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Albuminuria reduction fuels finerenone’s kidney benefits
PHILADELPHIA – Reducing albuminuria is a key mediator of the way finerenone (Kerendia, Bayer) reduces adverse renal and cardiovascular events in people with type 2 diabetes and chronic kidney disease (CKD), based on findings from two novel mediation analyses run on data from more than 12,000 people included in the two finerenone pivotal trials.
Results from these analyses showed that that finerenone treatment produced in the FIDELIO-DKD and FIGARO-DKD phase 3 trials. FIDELIO-DKD, which had protection against adverse kidney outcomes as its primary endpoint, supplied the data that led to finerenone’s approval in 2021 by the U.S. Food and Drug Administration for treating people with type 2 diabetes and CKD.
The findings of the mediation analyses underscore the important role that albuminuria plays in the nephropathy and related comorbidities associated with type 2 diabetes and CKD and highlight the importance of ongoing monitoring of albuminuria to guide treatments aimed at minimizing this pathology, said Rajiv Agarwal, MD, who presented a poster on the mediation analyses at Kidney Week 2023, organized by the American Society of Nephrology.
“My hope is that this [report] heightens awareness of UACR” as an important marker of both CKD and of the response by patients with CKD to their treatment, said Dr. Agarwal, a nephrologist and professor at Indiana University in Indianapolis.
“Only about half of people with type 2 diabetes get their UACR measured even though every guideline says measure UACR in people with diabetes. Our findings say that UACR is important not just for CKD diagnosis but also to give feedback” on whether management is working, Dr. Agarwal said in an interview.
Incorporate UACR into clinical decision-making
“My hope is that clinicians will look at UACR as something they should incorporate into clinical decision-making. I measure UACR in my patients [with CKD and type 2 diabetes] at every visit; it’s so inexpensive. Albuminuria is not a good sign. If it’s not reduced in a patient by at least 30% [the recommended minimum reduction by the American Diabetes Association for people who start with a UACR of at least 300 mg/g] clinicians should think of what else they could do to lower albuminuria”: Reduce salt intake, improve blood pressure control, make sure the patient is adherent to treatments, and add additional treatments, Dr. Agarwal advised.
Multiple efforts are now underway or will soon start to boost the rate at which at-risk people get their UACR measured, noted Leslie A. Inker, MD, in a separate talk during Kidney Week. These efforts include the National Kidney Foundation’s CKD Learning Collaborative, which aims to improve clinician awareness of CKD and improve routine testing for CKD. Early results during 2023 from this program in Missouri showed a nearly 8–percentage point increase in the screening rate for UACR levels in at-risk people, said Dr. Inker, professor and director of the Kidney and Blood Pressure Center at Tufts Medical Center in Boston.
A second advance was introduction in 2018 of the “kidney profile” lab order by the American College of Clinical Pathology that allows clinicians to order as a single test both an estimated glomerular filtration rate (eGFR) and a UACR.
Also, the Centers for Medicare & Medicaid Services and the National Committee for Quality Assurance have both taken steps to encourage UACR ordering. The NCQA established a new Healthcare Effectiveness Data and Information Set performance measure for U.S. physicians starting in 2023 that will track measurement of UACR and eGFR in people with diabetes. CMS also has made assessment of kidney health a measure of care quality in programs effective in 2023 and 2024, Dr. Inker noted.
Most subjects had elevated UACRs
The study run by Dr. Agarwal and his associates used data from 12,512 of the more than 13,000 people enrolled in either FIDELITY-DKD or FIGARO-DKD who had UACR measurements recorded at baseline, at 4 months into either study, or both. Their median UACR at the time they began on finerenone or placebo was 514 mg/g, with 67% having a UACR of at least 300 mg/g (macroalbuminuria) and 31% having a UACR of 30-299 mg/g (microalbuminuria). By design, virtually all patients in these two trials were on a renin-angiotensin system inhibitor (either an angiotensin-converting enzyme inhibitor or an angiotensin-receptor blocker), but given the time period when the two trials enrolled participants (during 2015-2018) only 7% of those enrolled were on a sodium-glucose cotransporter 2 inhibitor and only 7% were on a glucagonlike peptide–1 receptor agonist.
Four months after treatment began, 53% of those randomized to finerenone treatment and 27% of those in the placebo arm had their UACR reduced by at least 30% from baseline, the cutpoint chosen by Dr. Agarwal based on the American Diabetes Association guideline.
Kaplan-Meier analyses showed that the incidence of the primary kidney outcome – kidney failure, a sustained ≥ 57% decrease in eGFR from baseline, or kidney death – showed close correlation with at least a 30% reduction in UACR regardless of whether the patients in this subgroup received finerenone or placebo.
A different correlation was found in those with a less than 30% reduction in their UACR from baseline to 4 months, regardless of whether this happened on finerenone or placebo. People in the two finerenone trials who had a lesser reduction from baseline in their UACR also had a significantly higher rate of adverse kidney outcomes whether they received finerenone or placebo.
84% of finerenone’s kidney benefit linked to lowering of UACR
The causal-mediation analysis run by Dr. Agarwal quantified this observation, showing that 84% of finerenone’s effect on the kidney outcome was mediated by the reduction in UACR.
“It seems like the kidney benefit [from finerenone] travels through the level of albuminuria. This has broad implications for treatment of people with type 2 diabetes and CKD,” he said.
The link with reduction in albuminuria was weaker for the primary cardiovascular disease outcome: CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. The strongest effect on this outcome was only seen in Kaplan-Meier analysis in those on finerenone who had at least a 30% reduction in their UACR. Those on placebo and with a similarly robust 4-month reduction in UACR showed a much more modest cardiovascular benefit that resembled those on either finerenone or placebo who had a smaller, less than 30% UACR reduction. The mediation analysis of these data showed that UACR reduction accounted for about 37% of the observed cardiovascular benefit seen during the trials.
“The effect of UACR is much stronger for the kidney outcomes,” summed up Dr. Agarwal. The results suggest that for cardiovascular outcomes finerenone works through factors other than lowering of UACR, but he admitted that no one currently knows what those other factors might be.
Treat aggressively to lower UACR by 30%
“I wouldn’t stop finerenone treatment in people who do not get a 30% reduction in their UACR” because these analyses suggest that a portion of the overall benefits from finerenone occurs via other mechanisms, he said. But in patients whose UACR is not reduced by at least 30% “be more aggressive on other measures to reduce UACR,” he advised.
The mediation analyses he ran are “the first time this has been done in nephrology,” producing a “groundbreaking” analysis and finding, Dr. Agarwal said. He also highlighted that the findings primarily relate to the importance of controlling UACR rather than an endorsement of finerenone as the best way to achieve this.
“All I care about is that people think about UACR as a modifiable risk factor. It doesn’t have to be treated with finerenone. It could be a renin-angiotensin system inhibitor, it could be chlorthalidone [a thiazide diuretic]. It just happened that we had a large dataset of people treated with finerenone or placebo.”
