Candida infections. The results were reported in JAMA Dermatology.
“Safety is really what we think of most when we are talking about pediatric patients, especially since they may be on these for decades and ... since they most commonly start these therapies in adolescence,” said Amy Paller, MD, the study’s lead author, in an interview. “To be able to take this out 108 weeks, 2 years, is starting to get to a point where we are getting more comfortable with safety. Clearly, no new signals arose.” Dr. Paller is chair of the department of dermatology and professor of dermatology and pediatrics, Northwestern University, Chicago.
One of the biggest concerns with using IL-17 inhibitors such as ixekizumab to manage psoriasis is the development of IBD, said Dr. Paller. She noted that four cases of IBD were reported before the extension phase of the trial but that no new IBD cases were reported after week 48.
“We would not start this as a treatment of choice in someone with Crohn’s disease, or perhaps we would think twice about using it in someone with a strong family history [of Crohn’s disease],” said Dr. Paller, who is also the director of the Skin Biology and Diseases Resource-Based Center at Northwestern. “Otherwise, it does not make me concerned about its use.”
Commenting on the study, Kelly M. Cordoro, MD, professor of dermatology and pediatrics at the University of California, San Francisco, said that the trial’s results provide additional evidence regarding the optimal management of pediatric psoriasis.
“The landscape has shifted toward involving more pediatric patients in clinical trials, thereby providing dermatologists with data to select safe and effective therapies to manage children with psoriasis,” Dr. Cordoro said in an interview. “We have data showing that children with psoriasis have been undertreated, likely because of concerns about safety. The more evidence available from trials such as this, the more likely children are to receive necessary treatment.”
The efficacy data from the study on difficult-to-treat areas of psoriasis, in addition to improvements in BSA and PASI measures, are significant for clinicians deciding on a therapy for patients with psoriasis concentrated in specific body sites. “It was very valuable that the efficacy data was provided by site, such as scalp, palmoplantar, nails, and genital psoriasis, as these are low-BSA but high-impact areas for patients,” said Dr. Cordoro.
The trial data on Crohn’s disease buttress her decision to continue to refrain from initiating ixekizumab in a child with IBD or who is at high risk for IBD. “I was happy to see that there was not a signal for Candida infection,” she added.
Interestingly, in the substudy in the European population, in which there was a double-blind, randomized withdrawal period, fewer patients who were reassigned to receive ixekizumab experienced relapse, compared with those who were reassigned to receive placebo. A total of 90.9% of patients who received placebo experienced relapse, compared with 17.6% of patients treated with ixekizumab. The median time to relapse in the placebo group was 149 days.
“There are data in the adult population that suggest intermittent treatment does allow for recapture of clinical response,” said Dr. Cordoro. “While it is not a large enough dataset to know definitively, this substudy of patients suggests the possibility of intermittent treatment and the ability to regain control [of psoriasis] after a period off drug.”
The study was funded by Eli Lilly. Dr. Paller is an investigator and consultant for Eli Lilly. Several other authors have received grants, personal fees, and/or were a consultant to Eli Lilly, and two authors are Eli Lilly employees. Dr. Cordoro reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
with the interleukin (IL)-17 inhibitor, investigators reported.
In addition, findings of a substudy, which evaluated randomized withdrawal of treatment after 60 weeks, suggest patients were able to regain benefit after not being treated for a period.
Ixekizumab (Taltz) was approved by the U.S. Food and Drug Administration for treating pediatric psoriasis in March 2020 for patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The trial (IXORA-PEDS) involved 171 patients aged 6-17 years (mean age, 13.5 years; 99 females and 72 males), who were randomly assigned to receive ixekizumab via subcutaneous administration every 4 weeks (115) or placebo for 12 weeks (56). Thereafter, 166 patients continued in an open-label maintenance period in which they were treated every 4 weeks for 12-60 weeks. This was followed by an extension period of up to 108 weeks, which was completed by 139 patients (83.7%). At baseline, the patients’ Psoriasis Area and Severity Index (PASI) score was 12 or higher, the static Physician’s Global Assessment (sPGA) score was 3 or higher, and 10% or more of body surface area was affected.
In the study, at 12 weeks, treatment with ixekizumab was superior to placebo, with sustained responses through 48 weeks. In the follow-up phase, primary and secondary endpoints were sustained through week 108, with patients achieving or maintaining PASI 75 (91.7%), PASI 90 (79%), PASI 100 (55.1%), sPGA 0 or 1 (78.3%), and sPGA 0 (52.4%). Significant improvements in itch were seen at 12 weeks and were sustained with “meaningful improvements in itch for 78.5% of these patients at week 108,” the investigators report.
Among the patients who received ixekizumab, clearance rates in areas that are difficult to treat increased from week 12 to week 108 among those affected. During this time, clearance of nail psoriasis increased from 22.8% to 68.1%, clearance of palmoplantar psoriasis increased from 46.2% to 90%, clearance of scalp psoriasis increased from 70.7% to 76.2%, and clearance of genital psoriasis increased from 83.3% to 87.5%.
No new safety findings during weeks 48-108 of the trial were reported, including no new cases of inflammatory bowel disease (IBD) or Candida infections. The results were reported in JAMA Dermatology.
“Safety is really what we think of most when we are talking about pediatric patients, especially since they may be on these for decades and ... since they most commonly start these therapies in adolescence,” said Amy Paller, MD, the study’s lead author, in an interview. “To be able to take this out 108 weeks, 2 years, is starting to get to a point where we are getting more comfortable with safety. Clearly, no new signals arose.” Dr. Paller is chair of the department of dermatology and professor of dermatology and pediatrics, Northwestern University, Chicago.
One of the biggest concerns with using IL-17 inhibitors such as ixekizumab to manage psoriasis is the development of IBD, said Dr. Paller. She noted that four cases of IBD were reported before the extension phase of the trial but that no new IBD cases were reported after week 48.
“We would not start this as a treatment of choice in someone with Crohn’s disease, or perhaps we would think twice about using it in someone with a strong family history [of Crohn’s disease],” said Dr. Paller, who is also the director of the Skin Biology and Diseases Resource-Based Center at Northwestern. “Otherwise, it does not make me concerned about its use.”
