Psoriatic Arthritis ICYMI

Key clinical point: Guselkumab significantly reduced serum levels of acute phase proteins and T-helper cell effector cytokines in patients with psoriatic arthritis (PsA) and achieved a range comparable to those in healthy controls (HCs).

Major finding: Treatment with guselkumab significantly reduced serum levels of acute-phase C-reactive protein, serum amyloid A, interleukin (IL)-6, IL-17A, IL-17F, and IL-22 by week 4 and continued to decline over week 24, whereas no significant change was observed with placebo (P less than .05). At 24 weeks, IL-17A and IL-17F levels with either dose of guselkumab were not significantly different from that of HCs.

Study details: Findings are from phase 3 DISCOVER-1 and DISCOVER-2 studies involving 300 patients with PsA who were randomly assigned to subcutaneous guselkumab or placebo. A group of 34 HCs were procured independently for the DISCOVER clinical studies.

Disclosures: The study was supported by the Janssen Research and Development. S Siebert and I B McInnes reported receiving research grants, consulting fees, and/or honoraria from various pharmaceutical companies including Janssen. Eight authors declared being employees and shareholders of Janssen Research & Development.

Source: Sweet K et al. RMD Open. 2021 May 19. doi: 10.1136/rmdopen-2021-001679.

Key clinical point: Guselkumab significantly reduced serum levels of acute phase proteins and T-helper cell effector cytokines in patients with psoriatic arthritis (PsA) and achieved a range comparable to those in healthy controls (HCs).

Major finding: Treatment with guselkumab significantly reduced serum levels of acute-phase C-reactive protein, serum amyloid A, interleukin (IL)-6, IL-17A, IL-17F, and IL-22 by week 4 and continued to decline over week 24, whereas no significant change was observed with placebo (P less than .05). At 24 weeks, IL-17A and IL-17F levels with either dose of guselkumab were not significantly different from that of HCs.

Study details: Findings are from phase 3 DISCOVER-1 and DISCOVER-2 studies involving 300 patients with PsA who were randomly assigned to subcutaneous guselkumab or placebo. A group of 34 HCs were procured independently for the DISCOVER clinical studies.

Disclosures: The study was supported by the Janssen Research and Development. S Siebert and I B McInnes reported receiving research grants, consulting fees, and/or honoraria from various pharmaceutical companies including Janssen. Eight authors declared being employees and shareholders of Janssen Research & Development.

Source: Sweet K et al. RMD Open. 2021 May 19. doi: 10.1136/rmdopen-2021-001679.

Key clinical point: Guselkumab significantly reduced serum levels of acute phase proteins and T-helper cell effector cytokines in patients with psoriatic arthritis (PsA) and achieved a range comparable to those in healthy controls (HCs).

Major finding: Treatment with guselkumab significantly reduced serum levels of acute-phase C-reactive protein, serum amyloid A, interleukin (IL)-6, IL-17A, IL-17F, and IL-22 by week 4 and continued to decline over week 24, whereas no significant change was observed with placebo (P less than .05). At 24 weeks, IL-17A and IL-17F levels with either dose of guselkumab were not significantly different from that of HCs.

Study details: Findings are from phase 3 DISCOVER-1 and DISCOVER-2 studies involving 300 patients with PsA who were randomly assigned to subcutaneous guselkumab or placebo. A group of 34 HCs were procured independently for the DISCOVER clinical studies.

Disclosures: The study was supported by the Janssen Research and Development. S Siebert and I B McInnes reported receiving research grants, consulting fees, and/or honoraria from various pharmaceutical companies including Janssen. Eight authors declared being employees and shareholders of Janssen Research & Development.

Source: Sweet K et al. RMD Open. 2021 May 19. doi: 10.1136/rmdopen-2021-001679.

Key clinical point: Apremilast therapy was associated with weight loss, principally abdominal subcutaneous fat, and improvement in psoriatic disease activity in patients with psoriatic arthritis (PsA) or psoriasis.

Major finding: At 6 months after therapy, apremilast was significantly associated with a mean weight loss of 2.2 kg and a mean body mass index decrease of 0.8 kg/m² (both P less than .001). On assessing the nature of this weight loss, there was reduction in the total abdominal fat volume (mean decrease, 0.52 L; P = .022), mainly the abdominal subcutaneous adipose tissue (mean decrease, 0.37 L; P = .022). After 6 months of apremilast treatment, there were improvements in tender and swollen joint counts and disease activity.

Study details: This was a prospective, open-label study (IMAPA) involving 60 patients with PsA (n=56) and/or psoriasis (n=4) who received 30 mg of apremilast as part of routine care.

Disclosures: This study was supported by Amgen and the British Heart Foundation (BHF). The lead author reported receiving grants from the BHF Centre of Excellence. Three of the authors reported receiving grants and personal fees from various sources. All the other authors reported no conflicts of interest.

Source: Ferguson LD et al. Rheumatology (Oxford). 2021 Jun 7. doi: 10.1093/rheumatology/keab474.

Key clinical point: Apremilast therapy was associated with weight loss, principally abdominal subcutaneous fat, and improvement in psoriatic disease activity in patients with psoriatic arthritis (PsA) or psoriasis.

Major finding: At 6 months after therapy, apremilast was significantly associated with a mean weight loss of 2.2 kg and a mean body mass index decrease of 0.8 kg/m² (both P less than .001). On assessing the nature of this weight loss, there was reduction in the total abdominal fat volume (mean decrease, 0.52 L; P = .022), mainly the abdominal subcutaneous adipose tissue (mean decrease, 0.37 L; P = .022). After 6 months of apremilast treatment, there were improvements in tender and swollen joint counts and disease activity.

Study details: This was a prospective, open-label study (IMAPA) involving 60 patients with PsA (n=56) and/or psoriasis (n=4) who received 30 mg of apremilast as part of routine care.

Disclosures: This study was supported by Amgen and the British Heart Foundation (BHF). The lead author reported receiving grants from the BHF Centre of Excellence. Three of the authors reported receiving grants and personal fees from various sources. All the other authors reported no conflicts of interest.

Source: Ferguson LD et al. Rheumatology (Oxford). 2021 Jun 7. doi: 10.1093/rheumatology/keab474.

Key clinical point: Apremilast therapy was associated with weight loss, principally abdominal subcutaneous fat, and improvement in psoriatic disease activity in patients with psoriatic arthritis (PsA) or psoriasis.

Major finding: At 6 months after therapy, apremilast was significantly associated with a mean weight loss of 2.2 kg and a mean body mass index decrease of 0.8 kg/m² (both P less than .001). On assessing the nature of this weight loss, there was reduction in the total abdominal fat volume (mean decrease, 0.52 L; P = .022), mainly the abdominal subcutaneous adipose tissue (mean decrease, 0.37 L; P = .022). After 6 months of apremilast treatment, there were improvements in tender and swollen joint counts and disease activity.

Study details: This was a prospective, open-label study (IMAPA) involving 60 patients with PsA (n=56) and/or psoriasis (n=4) who received 30 mg of apremilast as part of routine care.

Disclosures: This study was supported by Amgen and the British Heart Foundation (BHF). The lead author reported receiving grants from the BHF Centre of Excellence. Three of the authors reported receiving grants and personal fees from various sources. All the other authors reported no conflicts of interest.

Source: Ferguson LD et al. Rheumatology (Oxford). 2021 Jun 7. doi: 10.1093/rheumatology/keab474.

Key clinical point: Comedication with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) was associated with 25% improved clinical remission rates compared with tumor necrosis factor inhibitors (TNFi) monotherapy in patients with psoriatic arthritis (PsA) who initiated first-ever TNFi.

Major finding: At 12 months, the rate of achieving clinical remission was significantly higher with comedication vs. monotherapy (odds ratio [OR], 1.25; 95% confidence interval [CI], 1.12-1.41). Methotrexate comedication showed better remission for adalimumab (OR, 1.45; 95% CI, 1.23-1.72) and infliximab (OR, 1.55; 95% CI, 1.21-1.98) vs. monotherapy. No effect of comedication was observed for etanercept.

Study details: The data come from an observational study of 15,332 patients with PsA who initiated treatment with TNFi, of whom 9,440 were included in the TNFi and csDMARD comedication group and 5,892 in the TNFi monotherapy group.

Disclosures: This work was supported by Novartis. The authors including the lead author reported receiving consulting fees, speaking fees, and/or honoraria from various sources.

Source: Lindström U et al. Ann Rheum Dis. 2021 Jun 3. doi: 10.1136/annrheumdis-2021-220097.

Key clinical point: Comedication with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) was associated with 25% improved clinical remission rates compared with tumor necrosis factor inhibitors (TNFi) monotherapy in patients with psoriatic arthritis (PsA) who initiated first-ever TNFi.

Major finding: At 12 months, the rate of achieving clinical remission was significantly higher with comedication vs. monotherapy (odds ratio [OR], 1.25; 95% confidence interval [CI], 1.12-1.41). Methotrexate comedication showed better remission for adalimumab (OR, 1.45; 95% CI, 1.23-1.72) and infliximab (OR, 1.55; 95% CI, 1.21-1.98) vs. monotherapy. No effect of comedication was observed for etanercept.

Study details: The data come from an observational study of 15,332 patients with PsA who initiated treatment with TNFi, of whom 9,440 were included in the TNFi and csDMARD comedication group and 5,892 in the TNFi monotherapy group.

Disclosures: This work was supported by Novartis. The authors including the lead author reported receiving consulting fees, speaking fees, and/or honoraria from various sources.

Source: Lindström U et al. Ann Rheum Dis. 2021 Jun 3. doi: 10.1136/annrheumdis-2021-220097.

Key clinical point: Comedication with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) was associated with 25% improved clinical remission rates compared with tumor necrosis factor inhibitors (TNFi) monotherapy in patients with psoriatic arthritis (PsA) who initiated first-ever TNFi.