He said that future mediation analyses should look at the link between outcomes and UACR reductions produced by agents from the classes of sodium-glucose cotransporter 2 inhibitors and the glucagonlike peptide–1 receptor agonists.
FIDELIO-DKD and FIGARO-DKD were both sponsored by Bayer, the company that markets finerenone. Dr. Agarwal has received personal fees and nonfinancial support from Bayer. He has also received personal fees and nonfinancial support from Akebia Therapeutics, AstraZeneca, Boehringer Ingelheim, Eli Lilly, and Vifor Pharma, and he is a member of data safety monitoring committees for Chinook and Vertex. Dr. Inker is a consultant to Diamtrix, and her department receives research funding from Chinook, Omeros, Reata, and Tricida.
PHILADELPHIA – Reducing albuminuria is a key mediator of the way finerenone (Kerendia, Bayer) reduces adverse renal and cardiovascular events in people with type 2 diabetes and chronic kidney disease (CKD), based on findings from two novel mediation analyses run on data from more than 12,000 people included in the two finerenone pivotal trials.
Results from these analyses showed that that finerenone treatment produced in the FIDELIO-DKD and FIGARO-DKD phase 3 trials. FIDELIO-DKD, which had protection against adverse kidney outcomes as its primary endpoint, supplied the data that led to finerenone’s approval in 2021 by the U.S. Food and Drug Administration for treating people with type 2 diabetes and CKD.
The findings of the mediation analyses underscore the important role that albuminuria plays in the nephropathy and related comorbidities associated with type 2 diabetes and CKD and highlight the importance of ongoing monitoring of albuminuria to guide treatments aimed at minimizing this pathology, said Rajiv Agarwal, MD, who presented a poster on the mediation analyses at Kidney Week 2023, organized by the American Society of Nephrology.
“My hope is that this [report] heightens awareness of UACR” as an important marker of both CKD and of the response by patients with CKD to their treatment, said Dr. Agarwal, a nephrologist and professor at Indiana University in Indianapolis.
“Only about half of people with type 2 diabetes get their UACR measured even though every guideline says measure UACR in people with diabetes. Our findings say that UACR is important not just for CKD diagnosis but also to give feedback” on whether management is working, Dr. Agarwal said in an interview.
Incorporate UACR into clinical decision-making
“My hope is that clinicians will look at UACR as something they should incorporate into clinical decision-making. I measure UACR in my patients [with CKD and type 2 diabetes] at every visit; it’s so inexpensive. Albuminuria is not a good sign. If it’s not reduced in a patient by at least 30% [the recommended minimum reduction by the American Diabetes Association for people who start with a UACR of at least 300 mg/g] clinicians should think of what else they could do to lower albuminuria”: Reduce salt intake, improve blood pressure control, make sure the patient is adherent to treatments, and add additional treatments, Dr. Agarwal advised.
Multiple efforts are now underway or will soon start to boost the rate at which at-risk people get their UACR measured, noted Leslie A. Inker, MD, in a separate talk during Kidney Week. These efforts include the National Kidney Foundation’s CKD Learning Collaborative, which aims to improve clinician awareness of CKD and improve routine testing for CKD. Early results during 2023 from this program in Missouri showed a nearly 8–percentage point increase in the screening rate for UACR levels in at-risk people, said Dr. Inker, professor and director of the Kidney and Blood Pressure Center at Tufts Medical Center in Boston.
A second advance was introduction in 2018 of the “kidney profile” lab order by the American College of Clinical Pathology that allows clinicians to order as a single test both an estimated glomerular filtration rate (eGFR) and a UACR.
Also, the Centers for Medicare & Medicaid Services and the National Committee for Quality Assurance have both taken steps to encourage UACR ordering. The NCQA established a new Healthcare Effectiveness Data and Information Set performance measure for U.S. physicians starting in 2023 that will track measurement of UACR and eGFR in people with diabetes. CMS also has made assessment of kidney health a measure of care quality in programs effective in 2023 and 2024, Dr. Inker noted.
Most subjects had elevated UACRs
The study run by Dr. Agarwal and his associates used data from 12,512 of the more than 13,000 people enrolled in either FIDELITY-DKD or FIGARO-DKD who had UACR measurements recorded at baseline, at 4 months into either study, or both. Their median UACR at the time they began on finerenone or placebo was 514 mg/g, with 67% having a UACR of at least 300 mg/g (macroalbuminuria) and 31% having a UACR of 30-299 mg/g (microalbuminuria). By design, virtually all patients in these two trials were on a renin-angiotensin system inhibitor (either an angiotensin-converting enzyme inhibitor or an angiotensin-receptor blocker), but given the time period when the two trials enrolled participants (during 2015-2018) only 7% of those enrolled were on a sodium-glucose cotransporter 2 inhibitor and only 7% were on a glucagonlike peptide–1 receptor agonist.
Four months after treatment began, 53% of those randomized to finerenone treatment and 27% of those in the placebo arm had their UACR reduced by at least 30% from baseline, the cutpoint chosen by Dr. Agarwal based on the American Diabetes Association guideline.
Kaplan-Meier analyses showed that the incidence of the primary kidney outcome – kidney failure, a sustained ≥ 57% decrease in eGFR from baseline, or kidney death – showed close correlation with at least a 30% reduction in UACR regardless of whether the patients in this subgroup received finerenone or placebo.
A different correlation was found in those with a less than 30% reduction in their UACR from baseline to 4 months, regardless of whether this happened on finerenone or placebo. People in the two finerenone trials who had a lesser reduction from baseline in their UACR also had a significantly higher rate of adverse kidney outcomes whether they received finerenone or placebo.
84% of finerenone’s kidney benefit linked to lowering of UACR
The causal-mediation analysis run by Dr. Agarwal quantified this observation, showing that 84% of finerenone’s effect on the kidney outcome was mediated by the reduction in UACR.
“It seems like the kidney benefit [from finerenone] travels through the level of albuminuria. This has broad implications for treatment of people with type 2 diabetes and CKD,” he said.
The link with reduction in albuminuria was weaker for the primary cardiovascular disease outcome: CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. The strongest effect on this outcome was only seen in Kaplan-Meier analysis in those on finerenone who had at least a 30% reduction in their UACR. Those on placebo and with a similarly robust 4-month reduction in UACR showed a much more modest cardiovascular benefit that resembled those on either finerenone or placebo who had a smaller, less than 30% UACR reduction. The mediation analysis of these data showed that UACR reduction accounted for about 37% of the observed cardiovascular benefit seen during the trials.
“The effect of UACR is much stronger for the kidney outcomes,” summed up Dr. Agarwal. The results suggest that for cardiovascular outcomes finerenone works through factors other than lowering of UACR, but he admitted that no one currently knows what those other factors might be.
Treat aggressively to lower UACR by 30%
“I wouldn’t stop finerenone treatment in people who do not get a 30% reduction in their UACR” because these analyses suggest that a portion of the overall benefits from finerenone occurs via other mechanisms, he said. But in patients whose UACR is not reduced by at least 30% “be more aggressive on other measures to reduce UACR,” he advised.