Commenting on the study, Kelly M. Cordoro, MD, professor of dermatology and pediatrics at the University of California, San Francisco, said that the trial’s results provide additional evidence regarding the optimal management of pediatric psoriasis.
“The landscape has shifted toward involving more pediatric patients in clinical trials, thereby providing dermatologists with data to select safe and effective therapies to manage children with psoriasis,” Dr. Cordoro said in an interview. “We have data showing that children with psoriasis have been undertreated, likely because of concerns about safety. The more evidence available from trials such as this, the more likely children are to receive necessary treatment.”
The efficacy data from the study on difficult-to-treat areas of psoriasis, in addition to improvements in BSA and PASI measures, are significant for clinicians deciding on a therapy for patients with psoriasis concentrated in specific body sites. “It was very valuable that the efficacy data was provided by site, such as scalp, palmoplantar, nails, and genital psoriasis, as these are low-BSA but high-impact areas for patients,” said Dr. Cordoro.
The trial data on Crohn’s disease buttress her decision to continue to refrain from initiating ixekizumab in a child with IBD or who is at high risk for IBD. “I was happy to see that there was not a signal for Candida infection,” she added.
Interestingly, in the substudy in the European population, in which there was a double-blind, randomized withdrawal period, fewer patients who were reassigned to receive ixekizumab experienced relapse, compared with those who were reassigned to receive placebo. A total of 90.9% of patients who received placebo experienced relapse, compared with 17.6% of patients treated with ixekizumab. The median time to relapse in the placebo group was 149 days.
“There are data in the adult population that suggest intermittent treatment does allow for recapture of clinical response,” said Dr. Cordoro. “While it is not a large enough dataset to know definitively, this substudy of patients suggests the possibility of intermittent treatment and the ability to regain control [of psoriasis] after a period off drug.”
The study was funded by Eli Lilly. Dr. Paller is an investigator and consultant for Eli Lilly. Several other authors have received grants, personal fees, and/or were a consultant to Eli Lilly, and two authors are Eli Lilly employees. Dr. Cordoro reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Secukinumab’s antipsoriatic effects confirmed in U.S. patient population
and those who up-titrated to 300 mg from the lower approved dose of 150 mg also saw benefits obtained at that level.
Researchers conducted a postmarketing trial of secukinumab in patients at U.S. centers, called CHOICE, after it was approved for psoriasis and PsA in 2015 and 2016 based on trials mainly conducted outside of the United States. The American patients in those studies “had a baseline clinical profile indicating harder-to-treat disease than the total study population, including higher body mass index (BMI), higher tender and swollen joint counts, increased prevalence of enthesitis and dactylitis, and more tumor necrosis factor inhibitor (TNFi) experience,” Tien Q. Nguyen, MD, a dermatologist in private practice in Irvine, Calif., and colleagues wrote in the Journal of Rheumatology.
In order to get a better sense of how secukinumab performs in U.S. patients who have not been treated with biologics, the researchers conducted the multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 4 CHOICE trial. It recruited patients for about 26 months at 67 U.S. centers during 2016-2018. The 258 patients randomized in the study to 300 mg (n = 103), 150 mg secukinumab (n = 103), or placebo (n = 52) had a mean time since PsA diagnosis of 3.0-3.9 years and all had a mean BMI of greater than 30 kg/m2, with dactylitis present in 48% and enthesitis in 73%. About one-third were taking methotrexate at baseline.
At week 16, patients taking secukinumab 300 mg were about 3.5 times more likely to have 20% improvement in American College of Rheumatology response criteria than with placebo (51.5% vs. 23.1%), whereas the response rate with 150 mg was not significantly different from placebo (36.9%). Rates of achieving ACR50 were significantly greater for both 300- and 150-mg doses versus placebo (28.2% and 24.3% vs. 5.8%), but only 300 mg led to a statistically significant difference in the rate of ACR70 responses, compared with placebo (17.5% vs. 1.9%).
In general, efficacy based on ACR20/50/70 responses and either remission or low disease activity on the Disease Activity in Psoriatic Arthritis index was lower among patients with less than 10 tender joints and less than 10 swollen joints at baseline. Methotrexate use at baseline did not affect ACR20 rates at week 16 in patients taking secukinumab, but the effect of methotrexate on ACR20 rates was noticeable among placebo-treated patients (38.9% vs. 14.7%). Enthesitis appeared to resolve significantly more often among patients on secukinumab, and more patients on secukinumab also had their dactylitis resolve, but the difference was not statistically significant.
Patients with psoriasis affecting more than 3% of their body surface area experienced higher response rates on the Psoriasis Area Severity Index (PASI) for 75%, 90%, and 100% skin lesion clearance than did patients taking placebo.
Patients who switched from 150 mg to 300 mg secukinumab after week 16 in the second treatment period of the trial more often achieved ACR20/50/70 responses by week 52, going from 2.4% to 65.9% of the up-titration subset for ACR20 and from 0% to 34.1% for ACR50 and to 12.2% for ACR70. Patients on placebo who switched also experienced increases in these response rates out to week 52. However, BMI above 30 kg/m2 led to numerically lower ACR50, ACR70, and PASI response rates at week 52.
The researchers noted that the response rates observed in CHOICE were lower than for the pivotal trials used for Food and Drug Administration approval for PsA, which “may have been due to patients in CHOICE having higher disease activity scores at baseline, compared with TNFi-naive patients” in the pivotal trials.
The safety profile of secukinumab appeared to be no different from what has been reported previously. The researchers said that, throughout the 52-week study, the most common adverse events in patients receiving secukinumab were upper respiratory tract infection in about 13% and diarrhea in about 7%. Most adverse events were mild or moderate, with serious adverse events occurring in 9.6% of patients taking secukinumab 300 mg and in 7.8% of patients taking secukinumab 150 mg over the 52 weeks.
“Overall, the findings from CHOICE were consistent with previous studies and demonstrated that secukinumab provides significant and sustained improvements in signs and symptoms of psoriatic arthritis. Our findings suggest that secukinumab 300 mg is safe and efficacious as a first-line biologic treatment for patients with PsA. Further studies will also help determine the optimal dose of secukinumab for treating overweight patients or those with high disease activity at treatment initiation,” the authors wrote.