Major finding: At 12 months, the rate of achieving clinical remission was significantly higher with comedication vs. monotherapy (odds ratio [OR], 1.25; 95% confidence interval [CI], 1.12-1.41). Methotrexate comedication showed better remission for adalimumab (OR, 1.45; 95% CI, 1.23-1.72) and infliximab (OR, 1.55; 95% CI, 1.21-1.98) vs. monotherapy. No effect of comedication was observed for etanercept.

Study details: The data come from an observational study of 15,332 patients with PsA who initiated treatment with TNFi, of whom 9,440 were included in the TNFi and csDMARD comedication group and 5,892 in the TNFi monotherapy group.

Disclosures: This work was supported by Novartis. The authors including the lead author reported receiving consulting fees, speaking fees, and/or honoraria from various sources.

Source: Lindström U et al. Ann Rheum Dis. 2021 Jun 3. doi: 10.1136/annrheumdis-2021-220097.

Key clinical point: Apremilast improved signs and symptoms of psoriatic arthritis (PsA) in patients naive to disease-modifying antirheumatic drugs (DMARDs), which was sustained with continued therapy over 260 weeks along with a favorable safety profile.

Major finding: At week 260, 65.8%/39.0%/20.3% of patients had an American College of Rheumatology 20/50/70 response with apremilast 30 mg, respectively. Furthermore, swollen and tender joint counts reduced by 84.8% and 76.4%, respectively. Efficacy outcomes were similar with apremilast 20 mg. In both doses, there were no new safety concerns or increased incidence or severity of adverse events.

Study details: Findings are from PALACE4, a 260-week, open-label phase 3 study of 527 DMARD-naïve patients with PsA who were randomly allocated to receive placebo (n=176), apremilast 30 mg (n=176), or apremilast 20 mg twice daily (n=175).

Disclosures: The PALACE4 study was funded by Celgene. The authors reported receiving consulting fees, speaking fees, and/or honoraria from various sources. B Guerette, M Paris, and L Teng reported being employees of Amgen Inc. N Delev reported being a former employee of Celgene.

Source: Wells AF. Rheumatology (Oxford). 2021 Jun 8. doi: 10.1093/rheumatology/keab449.

Key clinical point: Apremilast improved signs and symptoms of psoriatic arthritis (PsA) in patients naive to disease-modifying antirheumatic drugs (DMARDs), which was sustained with continued therapy over 260 weeks along with a favorable safety profile.

Major finding: At week 260, 65.8%/39.0%/20.3% of patients had an American College of Rheumatology 20/50/70 response with apremilast 30 mg, respectively. Furthermore, swollen and tender joint counts reduced by 84.8% and 76.4%, respectively. Efficacy outcomes were similar with apremilast 20 mg. In both doses, there were no new safety concerns or increased incidence or severity of adverse events.

Study details: Findings are from PALACE4, a 260-week, open-label phase 3 study of 527 DMARD-naïve patients with PsA who were randomly allocated to receive placebo (n=176), apremilast 30 mg (n=176), or apremilast 20 mg twice daily (n=175).

Disclosures: The PALACE4 study was funded by Celgene. The authors reported receiving consulting fees, speaking fees, and/or honoraria from various sources. B Guerette, M Paris, and L Teng reported being employees of Amgen Inc. N Delev reported being a former employee of Celgene.

Source: Wells AF. Rheumatology (Oxford). 2021 Jun 8. doi: 10.1093/rheumatology/keab449.

Key clinical point: Apremilast improved signs and symptoms of psoriatic arthritis (PsA) in patients naive to disease-modifying antirheumatic drugs (DMARDs), which was sustained with continued therapy over 260 weeks along with a favorable safety profile.

Major finding: At week 260, 65.8%/39.0%/20.3% of patients had an American College of Rheumatology 20/50/70 response with apremilast 30 mg, respectively. Furthermore, swollen and tender joint counts reduced by 84.8% and 76.4%, respectively. Efficacy outcomes were similar with apremilast 20 mg. In both doses, there were no new safety concerns or increased incidence or severity of adverse events.

Study details: Findings are from PALACE4, a 260-week, open-label phase 3 study of 527 DMARD-naïve patients with PsA who were randomly allocated to receive placebo (n=176), apremilast 30 mg (n=176), or apremilast 20 mg twice daily (n=175).

Disclosures: The PALACE4 study was funded by Celgene. The authors reported receiving consulting fees, speaking fees, and/or honoraria from various sources. B Guerette, M Paris, and L Teng reported being employees of Amgen Inc. N Delev reported being a former employee of Celgene.

Source: Wells AF. Rheumatology (Oxford). 2021 Jun 8. doi: 10.1093/rheumatology/keab449.

Most research published on psoriatic arthritis (PsA) in the month of June 2021 were related to treatment. Conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and anti-tumour necrosis factor (TNF) remain the most used drugs to treat PsA worldwide. However, the benefits of combining csDMARDs and anti-TNF therapies have been less well studied. Lindström et al studied this question using data from 15,332 patients with PsA from 13 European countries participating in the EuroSpA collaboration who initiated a first anti-TNF treatment in 2006–2017.  Sixty-two percent of the patients were on combined therapy, while 38% were no anti-TNF monotherapy. Overall, combined treatment was associated with better remission rates, pooled odds ratio (OR) 1.25 (1.12–1.41). Methotrexate (MTX) comedication was associated with improved rates of remission with adalimumab (OR 1.45 [1.23–1.72]) and infliximab (OR 1.55 [1.21–1.98]) and improved drug retention with infliximab. No effect of comedication could be demonstrated for etanercept. Thus, in clinical practice there may be an advantage to combine MTX with infliximab or adalimumab.

Biosimilars provide similar efficacy and safety to originator biologics at lower cost. Many jurisdictions are mandating nonmedical switch from a biologic to a biosimilar but concerns about such administrative switches remain among patients and physicians. Giunta et al report their observations in patients undergoing nonmedical switch from originator adalimumab to biosimilar adalimumab (ABP 501/ adalimumab-atto). In this retrospective study of 94 patients, 46 of whom underwent nonmedical switch from originator adalimumab to ABP 501, they found no significant differences in PASI or DAS-28 ESR at before and after switch in patients undergoing nonmedical switch from adalimumab originator to ABP 501. This study, although small and observational, adds to the growing body of literature on the effectiveness and safety of biosimilars including nonmedical switching.

About newer therapies, Mease et al reported the 52-week results of the phase 2b trial with tildrakizumab (an anti-IL23 biologic) in PsA. In this study, 391 patients with PsA who were randomly assigned to tildrakizumab 200 mg every 4 weeks (Q4W), tildrakizumab 200 mg, 100 mg, or 20 mg every 12 weeks or placebo Q4W. At week 24, the proportion of patients achieving at least 20% improvement in the American College of Rheumatology response was significantly higher for any dose of tildrakizumab vs placebo (71.4%-79.5% vs 50.6%; all P ≤.0125). However, improvement in dactylitis and enthesitis was not observed. No new safety signals were observed through W52. Tildrakizumab may be another option for the management of PsA but requires further evaluation in phase 3 trials.

About gender differences, Prior-Español et al using the Spanish BIOBADASER III registry demonstrated that women with PsA were at greater risk of discontinuing DMARDs because of both lack of efficacy and adverse events. Finally, Ferguson et al reported results from a prospective, open label study of adults receiving apremilast 30 mg as part of routine care for psoriatic disease. They show that in addition to reduction in disease activity, apremilast treatment was significantly associated with a mean weight loss of 2.2 kg and a mean body mass index decrease of 0.8 kg/m² (both P < .001). Improvement in disease activity did not correlate with weight change.

Most research published on psoriatic arthritis (PsA) in the month of June 2021 were related to treatment. Conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and anti-tumour necrosis factor (TNF) remain the most used drugs to treat PsA worldwide. However, the benefits of combining csDMARDs and anti-TNF therapies have been less well studied. Lindström et al studied this question using data from 15,332 patients with PsA from 13 European countries participating in the EuroSpA collaboration who initiated a first anti-TNF treatment in 2006–2017.  Sixty-two percent of the patients were on combined therapy, while 38% were no anti-TNF monotherapy. Overall, combined treatment was associated with better remission rates, pooled odds ratio (OR) 1.25 (1.12–1.41). Methotrexate (MTX) comedication was associated with improved rates of remission with adalimumab (OR 1.45 [1.23–1.72]) and infliximab (OR 1.55 [1.21–1.98]) and improved drug retention with infliximab. No effect of comedication could be demonstrated for etanercept. Thus, in clinical practice there may be an advantage to combine MTX with infliximab or adalimumab.

Biosimilars provide similar efficacy and safety to originator biologics at lower cost. Many jurisdictions are mandating nonmedical switch from a biologic to a biosimilar but concerns about such administrative switches remain among patients and physicians. Giunta et al report their observations in patients undergoing nonmedical switch from originator adalimumab to biosimilar adalimumab (ABP 501/ adalimumab-atto). In this retrospective study of 94 patients, 46 of whom underwent nonmedical switch from originator adalimumab to ABP 501, they found no significant differences in PASI or DAS-28 ESR at before and after switch in patients undergoing nonmedical switch from adalimumab originator to ABP 501. This study, although small and observational, adds to the growing body of literature on the effectiveness and safety of biosimilars including nonmedical switching.

About newer therapies, Mease et al reported the 52-week results of the phase 2b trial with tildrakizumab (an anti-IL23 biologic) in PsA. In this study, 391 patients with PsA who were randomly assigned to tildrakizumab 200 mg every 4 weeks (Q4W), tildrakizumab 200 mg, 100 mg, or 20 mg every 12 weeks or placebo Q4W. At week 24, the proportion of patients achieving at least 20% improvement in the American College of Rheumatology response was significantly higher for any dose of tildrakizumab vs placebo (71.4%-79.5% vs 50.6%; all P ≤.0125). However, improvement in dactylitis and enthesitis was not observed. No new safety signals were observed through W52. Tildrakizumab may be another option for the management of PsA but requires further evaluation in phase 3 trials.