The mediation analyses he ran are “the first time this has been done in nephrology,” producing a “groundbreaking” analysis and finding, Dr. Agarwal said. He also highlighted that the findings primarily relate to the importance of controlling UACR rather than an endorsement of finerenone as the best way to achieve this.
“All I care about is that people think about UACR as a modifiable risk factor. It doesn’t have to be treated with finerenone. It could be a renin-angiotensin system inhibitor, it could be chlorthalidone [a thiazide diuretic]. It just happened that we had a large dataset of people treated with finerenone or placebo.”
He said that future mediation analyses should look at the link between outcomes and UACR reductions produced by agents from the classes of sodium-glucose cotransporter 2 inhibitors and the glucagonlike peptide–1 receptor agonists.
FIDELIO-DKD and FIGARO-DKD were both sponsored by Bayer, the company that markets finerenone. Dr. Agarwal has received personal fees and nonfinancial support from Bayer. He has also received personal fees and nonfinancial support from Akebia Therapeutics, AstraZeneca, Boehringer Ingelheim, Eli Lilly, and Vifor Pharma, and he is a member of data safety monitoring committees for Chinook and Vertex. Dr. Inker is a consultant to Diamtrix, and her department receives research funding from Chinook, Omeros, Reata, and Tricida.
PHILADELPHIA – Reducing albuminuria is a key mediator of the way finerenone (Kerendia, Bayer) reduces adverse renal and cardiovascular events in people with type 2 diabetes and chronic kidney disease (CKD), based on findings from two novel mediation analyses run on data from more than 12,000 people included in the two finerenone pivotal trials.
Results from these analyses showed that that finerenone treatment produced in the FIDELIO-DKD and FIGARO-DKD phase 3 trials. FIDELIO-DKD, which had protection against adverse kidney outcomes as its primary endpoint, supplied the data that led to finerenone’s approval in 2021 by the U.S. Food and Drug Administration for treating people with type 2 diabetes and CKD.
The findings of the mediation analyses underscore the important role that albuminuria plays in the nephropathy and related comorbidities associated with type 2 diabetes and CKD and highlight the importance of ongoing monitoring of albuminuria to guide treatments aimed at minimizing this pathology, said Rajiv Agarwal, MD, who presented a poster on the mediation analyses at Kidney Week 2023, organized by the American Society of Nephrology.
“My hope is that this [report] heightens awareness of UACR” as an important marker of both CKD and of the response by patients with CKD to their treatment, said Dr. Agarwal, a nephrologist and professor at Indiana University in Indianapolis.
“Only about half of people with type 2 diabetes get their UACR measured even though every guideline says measure UACR in people with diabetes. Our findings say that UACR is important not just for CKD diagnosis but also to give feedback” on whether management is working, Dr. Agarwal said in an interview.
Incorporate UACR into clinical decision-making
“My hope is that clinicians will look at UACR as something they should incorporate into clinical decision-making. I measure UACR in my patients [with CKD and type 2 diabetes] at every visit; it’s so inexpensive. Albuminuria is not a good sign. If it’s not reduced in a patient by at least 30% [the recommended minimum reduction by the American Diabetes Association for people who start with a UACR of at least 300 mg/g] clinicians should think of what else they could do to lower albuminuria”: Reduce salt intake, improve blood pressure control, make sure the patient is adherent to treatments, and add additional treatments, Dr. Agarwal advised.
Multiple efforts are now underway or will soon start to boost the rate at which at-risk people get their UACR measured, noted Leslie A. Inker, MD, in a separate talk during Kidney Week. These efforts include the National Kidney Foundation’s CKD Learning Collaborative, which aims to improve clinician awareness of CKD and improve routine testing for CKD. Early results during 2023 from this program in Missouri showed a nearly 8–percentage point increase in the screening rate for UACR levels in at-risk people, said Dr. Inker, professor and director of the Kidney and Blood Pressure Center at Tufts Medical Center in Boston.
A second advance was introduction in 2018 of the “kidney profile” lab order by the American College of Clinical Pathology that allows clinicians to order as a single test both an estimated glomerular filtration rate (eGFR) and a UACR.
Also, the Centers for Medicare & Medicaid Services and the National Committee for Quality Assurance have both taken steps to encourage UACR ordering. The NCQA established a new Healthcare Effectiveness Data and Information Set performance measure for U.S. physicians starting in 2023 that will track measurement of UACR and eGFR in people with diabetes. CMS also has made assessment of kidney health a measure of care quality in programs effective in 2023 and 2024, Dr. Inker noted.
Most subjects had elevated UACRs
The study run by Dr. Agarwal and his associates used data from 12,512 of the more than 13,000 people enrolled in either FIDELITY-DKD or FIGARO-DKD who had UACR measurements recorded at baseline, at 4 months into either study, or both. Their median UACR at the time they began on finerenone or placebo was 514 mg/g, with 67% having a UACR of at least 300 mg/g (macroalbuminuria) and 31% having a UACR of 30-299 mg/g (microalbuminuria). By design, virtually all patients in these two trials were on a renin-angiotensin system inhibitor (either an angiotensin-converting enzyme inhibitor or an angiotensin-receptor blocker), but given the time period when the two trials enrolled participants (during 2015-2018) only 7% of those enrolled were on a sodium-glucose cotransporter 2 inhibitor and only 7% were on a glucagonlike peptide–1 receptor agonist.
Four months after treatment began, 53% of those randomized to finerenone treatment and 27% of those in the placebo arm had their UACR reduced by at least 30% from baseline, the cutpoint chosen by Dr. Agarwal based on the American Diabetes Association guideline.
Kaplan-Meier analyses showed that the incidence of the primary kidney outcome – kidney failure, a sustained ≥ 57% decrease in eGFR from baseline, or kidney death – showed close correlation with at least a 30% reduction in UACR regardless of whether the patients in this subgroup received finerenone or placebo.
A different correlation was found in those with a less than 30% reduction in their UACR from baseline to 4 months, regardless of whether this happened on finerenone or placebo. People in the two finerenone trials who had a lesser reduction from baseline in their UACR also had a significantly higher rate of adverse kidney outcomes whether they received finerenone or placebo.
84% of finerenone’s kidney benefit linked to lowering of UACR
The causal-mediation analysis run by Dr. Agarwal quantified this observation, showing that 84% of finerenone’s effect on the kidney outcome was mediated by the reduction in UACR.
“It seems like the kidney benefit [from finerenone] travels through the level of albuminuria. This has broad implications for treatment of people with type 2 diabetes and CKD,” he said.
The link with reduction in albuminuria was weaker for the primary cardiovascular disease outcome: CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. The strongest effect on this outcome was only seen in Kaplan-Meier analysis in those on finerenone who had at least a 30% reduction in their UACR. Those on placebo and with a similarly robust 4-month reduction in UACR showed a much more modest cardiovascular benefit that resembled those on either finerenone or placebo who had a smaller, less than 30% UACR reduction. The mediation analysis of these data showed that UACR reduction accounted for about 37% of the observed cardiovascular benefit seen during the trials.