The study was funded by Novartis, which manufactures secukinumab. Dr. Nguyen and some coauthors reported serving as a consultant, investigator, and/or speaker for numerous pharmaceutical companies, including Novartis.
and those who up-titrated to 300 mg from the lower approved dose of 150 mg also saw benefits obtained at that level.
Researchers conducted a postmarketing trial of secukinumab in patients at U.S. centers, called CHOICE, after it was approved for psoriasis and PsA in 2015 and 2016 based on trials mainly conducted outside of the United States. The American patients in those studies “had a baseline clinical profile indicating harder-to-treat disease than the total study population, including higher body mass index (BMI), higher tender and swollen joint counts, increased prevalence of enthesitis and dactylitis, and more tumor necrosis factor inhibitor (TNFi) experience,” Tien Q. Nguyen, MD, a dermatologist in private practice in Irvine, Calif., and colleagues wrote in the Journal of Rheumatology.
In order to get a better sense of how secukinumab performs in U.S. patients who have not been treated with biologics, the researchers conducted the multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 4 CHOICE trial. It recruited patients for about 26 months at 67 U.S. centers during 2016-2018. The 258 patients randomized in the study to 300 mg (n = 103), 150 mg secukinumab (n = 103), or placebo (n = 52) had a mean time since PsA diagnosis of 3.0-3.9 years and all had a mean BMI of greater than 30 kg/m2, with dactylitis present in 48% and enthesitis in 73%. About one-third were taking methotrexate at baseline.
At week 16, patients taking secukinumab 300 mg were about 3.5 times more likely to have 20% improvement in American College of Rheumatology response criteria than with placebo (51.5% vs. 23.1%), whereas the response rate with 150 mg was not significantly different from placebo (36.9%). Rates of achieving ACR50 were significantly greater for both 300- and 150-mg doses versus placebo (28.2% and 24.3% vs. 5.8%), but only 300 mg led to a statistically significant difference in the rate of ACR70 responses, compared with placebo (17.5% vs. 1.9%).
In general, efficacy based on ACR20/50/70 responses and either remission or low disease activity on the Disease Activity in Psoriatic Arthritis index was lower among patients with less than 10 tender joints and less than 10 swollen joints at baseline. Methotrexate use at baseline did not affect ACR20 rates at week 16 in patients taking secukinumab, but the effect of methotrexate on ACR20 rates was noticeable among placebo-treated patients (38.9% vs. 14.7%). Enthesitis appeared to resolve significantly more often among patients on secukinumab, and more patients on secukinumab also had their dactylitis resolve, but the difference was not statistically significant.
Patients with psoriasis affecting more than 3% of their body surface area experienced higher response rates on the Psoriasis Area Severity Index (PASI) for 75%, 90%, and 100% skin lesion clearance than did patients taking placebo.
Patients who switched from 150 mg to 300 mg secukinumab after week 16 in the second treatment period of the trial more often achieved ACR20/50/70 responses by week 52, going from 2.4% to 65.9% of the up-titration subset for ACR20 and from 0% to 34.1% for ACR50 and to 12.2% for ACR70. Patients on placebo who switched also experienced increases in these response rates out to week 52. However, BMI above 30 kg/m2 led to numerically lower ACR50, ACR70, and PASI response rates at week 52.
The researchers noted that the response rates observed in CHOICE were lower than for the pivotal trials used for Food and Drug Administration approval for PsA, which “may have been due to patients in CHOICE having higher disease activity scores at baseline, compared with TNFi-naive patients” in the pivotal trials.
The safety profile of secukinumab appeared to be no different from what has been reported previously. The researchers said that, throughout the 52-week study, the most common adverse events in patients receiving secukinumab were upper respiratory tract infection in about 13% and diarrhea in about 7%. Most adverse events were mild or moderate, with serious adverse events occurring in 9.6% of patients taking secukinumab 300 mg and in 7.8% of patients taking secukinumab 150 mg over the 52 weeks.
“Overall, the findings from CHOICE were consistent with previous studies and demonstrated that secukinumab provides significant and sustained improvements in signs and symptoms of psoriatic arthritis. Our findings suggest that secukinumab 300 mg is safe and efficacious as a first-line biologic treatment for patients with PsA. Further studies will also help determine the optimal dose of secukinumab for treating overweight patients or those with high disease activity at treatment initiation,” the authors wrote.
The study was funded by Novartis, which manufactures secukinumab. Dr. Nguyen and some coauthors reported serving as a consultant, investigator, and/or speaker for numerous pharmaceutical companies, including Novartis.
and those who up-titrated to 300 mg from the lower approved dose of 150 mg also saw benefits obtained at that level.
Researchers conducted a postmarketing trial of secukinumab in patients at U.S. centers, called CHOICE, after it was approved for psoriasis and PsA in 2015 and 2016 based on trials mainly conducted outside of the United States. The American patients in those studies “had a baseline clinical profile indicating harder-to-treat disease than the total study population, including higher body mass index (BMI), higher tender and swollen joint counts, increased prevalence of enthesitis and dactylitis, and more tumor necrosis factor inhibitor (TNFi) experience,” Tien Q. Nguyen, MD, a dermatologist in private practice in Irvine, Calif., and colleagues wrote in the Journal of Rheumatology.
In order to get a better sense of how secukinumab performs in U.S. patients who have not been treated with biologics, the researchers conducted the multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 4 CHOICE trial. It recruited patients for about 26 months at 67 U.S. centers during 2016-2018. The 258 patients randomized in the study to 300 mg (n = 103), 150 mg secukinumab (n = 103), or placebo (n = 52) had a mean time since PsA diagnosis of 3.0-3.9 years and all had a mean BMI of greater than 30 kg/m2, with dactylitis present in 48% and enthesitis in 73%. About one-third were taking methotrexate at baseline.
