Clinical Edge Journal Scan

Key clinical point: In the real-world setting, secukinumab has a satisfactory retention rate in psoriatic arthritis (PsA). However, retention rates are lower in PsA than in psoriasis, with arthritis and obesity being significant predictors of shorter drug survival.

Major finding: Retention rate of secukinumab was higher in psoriasis vs. PsA at 12 (85% vs. 68%) and 24 (61% vs. 57%) months, with the risk for secukinumab discontinuation being higher among patients with arthritis in the overall cohort (hazard ratio 2.43; P = .035) and in patients with obesity in the PsA cohort (P = .021).

Study details: Findings are from a real-life study including 62 patients with psoriasis and 90 patients with PsA who initiated treatment with secukinumab and were followed up for 24 months or until discontinuation.

Disclosures: This study did not receive any funding. R Ramonda and S Piaserico declared receiving honoraria and speaker fees form Novartis, Abbvie, Pfizer, MSD, and Janssen.

Source: Ortolan A et al. Secukinumab drug survival in psoriasis and psoriatic arthritis patients: A 24-month real-life study. Dermatology. 2022 (Mar 9). Doi: 10.1159/000522008

Key clinical point: In the real-world setting, secukinumab has a satisfactory retention rate in psoriatic arthritis (PsA). However, retention rates are lower in PsA than in psoriasis, with arthritis and obesity being significant predictors of shorter drug survival.

Major finding: Retention rate of secukinumab was higher in psoriasis vs. PsA at 12 (85% vs. 68%) and 24 (61% vs. 57%) months, with the risk for secukinumab discontinuation being higher among patients with arthritis in the overall cohort (hazard ratio 2.43; P = .035) and in patients with obesity in the PsA cohort (P = .021).

Study details: Findings are from a real-life study including 62 patients with psoriasis and 90 patients with PsA who initiated treatment with secukinumab and were followed up for 24 months or until discontinuation.

Disclosures: This study did not receive any funding. R Ramonda and S Piaserico declared receiving honoraria and speaker fees form Novartis, Abbvie, Pfizer, MSD, and Janssen.

Source: Ortolan A et al. Secukinumab drug survival in psoriasis and psoriatic arthritis patients: A 24-month real-life study. Dermatology. 2022 (Mar 9). Doi: 10.1159/000522008

Key clinical point: In the real-world setting, secukinumab has a satisfactory retention rate in psoriatic arthritis (PsA). However, retention rates are lower in PsA than in psoriasis, with arthritis and obesity being significant predictors of shorter drug survival.

Major finding: Retention rate of secukinumab was higher in psoriasis vs. PsA at 12 (85% vs. 68%) and 24 (61% vs. 57%) months, with the risk for secukinumab discontinuation being higher among patients with arthritis in the overall cohort (hazard ratio 2.43; P = .035) and in patients with obesity in the PsA cohort (P = .021).

Study details: Findings are from a real-life study including 62 patients with psoriasis and 90 patients with PsA who initiated treatment with secukinumab and were followed up for 24 months or until discontinuation.

Disclosures: This study did not receive any funding. R Ramonda and S Piaserico declared receiving honoraria and speaker fees form Novartis, Abbvie, Pfizer, MSD, and Janssen.

Source: Ortolan A et al. Secukinumab drug survival in psoriasis and psoriatic arthritis patients: A 24-month real-life study. Dermatology. 2022 (Mar 9). Doi: 10.1159/000522008

Key clinical point: The association between abnormalities in renal function parameters and disease activity may be guided by the degree of disease control in psoriatic arthritis (PsA), with disease relapse having a significant effect on renal function in patients with PsA.

Major finding: Renal dysfunction was experienced by 38.5%-58.3% of patients with PsA within 12 months of treatment initiation. Patients with vs. without disease relapse had significantly higher mean serum creatinine levels (P = .031) at treatment initiation; however, clinical remission or treatment type did not seem to affect renal function parameters.

Study details: This single-center retrospective study included 45 patients with PsA (n = 23) or rheumatoid arthritis (n = 22) who received appropriate medication and underwent renal function evaluation every 3-6 months.

Disclosures: This study was supported by Novartis. The authors declared no conflict of interests.

Source: Atzeni F et al. Frequency of renal function parameter abnormalities in patients with psoriatic arthritis and rheumatoid arthritis: Real-world evidence from clinical practice. J Clin Med. 2022;11(4):1029 (Feb 16). Doi: 10.3390/jcm11041029

Key clinical point: The association between abnormalities in renal function parameters and disease activity may be guided by the degree of disease control in psoriatic arthritis (PsA), with disease relapse having a significant effect on renal function in patients with PsA.