“The effect of UACR is much stronger for the kidney outcomes,” summed up Dr. Agarwal. The results suggest that for cardiovascular outcomes finerenone works through factors other than lowering of UACR, but he admitted that no one currently knows what those other factors might be.
Treat aggressively to lower UACR by 30%
“I wouldn’t stop finerenone treatment in people who do not get a 30% reduction in their UACR” because these analyses suggest that a portion of the overall benefits from finerenone occurs via other mechanisms, he said. But in patients whose UACR is not reduced by at least 30% “be more aggressive on other measures to reduce UACR,” he advised.
The mediation analyses he ran are “the first time this has been done in nephrology,” producing a “groundbreaking” analysis and finding, Dr. Agarwal said. He also highlighted that the findings primarily relate to the importance of controlling UACR rather than an endorsement of finerenone as the best way to achieve this.
“All I care about is that people think about UACR as a modifiable risk factor. It doesn’t have to be treated with finerenone. It could be a renin-angiotensin system inhibitor, it could be chlorthalidone [a thiazide diuretic]. It just happened that we had a large dataset of people treated with finerenone or placebo.”
He said that future mediation analyses should look at the link between outcomes and UACR reductions produced by agents from the classes of sodium-glucose cotransporter 2 inhibitors and the glucagonlike peptide–1 receptor agonists.
FIDELIO-DKD and FIGARO-DKD were both sponsored by Bayer, the company that markets finerenone. Dr. Agarwal has received personal fees and nonfinancial support from Bayer. He has also received personal fees and nonfinancial support from Akebia Therapeutics, AstraZeneca, Boehringer Ingelheim, Eli Lilly, and Vifor Pharma, and he is a member of data safety monitoring committees for Chinook and Vertex. Dr. Inker is a consultant to Diamtrix, and her department receives research funding from Chinook, Omeros, Reata, and Tricida.
AT KIDNEY WEEK 2023
Entheseal ultrasound by dermatologists may not be effective for screening PsA
Key clinical point: In patients with psoriasis, the German Psoriasis Arthritis Diagnostic (GEPARD) questionnaire followed by a dermatological assessment can detect psoriatic arthritis (PsA) risk almost accurately, and entheseal ultrasound by dermatologists shows no additional benefits in this regard.
Major finding: PsA was diagnosed in 6 out of 40 patients, with a sensitivity of 100%; however, dermatologic ultrasound evaluation of the entheses alone was unable to confirm these findings. Of the remaining 34 patients with psoriasis, 8 were deemed by dermatologists as possibly having PsA based on the ultrasound examination although rheumatologists detected ultrasound abnormalities in only 3 patients.
Study details: Findings are from a cross-sectional study including 40 patients with psoriasis who completed the GEPARD questionnaire and subsequently underwent an assessment for PsA by a dermatologist and an ultrasound examination.
Disclosures: This study was supported by a conditional research grant from Rheumazentrum Erlangen-Nuremberg e.V. and AGJR Verbundprojekt. The authors declared no conflicts of interest.
Source: Bartsch V et al. Screening for psoriatic arthritis in dermatological settings—Are handheld ultrasound devices the gamechangers we hoped for? Rheumatology (Oxford). 2023 (Nov 3). doi: 10.1093/rheumatology/kead592
Key clinical point: In patients with psoriasis, the German Psoriasis Arthritis Diagnostic (GEPARD) questionnaire followed by a dermatological assessment can detect psoriatic arthritis (PsA) risk almost accurately, and entheseal ultrasound by dermatologists shows no additional benefits in this regard.
Major finding: PsA was diagnosed in 6 out of 40 patients, with a sensitivity of 100%; however, dermatologic ultrasound evaluation of the entheses alone was unable to confirm these findings. Of the remaining 34 patients with psoriasis, 8 were deemed by dermatologists as possibly having PsA based on the ultrasound examination although rheumatologists detected ultrasound abnormalities in only 3 patients.
Study details: Findings are from a cross-sectional study including 40 patients with psoriasis who completed the GEPARD questionnaire and subsequently underwent an assessment for PsA by a dermatologist and an ultrasound examination.
Disclosures: This study was supported by a conditional research grant from Rheumazentrum Erlangen-Nuremberg e.V. and AGJR Verbundprojekt. The authors declared no conflicts of interest.
Source: Bartsch V et al. Screening for psoriatic arthritis in dermatological settings—Are handheld ultrasound devices the gamechangers we hoped for? Rheumatology (Oxford). 2023 (Nov 3). doi: 10.1093/rheumatology/kead592
Key clinical point: In patients with psoriasis, the German Psoriasis Arthritis Diagnostic (GEPARD) questionnaire followed by a dermatological assessment can detect psoriatic arthritis (PsA) risk almost accurately, and entheseal ultrasound by dermatologists shows no additional benefits in this regard.
Major finding: PsA was diagnosed in 6 out of 40 patients, with a sensitivity of 100%; however, dermatologic ultrasound evaluation of the entheses alone was unable to confirm these findings. Of the remaining 34 patients with psoriasis, 8 were deemed by dermatologists as possibly having PsA based on the ultrasound examination although rheumatologists detected ultrasound abnormalities in only 3 patients.
Study details: Findings are from a cross-sectional study including 40 patients with psoriasis who completed the GEPARD questionnaire and subsequently underwent an assessment for PsA by a dermatologist and an ultrasound examination.
Disclosures: This study was supported by a conditional research grant from Rheumazentrum Erlangen-Nuremberg e.V. and AGJR Verbundprojekt. The authors declared no conflicts of interest.
Source: Bartsch V et al. Screening for psoriatic arthritis in dermatological settings—Are handheld ultrasound devices the gamechangers we hoped for? Rheumatology (Oxford). 2023 (Nov 3). doi: 10.1093/rheumatology/kead592
Syndesmophyte formation is a rare event in PsA
Key clinical point: Patients with psoriatic arthritis (PsA), except those with elevated C-reactive protein (CRP) levels (≥10 mg/L) and radiographic sacroiliac involvement, generally had a very low likelihood of developing syndesmophytes.
Major finding: At 2 years of follow-up, the majority (~90%) of patients showed no new syndesmophyte development, with syndesmophyte development being reported in only 11 patients. The probability of developing vs not developing syndesmophytes increased numerically by 3 and 14 times in patients with radiographic sacroiliitis and in those with radiographic sacroiliitis plus elevated CRP levels, respectively.
Study details: Findings are from an analysis of the data of 150 patients with PsA from the Belgian Epidemiological Psoriatic Arthritis Study (BEPAS) trial who had baseline and 2-year follow-up radiographs available.
Disclosures: The BEPAS trial was funded by MSD Belgium. Some authors declared receiving consultancy fees, speaker fees, or research grants from or having other ties with various sources, including MSD.