At week 16, patients taking secukinumab 300 mg were about 3.5 times more likely to have 20% improvement in American College of Rheumatology response criteria than with placebo (51.5% vs. 23.1%), whereas the response rate with 150 mg was not significantly different from placebo (36.9%). Rates of achieving ACR50 were significantly greater for both 300- and 150-mg doses versus placebo (28.2% and 24.3% vs. 5.8%), but only 300 mg led to a statistically significant difference in the rate of ACR70 responses, compared with placebo (17.5% vs. 1.9%).
In general, efficacy based on ACR20/50/70 responses and either remission or low disease activity on the Disease Activity in Psoriatic Arthritis index was lower among patients with less than 10 tender joints and less than 10 swollen joints at baseline. Methotrexate use at baseline did not affect ACR20 rates at week 16 in patients taking secukinumab, but the effect of methotrexate on ACR20 rates was noticeable among placebo-treated patients (38.9% vs. 14.7%). Enthesitis appeared to resolve significantly more often among patients on secukinumab, and more patients on secukinumab also had their dactylitis resolve, but the difference was not statistically significant.
Patients with psoriasis affecting more than 3% of their body surface area experienced higher response rates on the Psoriasis Area Severity Index (PASI) for 75%, 90%, and 100% skin lesion clearance than did patients taking placebo.
Patients who switched from 150 mg to 300 mg secukinumab after week 16 in the second treatment period of the trial more often achieved ACR20/50/70 responses by week 52, going from 2.4% to 65.9% of the up-titration subset for ACR20 and from 0% to 34.1% for ACR50 and to 12.2% for ACR70. Patients on placebo who switched also experienced increases in these response rates out to week 52. However, BMI above 30 kg/m2 led to numerically lower ACR50, ACR70, and PASI response rates at week 52.
The researchers noted that the response rates observed in CHOICE were lower than for the pivotal trials used for Food and Drug Administration approval for PsA, which “may have been due to patients in CHOICE having higher disease activity scores at baseline, compared with TNFi-naive patients” in the pivotal trials.
The safety profile of secukinumab appeared to be no different from what has been reported previously. The researchers said that, throughout the 52-week study, the most common adverse events in patients receiving secukinumab were upper respiratory tract infection in about 13% and diarrhea in about 7%. Most adverse events were mild or moderate, with serious adverse events occurring in 9.6% of patients taking secukinumab 300 mg and in 7.8% of patients taking secukinumab 150 mg over the 52 weeks.
“Overall, the findings from CHOICE were consistent with previous studies and demonstrated that secukinumab provides significant and sustained improvements in signs and symptoms of psoriatic arthritis. Our findings suggest that secukinumab 300 mg is safe and efficacious as a first-line biologic treatment for patients with PsA. Further studies will also help determine the optimal dose of secukinumab for treating overweight patients or those with high disease activity at treatment initiation,” the authors wrote.
The study was funded by Novartis, which manufactures secukinumab. Dr. Nguyen and some coauthors reported serving as a consultant, investigator, and/or speaker for numerous pharmaceutical companies, including Novartis.
FROM THE JOURNAL OF RHEUMATOLOGY
Fluorescence optical imaging holds potential for detecting early signs of PsA
Key clinical point: This follow-up comparison of fluorescence optical imaging (FOI) with musculoskeletal ultrasound (MSUS) showed that FOI can be considered a useful screening tool for the early diagnosis of psoriatic arthritis (PsA).
Major finding: Patients diagnosed with PsA after the baseline evaluation had a higher prevalence of joints with pathological enhancement in FOI during follow-up (P = .046), notably in phase 2 FOI (P = .037). Similar to MSUS (area under the curve [AUC] 0.77), detecting newly affected joints by FOI (phase 2 in PrimaVista Mode; AUC 0.78) was positively linked with the shift of diagnosis from suspected to confirmed PsA.
Study details: In this follow-up study of 30 patients with psoriasis who had tender or swollen joints, the FOI of both the hands and the grayscale/power Doppler MSUS of the clinically dominant hand were compared.
Disclosures: This study was supported by the BMBF, German Ministry for Education and Research. The authors declared no conflict of interests.
Source: Buttner J et al. Follow-up comparison of fluorescence optical imaging with musculoskeletal ultrasound for early detection of psoriatic arthritis. Front Med. 2022;9:845545 (Mar 18). Doi: 10.3389/fmed.2022.845545
Key clinical point: This follow-up comparison of fluorescence optical imaging (FOI) with musculoskeletal ultrasound (MSUS) showed that FOI can be considered a useful screening tool for the early diagnosis of psoriatic arthritis (PsA).
Major finding: Patients diagnosed with PsA after the baseline evaluation had a higher prevalence of joints with pathological enhancement in FOI during follow-up (P = .046), notably in phase 2 FOI (P = .037). Similar to MSUS (area under the curve [AUC] 0.77), detecting newly affected joints by FOI (phase 2 in PrimaVista Mode; AUC 0.78) was positively linked with the shift of diagnosis from suspected to confirmed PsA.
Study details: In this follow-up study of 30 patients with psoriasis who had tender or swollen joints, the FOI of both the hands and the grayscale/power Doppler MSUS of the clinically dominant hand were compared.
Disclosures: This study was supported by the BMBF, German Ministry for Education and Research. The authors declared no conflict of interests.
Source: Buttner J et al. Follow-up comparison of fluorescence optical imaging with musculoskeletal ultrasound for early detection of psoriatic arthritis. Front Med. 2022;9:845545 (Mar 18). Doi: 10.3389/fmed.2022.845545
Key clinical point: This follow-up comparison of fluorescence optical imaging (FOI) with musculoskeletal ultrasound (MSUS) showed that FOI can be considered a useful screening tool for the early diagnosis of psoriatic arthritis (PsA).
Major finding: Patients diagnosed with PsA after the baseline evaluation had a higher prevalence of joints with pathological enhancement in FOI during follow-up (P = .046), notably in phase 2 FOI (P = .037). Similar to MSUS (area under the curve [AUC] 0.77), detecting newly affected joints by FOI (phase 2 in PrimaVista Mode; AUC 0.78) was positively linked with the shift of diagnosis from suspected to confirmed PsA.
Study details: In this follow-up study of 30 patients with psoriasis who had tender or swollen joints, the FOI of both the hands and the grayscale/power Doppler MSUS of the clinically dominant hand were compared.