About gender differences, Prior-Español et al using the Spanish BIOBADASER III registry demonstrated that women with PsA were at greater risk of discontinuing DMARDs because of both lack of efficacy and adverse events. Finally, Ferguson et al reported results from a prospective, open label study of adults receiving apremilast 30 mg as part of routine care for psoriatic disease. They show that in addition to reduction in disease activity, apremilast treatment was significantly associated with a mean weight loss of 2.2 kg and a mean body mass index decrease of 0.8 kg/m² (both P < .001). Improvement in disease activity did not correlate with weight change.

Most research published on psoriatic arthritis (PsA) in the month of June 2021 were related to treatment. Conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and anti-tumour necrosis factor (TNF) remain the most used drugs to treat PsA worldwide. However, the benefits of combining csDMARDs and anti-TNF therapies have been less well studied. Lindström et al studied this question using data from 15,332 patients with PsA from 13 European countries participating in the EuroSpA collaboration who initiated a first anti-TNF treatment in 2006–2017.  Sixty-two percent of the patients were on combined therapy, while 38% were no anti-TNF monotherapy. Overall, combined treatment was associated with better remission rates, pooled odds ratio (OR) 1.25 (1.12–1.41). Methotrexate (MTX) comedication was associated with improved rates of remission with adalimumab (OR 1.45 [1.23–1.72]) and infliximab (OR 1.55 [1.21–1.98]) and improved drug retention with infliximab. No effect of comedication could be demonstrated for etanercept. Thus, in clinical practice there may be an advantage to combine MTX with infliximab or adalimumab.

Biosimilars provide similar efficacy and safety to originator biologics at lower cost. Many jurisdictions are mandating nonmedical switch from a biologic to a biosimilar but concerns about such administrative switches remain among patients and physicians. Giunta et al report their observations in patients undergoing nonmedical switch from originator adalimumab to biosimilar adalimumab (ABP 501/ adalimumab-atto). In this retrospective study of 94 patients, 46 of whom underwent nonmedical switch from originator adalimumab to ABP 501, they found no significant differences in PASI or DAS-28 ESR at before and after switch in patients undergoing nonmedical switch from adalimumab originator to ABP 501. This study, although small and observational, adds to the growing body of literature on the effectiveness and safety of biosimilars including nonmedical switching.

About newer therapies, Mease et al reported the 52-week results of the phase 2b trial with tildrakizumab (an anti-IL23 biologic) in PsA. In this study, 391 patients with PsA who were randomly assigned to tildrakizumab 200 mg every 4 weeks (Q4W), tildrakizumab 200 mg, 100 mg, or 20 mg every 12 weeks or placebo Q4W. At week 24, the proportion of patients achieving at least 20% improvement in the American College of Rheumatology response was significantly higher for any dose of tildrakizumab vs placebo (71.4%-79.5% vs 50.6%; all P ≤.0125). However, improvement in dactylitis and enthesitis was not observed. No new safety signals were observed through W52. Tildrakizumab may be another option for the management of PsA but requires further evaluation in phase 3 trials.

About gender differences, Prior-Español et al using the Spanish BIOBADASER III registry demonstrated that women with PsA were at greater risk of discontinuing DMARDs because of both lack of efficacy and adverse events. Finally, Ferguson et al reported results from a prospective, open label study of adults receiving apremilast 30 mg as part of routine care for psoriatic disease. They show that in addition to reduction in disease activity, apremilast treatment was significantly associated with a mean weight loss of 2.2 kg and a mean body mass index decrease of 0.8 kg/m² (both P < .001). Improvement in disease activity did not correlate with weight change.

Psoriasis patients treated with biological disease-modifying antirheumatic drugs had a significantly lower incidence of psoriatic arthritis (PsA) compared with those treated with phototherapy, in a study of 464 adults.

Epidemiologic data show that PsA may be diagnosed as long as 5-10 years after a diagnosis of plaque psoriasis, but PsA ultimately occurs in up to 25% of cases, wrote the study investigators, Paolo Gisondi, MD, of the section of dermatology and venereology, department of medicine, at Università degli Studi di Verona, Italy, and colleagues.

“The delay between the onset of skin manifestations of psoriasis and joint disease may provide a therapeutic window of clinical opportunity for preventing the progression from psoriasis to PsA,” but the impact of continuous systemic treatment with biological disease-modifying antirheumatic drugs (DMARDs) has not been well studied, the researchers said.

In the retrospective, nonrandomized study published in Annals of the Rheumatic Diseases, the researchers reviewed data from adults with moderate to severe plaque psoriasis who received continuous treatment with biologic DMARDs, compared with those who received narrow-band ultraviolet light B (nb-UVB) phototherapy, between January 2012 and September 2020.

Patients with a past or present PsA diagnosis were excluded from the study. A total of 234 patients were treated with biologic DMARDs for at least 5 years and 230 were treated with at least three courses of nb-UVB phototherapy; all patients were followed for an average of 7 years.

PsA was determined based on the Classification for Psoriatic Arthritis criteria. Incidence was defined in terms of cases per 100 patients per year.

During the follow-up period, 51 patients (11%) developed incident PsA: 19 (8%) in the biologic DMARDs group and 32 (14%) in the nb-UVB phototherapy group. The annual incidence rate of PsA was 1.20 cases per 100 patients per year in the biologic DMARDs group compared with 2.17 cases per 100 patients per year in the phototherapy group (P = .006).

In a multivariate analysis, independent risk factors for PsA were older age (adjusted hazard ratio, 1.04; P < .001), nail psoriasis (aHR 3.15; P = .001), and psoriasis duration greater than 10 years (aHR, 2.02; P = .001). Most other baseline demographics, including smoking status, baseline Psoriasis Area and Severity Index (PASI) scores, and comorbidities, were similar in patients who did and did not develop PsA.

Of the patients taking biologic DMARDs, 39 (17%) were treated with infliximab, 17 (7%) with etanercept, 67 (29%) with adalimumab, 50 (21%) with ustekinumab, and 61 (26%) with secukinumab; 35 of these patients switched biologics during the study period.

The study findings were limited by several factors including the retrospective design and the resulting potential for biases, notably the potential confounding bias by indication because of the lack of randomization, the researchers noted. Another limitation was the inability to perform a subgroup analysis of biologic DMARD classes because of the small sample size, the authors said. However, they added, the findings were strengthened by the complete database and accurate PsA diagnoses supported by an expert rheumatologist.

Larger prospective and intervention studies are needed to validate the results, the researchers emphasized. However, data from the current study suggest that continued treatment with biologic DMARDs “may reduce the risk of incident PsA in patients with moderate to severe chronic plaque psoriasis,” they concluded.

The study was supported by the European Union’s Horizon 2020 Research and Innovation Program. Dr. Gisondi and several coauthors disclosed relationships with Abbvie, Almirall, Amgen, Janssen, Leo Pharma, Eli Lilly, Novartis, Pierre Fabre, Sandoz, Sanofi, and UCB. The study was supported by the European Union’s Horizon 2020 Research and Innovation Program.

Psoriasis patients treated with biological disease-modifying antirheumatic drugs had a significantly lower incidence of psoriatic arthritis (PsA) compared with those treated with phototherapy, in a study of 464 adults.

Epidemiologic data show that PsA may be diagnosed as long as 5-10 years after a diagnosis of plaque psoriasis, but PsA ultimately occurs in up to 25% of cases, wrote the study investigators, Paolo Gisondi, MD, of the section of dermatology and venereology, department of medicine, at Università degli Studi di Verona, Italy, and colleagues.

“The delay between the onset of skin manifestations of psoriasis and joint disease may provide a therapeutic window of clinical opportunity for preventing the progression from psoriasis to PsA,” but the impact of continuous systemic treatment with biological disease-modifying antirheumatic drugs (DMARDs) has not been well studied, the researchers said.

In the retrospective, nonrandomized study published in Annals of the Rheumatic Diseases, the researchers reviewed data from adults with moderate to severe plaque psoriasis who received continuous treatment with biologic DMARDs, compared with those who received narrow-band ultraviolet light B (nb-UVB) phototherapy, between January 2012 and September 2020.

Patients with a past or present PsA diagnosis were excluded from the study. A total of 234 patients were treated with biologic DMARDs for at least 5 years and 230 were treated with at least three courses of nb-UVB phototherapy; all patients were followed for an average of 7 years.

PsA was determined based on the Classification for Psoriatic Arthritis criteria. Incidence was defined in terms of cases per 100 patients per year.

During the follow-up period, 51 patients (11%) developed incident PsA: 19 (8%) in the biologic DMARDs group and 32 (14%) in the nb-UVB phototherapy group. The annual incidence rate of PsA was 1.20 cases per 100 patients per year in the biologic DMARDs group compared with 2.17 cases per 100 patients per year in the phototherapy group (P = .006).

In a multivariate analysis, independent risk factors for PsA were older age (adjusted hazard ratio, 1.04; P < .001), nail psoriasis (aHR 3.15; P = .001), and psoriasis duration greater than 10 years (aHR, 2.02; P = .001). Most other baseline demographics, including smoking status, baseline Psoriasis Area and Severity Index (PASI) scores, and comorbidities, were similar in patients who did and did not develop PsA.

Of the patients taking biologic DMARDs, 39 (17%) were treated with infliximab, 17 (7%) with etanercept, 67 (29%) with adalimumab, 50 (21%) with ustekinumab, and 61 (26%) with secukinumab; 35 of these patients switched biologics during the study period.

The study findings were limited by several factors including the retrospective design and the resulting potential for biases, notably the potential confounding bias by indication because of the lack of randomization, the researchers noted. Another limitation was the inability to perform a subgroup analysis of biologic DMARD classes because of the small sample size, the authors said. However, they added, the findings were strengthened by the complete database and accurate PsA diagnoses supported by an expert rheumatologist.

Larger prospective and intervention studies are needed to validate the results, the researchers emphasized. However, data from the current study suggest that continued treatment with biologic DMARDs “may reduce the risk of incident PsA in patients with moderate to severe chronic plaque psoriasis,” they concluded.

The study was supported by the European Union’s Horizon 2020 Research and Innovation Program. Dr. Gisondi and several coauthors disclosed relationships with Abbvie, Almirall, Amgen, Janssen, Leo Pharma, Eli Lilly, Novartis, Pierre Fabre, Sandoz, Sanofi, and UCB. The study was supported by the European Union’s Horizon 2020 Research and Innovation Program.