Source: de Hooge M et al. Specific descriptions of axial involvement are associated with radiographic damage development after 2 years in psoriatic arthritis patients. Ann Rheum Dis. 2023 (Nov 2). doi: 10.1136/ard-2023-224501
Key clinical point: Patients with psoriatic arthritis (PsA), except those with elevated C-reactive protein (CRP) levels (≥10 mg/L) and radiographic sacroiliac involvement, generally had a very low likelihood of developing syndesmophytes.
Major finding: At 2 years of follow-up, the majority (~90%) of patients showed no new syndesmophyte development, with syndesmophyte development being reported in only 11 patients. The probability of developing vs not developing syndesmophytes increased numerically by 3 and 14 times in patients with radiographic sacroiliitis and in those with radiographic sacroiliitis plus elevated CRP levels, respectively.
Study details: Findings are from an analysis of the data of 150 patients with PsA from the Belgian Epidemiological Psoriatic Arthritis Study (BEPAS) trial who had baseline and 2-year follow-up radiographs available.
Disclosures: The BEPAS trial was funded by MSD Belgium. Some authors declared receiving consultancy fees, speaker fees, or research grants from or having other ties with various sources, including MSD.
Source: de Hooge M et al. Specific descriptions of axial involvement are associated with radiographic damage development after 2 years in psoriatic arthritis patients. Ann Rheum Dis. 2023 (Nov 2). doi: 10.1136/ard-2023-224501
Key clinical point: Patients with psoriatic arthritis (PsA), except those with elevated C-reactive protein (CRP) levels (≥10 mg/L) and radiographic sacroiliac involvement, generally had a very low likelihood of developing syndesmophytes.
Major finding: At 2 years of follow-up, the majority (~90%) of patients showed no new syndesmophyte development, with syndesmophyte development being reported in only 11 patients. The probability of developing vs not developing syndesmophytes increased numerically by 3 and 14 times in patients with radiographic sacroiliitis and in those with radiographic sacroiliitis plus elevated CRP levels, respectively.
Study details: Findings are from an analysis of the data of 150 patients with PsA from the Belgian Epidemiological Psoriatic Arthritis Study (BEPAS) trial who had baseline and 2-year follow-up radiographs available.
Disclosures: The BEPAS trial was funded by MSD Belgium. Some authors declared receiving consultancy fees, speaker fees, or research grants from or having other ties with various sources, including MSD.
Source: de Hooge M et al. Specific descriptions of axial involvement are associated with radiographic damage development after 2 years in psoriatic arthritis patients. Ann Rheum Dis. 2023 (Nov 2). doi: 10.1136/ard-2023-224501
Early efficacy with guselkumab predicts lower radiographic progression in PsA
Key clinical point: Improvement in the Disease Activity Index in PsA (DAPSA) scores as early as week 8 was associated with a lower progression of structural joint damage at 2 years in biologic-naive patients with psoriatic arthritis (PsA) who were treated with guselkumab.
Major finding: A greater improvement in DAPSA scores as early as week 8 (parameter estimate [β] −0.03, P = .0096) and the achievement of DAPSA low disease activity at week 8 (least squares mean difference −1.44; P = .0151) were associated with a significantly lower radiographic progression of joint damage through week 100.
Study details: This post hoc analysis included 449 biologic-naive patients with PsA from the DISCOVER-2 trial who received 100 mg guselkumab every 4 or 8 weeks.
Disclosures: The DISCOVER-2 trial was funded by Janssen Research & Development, LLC. Five authors declared being employees of Janssen or owning stock or stock options in Johnson & Johnson. The other authors declared ties with various sources, including Janssen.
Source: Mease PJ et al. Earlier clinical response predicts low rates of radiographic progression in biologic-naïve patients with active psoriatic arthritis receiving guselkumab treatment. Clin Rheumatol. 2023 (Oct 3). doi: 10.1007/s10067-023-06745-y
Key clinical point: Improvement in the Disease Activity Index in PsA (DAPSA) scores as early as week 8 was associated with a lower progression of structural joint damage at 2 years in biologic-naive patients with psoriatic arthritis (PsA) who were treated with guselkumab.
Major finding: A greater improvement in DAPSA scores as early as week 8 (parameter estimate [β] −0.03, P = .0096) and the achievement of DAPSA low disease activity at week 8 (least squares mean difference −1.44; P = .0151) were associated with a significantly lower radiographic progression of joint damage through week 100.
Study details: This post hoc analysis included 449 biologic-naive patients with PsA from the DISCOVER-2 trial who received 100 mg guselkumab every 4 or 8 weeks.
Disclosures: The DISCOVER-2 trial was funded by Janssen Research & Development, LLC. Five authors declared being employees of Janssen or owning stock or stock options in Johnson & Johnson. The other authors declared ties with various sources, including Janssen.
Source: Mease PJ et al. Earlier clinical response predicts low rates of radiographic progression in biologic-naïve patients with active psoriatic arthritis receiving guselkumab treatment. Clin Rheumatol. 2023 (Oct 3). doi: 10.1007/s10067-023-06745-y
Key clinical point: Improvement in the Disease Activity Index in PsA (DAPSA) scores as early as week 8 was associated with a lower progression of structural joint damage at 2 years in biologic-naive patients with psoriatic arthritis (PsA) who were treated with guselkumab.
Major finding: A greater improvement in DAPSA scores as early as week 8 (parameter estimate [β] −0.03, P = .0096) and the achievement of DAPSA low disease activity at week 8 (least squares mean difference −1.44; P = .0151) were associated with a significantly lower radiographic progression of joint damage through week 100.
Study details: This post hoc analysis included 449 biologic-naive patients with PsA from the DISCOVER-2 trial who received 100 mg guselkumab every 4 or 8 weeks.
Disclosures: The DISCOVER-2 trial was funded by Janssen Research & Development, LLC. Five authors declared being employees of Janssen or owning stock or stock options in Johnson & Johnson. The other authors declared ties with various sources, including Janssen.
Source: Mease PJ et al. Earlier clinical response predicts low rates of radiographic progression in biologic-naïve patients with active psoriatic arthritis receiving guselkumab treatment. Clin Rheumatol. 2023 (Oct 3). doi: 10.1007/s10067-023-06745-y
Meta-analysis identifies the biologic and small-molecule therapies associated with infection risk in PsA
Key clinical point: The risk for infections in patients with psoriatic arthritis (PsA) did not increase with most biologic and small-molecule therapies, except bimekizumab, apremilast, and 30 mg upadacitinib.
Major finding: In patients with PsA, bimekizumab (relative risk [RR] 14.23; 95% CI 1.97-102.60), apremilast (RR 1.41; 95% CI 1.08-1.83) and 30 mg upadacitinib (RR 1.37; 95% CI 1.05-1.80) led to a significantly higher risk of infections compared to placebo, with 30 mg upadacitinib vs placebo also increasing the risk for serious infections (RR 3.66; 95% CI 1.43-9.38).
Study details: Findings are from a network meta-analysis of 94 randomized controlled trials including 54,369 patients with PsA or psoriasis who were treated with 14 biologics, five small molecules, or placebo.