Disclosures: This study was supported by the BMBF, German Ministry for Education and Research. The authors declared no conflict of interests.
Source: Buttner J et al. Follow-up comparison of fluorescence optical imaging with musculoskeletal ultrasound for early detection of psoriatic arthritis. Front Med. 2022;9:845545 (Mar 18). Doi: 10.3389/fmed.2022.845545
Guselkumab reduces collagen degradation biomarker levels associated with active PsA
Key clinical point: Serum levels of certain collagen degradation biomarkers were elevated in patients with psoriatic arthritis (PsA) vs. healthy controls (HC) and could be effectively lowered with guselkumab.
Major finding: Baseline serum concentrations of collagen degradation biomarkers C1M, C3M, C4M, and C6M were ≥1.25-times higher in patients with PsA vs. HC (adjusted P < .05). At week 24, 100 mg guselkumab every 4 weeks vs. placebo significantly reduced C1M, C3M, and C4M levels, whereas guselkumab 100 mg every 8 weeks vs. placebo significantly reduced C3M, C4M, and C6M levels (all adjusted P < .05), with improvements maintained up to week 52 (all adjusted P ≤ .0001).
Study details: Findings are from an exploratory analysis of the phase 3 DISCOVER 2 study that included 260 patients with active PsA and an inadequate response to standard and 76 HC.
Disclosures: This study was supported by Janssen Research & Development, LLC. Eight authors declared being employees of Janssen and owned stock in Johnson & Johnson, the parent company for Janssen. The other authors reported ties with several sources, including Janssen.
Source: Schett G et al. collagen turnover biomarkers associate with active psoriatic arthritis and decrease with guselkumab treatment in a phase 3 clinical trial (DISCOVER-2). Rheumatol Ther. 2022 (Mar 30). Doi: 10.1007/s40744-022-00444-x
Key clinical point: Serum levels of certain collagen degradation biomarkers were elevated in patients with psoriatic arthritis (PsA) vs. healthy controls (HC) and could be effectively lowered with guselkumab.
Major finding: Baseline serum concentrations of collagen degradation biomarkers C1M, C3M, C4M, and C6M were ≥1.25-times higher in patients with PsA vs. HC (adjusted P < .05). At week 24, 100 mg guselkumab every 4 weeks vs. placebo significantly reduced C1M, C3M, and C4M levels, whereas guselkumab 100 mg every 8 weeks vs. placebo significantly reduced C3M, C4M, and C6M levels (all adjusted P < .05), with improvements maintained up to week 52 (all adjusted P ≤ .0001).
Study details: Findings are from an exploratory analysis of the phase 3 DISCOVER 2 study that included 260 patients with active PsA and an inadequate response to standard and 76 HC.
Disclosures: This study was supported by Janssen Research & Development, LLC. Eight authors declared being employees of Janssen and owned stock in Johnson & Johnson, the parent company for Janssen. The other authors reported ties with several sources, including Janssen.
Source: Schett G et al. collagen turnover biomarkers associate with active psoriatic arthritis and decrease with guselkumab treatment in a phase 3 clinical trial (DISCOVER-2). Rheumatol Ther. 2022 (Mar 30). Doi: 10.1007/s40744-022-00444-x
Key clinical point: Serum levels of certain collagen degradation biomarkers were elevated in patients with psoriatic arthritis (PsA) vs. healthy controls (HC) and could be effectively lowered with guselkumab.
Major finding: Baseline serum concentrations of collagen degradation biomarkers C1M, C3M, C4M, and C6M were ≥1.25-times higher in patients with PsA vs. HC (adjusted P < .05). At week 24, 100 mg guselkumab every 4 weeks vs. placebo significantly reduced C1M, C3M, and C4M levels, whereas guselkumab 100 mg every 8 weeks vs. placebo significantly reduced C3M, C4M, and C6M levels (all adjusted P < .05), with improvements maintained up to week 52 (all adjusted P ≤ .0001).
Study details: Findings are from an exploratory analysis of the phase 3 DISCOVER 2 study that included 260 patients with active PsA and an inadequate response to standard and 76 HC.
Disclosures: This study was supported by Janssen Research & Development, LLC. Eight authors declared being employees of Janssen and owned stock in Johnson & Johnson, the parent company for Janssen. The other authors reported ties with several sources, including Janssen.
Source: Schett G et al. collagen turnover biomarkers associate with active psoriatic arthritis and decrease with guselkumab treatment in a phase 3 clinical trial (DISCOVER-2). Rheumatol Ther. 2022 (Mar 30). Doi: 10.1007/s40744-022-00444-x
Large integrated safety analysis reinforces known safety profile of ixekizumab in PsA
Key clinical point: Ixekizumab demonstrated an overall consistent safety and tolerability profile with no unexpected/new adverse events (AE) in patients with psoriatic arthritis (PsA) and up to 3 years of exposure to ixekizumab.
Major finding: Treatment-emergent (mostly mild/moderate) and serious AE occurred in 80.7% and 9.6% of patients, respectively. The most common infections were nasopharyngitis, upper respiratory tract infection, bronchitis, and sinusitis, with frequency for serious events being ≤2%. The exposure-adjusted incidence rate for treatment-emergent AE reduced from 87 in the first year to 67.3 in the third year of ixekizumab exposure and was <2 for malignancies, inflammatory bowel disease, depression, and major adverse cerebrocardiovascular events.
Study details: This integrated safety analysis of four phase 3 trials included 1401 patients with active PsA and a cumulative ixekizumab exposure of 2247.7 patient-years.
Disclosures: This study was supported by Eli Lilly and Company. Five authors declared being employees and shareholders of Eli Lilly and Company and other authors reported ties with various sources, including Eli Lilly.
Source: Deodhar AA et al. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 (Apr 7). Doi: 10.1136/annrheumdis-2021-222027
Key clinical point: Ixekizumab demonstrated an overall consistent safety and tolerability profile with no unexpected/new adverse events (AE) in patients with psoriatic arthritis (PsA) and up to 3 years of exposure to ixekizumab.