Psoriasis patients treated with biological disease-modifying antirheumatic drugs had a significantly lower incidence of psoriatic arthritis (PsA) compared with those treated with phototherapy, in a study of 464 adults.

Epidemiologic data show that PsA may be diagnosed as long as 5-10 years after a diagnosis of plaque psoriasis, but PsA ultimately occurs in up to 25% of cases, wrote the study investigators, Paolo Gisondi, MD, of the section of dermatology and venereology, department of medicine, at Università degli Studi di Verona, Italy, and colleagues.

“The delay between the onset of skin manifestations of psoriasis and joint disease may provide a therapeutic window of clinical opportunity for preventing the progression from psoriasis to PsA,” but the impact of continuous systemic treatment with biological disease-modifying antirheumatic drugs (DMARDs) has not been well studied, the researchers said.

In the retrospective, nonrandomized study published in Annals of the Rheumatic Diseases, the researchers reviewed data from adults with moderate to severe plaque psoriasis who received continuous treatment with biologic DMARDs, compared with those who received narrow-band ultraviolet light B (nb-UVB) phototherapy, between January 2012 and September 2020.

Patients with a past or present PsA diagnosis were excluded from the study. A total of 234 patients were treated with biologic DMARDs for at least 5 years and 230 were treated with at least three courses of nb-UVB phototherapy; all patients were followed for an average of 7 years.

PsA was determined based on the Classification for Psoriatic Arthritis criteria. Incidence was defined in terms of cases per 100 patients per year.

During the follow-up period, 51 patients (11%) developed incident PsA: 19 (8%) in the biologic DMARDs group and 32 (14%) in the nb-UVB phototherapy group. The annual incidence rate of PsA was 1.20 cases per 100 patients per year in the biologic DMARDs group compared with 2.17 cases per 100 patients per year in the phototherapy group (P = .006).

In a multivariate analysis, independent risk factors for PsA were older age (adjusted hazard ratio, 1.04; P < .001), nail psoriasis (aHR 3.15; P = .001), and psoriasis duration greater than 10 years (aHR, 2.02; P = .001). Most other baseline demographics, including smoking status, baseline Psoriasis Area and Severity Index (PASI) scores, and comorbidities, were similar in patients who did and did not develop PsA.

Of the patients taking biologic DMARDs, 39 (17%) were treated with infliximab, 17 (7%) with etanercept, 67 (29%) with adalimumab, 50 (21%) with ustekinumab, and 61 (26%) with secukinumab; 35 of these patients switched biologics during the study period.

The study findings were limited by several factors including the retrospective design and the resulting potential for biases, notably the potential confounding bias by indication because of the lack of randomization, the researchers noted. Another limitation was the inability to perform a subgroup analysis of biologic DMARD classes because of the small sample size, the authors said. However, they added, the findings were strengthened by the complete database and accurate PsA diagnoses supported by an expert rheumatologist.

Larger prospective and intervention studies are needed to validate the results, the researchers emphasized. However, data from the current study suggest that continued treatment with biologic DMARDs “may reduce the risk of incident PsA in patients with moderate to severe chronic plaque psoriasis,” they concluded.

The study was supported by the European Union’s Horizon 2020 Research and Innovation Program. Dr. Gisondi and several coauthors disclosed relationships with Abbvie, Almirall, Amgen, Janssen, Leo Pharma, Eli Lilly, Novartis, Pierre Fabre, Sandoz, Sanofi, and UCB. The study was supported by the European Union’s Horizon 2020 Research and Innovation Program.

Secukinumab (Cosentyx), an interleukin-17A inhibitor, is effective and reasonably well tolerated for treatment of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in children and adolescents, according to a phase 3 trial presented at a late breaking abstracts session of the annual European Congress of Rheumatology.

On the primary outcome of time to flare, the curves for secukinumab and placebo separated almost immediately, with fewer than half the number of flares occurring in the experimental arm over the course of the study, according to Nicolino Ruperto, MD, senior research scientist at IRCCS Istituto Giannina Gaslini in Genoa, Italy.

The trial, called JUNIPERA, was conducted over 2 years and included an open-label treatment period (TP1) and then a randomized, placebo-controlled comparison (TP2). In TP1, 86 children were initiated on open-label secukinumab administered subcutaneously on weeks 1, 2, 3, 4, 8, and 12. The dose was 75 mg for children less than 50 kg and 150 kg for those heavier.
 

Average patient age was 13.1 years

Of these 86 children, 52 had ERA and 34 had JPsA. Disease duration of at least 6 months was required for entry. Patients up to the age of 18 years were permitted to enroll. The average age was 13.1 years. Most patients, two-thirds of whom were male, had received an immunomodulator prior to study entry.

At the end of TP1, 69.9% of patients had achieved 70% improvement in the Juvenile Idiopathic Arthritis American College of Rheumatology joint score (JIA ACR70). The 90.4% of patients who achieved JIA ACR30 were invited to enroll in TP2. A total of 75 patients did so.

At the end of TP2, response rates strongly favored secukinumab over placebo for JIA ACR30 (89.2% vs. 64.9%; P = .014) and JIA ACR70 (67.7% vs. 43.2%; P = .042). Higher but not statistically significant differences in response rates were seen for secukinumab over placebo for JIA ACR50 (78.4% vs. 62.2%; P = .152), JIA ACR90 (51.4% vs. 40.5%; P = .431) and JIA ACR100 (43.2% vs. 37.8%; P = .755).

During TP2, there were 10 flares in the group randomized to secukinumab versus 21 flares in the placebo group, translating by hazard ratio (HR) into a 72% risk reduction (HR, 0.28; P < .001).

Side effects similar to those in adults

The types and rates of serious adverse events were similar to those reported previously in adult patients, according to Dr. Ruperto. Although the rate of serious adverse events (14.6% vs. 10.6%) was only moderately higher in the experimental arm, more patients randomized to secukinumab than placebo discontinued therapy (13.2% vs. 6.3%) before the end of follow-up.

The side effects that occurred more commonly on secukinumab included gastrointestinal complaints, such as diarrhea (22.9% vs. 15.8%). Other adverse events occurring in more than 10% of patients included headache and nasopharyngitis, but most side effects were mild and resolved.

Although the proportion of patients with flare increased over time in both groups, Dr. Ruperto reported that protection against flares and relative improvement in clinical markers of disease activity relative to placebo “were sustained out to 2 years of follow-up.”

The submission of these data to regulatory agencies is anticipated. If secukinumab is given an indication for these forms of arthritis, it will join an indication for plaque psoriasis in children that was granted just a few days before these data were presented. The psoriasis indication is the only current use approved for children in the United States.
 

More biologics needed for JPsA

Additional biologics will be helpful for children with arthritis who are poorly controlled on available treatments, according to Natasha M. Ruth, MD, director of the division of pediatric rheumatology at the Medical University of South Carolina, Charleston. Dr. Ruth was senior author of a case study published 2 years ago in which secukinumab was used to control psoriatic arthritis and nail manifestations of psoriasis.

“It was a girl who had already failed to improve adequately to TNF inhibitors,” reported Dr. Ruth, who had said the child and her parent were very concerned about the nail appearance.

“The nail involvement completely resolved, so it was a very good result in a difficult situation,” Dr. Ruth explained. She said that the decision to try secukinumab was made collaboratively in a clinic in which dermatologists and rheumatologists at her institution work together on difficult cases.

“There is a need for more biologics with different mechanisms of action,” Dr. Ruth said. Based on her experience, secukinumab could be an important addition to treatment options.

Dr. Ruperto reported having financial relationships with more than 20 pharmaceutical companies, including Novartis, which provided financial support for this trial. Many coauthors had financial relationships with multiple companies, including Novartis, and some were employees of the company. Dr. Ruth reported having no potential conflicts of interest.

Secukinumab (Cosentyx), an interleukin-17A inhibitor, is effective and reasonably well tolerated for treatment of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in children and adolescents, according to a phase 3 trial presented at a late breaking abstracts session of the annual European Congress of Rheumatology.

On the primary outcome of time to flare, the curves for secukinumab and placebo separated almost immediately, with fewer than half the number of flares occurring in the experimental arm over the course of the study, according to Nicolino Ruperto, MD, senior research scientist at IRCCS Istituto Giannina Gaslini in Genoa, Italy.

The trial, called JUNIPERA, was conducted over 2 years and included an open-label treatment period (TP1) and then a randomized, placebo-controlled comparison (TP2). In TP1, 86 children were initiated on open-label secukinumab administered subcutaneously on weeks 1, 2, 3, 4, 8, and 12. The dose was 75 mg for children less than 50 kg and 150 kg for those heavier.
 

Average patient age was 13.1 years

Of these 86 children, 52 had ERA and 34 had JPsA. Disease duration of at least 6 months was required for entry. Patients up to the age of 18 years were permitted to enroll. The average age was 13.1 years. Most patients, two-thirds of whom were male, had received an immunomodulator prior to study entry.

At the end of TP1, 69.9% of patients had achieved 70% improvement in the Juvenile Idiopathic Arthritis American College of Rheumatology joint score (JIA ACR70). The 90.4% of patients who achieved JIA ACR30 were invited to enroll in TP2. A total of 75 patients did so.

At the end of TP2, response rates strongly favored secukinumab over placebo for JIA ACR30 (89.2% vs. 64.9%; P = .014) and JIA ACR70 (67.7% vs. 43.2%; P = .042). Higher but not statistically significant differences in response rates were seen for secukinumab over placebo for JIA ACR50 (78.4% vs. 62.2%; P = .152), JIA ACR90 (51.4% vs. 40.5%; P = .431) and JIA ACR100 (43.2% vs. 37.8%; P = .755).

During TP2, there were 10 flares in the group randomized to secukinumab versus 21 flares in the placebo group, translating by hazard ratio (HR) into a 72% risk reduction (HR, 0.28; P < .001).