Disclosures: This study was partly funded by grants from the National Taiwan University Hospital and Chang Gung Memorial Hospital. HY Chiu and YH Huang declared receiving speaking fees or honoraria from, serving as principal investigator for, or having other ties with various sources.
Source: Chiu HY et al. Comparative short-term risks of infection and serious infection in patients receiving biologic and small-molecule therapies for psoriasis and psoriatic arthritis: A systemic review and network meta-analysis of randomized controlled trials. Ther Adv Chronic Dis. 2023;14:20406223231206225. (Oct 27). doi: 10.1177/20406223231206225
Key clinical point: The risk for infections in patients with psoriatic arthritis (PsA) did not increase with most biologic and small-molecule therapies, except bimekizumab, apremilast, and 30 mg upadacitinib.
Major finding: In patients with PsA, bimekizumab (relative risk [RR] 14.23; 95% CI 1.97-102.60), apremilast (RR 1.41; 95% CI 1.08-1.83) and 30 mg upadacitinib (RR 1.37; 95% CI 1.05-1.80) led to a significantly higher risk of infections compared to placebo, with 30 mg upadacitinib vs placebo also increasing the risk for serious infections (RR 3.66; 95% CI 1.43-9.38).
Study details: Findings are from a network meta-analysis of 94 randomized controlled trials including 54,369 patients with PsA or psoriasis who were treated with 14 biologics, five small molecules, or placebo.
Disclosures: This study was partly funded by grants from the National Taiwan University Hospital and Chang Gung Memorial Hospital. HY Chiu and YH Huang declared receiving speaking fees or honoraria from, serving as principal investigator for, or having other ties with various sources.
Source: Chiu HY et al. Comparative short-term risks of infection and serious infection in patients receiving biologic and small-molecule therapies for psoriasis and psoriatic arthritis: A systemic review and network meta-analysis of randomized controlled trials. Ther Adv Chronic Dis. 2023;14:20406223231206225. (Oct 27). doi: 10.1177/20406223231206225
Key clinical point: The risk for infections in patients with psoriatic arthritis (PsA) did not increase with most biologic and small-molecule therapies, except bimekizumab, apremilast, and 30 mg upadacitinib.
Major finding: In patients with PsA, bimekizumab (relative risk [RR] 14.23; 95% CI 1.97-102.60), apremilast (RR 1.41; 95% CI 1.08-1.83) and 30 mg upadacitinib (RR 1.37; 95% CI 1.05-1.80) led to a significantly higher risk of infections compared to placebo, with 30 mg upadacitinib vs placebo also increasing the risk for serious infections (RR 3.66; 95% CI 1.43-9.38).
Study details: Findings are from a network meta-analysis of 94 randomized controlled trials including 54,369 patients with PsA or psoriasis who were treated with 14 biologics, five small molecules, or placebo.
Disclosures: This study was partly funded by grants from the National Taiwan University Hospital and Chang Gung Memorial Hospital. HY Chiu and YH Huang declared receiving speaking fees or honoraria from, serving as principal investigator for, or having other ties with various sources.
Source: Chiu HY et al. Comparative short-term risks of infection and serious infection in patients receiving biologic and small-molecule therapies for psoriasis and psoriatic arthritis: A systemic review and network meta-analysis of randomized controlled trials. Ther Adv Chronic Dis. 2023;14:20406223231206225. (Oct 27). doi: 10.1177/20406223231206225
PsA tied to increased risk of depressive symptoms and functional impairment
Key clinical point: A diagnosis of psoriatic arthritis (PsA) significantly increased the odds of functional impairment and the prevalence of depressive symptoms in patients with psoriatic disease.
Major finding: A diagnosis of PsA was associated with increased odds of functional impairment in everyday life (odds ratio [OR] 9.56, P = .005) and the presence of moderate-to-severe depressive symptoms (OR 2.69, P = .046).
Study details: Findings are from a cross-sectional study including 300 patients with psoriatic disease, of whom 189 patients had PsA.
Disclosures: This study was partly sponsored by Novartis Pharma GmbH, Germany. Some authors declared receiving speaker honoraria, travel grants, or research funding from or having other ties with various sources, including Novartis. The other authors declared no conflicts of interest.
Source: Frede N et al. Psoriasis and psoriatic arthritis have a major impact on quality of life and depressive symptoms: A cross-sectional study of 300 patients. Rheumatol Ther. 2023 (Oct 15). doi: 10.1007/s40744-023-00602-9
Key clinical point: A diagnosis of psoriatic arthritis (PsA) significantly increased the odds of functional impairment and the prevalence of depressive symptoms in patients with psoriatic disease.
Major finding: A diagnosis of PsA was associated with increased odds of functional impairment in everyday life (odds ratio [OR] 9.56, P = .005) and the presence of moderate-to-severe depressive symptoms (OR 2.69, P = .046).
Study details: Findings are from a cross-sectional study including 300 patients with psoriatic disease, of whom 189 patients had PsA.
Disclosures: This study was partly sponsored by Novartis Pharma GmbH, Germany. Some authors declared receiving speaker honoraria, travel grants, or research funding from or having other ties with various sources, including Novartis. The other authors declared no conflicts of interest.
Source: Frede N et al. Psoriasis and psoriatic arthritis have a major impact on quality of life and depressive symptoms: A cross-sectional study of 300 patients. Rheumatol Ther. 2023 (Oct 15). doi: 10.1007/s40744-023-00602-9
Key clinical point: A diagnosis of psoriatic arthritis (PsA) significantly increased the odds of functional impairment and the prevalence of depressive symptoms in patients with psoriatic disease.
Major finding: A diagnosis of PsA was associated with increased odds of functional impairment in everyday life (odds ratio [OR] 9.56, P = .005) and the presence of moderate-to-severe depressive symptoms (OR 2.69, P = .046).
Study details: Findings are from a cross-sectional study including 300 patients with psoriatic disease, of whom 189 patients had PsA.
Disclosures: This study was partly sponsored by Novartis Pharma GmbH, Germany. Some authors declared receiving speaker honoraria, travel grants, or research funding from or having other ties with various sources, including Novartis. The other authors declared no conflicts of interest.
Source: Frede N et al. Psoriasis and psoriatic arthritis have a major impact on quality of life and depressive symptoms: A cross-sectional study of 300 patients. Rheumatol Ther. 2023 (Oct 15). doi: 10.1007/s40744-023-00602-9
Cathepsin K and G levels in serum and synovial fluid hold diagnostic potential in PsA
Key clinical point: Patients with psoriatic arthritis (PsA) had higher levels of cathepsins G and K in the serum and synovial fluid than patients with gonarthrosis or control individuals having no physical findings related to their internal organs, skin, or joints.
Major finding: Cathepsin G and cathepsin K levels in the serum (P < .01) and synovial fluid (P < .02) were significantly higher in the PsA group than in the gonarthrosis or control group. Serum cathepsin G levels > 6 ng/mL and serum cathepsin K levels > 0.86 ng/mL showed 100% diagnostic accuracy in distinguishing patients with PsA from control individuals and patients with gonarthrosis, respectively, whereas synovial fluid cathepsin G levels > 2 ng/mL showed 100% accuracy in distinguishing PsA from gonarthrosis.