Major finding: Treatment-emergent (mostly mild/moderate) and serious AE occurred in 80.7% and 9.6% of patients, respectively. The most common infections were nasopharyngitis, upper respiratory tract infection, bronchitis, and sinusitis, with frequency for serious events being ≤2%. The exposure-adjusted incidence rate for treatment-emergent AE reduced from 87 in the first year to 67.3 in the third year of ixekizumab exposure and was <2 for malignancies, inflammatory bowel disease, depression, and major adverse cerebrocardiovascular events.
Study details: This integrated safety analysis of four phase 3 trials included 1401 patients with active PsA and a cumulative ixekizumab exposure of 2247.7 patient-years.
Disclosures: This study was supported by Eli Lilly and Company. Five authors declared being employees and shareholders of Eli Lilly and Company and other authors reported ties with various sources, including Eli Lilly.
Source: Deodhar AA et al. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 (Apr 7). Doi: 10.1136/annrheumdis-2021-222027
Key clinical point: Ixekizumab demonstrated an overall consistent safety and tolerability profile with no unexpected/new adverse events (AE) in patients with psoriatic arthritis (PsA) and up to 3 years of exposure to ixekizumab.
Major finding: Treatment-emergent (mostly mild/moderate) and serious AE occurred in 80.7% and 9.6% of patients, respectively. The most common infections were nasopharyngitis, upper respiratory tract infection, bronchitis, and sinusitis, with frequency for serious events being ≤2%. The exposure-adjusted incidence rate for treatment-emergent AE reduced from 87 in the first year to 67.3 in the third year of ixekizumab exposure and was <2 for malignancies, inflammatory bowel disease, depression, and major adverse cerebrocardiovascular events.
Study details: This integrated safety analysis of four phase 3 trials included 1401 patients with active PsA and a cumulative ixekizumab exposure of 2247.7 patient-years.
Disclosures: This study was supported by Eli Lilly and Company. Five authors declared being employees and shareholders of Eli Lilly and Company and other authors reported ties with various sources, including Eli Lilly.
Source: Deodhar AA et al. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 (Apr 7). Doi: 10.1136/annrheumdis-2021-222027
Multimodal imaging of DIP-joint and SEC can help distinguish PsA from psoriasis or OA
Key clinical point: Ultrasound (US), magnetic resonance imaging (MRI), and X-ray could differentiate psoriatic arthritis (PsA) from psoriasis and hand osteoarthritis (OA) based on the degree of structural involvement in the distal interphalangeal (DIP)-joint and synovio-entheseal complex (SEC).
Major finding: US-detected new bone formation (NBF; risk ratio [RR] 0.52; P < .001) and DIP-joint synovial hypertrophy (RR 0.66; P = .005) along with PsA MRI scores (all P < .001) were associated with a lower risk for PsA vs. OA. Patients with PsA vs. psoriasis had a higher prevalence of X-ray entheseal change (mean difference 0.42; P = .024) and a higher trend toward US-detected NBF and erosions.
Study details: This prospective, cross-sectional study included 50 patients with DIP-joint PsA and nail involvement, 12 patients with psoriasis and nail involvement, and 13 patients with erosive and nonerosive OA.
Disclosures: The study was funded by Novartis, The Oak Foundation, and others. Some authors declared receiving speaker/consulting fees, research grants, or honoraria or serving as members of advisory board or consultants for several sources.
Source: Guldberg-Møller J et al. Multimodal imaging of the distal interphalangeal-joint synovio-entheseal complex in psoriatic arthritis (MIDAS): A cross-sectional study on the diagnostic accuracy of different imaging modalities comparing psoriatic arthritis to psoriasis and osteoarthritis. RMD Open. 2022;8:e002109 (Mar 28). Doi: 10.1136/rmdopen-2021-002109
Key clinical point: Ultrasound (US), magnetic resonance imaging (MRI), and X-ray could differentiate psoriatic arthritis (PsA) from psoriasis and hand osteoarthritis (OA) based on the degree of structural involvement in the distal interphalangeal (DIP)-joint and synovio-entheseal complex (SEC).
Major finding: US-detected new bone formation (NBF; risk ratio [RR] 0.52; P < .001) and DIP-joint synovial hypertrophy (RR 0.66; P = .005) along with PsA MRI scores (all P < .001) were associated with a lower risk for PsA vs. OA. Patients with PsA vs. psoriasis had a higher prevalence of X-ray entheseal change (mean difference 0.42; P = .024) and a higher trend toward US-detected NBF and erosions.
Study details: This prospective, cross-sectional study included 50 patients with DIP-joint PsA and nail involvement, 12 patients with psoriasis and nail involvement, and 13 patients with erosive and nonerosive OA.
Disclosures: The study was funded by Novartis, The Oak Foundation, and others. Some authors declared receiving speaker/consulting fees, research grants, or honoraria or serving as members of advisory board or consultants for several sources.
Source: Guldberg-Møller J et al. Multimodal imaging of the distal interphalangeal-joint synovio-entheseal complex in psoriatic arthritis (MIDAS): A cross-sectional study on the diagnostic accuracy of different imaging modalities comparing psoriatic arthritis to psoriasis and osteoarthritis. RMD Open. 2022;8:e002109 (Mar 28). Doi: 10.1136/rmdopen-2021-002109
Key clinical point: Ultrasound (US), magnetic resonance imaging (MRI), and X-ray could differentiate psoriatic arthritis (PsA) from psoriasis and hand osteoarthritis (OA) based on the degree of structural involvement in the distal interphalangeal (DIP)-joint and synovio-entheseal complex (SEC).
Major finding: US-detected new bone formation (NBF; risk ratio [RR] 0.52; P < .001) and DIP-joint synovial hypertrophy (RR 0.66; P = .005) along with PsA MRI scores (all P < .001) were associated with a lower risk for PsA vs. OA. Patients with PsA vs. psoriasis had a higher prevalence of X-ray entheseal change (mean difference 0.42; P = .024) and a higher trend toward US-detected NBF and erosions.
Study details: This prospective, cross-sectional study included 50 patients with DIP-joint PsA and nail involvement, 12 patients with psoriasis and nail involvement, and 13 patients with erosive and nonerosive OA.