Major finding: Renal dysfunction was experienced by 38.5%-58.3% of patients with PsA within 12 months of treatment initiation. Patients with vs. without disease relapse had significantly higher mean serum creatinine levels (P = .031) at treatment initiation; however, clinical remission or treatment type did not seem to affect renal function parameters.

Study details: This single-center retrospective study included 45 patients with PsA (n = 23) or rheumatoid arthritis (n = 22) who received appropriate medication and underwent renal function evaluation every 3-6 months.

Disclosures: This study was supported by Novartis. The authors declared no conflict of interests.

Source: Atzeni F et al. Frequency of renal function parameter abnormalities in patients with psoriatic arthritis and rheumatoid arthritis: Real-world evidence from clinical practice. J Clin Med. 2022;11(4):1029 (Feb 16). Doi: 10.3390/jcm11041029

Key clinical point: The association between abnormalities in renal function parameters and disease activity may be guided by the degree of disease control in psoriatic arthritis (PsA), with disease relapse having a significant effect on renal function in patients with PsA.

Major finding: Renal dysfunction was experienced by 38.5%-58.3% of patients with PsA within 12 months of treatment initiation. Patients with vs. without disease relapse had significantly higher mean serum creatinine levels (P = .031) at treatment initiation; however, clinical remission or treatment type did not seem to affect renal function parameters.

Study details: This single-center retrospective study included 45 patients with PsA (n = 23) or rheumatoid arthritis (n = 22) who received appropriate medication and underwent renal function evaluation every 3-6 months.

Disclosures: This study was supported by Novartis. The authors declared no conflict of interests.

Source: Atzeni F et al. Frequency of renal function parameter abnormalities in patients with psoriatic arthritis and rheumatoid arthritis: Real-world evidence from clinical practice. J Clin Med. 2022;11(4):1029 (Feb 16). Doi: 10.3390/jcm11041029

Key clinical point: The association between abnormalities in renal function parameters and disease activity may be guided by the degree of disease control in psoriatic arthritis (PsA), with disease relapse having a significant effect on renal function in patients with PsA.

Major finding: Renal dysfunction was experienced by 38.5%-58.3% of patients with PsA within 12 months of treatment initiation. Patients with vs. without disease relapse had significantly higher mean serum creatinine levels (P = .031) at treatment initiation; however, clinical remission or treatment type did not seem to affect renal function parameters.

Study details: This single-center retrospective study included 45 patients with PsA (n = 23) or rheumatoid arthritis (n = 22) who received appropriate medication and underwent renal function evaluation every 3-6 months.

Disclosures: This study was supported by Novartis. The authors declared no conflict of interests.

Source: Atzeni F et al. Frequency of renal function parameter abnormalities in patients with psoriatic arthritis and rheumatoid arthritis: Real-world evidence from clinical practice. J Clin Med. 2022;11(4):1029 (Feb 16). Doi: 10.3390/jcm11041029

Key clinical point: The association between abnormalities in renal function parameters and disease activity may be guided by the degree of disease control in psoriatic arthritis (PsA), with disease relapse having a significant effect on renal function in patients with PsA.

Major finding: Renal dysfunction was experienced by 38.5%-58.3% of patients with PsA within 12 months of treatment initiation. Patients with vs. without disease relapse had significantly higher mean serum creatinine levels (P = .031) at treatment initiation; however, clinical remission or treatment type did not seem to affect renal function parameters.

Study details: This single-center retrospective study included 45 patients with PsA (n = 23) or rheumatoid arthritis (n = 22) who received appropriate medication and underwent renal function evaluation every 3-6 months.

Disclosures: This study was supported by Novartis. The authors declared no conflict of interests.

Source: Atzeni F et al. Frequency of renal function parameter abnormalities in patients with psoriatic arthritis and rheumatoid arthritis: Real-world evidence from clinical practice. J Clin Med. 2022;11(4):1029 (Feb 16). Doi: 10.3390/jcm11041029

Key clinical point: The association between abnormalities in renal function parameters and disease activity may be guided by the degree of disease control in psoriatic arthritis (PsA), with disease relapse having a significant effect on renal function in patients with PsA.

Major finding: Renal dysfunction was experienced by 38.5%-58.3% of patients with PsA within 12 months of treatment initiation. Patients with vs. without disease relapse had significantly higher mean serum creatinine levels (P = .031) at treatment initiation; however, clinical remission or treatment type did not seem to affect renal function parameters.

Study details: This single-center retrospective study included 45 patients with PsA (n = 23) or rheumatoid arthritis (n = 22) who received appropriate medication and underwent renal function evaluation every 3-6 months.