Study details: This retrospective case-control study included 156 patients having PsA with synovial effusion, 50 patients with gonarthrosis, and 30 control individuals.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.
Source: Popova-Belova SD et al. Serum and synovial levels of cathepsin G and cathepsin K in patients with psoriatic arthritis and their correlation with disease activity indices. Diagnostics (Basel). 2023;13(20):3250 (Oct 19). doi: 10.3390/diagnostics13203250
Key clinical point: Patients with psoriatic arthritis (PsA) had higher levels of cathepsins G and K in the serum and synovial fluid than patients with gonarthrosis or control individuals having no physical findings related to their internal organs, skin, or joints.
Major finding: Cathepsin G and cathepsin K levels in the serum (P < .01) and synovial fluid (P < .02) were significantly higher in the PsA group than in the gonarthrosis or control group. Serum cathepsin G levels > 6 ng/mL and serum cathepsin K levels > 0.86 ng/mL showed 100% diagnostic accuracy in distinguishing patients with PsA from control individuals and patients with gonarthrosis, respectively, whereas synovial fluid cathepsin G levels > 2 ng/mL showed 100% accuracy in distinguishing PsA from gonarthrosis.
Study details: This retrospective case-control study included 156 patients having PsA with synovial effusion, 50 patients with gonarthrosis, and 30 control individuals.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.
Source: Popova-Belova SD et al. Serum and synovial levels of cathepsin G and cathepsin K in patients with psoriatic arthritis and their correlation with disease activity indices. Diagnostics (Basel). 2023;13(20):3250 (Oct 19). doi: 10.3390/diagnostics13203250
Key clinical point: Patients with psoriatic arthritis (PsA) had higher levels of cathepsins G and K in the serum and synovial fluid than patients with gonarthrosis or control individuals having no physical findings related to their internal organs, skin, or joints.
Major finding: Cathepsin G and cathepsin K levels in the serum (P < .01) and synovial fluid (P < .02) were significantly higher in the PsA group than in the gonarthrosis or control group. Serum cathepsin G levels > 6 ng/mL and serum cathepsin K levels > 0.86 ng/mL showed 100% diagnostic accuracy in distinguishing patients with PsA from control individuals and patients with gonarthrosis, respectively, whereas synovial fluid cathepsin G levels > 2 ng/mL showed 100% accuracy in distinguishing PsA from gonarthrosis.
Study details: This retrospective case-control study included 156 patients having PsA with synovial effusion, 50 patients with gonarthrosis, and 30 control individuals.
Disclosures: This study did not receive any external funding. The authors declared no conflicts of interest.
Source: Popova-Belova SD et al. Serum and synovial levels of cathepsin G and cathepsin K in patients with psoriatic arthritis and their correlation with disease activity indices. Diagnostics (Basel). 2023;13(20):3250 (Oct 19). doi: 10.3390/diagnostics13203250
Tildrakizumab may check the progression to PsA in psoriatic patients
Key clinical point: Tildrakizumab was able to reduce the occurrence of psoriatic arthritis (PsA) in patients with psoriasis by improving nailfold bleeding (NFB) and capillary enlargement, which are well-known risk factors for the development of PsA.
Major finding: NFB (hazard ratio [HR] 2.92; P = .003) and capillary enlargement (HR 4.61; P < .0001) were recognized as risk factors for PsA development; however, both conditions improved significantly after 1 month of tildrakizumab initiation, with the improvements being sustained up to 13 months (all P < .01). Therefore, tildrakizumab treatment significantly reduced the risk for PsA (HR 0.06; P = .007) in patients with psoriasis.
Study details: Findings are from a prospective cohort study which included 246 patients with psoriasis vulgaris having no prior exposure to systemic treatments and topical treatments for distal interphalangeal joints and nails who received either tildrakizumab (n = 20) or topical agents (n = 226).
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Fukasawa T et al. The optimal use of tildrakizumab in the elderly via improvement of Treg function and its preventive effect of psoriatic arthritis. Front Immunol. 2023;14:1286251. (Oct 19) doi: 10.3389/fimmu.2023.1286251
Key clinical point: Tildrakizumab was able to reduce the occurrence of psoriatic arthritis (PsA) in patients with psoriasis by improving nailfold bleeding (NFB) and capillary enlargement, which are well-known risk factors for the development of PsA.
Major finding: NFB (hazard ratio [HR] 2.92; P = .003) and capillary enlargement (HR 4.61; P < .0001) were recognized as risk factors for PsA development; however, both conditions improved significantly after 1 month of tildrakizumab initiation, with the improvements being sustained up to 13 months (all P < .01). Therefore, tildrakizumab treatment significantly reduced the risk for PsA (HR 0.06; P = .007) in patients with psoriasis.
Study details: Findings are from a prospective cohort study which included 246 patients with psoriasis vulgaris having no prior exposure to systemic treatments and topical treatments for distal interphalangeal joints and nails who received either tildrakizumab (n = 20) or topical agents (n = 226).
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Fukasawa T et al. The optimal use of tildrakizumab in the elderly via improvement of Treg function and its preventive effect of psoriatic arthritis. Front Immunol. 2023;14:1286251. (Oct 19) doi: 10.3389/fimmu.2023.1286251
Key clinical point: Tildrakizumab was able to reduce the occurrence of psoriatic arthritis (PsA) in patients with psoriasis by improving nailfold bleeding (NFB) and capillary enlargement, which are well-known risk factors for the development of PsA.
Major finding: NFB (hazard ratio [HR] 2.92; P = .003) and capillary enlargement (HR 4.61; P < .0001) were recognized as risk factors for PsA development; however, both conditions improved significantly after 1 month of tildrakizumab initiation, with the improvements being sustained up to 13 months (all P < .01). Therefore, tildrakizumab treatment significantly reduced the risk for PsA (HR 0.06; P = .007) in patients with psoriasis.
Study details: Findings are from a prospective cohort study which included 246 patients with psoriasis vulgaris having no prior exposure to systemic treatments and topical treatments for distal interphalangeal joints and nails who received either tildrakizumab (n = 20) or topical agents (n = 226).
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Fukasawa T et al. The optimal use of tildrakizumab in the elderly via improvement of Treg function and its preventive effect of psoriatic arthritis. Front Immunol. 2023;14:1286251. (Oct 19) doi: 10.3389/fimmu.2023.1286251
Ixekizumab improves disease signs and symptoms in patients with severe PsA
Key clinical point: Treatment with ixekizumab for 24 weeks improved disease activity outcomes without causing any new adverse events (AE) in patients with severe peripheral psoriatic arthritis (PsA).
Major finding: At week 24, a significantly higher proportion of patients with severe PsA receiving ixekizumab every 4 weeks and ixekizumab every 2 weeks vs placebo achieved ≥20% improvement in the American College of Rheumatology scores (63.3% and 60.4% vs 24.5%, P ≤ .001). No new AE were reported.