Side effects similar to those in adults

The types and rates of serious adverse events were similar to those reported previously in adult patients, according to Dr. Ruperto. Although the rate of serious adverse events (14.6% vs. 10.6%) was only moderately higher in the experimental arm, more patients randomized to secukinumab than placebo discontinued therapy (13.2% vs. 6.3%) before the end of follow-up.

The side effects that occurred more commonly on secukinumab included gastrointestinal complaints, such as diarrhea (22.9% vs. 15.8%). Other adverse events occurring in more than 10% of patients included headache and nasopharyngitis, but most side effects were mild and resolved.

Although the proportion of patients with flare increased over time in both groups, Dr. Ruperto reported that protection against flares and relative improvement in clinical markers of disease activity relative to placebo “were sustained out to 2 years of follow-up.”

The submission of these data to regulatory agencies is anticipated. If secukinumab is given an indication for these forms of arthritis, it will join an indication for plaque psoriasis in children that was granted just a few days before these data were presented. The psoriasis indication is the only current use approved for children in the United States.
 

More biologics needed for JPsA

Additional biologics will be helpful for children with arthritis who are poorly controlled on available treatments, according to Natasha M. Ruth, MD, director of the division of pediatric rheumatology at the Medical University of South Carolina, Charleston. Dr. Ruth was senior author of a case study published 2 years ago in which secukinumab was used to control psoriatic arthritis and nail manifestations of psoriasis.

“It was a girl who had already failed to improve adequately to TNF inhibitors,” reported Dr. Ruth, who had said the child and her parent were very concerned about the nail appearance.

“The nail involvement completely resolved, so it was a very good result in a difficult situation,” Dr. Ruth explained. She said that the decision to try secukinumab was made collaboratively in a clinic in which dermatologists and rheumatologists at her institution work together on difficult cases.

“There is a need for more biologics with different mechanisms of action,” Dr. Ruth said. Based on her experience, secukinumab could be an important addition to treatment options.

Dr. Ruperto reported having financial relationships with more than 20 pharmaceutical companies, including Novartis, which provided financial support for this trial. Many coauthors had financial relationships with multiple companies, including Novartis, and some were employees of the company. Dr. Ruth reported having no potential conflicts of interest.

Secukinumab (Cosentyx), an interleukin-17A inhibitor, is effective and reasonably well tolerated for treatment of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in children and adolescents, according to a phase 3 trial presented at a late breaking abstracts session of the annual European Congress of Rheumatology.

On the primary outcome of time to flare, the curves for secukinumab and placebo separated almost immediately, with fewer than half the number of flares occurring in the experimental arm over the course of the study, according to Nicolino Ruperto, MD, senior research scientist at IRCCS Istituto Giannina Gaslini in Genoa, Italy.

The trial, called JUNIPERA, was conducted over 2 years and included an open-label treatment period (TP1) and then a randomized, placebo-controlled comparison (TP2). In TP1, 86 children were initiated on open-label secukinumab administered subcutaneously on weeks 1, 2, 3, 4, 8, and 12. The dose was 75 mg for children less than 50 kg and 150 kg for those heavier.
 

Average patient age was 13.1 years

Of these 86 children, 52 had ERA and 34 had JPsA. Disease duration of at least 6 months was required for entry. Patients up to the age of 18 years were permitted to enroll. The average age was 13.1 years. Most patients, two-thirds of whom were male, had received an immunomodulator prior to study entry.

At the end of TP1, 69.9% of patients had achieved 70% improvement in the Juvenile Idiopathic Arthritis American College of Rheumatology joint score (JIA ACR70). The 90.4% of patients who achieved JIA ACR30 were invited to enroll in TP2. A total of 75 patients did so.

At the end of TP2, response rates strongly favored secukinumab over placebo for JIA ACR30 (89.2% vs. 64.9%; P = .014) and JIA ACR70 (67.7% vs. 43.2%; P = .042). Higher but not statistically significant differences in response rates were seen for secukinumab over placebo for JIA ACR50 (78.4% vs. 62.2%; P = .152), JIA ACR90 (51.4% vs. 40.5%; P = .431) and JIA ACR100 (43.2% vs. 37.8%; P = .755).

During TP2, there were 10 flares in the group randomized to secukinumab versus 21 flares in the placebo group, translating by hazard ratio (HR) into a 72% risk reduction (HR, 0.28; P < .001).

Side effects similar to those in adults

The types and rates of serious adverse events were similar to those reported previously in adult patients, according to Dr. Ruperto. Although the rate of serious adverse events (14.6% vs. 10.6%) was only moderately higher in the experimental arm, more patients randomized to secukinumab than placebo discontinued therapy (13.2% vs. 6.3%) before the end of follow-up.

The side effects that occurred more commonly on secukinumab included gastrointestinal complaints, such as diarrhea (22.9% vs. 15.8%). Other adverse events occurring in more than 10% of patients included headache and nasopharyngitis, but most side effects were mild and resolved.

Although the proportion of patients with flare increased over time in both groups, Dr. Ruperto reported that protection against flares and relative improvement in clinical markers of disease activity relative to placebo “were sustained out to 2 years of follow-up.”

The submission of these data to regulatory agencies is anticipated. If secukinumab is given an indication for these forms of arthritis, it will join an indication for plaque psoriasis in children that was granted just a few days before these data were presented. The psoriasis indication is the only current use approved for children in the United States.
 

More biologics needed for JPsA

Additional biologics will be helpful for children with arthritis who are poorly controlled on available treatments, according to Natasha M. Ruth, MD, director of the division of pediatric rheumatology at the Medical University of South Carolina, Charleston. Dr. Ruth was senior author of a case study published 2 years ago in which secukinumab was used to control psoriatic arthritis and nail manifestations of psoriasis.

“It was a girl who had already failed to improve adequately to TNF inhibitors,” reported Dr. Ruth, who had said the child and her parent were very concerned about the nail appearance.

“The nail involvement completely resolved, so it was a very good result in a difficult situation,” Dr. Ruth explained. She said that the decision to try secukinumab was made collaboratively in a clinic in which dermatologists and rheumatologists at her institution work together on difficult cases.

“There is a need for more biologics with different mechanisms of action,” Dr. Ruth said. Based on her experience, secukinumab could be an important addition to treatment options.

Dr. Ruperto reported having financial relationships with more than 20 pharmaceutical companies, including Novartis, which provided financial support for this trial. Many coauthors had financial relationships with multiple companies, including Novartis, and some were employees of the company. Dr. Ruth reported having no potential conflicts of interest.

Risankizumab (Skyrizi) was effective for treating psoriatic arthritis (PsA) in patients who did not respond to or who could not tolerate other biologics or standard disease-modifying antirheumatic drugs (DMARDs), according to a study presented at the annual European Congress of Rheumatology. It was also well tolerated.

“Treatment with risankizumab resulted in significantly greater improvements in signs and symptoms of psoriatic arthritis, including assessments of disease activity in joints and skin and patient-reported outcomes, compared with placebo, in patients who did not respond to or were intolerant to biologics or DMARDs,” reported Andrew Ostor, MD, of Monash University and Cabrini Hospital, both in Melbourne,. The safety profile was “consistent with that established for risankizumab in the treatment moderate to severe psoriasis,” he told attendees.

Risankizumab is approved in the United States for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It is a humanized immunoglobulin G1 monoclonal antibody that selectively inhibits cytokine interleukin-23 by binding to its p19 subunit. IL-23 has been implicated in the development of PsA.

This was a phase 3 trial with “promising results in line with the ACR 20 response [at least 20% improvement in American College of Rheumatology response criteria] of other biologics in psoriatic arthritis,” according to Gaëlle Varkas, MD, PhD, of the Ghent (the Netherlands) University VIB Center for Inflammation Research and the department of rheumatology, Ghent University Hospital. “Especially in patients with severe and/or refractory skin disease or inadequate response at the level of the joint to other DMARDs or biologics, risankizumab is filling a void,” Dr. Varkas, who was not involved in the research, said in an interview.

There were no major safety problems, although long-term data, especially in regard to cancer and cardiovascular effects, “are always of interest, as they can be missed in randomized, controlled trials,” she said. In addition, “efficacy in concomitant axial disease, uveitis, and inflammatory bowel disease might favor one treatment over the other.” Another clinically significant takeaway was risankizumab’s “better effect on skin psoriasis while maintaining the effect on joint manifestations.”
 

Details of 24-week trial results

The phase 3, randomized, placebo-controlled, double-blind KEEPSAKE 2 trial involved 444 patients who had active PsA, defined as at least five swollen joints and at least five tender joints. All the patients either had an inadequate response to or were intolerant of one or two biologics or at least one conventional synthetic DMARD.

A total of 224 patients were randomly assigned to receive 150 mg of subcutaneous risankizumab at baseline and at 4 and 16 weeks after baseline; 220 participants received placebo injections. The primary endpoint was the proportion of patients who had at least 20% improvement in American College of Rheumatology response criteria at week 24.

Demographic and clinical characteristics were similar in both groups at baseline. Among the participants, the total mean number of swollen joints was 13.3, and the total mean number of tender joints was 22.6. The participants had PsA for an average of 8.2 years. The proportions of patients previously treated with biologics and DMARDs were similar in both groups, as were the proportions of patients currently taking glucocorticoids, NSAIDs, or methotrexate or another DMARD. At week 24, there remained 199 patients in the placebo group and 215 in the risankizumab group.

Just over half (51.3%) of patients who took risankizumab achieved at least 20% improvement in their ACR 20 score, compared with just over a quarter (26.5%) of those who received placebo (P < .001). All secondary endpoints also showed statistically significant improvements (P < .001 for all except P < .009 for the Fatigue Functional Assessment of Chronic Illness Therapy–Fatigue [FACIT-Fatigue] secondary endpoint).

Scores on the Health Assessment Questionnaire–Disability Index were –0.22 in the risankizumab group and –0.05 in the placebo group (P < .001). In the risankizumab group, 55% of patients achieved at least a 90% reduction in scores on the Psoriasis Area Severity Index, compared with 10.2% of patients who received placebo. Similarly, 25.6% of patients who took risankizumab and 11.4% of patients who received placebo had minimal disease activity 24 weeks after baseline.