Disclosures: This study was supported by Novartis. The authors declared no conflict of interests.

Source: Atzeni F et al. Frequency of renal function parameter abnormalities in patients with psoriatic arthritis and rheumatoid arthritis: Real-world evidence from clinical practice. J Clin Med. 2022;11(4):1029 (Feb 16). Doi: 10.3390/jcm11041029

Key clinical point: In the initial 16 weeks of this phase 2 trial, patients with psoriatic arthritis (PsA) achieved higher response with deucravacitinib vs. placebo along with a consistent safety profile.

Major finding: At week 16, American College of Rheumatology-20 (ACR20) response was significantly higher with 6 mg once-daily deucravacitinib (adjusted odds ratio [aOR] 2.4; P = .0134) and 12 mg (aOR 3.6; P = .0004) vs. placebo (31.8%), with 12 mg deucravacitinib improving ACR20 response as early as at 8 weeks (P < .05). No serious adverse events were reported in patients treated with deucravacitinib.

Study details: Findings are from a phase 2 study including 203 patients with active PsA intolerant to ≥1 therapy who were randomly assigned to receive 6 mg deucravacitinib once a day, 12 mg deucravacitinib once daily, or placebo for 16 weeks.

Disclosures: This study was sponsored by Bristol Myers Squibb. Eight authors declared being employees or shareholders of Bristol Myers Squibb or of receiving payments or speaker/consultant fees from Bristol Myers Squibb.

Source: Mease PJ et al. Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis. Ann Rheum Dis. 2022 (Mar 3). Doi: 10.1136/annrheumdis-2021-221664

Key clinical point: In the initial 16 weeks of this phase 2 trial, patients with psoriatic arthritis (PsA) achieved higher response with deucravacitinib vs. placebo along with a consistent safety profile.

Major finding: At week 16, American College of Rheumatology-20 (ACR20) response was significantly higher with 6 mg once-daily deucravacitinib (adjusted odds ratio [aOR] 2.4; P = .0134) and 12 mg (aOR 3.6; P = .0004) vs. placebo (31.8%), with 12 mg deucravacitinib improving ACR20 response as early as at 8 weeks (P < .05). No serious adverse events were reported in patients treated with deucravacitinib.

Study details: Findings are from a phase 2 study including 203 patients with active PsA intolerant to ≥1 therapy who were randomly assigned to receive 6 mg deucravacitinib once a day, 12 mg deucravacitinib once daily, or placebo for 16 weeks.

Disclosures: This study was sponsored by Bristol Myers Squibb. Eight authors declared being employees or shareholders of Bristol Myers Squibb or of receiving payments or speaker/consultant fees from Bristol Myers Squibb.

Source: Mease PJ et al. Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis. Ann Rheum Dis. 2022 (Mar 3). Doi: 10.1136/annrheumdis-2021-221664

Key clinical point: In the initial 16 weeks of this phase 2 trial, patients with psoriatic arthritis (PsA) achieved higher response with deucravacitinib vs. placebo along with a consistent safety profile.

Major finding: At week 16, American College of Rheumatology-20 (ACR20) response was significantly higher with 6 mg once-daily deucravacitinib (adjusted odds ratio [aOR] 2.4; P = .0134) and 12 mg (aOR 3.6; P = .0004) vs. placebo (31.8%), with 12 mg deucravacitinib improving ACR20 response as early as at 8 weeks (P < .05). No serious adverse events were reported in patients treated with deucravacitinib.

Study details: Findings are from a phase 2 study including 203 patients with active PsA intolerant to ≥1 therapy who were randomly assigned to receive 6 mg deucravacitinib once a day, 12 mg deucravacitinib once daily, or placebo for 16 weeks.

Disclosures: This study was sponsored by Bristol Myers Squibb. Eight authors declared being employees or shareholders of Bristol Myers Squibb or of receiving payments or speaker/consultant fees from Bristol Myers Squibb.

Source: Mease PJ et al. Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis. Ann Rheum Dis. 2022 (Mar 3). Doi: 10.1136/annrheumdis-2021-221664

Key clinical point: A magnetic resonance imaging (MRI)-based scoring method was sensitive to changes in clinical outcomes of psoriatic arthritis (PsA) caused by abatacept, validating the responsiveness of the OMERACT PsA MRI Scoring System.

Major finding: Until day 169, patients receiving 30 mg/kg abatacept with a switch over to 10 mg/kg and those receiving 10 mg/kg abatacept reported significant reduction in MRI-detected synovitis (−0.97; P = .04) and tenosynovitis (−1.65; P = .01) vs. placebo, with patients switching from placebo to 10 mg/kg abatacept at day 169 showing significant improvements in total inflammation, synovitis, and tenosynovitis (P < .05) up to day 365.