Disclosures: The study was funded by Novartis, The Oak Foundation, and others. Some authors declared receiving speaker/consulting fees, research grants, or honoraria or serving as members of advisory board or consultants for several sources.
Source: Guldberg-Møller J et al. Multimodal imaging of the distal interphalangeal-joint synovio-entheseal complex in psoriatic arthritis (MIDAS): A cross-sectional study on the diagnostic accuracy of different imaging modalities comparing psoriatic arthritis to psoriasis and osteoarthritis. RMD Open. 2022;8:e002109 (Mar 28). Doi: 10.1136/rmdopen-2021-002109
Factors associated with increased sleep disturbance in PsA
Key clinical point: Sleep disturbance was more prevalent in patients with psoriatic arthritis (PsA) than in those with psoriasis or healthy controls (HC) without inflammatory illnesses and was associated with various inflammatory and noninflammatory variables.
Major finding: Sleep disturbances were reported by 66.1% of patients with PsA vs. 45.0% of patients with psoriasis, and 15.0% of HC. Poor quality sleep was associated with tender points (P = .017), pain (P = .009), and global health scores (P = .005) and could not be resolved by immunosuppressive medical therapy.
Study details: This cross-sectional study included 109 patients with PsA who initiated or switched treatment with conventional synthetic or biological disease-modifying antirheumatic drugs, 20 patients with psoriasis, and 20 HC.
Disclosures: This study was supported by the Elisabeth and Karl Ejnar Nis-Hanssens Mindelegat, Minister Erna Hamiltons Legat for Videnskab og Kunst, and Oak Foundation. Some authors declared serving as consultants, investigators, or speakers, or receiving fees, honoraria, and research funding from several sources. JG Gerwien declared being an employee and stakeholder of Eli Lilly.
Source: Skougaard M et al. Increased prevalence of sleep disturbance in psoriatic arthritis is associated with inflammatory and non-inflammatory measures. Scand J Rheumatol. 2022 (Mar 18). Doi: 10.1080/03009742.2022.2044116
Key clinical point: Sleep disturbance was more prevalent in patients with psoriatic arthritis (PsA) than in those with psoriasis or healthy controls (HC) without inflammatory illnesses and was associated with various inflammatory and noninflammatory variables.
Major finding: Sleep disturbances were reported by 66.1% of patients with PsA vs. 45.0% of patients with psoriasis, and 15.0% of HC. Poor quality sleep was associated with tender points (P = .017), pain (P = .009), and global health scores (P = .005) and could not be resolved by immunosuppressive medical therapy.
Study details: This cross-sectional study included 109 patients with PsA who initiated or switched treatment with conventional synthetic or biological disease-modifying antirheumatic drugs, 20 patients with psoriasis, and 20 HC.
Disclosures: This study was supported by the Elisabeth and Karl Ejnar Nis-Hanssens Mindelegat, Minister Erna Hamiltons Legat for Videnskab og Kunst, and Oak Foundation. Some authors declared serving as consultants, investigators, or speakers, or receiving fees, honoraria, and research funding from several sources. JG Gerwien declared being an employee and stakeholder of Eli Lilly.
Source: Skougaard M et al. Increased prevalence of sleep disturbance in psoriatic arthritis is associated with inflammatory and non-inflammatory measures. Scand J Rheumatol. 2022 (Mar 18). Doi: 10.1080/03009742.2022.2044116
Key clinical point: Sleep disturbance was more prevalent in patients with psoriatic arthritis (PsA) than in those with psoriasis or healthy controls (HC) without inflammatory illnesses and was associated with various inflammatory and noninflammatory variables.
Major finding: Sleep disturbances were reported by 66.1% of patients with PsA vs. 45.0% of patients with psoriasis, and 15.0% of HC. Poor quality sleep was associated with tender points (P = .017), pain (P = .009), and global health scores (P = .005) and could not be resolved by immunosuppressive medical therapy.
Study details: This cross-sectional study included 109 patients with PsA who initiated or switched treatment with conventional synthetic or biological disease-modifying antirheumatic drugs, 20 patients with psoriasis, and 20 HC.
Disclosures: This study was supported by the Elisabeth and Karl Ejnar Nis-Hanssens Mindelegat, Minister Erna Hamiltons Legat for Videnskab og Kunst, and Oak Foundation. Some authors declared serving as consultants, investigators, or speakers, or receiving fees, honoraria, and research funding from several sources. JG Gerwien declared being an employee and stakeholder of Eli Lilly.
Source: Skougaard M et al. Increased prevalence of sleep disturbance in psoriatic arthritis is associated with inflammatory and non-inflammatory measures. Scand J Rheumatol. 2022 (Mar 18). Doi: 10.1080/03009742.2022.2044116
Differential response to ixekizumab among males and females with PsA
Key clinical point: Female vs. male patients with psoriatic arthritis (PsA) and a prior inadequate response to treatment exhibited significantly higher disease activity at baseline and a worse response to ixekizumab.
Major finding: At baseline, female vs. male patients had significantly higher Health Assessment Questionnaire Disability Index scores (P ≤ .003), with a significantly higher proportion of male vs. female patients in the ixekizumab every 4 weeks (53.8% vs. 38.3%) and ixekizumab every 2 weeks (41.2% vs. 28.1%) treatment arms achieving ≥50% and ≥70% improvement in the American College of Rheumatology criteria, respectively (both P < .05).
Study details: This post hoc analysis of two phase 3 trials included 679 patients with active PsA who were either biologic-naive (SPIRIT-P1) or showed an inadequate response to 1 or 2 tumor necrosis factor inhibitors (SPIRIT-P2) and were randomly assigned to receive ixekizumab or placebo.
Disclosures: This study was supported by Eli Lilly and Company. Five authors declared being employees and shareholders of Eli Lilly and Company and other authors reported ties with various sources, including Eli Lilly.
Source: Eder L et al. Responses to ixekizumab in male and female patients with psoriatic arthritis: Results from two randomized, phase 3 clinical trials. Rheumatol Ther. 2022 (Apr 9). Doi: 10.1007/s40744-022-00445-w
Key clinical point: Female vs. male patients with psoriatic arthritis (PsA) and a prior inadequate response to treatment exhibited significantly higher disease activity at baseline and a worse response to ixekizumab.