In the 36-item Short Form Health Survey Physical Component Summary, the score change among risankizumab patients was 5.9, compared with 2 among the patients who received placebo. The change in FACIT-Fatigue score was 4.9 for patients who took risankizumab and 2.6 for patients who received placebo.

The researchers also assessed how many patients achieved higher levels of response to treatment. At least a 50% improvement in ACR response criteria occurred among 26.3% of patients taking risankizumab and 9.3% of patients taking placebo (P < .001). ACR 70 responses were seen in 12% of patients receiving risankizumab, compared with 5.9% of patients receiving placebo (P < .02). In the risankizumab group, 72.5% of patients had resolution of dactylitis and 42.9% had resolution of enthesitis, compared with 42.1% and 30.4%, respectively, in the placebo group.

Serious adverse events occurred in 4% of patients who received risankizumab and 5.5% of patients who received placebo. Serious infections occurred in 0.9% of those receiving risankizumab and 2.3% of those receiving placebo. Rates of treatment-emergent adverse events were also similar in the risankizumab (55.4%) and placebo (54.8%) groups.

In response to a question about whether it was possible to identify patients who might respond better to IL-23 inhibitors, compared with IL-17 inhibitors, Dr. Ostor acknowledged that rheumatologic practice is not yet proficient at using biomarkers to direct therapy, so the benefit from these drugs lay elsewhere.

“What I think is great is the luxury of choice these days,” Dr. Ostor told attendees. “We have these agents now, including risankizumab, that do work very effectively across the spectrum of the clinical features. It’s just lovely to have these agents available that can truly make a difference to the clinical picture of the individual.”

The trial was sponsored by AbbVie. Dr. Ostor has received research grants or speaking or consulting fees from AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi, and UCB. Dr. Varkas has received research grants or speaker fees from AbbVie and Pfizer.

A version of this article first appeared on Medscape.com.

Risankizumab (Skyrizi) was effective for treating psoriatic arthritis (PsA) in patients who did not respond to or who could not tolerate other biologics or standard disease-modifying antirheumatic drugs (DMARDs), according to a study presented at the annual European Congress of Rheumatology. It was also well tolerated.

“Treatment with risankizumab resulted in significantly greater improvements in signs and symptoms of psoriatic arthritis, including assessments of disease activity in joints and skin and patient-reported outcomes, compared with placebo, in patients who did not respond to or were intolerant to biologics or DMARDs,” reported Andrew Ostor, MD, of Monash University and Cabrini Hospital, both in Melbourne,. The safety profile was “consistent with that established for risankizumab in the treatment moderate to severe psoriasis,” he told attendees.

Risankizumab is approved in the United States for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It is a humanized immunoglobulin G1 monoclonal antibody that selectively inhibits cytokine interleukin-23 by binding to its p19 subunit. IL-23 has been implicated in the development of PsA.

This was a phase 3 trial with “promising results in line with the ACR 20 response [at least 20% improvement in American College of Rheumatology response criteria] of other biologics in psoriatic arthritis,” according to Gaëlle Varkas, MD, PhD, of the Ghent (the Netherlands) University VIB Center for Inflammation Research and the department of rheumatology, Ghent University Hospital. “Especially in patients with severe and/or refractory skin disease or inadequate response at the level of the joint to other DMARDs or biologics, risankizumab is filling a void,” Dr. Varkas, who was not involved in the research, said in an interview.

There were no major safety problems, although long-term data, especially in regard to cancer and cardiovascular effects, “are always of interest, as they can be missed in randomized, controlled trials,” she said. In addition, “efficacy in concomitant axial disease, uveitis, and inflammatory bowel disease might favor one treatment over the other.” Another clinically significant takeaway was risankizumab’s “better effect on skin psoriasis while maintaining the effect on joint manifestations.”
 

Details of 24-week trial results

The phase 3, randomized, placebo-controlled, double-blind KEEPSAKE 2 trial involved 444 patients who had active PsA, defined as at least five swollen joints and at least five tender joints. All the patients either had an inadequate response to or were intolerant of one or two biologics or at least one conventional synthetic DMARD.

A total of 224 patients were randomly assigned to receive 150 mg of subcutaneous risankizumab at baseline and at 4 and 16 weeks after baseline; 220 participants received placebo injections. The primary endpoint was the proportion of patients who had at least 20% improvement in American College of Rheumatology response criteria at week 24.

Demographic and clinical characteristics were similar in both groups at baseline. Among the participants, the total mean number of swollen joints was 13.3, and the total mean number of tender joints was 22.6. The participants had PsA for an average of 8.2 years. The proportions of patients previously treated with biologics and DMARDs were similar in both groups, as were the proportions of patients currently taking glucocorticoids, NSAIDs, or methotrexate or another DMARD. At week 24, there remained 199 patients in the placebo group and 215 in the risankizumab group.

Just over half (51.3%) of patients who took risankizumab achieved at least 20% improvement in their ACR 20 score, compared with just over a quarter (26.5%) of those who received placebo (P < .001). All secondary endpoints also showed statistically significant improvements (P < .001 for all except P < .009 for the Fatigue Functional Assessment of Chronic Illness Therapy–Fatigue [FACIT-Fatigue] secondary endpoint).

Scores on the Health Assessment Questionnaire–Disability Index were –0.22 in the risankizumab group and –0.05 in the placebo group (P < .001). In the risankizumab group, 55% of patients achieved at least a 90% reduction in scores on the Psoriasis Area Severity Index, compared with 10.2% of patients who received placebo. Similarly, 25.6% of patients who took risankizumab and 11.4% of patients who received placebo had minimal disease activity 24 weeks after baseline.

In the 36-item Short Form Health Survey Physical Component Summary, the score change among risankizumab patients was 5.9, compared with 2 among the patients who received placebo. The change in FACIT-Fatigue score was 4.9 for patients who took risankizumab and 2.6 for patients who received placebo.

The researchers also assessed how many patients achieved higher levels of response to treatment. At least a 50% improvement in ACR response criteria occurred among 26.3% of patients taking risankizumab and 9.3% of patients taking placebo (P < .001). ACR 70 responses were seen in 12% of patients receiving risankizumab, compared with 5.9% of patients receiving placebo (P < .02). In the risankizumab group, 72.5% of patients had resolution of dactylitis and 42.9% had resolution of enthesitis, compared with 42.1% and 30.4%, respectively, in the placebo group.

Serious adverse events occurred in 4% of patients who received risankizumab and 5.5% of patients who received placebo. Serious infections occurred in 0.9% of those receiving risankizumab and 2.3% of those receiving placebo. Rates of treatment-emergent adverse events were also similar in the risankizumab (55.4%) and placebo (54.8%) groups.

In response to a question about whether it was possible to identify patients who might respond better to IL-23 inhibitors, compared with IL-17 inhibitors, Dr. Ostor acknowledged that rheumatologic practice is not yet proficient at using biomarkers to direct therapy, so the benefit from these drugs lay elsewhere.

“What I think is great is the luxury of choice these days,” Dr. Ostor told attendees. “We have these agents now, including risankizumab, that do work very effectively across the spectrum of the clinical features. It’s just lovely to have these agents available that can truly make a difference to the clinical picture of the individual.”

The trial was sponsored by AbbVie. Dr. Ostor has received research grants or speaking or consulting fees from AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi, and UCB. Dr. Varkas has received research grants or speaker fees from AbbVie and Pfizer.

A version of this article first appeared on Medscape.com.

Risankizumab (Skyrizi) was effective for treating psoriatic arthritis (PsA) in patients who did not respond to or who could not tolerate other biologics or standard disease-modifying antirheumatic drugs (DMARDs), according to a study presented at the annual European Congress of Rheumatology. It was also well tolerated.

“Treatment with risankizumab resulted in significantly greater improvements in signs and symptoms of psoriatic arthritis, including assessments of disease activity in joints and skin and patient-reported outcomes, compared with placebo, in patients who did not respond to or were intolerant to biologics or DMARDs,” reported Andrew Ostor, MD, of Monash University and Cabrini Hospital, both in Melbourne,. The safety profile was “consistent with that established for risankizumab in the treatment moderate to severe psoriasis,” he told attendees.

Risankizumab is approved in the United States for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. It is a humanized immunoglobulin G1 monoclonal antibody that selectively inhibits cytokine interleukin-23 by binding to its p19 subunit. IL-23 has been implicated in the development of PsA.

This was a phase 3 trial with “promising results in line with the ACR 20 response [at least 20% improvement in American College of Rheumatology response criteria] of other biologics in psoriatic arthritis,” according to Gaëlle Varkas, MD, PhD, of the Ghent (the Netherlands) University VIB Center for Inflammation Research and the department of rheumatology, Ghent University Hospital. “Especially in patients with severe and/or refractory skin disease or inadequate response at the level of the joint to other DMARDs or biologics, risankizumab is filling a void,” Dr. Varkas, who was not involved in the research, said in an interview.

There were no major safety problems, although long-term data, especially in regard to cancer and cardiovascular effects, “are always of interest, as they can be missed in randomized, controlled trials,” she said. In addition, “efficacy in concomitant axial disease, uveitis, and inflammatory bowel disease might favor one treatment over the other.” Another clinically significant takeaway was risankizumab’s “better effect on skin psoriasis while maintaining the effect on joint manifestations.”
 

Details of 24-week trial results

The phase 3, randomized, placebo-controlled, double-blind KEEPSAKE 2 trial involved 444 patients who had active PsA, defined as at least five swollen joints and at least five tender joints. All the patients either had an inadequate response to or were intolerant of one or two biologics or at least one conventional synthetic DMARD.

A total of 224 patients were randomly assigned to receive 150 mg of subcutaneous risankizumab at baseline and at 4 and 16 weeks after baseline; 220 participants received placebo injections. The primary endpoint was the proportion of patients who had at least 20% improvement in American College of Rheumatology response criteria at week 24.