Study details: Findings are from a post hoc analysis of the SPIRIT-P1 trial including 204 patients with severe peripheral PsA who received ixekizumab, adalimumab, or placebo for 24 weeks.
Disclosures: This study was funded by Eli Lilly and Company. Four authors declared being employees or stockholders of Eli Lilly Japan KK, Lilly Deutschland GmbH, or Eli Lilly and Company. The other authors declared ties with various sources, including Eli Lilly.
Source: Kameda H et al. Ixekizumab efficacy in patients with severe peripheral psoriatic arthritis: A post hoc analysis of a phase 3, randomized, double-blind, placebo-controlled study (SPIRIT-P1). Rheumatol Ther. 2023 (Oct 19). doi: 10.1007/s40744-023-00605-6
Key clinical point: Treatment with ixekizumab for 24 weeks improved disease activity outcomes without causing any new adverse events (AE) in patients with severe peripheral psoriatic arthritis (PsA).
Major finding: At week 24, a significantly higher proportion of patients with severe PsA receiving ixekizumab every 4 weeks and ixekizumab every 2 weeks vs placebo achieved ≥20% improvement in the American College of Rheumatology scores (63.3% and 60.4% vs 24.5%, P ≤ .001). No new AE were reported.
Study details: Findings are from a post hoc analysis of the SPIRIT-P1 trial including 204 patients with severe peripheral PsA who received ixekizumab, adalimumab, or placebo for 24 weeks.
Disclosures: This study was funded by Eli Lilly and Company. Four authors declared being employees or stockholders of Eli Lilly Japan KK, Lilly Deutschland GmbH, or Eli Lilly and Company. The other authors declared ties with various sources, including Eli Lilly.
Source: Kameda H et al. Ixekizumab efficacy in patients with severe peripheral psoriatic arthritis: A post hoc analysis of a phase 3, randomized, double-blind, placebo-controlled study (SPIRIT-P1). Rheumatol Ther. 2023 (Oct 19). doi: 10.1007/s40744-023-00605-6
Key clinical point: Treatment with ixekizumab for 24 weeks improved disease activity outcomes without causing any new adverse events (AE) in patients with severe peripheral psoriatic arthritis (PsA).
Major finding: At week 24, a significantly higher proportion of patients with severe PsA receiving ixekizumab every 4 weeks and ixekizumab every 2 weeks vs placebo achieved ≥20% improvement in the American College of Rheumatology scores (63.3% and 60.4% vs 24.5%, P ≤ .001). No new AE were reported.
Study details: Findings are from a post hoc analysis of the SPIRIT-P1 trial including 204 patients with severe peripheral PsA who received ixekizumab, adalimumab, or placebo for 24 weeks.
Disclosures: This study was funded by Eli Lilly and Company. Four authors declared being employees or stockholders of Eli Lilly Japan KK, Lilly Deutschland GmbH, or Eli Lilly and Company. The other authors declared ties with various sources, including Eli Lilly.
Source: Kameda H et al. Ixekizumab efficacy in patients with severe peripheral psoriatic arthritis: A post hoc analysis of a phase 3, randomized, double-blind, placebo-controlled study (SPIRIT-P1). Rheumatol Ther. 2023 (Oct 19). doi: 10.1007/s40744-023-00605-6
Real-world study shows favorable efficacy-safety profile of dual targeted therapy in refractory PsA
Key clinical point: Dual targeted therapy (DTT) combining two biological disease-modifying antirheumatic drugs (bDMARD) or targeted synthetic (ts) DMARD led to satisfactory clinical improvements and no serious adverse events in patients with difficult-to-treat refractory psoriatic arthritis (PsA).
Major finding: At a median exposure of 14.86 months, the DTT retention rate in patients with PsA was 42.8%, with 40.0% and 53.3% of patients achieving remission or low activity and major clinical improvements, respectively. Treatment discontinuation due to adverse events was reported in one patient with PsA and multiple comorbidities.
Study details: Findings are from an observational, retrospective, cross-sectional study including patients with refractory PsA (n = 14) or spondyloarthritis (n = 22) who simultaneously received two bDMARD or tsDMARD with different therapeutic targets.
Disclosures: This study did not receive any funding. R García-Vicuña declared receiving educational grants, research grants, consultancies, speaking fees, or support for attending meetings from various sources.
Source: Valero-Martinez C et al. Dual targeted therapy in patients with psoriatic arthritis and spondyloarthritis: A real-world multicenter experience from Spain. Front Immunol. 2023;14:1283251 (Oct 23). doi: 10.3389/fimmu.2023.1283251
Key clinical point: Dual targeted therapy (DTT) combining two biological disease-modifying antirheumatic drugs (bDMARD) or targeted synthetic (ts) DMARD led to satisfactory clinical improvements and no serious adverse events in patients with difficult-to-treat refractory psoriatic arthritis (PsA).
Major finding: At a median exposure of 14.86 months, the DTT retention rate in patients with PsA was 42.8%, with 40.0% and 53.3% of patients achieving remission or low activity and major clinical improvements, respectively. Treatment discontinuation due to adverse events was reported in one patient with PsA and multiple comorbidities.
Study details: Findings are from an observational, retrospective, cross-sectional study including patients with refractory PsA (n = 14) or spondyloarthritis (n = 22) who simultaneously received two bDMARD or tsDMARD with different therapeutic targets.
Disclosures: This study did not receive any funding. R García-Vicuña declared receiving educational grants, research grants, consultancies, speaking fees, or support for attending meetings from various sources.
Source: Valero-Martinez C et al. Dual targeted therapy in patients with psoriatic arthritis and spondyloarthritis: A real-world multicenter experience from Spain. Front Immunol. 2023;14:1283251 (Oct 23). doi: 10.3389/fimmu.2023.1283251
Key clinical point: Dual targeted therapy (DTT) combining two biological disease-modifying antirheumatic drugs (bDMARD) or targeted synthetic (ts) DMARD led to satisfactory clinical improvements and no serious adverse events in patients with difficult-to-treat refractory psoriatic arthritis (PsA).
Major finding: At a median exposure of 14.86 months, the DTT retention rate in patients with PsA was 42.8%, with 40.0% and 53.3% of patients achieving remission or low activity and major clinical improvements, respectively. Treatment discontinuation due to adverse events was reported in one patient with PsA and multiple comorbidities.
Study details: Findings are from an observational, retrospective, cross-sectional study including patients with refractory PsA (n = 14) or spondyloarthritis (n = 22) who simultaneously received two bDMARD or tsDMARD with different therapeutic targets.
Disclosures: This study did not receive any funding. R García-Vicuña declared receiving educational grants, research grants, consultancies, speaking fees, or support for attending meetings from various sources.
Source: Valero-Martinez C et al. Dual targeted therapy in patients with psoriatic arthritis and spondyloarthritis: A real-world multicenter experience from Spain. Front Immunol. 2023;14:1283251 (Oct 23). doi: 10.3389/fimmu.2023.1283251