Major finding: At baseline, female vs. male patients had significantly higher Health Assessment Questionnaire Disability Index scores (P ≤ .003), with a significantly higher proportion of male vs. female patients in the ixekizumab every 4 weeks (53.8% vs. 38.3%) and ixekizumab every 2 weeks (41.2% vs. 28.1%) treatment arms achieving ≥50% and ≥70% improvement in the American College of Rheumatology criteria, respectively (both P < .05).
Study details: This post hoc analysis of two phase 3 trials included 679 patients with active PsA who were either biologic-naive (SPIRIT-P1) or showed an inadequate response to 1 or 2 tumor necrosis factor inhibitors (SPIRIT-P2) and were randomly assigned to receive ixekizumab or placebo.
Disclosures: This study was supported by Eli Lilly and Company. Five authors declared being employees and shareholders of Eli Lilly and Company and other authors reported ties with various sources, including Eli Lilly.
Source: Eder L et al. Responses to ixekizumab in male and female patients with psoriatic arthritis: Results from two randomized, phase 3 clinical trials. Rheumatol Ther. 2022 (Apr 9). Doi: 10.1007/s40744-022-00445-w
Key clinical point: Female vs. male patients with psoriatic arthritis (PsA) and a prior inadequate response to treatment exhibited significantly higher disease activity at baseline and a worse response to ixekizumab.
Major finding: At baseline, female vs. male patients had significantly higher Health Assessment Questionnaire Disability Index scores (P ≤ .003), with a significantly higher proportion of male vs. female patients in the ixekizumab every 4 weeks (53.8% vs. 38.3%) and ixekizumab every 2 weeks (41.2% vs. 28.1%) treatment arms achieving ≥50% and ≥70% improvement in the American College of Rheumatology criteria, respectively (both P < .05).
Study details: This post hoc analysis of two phase 3 trials included 679 patients with active PsA who were either biologic-naive (SPIRIT-P1) or showed an inadequate response to 1 or 2 tumor necrosis factor inhibitors (SPIRIT-P2) and were randomly assigned to receive ixekizumab or placebo.
Disclosures: This study was supported by Eli Lilly and Company. Five authors declared being employees and shareholders of Eli Lilly and Company and other authors reported ties with various sources, including Eli Lilly.
Source: Eder L et al. Responses to ixekizumab in male and female patients with psoriatic arthritis: Results from two randomized, phase 3 clinical trials. Rheumatol Ther. 2022 (Apr 9). Doi: 10.1007/s40744-022-00445-w
Dermatological improvements translate to enhanced QoL in PsA
Key clinical point: Dermatological symptoms are substantially associated with the quality of life (QoL) in patients with active psoriatic arthritis (PsA) and improvements in dermatology measures could translate to clinically meaningful improvements in their QoL.
Major finding: Itch severity item (ISI) scores of 7-10, Physician’s Global Assessment of Psoriasis (PGA-PsO) scores of 4, and Patient’s Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) scores of 90-100 mm corresponded with Dermatology Life Quality Index (DLQI) scores categorized as having a very large effect on a patient’s life. An improvement of ≥3 points in ISI, ≥2 points in PGA-PsO, and ≥40 mm in PGJS-VAS translated to a clinically meaningful improvement in DLQI scores.
Study details: This post hoc analysis of two phase 3 studies, OPAL Broaden and OPAL Beyond, included 816 patients with active PsA and an inadequate response to previous therapies who received tofacitinib, adalimumab, or placebo.
Disclosures: This study was funded by Pfizer. Four authors reported being employees or stockholders of Pfizer. The other authors reported ties with several sources, including Pfizer.
Source: Taylor PC et al. Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies. J Dermatol Treat. 2022 (Apr 11). Doi: 10.1080/09546634.2022.2060924
Key clinical point: Dermatological symptoms are substantially associated with the quality of life (QoL) in patients with active psoriatic arthritis (PsA) and improvements in dermatology measures could translate to clinically meaningful improvements in their QoL.
Major finding: Itch severity item (ISI) scores of 7-10, Physician’s Global Assessment of Psoriasis (PGA-PsO) scores of 4, and Patient’s Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) scores of 90-100 mm corresponded with Dermatology Life Quality Index (DLQI) scores categorized as having a very large effect on a patient’s life. An improvement of ≥3 points in ISI, ≥2 points in PGA-PsO, and ≥40 mm in PGJS-VAS translated to a clinically meaningful improvement in DLQI scores.
Study details: This post hoc analysis of two phase 3 studies, OPAL Broaden and OPAL Beyond, included 816 patients with active PsA and an inadequate response to previous therapies who received tofacitinib, adalimumab, or placebo.
Disclosures: This study was funded by Pfizer. Four authors reported being employees or stockholders of Pfizer. The other authors reported ties with several sources, including Pfizer.
Source: Taylor PC et al. Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies. J Dermatol Treat. 2022 (Apr 11). Doi: 10.1080/09546634.2022.2060924
Key clinical point: Dermatological symptoms are substantially associated with the quality of life (QoL) in patients with active psoriatic arthritis (PsA) and improvements in dermatology measures could translate to clinically meaningful improvements in their QoL.
Major finding: Itch severity item (ISI) scores of 7-10, Physician’s Global Assessment of Psoriasis (PGA-PsO) scores of 4, and Patient’s Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) scores of 90-100 mm corresponded with Dermatology Life Quality Index (DLQI) scores categorized as having a very large effect on a patient’s life. An improvement of ≥3 points in ISI, ≥2 points in PGA-PsO, and ≥40 mm in PGJS-VAS translated to a clinically meaningful improvement in DLQI scores.
Study details: This post hoc analysis of two phase 3 studies, OPAL Broaden and OPAL Beyond, included 816 patients with active PsA and an inadequate response to previous therapies who received tofacitinib, adalimumab, or placebo.
Disclosures: This study was funded by Pfizer. Four authors reported being employees or stockholders of Pfizer. The other authors reported ties with several sources, including Pfizer.
Source: Taylor PC et al. Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies. J Dermatol Treat. 2022 (Apr 11). Doi: 10.1080/09546634.2022.2060924