Demographic and clinical characteristics were similar in both groups at baseline. Among the participants, the total mean number of swollen joints was 13.3, and the total mean number of tender joints was 22.6. The participants had PsA for an average of 8.2 years. The proportions of patients previously treated with biologics and DMARDs were similar in both groups, as were the proportions of patients currently taking glucocorticoids, NSAIDs, or methotrexate or another DMARD. At week 24, there remained 199 patients in the placebo group and 215 in the risankizumab group.

Just over half (51.3%) of patients who took risankizumab achieved at least 20% improvement in their ACR 20 score, compared with just over a quarter (26.5%) of those who received placebo (P < .001). All secondary endpoints also showed statistically significant improvements (P < .001 for all except P < .009 for the Fatigue Functional Assessment of Chronic Illness Therapy–Fatigue [FACIT-Fatigue] secondary endpoint).

Scores on the Health Assessment Questionnaire–Disability Index were –0.22 in the risankizumab group and –0.05 in the placebo group (P < .001). In the risankizumab group, 55% of patients achieved at least a 90% reduction in scores on the Psoriasis Area Severity Index, compared with 10.2% of patients who received placebo. Similarly, 25.6% of patients who took risankizumab and 11.4% of patients who received placebo had minimal disease activity 24 weeks after baseline.

In the 36-item Short Form Health Survey Physical Component Summary, the score change among risankizumab patients was 5.9, compared with 2 among the patients who received placebo. The change in FACIT-Fatigue score was 4.9 for patients who took risankizumab and 2.6 for patients who received placebo.

The researchers also assessed how many patients achieved higher levels of response to treatment. At least a 50% improvement in ACR response criteria occurred among 26.3% of patients taking risankizumab and 9.3% of patients taking placebo (P < .001). ACR 70 responses were seen in 12% of patients receiving risankizumab, compared with 5.9% of patients receiving placebo (P < .02). In the risankizumab group, 72.5% of patients had resolution of dactylitis and 42.9% had resolution of enthesitis, compared with 42.1% and 30.4%, respectively, in the placebo group.

Serious adverse events occurred in 4% of patients who received risankizumab and 5.5% of patients who received placebo. Serious infections occurred in 0.9% of those receiving risankizumab and 2.3% of those receiving placebo. Rates of treatment-emergent adverse events were also similar in the risankizumab (55.4%) and placebo (54.8%) groups.

In response to a question about whether it was possible to identify patients who might respond better to IL-23 inhibitors, compared with IL-17 inhibitors, Dr. Ostor acknowledged that rheumatologic practice is not yet proficient at using biomarkers to direct therapy, so the benefit from these drugs lay elsewhere.

“What I think is great is the luxury of choice these days,” Dr. Ostor told attendees. “We have these agents now, including risankizumab, that do work very effectively across the spectrum of the clinical features. It’s just lovely to have these agents available that can truly make a difference to the clinical picture of the individual.”

The trial was sponsored by AbbVie. Dr. Ostor has received research grants or speaking or consulting fees from AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, Sanofi, and UCB. Dr. Varkas has received research grants or speaker fees from AbbVie and Pfizer.

A version of this article first appeared on Medscape.com.

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) has included more drugs and data and is moving toward a slightly more stepped approach to treating some forms of psoriatic disease in the latest iteration of their recommendations.

“There’s been an explosion over the last few years in terms of the number of medications,” available to treat psoriasis and psoriatic arthritis, Laura C. Coates, MBChB, PhD, said in an interview ahead of presenting the draft recommendations at the annual European Congress of Rheumatology.

“The good thing about having more drugs is you’ve got more choice, but actually it makes these recommendations even more important because it becomes more complicated to choose optimal treatment for individuals,” added Dr. Coates, a senior clinical research fellow at the University of Oxford (England).

“We’ve been waiting for a while now for the new GRAPPA recommendations,” Laure Gossec, MD, PhD, of Sorbonne University and Pitié-Salpêtrière Hospital in Paris, said in a separate interview.

New overarching principle and position statements

The goal of the recommendations hasn’t really changed since the first iteration of the guidelines in 2009, Dr. Coates noted in her presentation. They are intended to provide clinicians with recommendations “based on the best available evidence” for the management of patients with psoriatic disease.

To that end, a through process was followed, starting with the setting of PICO (Patient/population/problem; intervention; comparison; outcome) questions followed by systematic literature searches, data extraction, and review that assess the quality of evidence and then grade it accordingly before using it to inform the recommendation statements.

There is a new overarching principle that says: “These recommendations, which include the most current data concerning the optimal assessment of and therapeutic approached to psoriatic arthritis, present contextual considerations to empower shared decision making.”

The other overarching principles remain the same as in the 2015 version, with “minor wording changes particularly around the comorbidities overarching principle,” Dr. Coates said.

Also new are two position statements. “One of them is specifically around biosimilars, because that’s been a big shift since 2015,” Dr. Coates said. “It has basic rules about what evidence there should be, what we should consider when we’re using them, and patient involvement and decision making.”

The second statement covers “similar advice on tapering or discontinuing therapy – what we do when people are doing really well, how we should stop or taper, and which drugs we should choose to stop along with shared decision making with patients.”

GRAPPA intentionally gives clinicians more freedom

While there may be data to show differences in efficacy and side effects between the various drugs cited in the recommendations, “GRAPPA makes the choice to not prioritize one drug over another,” Dr. Gossec said. This decision gives “a lot of freedom then to the physician to make the decision.”

One important change according to Dr. Gossec is that oral “NSAIDs have clearly been put back as first-line treatment, before going on to disease-modifying drugs for most of the musculoskeletal manifestations. She added that for skin manifestations, topical NSAIDs were recommended, but that NSAIDs were more recommended for IBD and uveitis of course.

“I feel that’s a big step towards more of a step-up approach,” Dr. Gossec said. “The old recommendations were not clear that you would precede an NSAID before moving on to a disease-modifying drug. So, I think that makes it a little bit more similar to the 2019 EULAR recommendations.” The use of csDMARDs such as methotrexate has also been “pushed up a notch” in peripheral arthritis, she said.

What’s next?

There are a few fine tunings still to be made before the final recommendations are published. They also have to be discussed at the meeting of the GRAPPA task force, which consists of rheumatologists, dermatologists, and patient representatives.

Besides the recommendations manuscript, there will be individual papers detailing the evidence underpinning the recommendations in each of the eight domains, Dr. Coates noted. Those “will look at relative efficacy in detail,” she said. “There will be a lot more discussion/evidence summary included” to help with drug selection.

“We also plan to have some case studies to illustrate how the recommendations can be used, similar to that included in the 2015 recommendations,” she added.

Paul Studenic, MD, PhD, of the Karolinska Institute in Stockholm and Medical University of Vienna, tweeted that the GRAPPA recommendations showed treatment “needs to be tailored to the patient” taking “comorbidities as well as the heterogeneity of features of the clinical presentation into account.”

He said in an interview: “The third edition of the GRAPPA is a huge collaborative effort.” The new overarching principle put the recommendations in the context of shared decision making and, he added, they emphasize an “integrated management plan taking not only ‘classical’-related manifestations like uveitis into account but [also] a spectrum of comorbidities and reproductive health.”

GRAPPA is a not-for-profit organization and receives funding from multiple pharmaceutical companies. Currently this includes AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Janssen, Eli Lilly, Novartis, Pfizer, UCB, and Sun Pharma with Galapagos and Nordic Bioscience as Innovation Partners. Dr. Coates acknowledged receiving research funding, honoraria, speaker fees or all of these from most of the aforementioned companies.

Dr. Gossec has received research funding or other support from numerous pharmaceutical companies and is a member of GRAPPA and the task force that developed the EULAR guidelines on the pharmacological management of psoriatic arthritis.

Dr. Studenic had nothing to disclose.

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) has included more drugs and data and is moving toward a slightly more stepped approach to treating some forms of psoriatic disease in the latest iteration of their recommendations.

“There’s been an explosion over the last few years in terms of the number of medications,” available to treat psoriasis and psoriatic arthritis, Laura C. Coates, MBChB, PhD, said in an interview ahead of presenting the draft recommendations at the annual European Congress of Rheumatology.

“The good thing about having more drugs is you’ve got more choice, but actually it makes these recommendations even more important because it becomes more complicated to choose optimal treatment for individuals,” added Dr. Coates, a senior clinical research fellow at the University of Oxford (England).

“We’ve been waiting for a while now for the new GRAPPA recommendations,” Laure Gossec, MD, PhD, of Sorbonne University and Pitié-Salpêtrière Hospital in Paris, said in a separate interview.

New overarching principle and position statements

The goal of the recommendations hasn’t really changed since the first iteration of the guidelines in 2009, Dr. Coates noted in her presentation. They are intended to provide clinicians with recommendations “based on the best available evidence” for the management of patients with psoriatic disease.

To that end, a through process was followed, starting with the setting of PICO (Patient/population/problem; intervention; comparison; outcome) questions followed by systematic literature searches, data extraction, and review that assess the quality of evidence and then grade it accordingly before using it to inform the recommendation statements.

There is a new overarching principle that says: “These recommendations, which include the most current data concerning the optimal assessment of and therapeutic approached to psoriatic arthritis, present contextual considerations to empower shared decision making.”

The other overarching principles remain the same as in the 2015 version, with “minor wording changes particularly around the comorbidities overarching principle,” Dr. Coates said.

Also new are two position statements. “One of them is specifically around biosimilars, because that’s been a big shift since 2015,” Dr. Coates said. “It has basic rules about what evidence there should be, what we should consider when we’re using them, and patient involvement and decision making.”

The second statement covers “similar advice on tapering or discontinuing therapy – what we do when people are doing really well, how we should stop or taper, and which drugs we should choose to stop along with shared decision making with patients.”

GRAPPA intentionally gives clinicians more freedom

While there may be data to show differences in efficacy and side effects between the various drugs cited in the recommendations, “GRAPPA makes the choice to not prioritize one drug over another,” Dr. Gossec said. This decision gives “a lot of freedom then to the physician to make the decision.”

One important change according to Dr. Gossec is that oral “NSAIDs have clearly been put back as first-line treatment, before going on to disease-modifying drugs for most of the musculoskeletal manifestations. She added that for skin manifestations, topical NSAIDs were recommended, but that NSAIDs were more recommended for IBD and uveitis of course.

“I feel that’s a big step towards more of a step-up approach,” Dr. Gossec said. “The old recommendations were not clear that you would precede an NSAID before moving on to a disease-modifying drug. So, I think that makes it a little bit more similar to the 2019 EULAR recommendations.” The use of csDMARDs such as methotrexate has also been “pushed up a notch” in peripheral arthritis, she said.

What’s next?

There are a few fine tunings still to be made before the final recommendations are published. They also have to be discussed at the meeting of the GRAPPA task force, which consists of rheumatologists, dermatologists, and patient representatives.

Besides the recommendations manuscript, there will be individual papers detailing the evidence underpinning the recommendations in each of the eight domains, Dr. Coates noted. Those “will look at relative efficacy in detail,” she said. “There will be a lot more discussion/evidence summary included” to help with drug selection.

“We also plan to have some case studies to illustrate how the recommendations can be used, similar to that included in the 2015 recommendations,” she added.

Paul Studenic, MD, PhD, of the Karolinska Institute in Stockholm and Medical University of Vienna, tweeted that the GRAPPA recommendations showed treatment “needs to be tailored to the patient” taking “comorbidities as well as the heterogeneity of features of the clinical presentation into account.”

He said in an interview: “The third edition of the GRAPPA is a huge collaborative effort.” The new overarching principle put the recommendations in the context of shared decision making and, he added, they emphasize an “integrated management plan taking not only ‘classical’-related manifestations like uveitis into account but [also] a spectrum of comorbidities and reproductive health.”

GRAPPA is a not-for-profit organization and receives funding from multiple pharmaceutical companies. Currently this includes AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Janssen, Eli Lilly, Novartis, Pfizer, UCB, and Sun Pharma with Galapagos and Nordic Bioscience as Innovation Partners. Dr. Coates acknowledged receiving research funding, honoraria, speaker fees or all of these from most of the aforementioned companies.

Dr. Gossec has received research funding or other support from numerous pharmaceutical companies and is a member of GRAPPA and the task force that developed the EULAR guidelines on the pharmacological management of psoriatic arthritis.

Dr. Studenic had nothing to disclose.

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) has included more drugs and data and is moving toward a slightly more stepped approach to treating some forms of psoriatic disease in the latest iteration of their recommendations.

“There’s been an explosion over the last few years in terms of the number of medications,” available to treat psoriasis and psoriatic arthritis, Laura C. Coates, MBChB, PhD, said in an interview ahead of presenting the draft recommendations at the annual European Congress of Rheumatology.

“The good thing about having more drugs is you’ve got more choice, but actually it makes these recommendations even more important because it becomes more complicated to choose optimal treatment for individuals,” added Dr. Coates, a senior clinical research fellow at the University of Oxford (England).

“We’ve been waiting for a while now for the new GRAPPA recommendations,” Laure Gossec, MD, PhD, of Sorbonne University and Pitié-Salpêtrière Hospital in Paris, said in a separate interview.

New overarching principle and position statements

The goal of the recommendations hasn’t really changed since the first iteration of the guidelines in 2009, Dr. Coates noted in her presentation. They are intended to provide clinicians with recommendations “based on the best available evidence” for the management of patients with psoriatic disease.

To that end, a through process was followed, starting with the setting of PICO (Patient/population/problem; intervention; comparison; outcome) questions followed by systematic literature searches, data extraction, and review that assess the quality of evidence and then grade it accordingly before using it to inform the recommendation statements.

There is a new overarching principle that says: “These recommendations, which include the most current data concerning the optimal assessment of and therapeutic approached to psoriatic arthritis, present contextual considerations to empower shared decision making.”

The other overarching principles remain the same as in the 2015 version, with “minor wording changes particularly around the comorbidities overarching principle,” Dr. Coates said.

Also new are two position statements. “One of them is specifically around biosimilars, because that’s been a big shift since 2015,” Dr. Coates said. “It has basic rules about what evidence there should be, what we should consider when we’re using them, and patient involvement and decision making.”

The second statement covers “similar advice on tapering or discontinuing therapy – what we do when people are doing really well, how we should stop or taper, and which drugs we should choose to stop along with shared decision making with patients.”

GRAPPA intentionally gives clinicians more freedom

While there may be data to show differences in efficacy and side effects between the various drugs cited in the recommendations, “GRAPPA makes the choice to not prioritize one drug over another,” Dr. Gossec said. This decision gives “a lot of freedom then to the physician to make the decision.”

One important change according to Dr. Gossec is that oral “NSAIDs have clearly been put back as first-line treatment, before going on to disease-modifying drugs for most of the musculoskeletal manifestations. She added that for skin manifestations, topical NSAIDs were recommended, but that NSAIDs were more recommended for IBD and uveitis of course.

“I feel that’s a big step towards more of a step-up approach,” Dr. Gossec said. “The old recommendations were not clear that you would precede an NSAID before moving on to a disease-modifying drug. So, I think that makes it a little bit more similar to the 2019 EULAR recommendations.” The use of csDMARDs such as methotrexate has also been “pushed up a notch” in peripheral arthritis, she said.

What’s next?

There are a few fine tunings still to be made before the final recommendations are published. They also have to be discussed at the meeting of the GRAPPA task force, which consists of rheumatologists, dermatologists, and patient representatives.

Besides the recommendations manuscript, there will be individual papers detailing the evidence underpinning the recommendations in each of the eight domains, Dr. Coates noted. Those “will look at relative efficacy in detail,” she said. “There will be a lot more discussion/evidence summary included” to help with drug selection.

“We also plan to have some case studies to illustrate how the recommendations can be used, similar to that included in the 2015 recommendations,” she added.

Paul Studenic, MD, PhD, of the Karolinska Institute in Stockholm and Medical University of Vienna, tweeted that the GRAPPA recommendations showed treatment “needs to be tailored to the patient” taking “comorbidities as well as the heterogeneity of features of the clinical presentation into account.”

He said in an interview: “The third edition of the GRAPPA is a huge collaborative effort.” The new overarching principle put the recommendations in the context of shared decision making and, he added, they emphasize an “integrated management plan taking not only ‘classical’-related manifestations like uveitis into account but [also] a spectrum of comorbidities and reproductive health.”

GRAPPA is a not-for-profit organization and receives funding from multiple pharmaceutical companies. Currently this includes AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Janssen, Eli Lilly, Novartis, Pfizer, UCB, and Sun Pharma with Galapagos and Nordic Bioscience as Innovation Partners. Dr. Coates acknowledged receiving research funding, honoraria, speaker fees or all of these from most of the aforementioned companies.

Dr. Gossec has received research funding or other support from numerous pharmaceutical companies and is a member of GRAPPA and the task force that developed the EULAR guidelines on the pharmacological management of psoriatic arthritis.

Dr. Studenic had nothing to disclose.

Key clinical point: Psoriatic arthritis (PsA) adversely affected maternal outcomes in pregnant women; however, there was no adverse effect on neonatal outcomes.

Major finding: The risk for cesarean delivery (odds ratio [OR], 1.45; 95% confidence interval [CI], 1.27-1.66), preterm birth (OR, 1.48; 95% CI, 1.24-1.78), preeclampsia (OR, 1.45; 95% CI, 1.13-1.85), and gestational hypertension (OR, 1.49; 95% CI, 1.09-2.06) was significantly higher in pregnant women with PsA vs. general population. However, no statistically increased risk for fetal complications was observed in women with PsA.

Study details: Findings are from a meta-analysis of 16 observational studies including more than 46,909 cases of psoriasis/PsA with over 53,541 pregnancies and more than 4,771,352 healthy controls with over 8,044,996 pregnancies.

Disclosures: This study was funded by the National Natural Science Foundation of China. All authors declared no conflicts of interest.

Source: Xie W et al. Rheumatology (Oxford). 2021 Apr 20. doi: 10.1093/rheumatology/keab357.

Key clinical point: Psoriatic arthritis (PsA) adversely affected maternal outcomes in pregnant women; however, there was no adverse effect on neonatal outcomes.

Major finding: The risk for cesarean delivery (odds ratio [OR], 1.45; 95% confidence interval [CI], 1.27-1.66), preterm birth (OR, 1.48; 95% CI, 1.24-1.78), preeclampsia (OR, 1.45; 95% CI, 1.13-1.85), and gestational hypertension (OR, 1.49; 95% CI, 1.09-2.06) was significantly higher in pregnant women with PsA vs. general population. However, no statistically increased risk for fetal complications was observed in women with PsA.

Study details: Findings are from a meta-analysis of 16 observational studies including more than 46,909 cases of psoriasis/PsA with over 53,541 pregnancies and more than 4,771,352 healthy controls with over 8,044,996 pregnancies.

Disclosures: This study was funded by the National Natural Science Foundation of China. All authors declared no conflicts of interest.

Source: Xie W et al. Rheumatology (Oxford). 2021 Apr 20. doi: 10.1093/rheumatology/keab357.

Key clinical point: Psoriatic arthritis (PsA) adversely affected maternal outcomes in pregnant women; however, there was no adverse effect on neonatal outcomes.

Major finding: The risk for cesarean delivery (odds ratio [OR], 1.45; 95% confidence interval [CI], 1.27-1.66), preterm birth (OR, 1.48; 95% CI, 1.24-1.78), preeclampsia (OR, 1.45; 95% CI, 1.13-1.85), and gestational hypertension (OR, 1.49; 95% CI, 1.09-2.06) was significantly higher in pregnant women with PsA vs. general population. However, no statistically increased risk for fetal complications was observed in women with PsA.

Study details: Findings are from a meta-analysis of 16 observational studies including more than 46,909 cases of psoriasis/PsA with over 53,541 pregnancies and more than 4,771,352 healthy controls with over 8,044,996 pregnancies.

Disclosures: This study was funded by the National Natural Science Foundation of China. All authors declared no conflicts of interest.

Source: Xie W et al. Rheumatology (Oxford). 2021 Apr 20. doi: 10.1093/rheumatology/keab357.