Study details: This was a post hoc analysis of a phase 2b study including 123 patients with active PsA and an inadequate response to disease-modifying antirheumatic drugs randomly assigned to receive abatacept or placebo.

Disclosures: This study was funded by Bristol Myers Squibb. The authors declared serving on speakers’ bureaus and as consultants or receiving grants/research support from several sources. Six authors declared being employees or shareholders of Bristol Myers Squibb.

Source: Østergaard M et al. Implementation of the OMERACT Psoriatic Arthritis Magnetic Resonance Imaging Scoring System in a randomized phase IIb study of abatacept in psoriatic arthritis. Rheumatology (Oxford). 2022 (Feb 8). Doi: 10.1093/rheumatology/keac073

Key clinical point: A magnetic resonance imaging (MRI)-based scoring method was sensitive to changes in clinical outcomes of psoriatic arthritis (PsA) caused by abatacept, validating the responsiveness of the OMERACT PsA MRI Scoring System.

Major finding: Until day 169, patients receiving 30 mg/kg abatacept with a switch over to 10 mg/kg and those receiving 10 mg/kg abatacept reported significant reduction in MRI-detected synovitis (−0.97; P = .04) and tenosynovitis (−1.65; P = .01) vs. placebo, with patients switching from placebo to 10 mg/kg abatacept at day 169 showing significant improvements in total inflammation, synovitis, and tenosynovitis (P < .05) up to day 365.

Study details: This was a post hoc analysis of a phase 2b study including 123 patients with active PsA and an inadequate response to disease-modifying antirheumatic drugs randomly assigned to receive abatacept or placebo.

Disclosures: This study was funded by Bristol Myers Squibb. The authors declared serving on speakers’ bureaus and as consultants or receiving grants/research support from several sources. Six authors declared being employees or shareholders of Bristol Myers Squibb.

Source: Østergaard M et al. Implementation of the OMERACT Psoriatic Arthritis Magnetic Resonance Imaging Scoring System in a randomized phase IIb study of abatacept in psoriatic arthritis. Rheumatology (Oxford). 2022 (Feb 8). Doi: 10.1093/rheumatology/keac073

Key clinical point: A magnetic resonance imaging (MRI)-based scoring method was sensitive to changes in clinical outcomes of psoriatic arthritis (PsA) caused by abatacept, validating the responsiveness of the OMERACT PsA MRI Scoring System.

Major finding: Until day 169, patients receiving 30 mg/kg abatacept with a switch over to 10 mg/kg and those receiving 10 mg/kg abatacept reported significant reduction in MRI-detected synovitis (−0.97; P = .04) and tenosynovitis (−1.65; P = .01) vs. placebo, with patients switching from placebo to 10 mg/kg abatacept at day 169 showing significant improvements in total inflammation, synovitis, and tenosynovitis (P < .05) up to day 365.

Study details: This was a post hoc analysis of a phase 2b study including 123 patients with active PsA and an inadequate response to disease-modifying antirheumatic drugs randomly assigned to receive abatacept or placebo.

Disclosures: This study was funded by Bristol Myers Squibb. The authors declared serving on speakers’ bureaus and as consultants or receiving grants/research support from several sources. Six authors declared being employees or shareholders of Bristol Myers Squibb.

Source: Østergaard M et al. Implementation of the OMERACT Psoriatic Arthritis Magnetic Resonance Imaging Scoring System in a randomized phase IIb study of abatacept in psoriatic arthritis. Rheumatology (Oxford). 2022 (Feb 8). Doi: 10.1093/rheumatology/keac073

Key clinical point: Humoral response to BNT162b2 mRNA SARS-CoV-2 vaccine was reduced in patients with psoriatic arthritis (PsA) who received immunomodulatory treatment with antitumor necrosis factor (TNF) therapy, methotrexate, or interleukin 17 inhibitor compared with those without PsA.

Major finding: The median anti-SARS-CoV-2 spike receptor-binding domain immunoglobulin G (IgG) antibody level after 3 weeks of receiving the second dose of BNT162b2 mRNA SARS-CoV-2 vaccine was significantly higher in individuals without vs. with PsA (1,562.00 vs. 928.00 binding antibody units (BAU)/mL; P ≤ .001). The levels were, however, similar across anti-TNF therapy, secukinumab, or methotrexate treatment groups (P = .73).

Study details: Findings are from a prospective study including 110 patients with PsA in clinical remission who received immunomodulatory treatment and were matched with 96 healthy healthcare workers, all of whom had previously received two shots of the BNT162b2 mRNA SARS-CoV-2 vaccine.

Disclosures: The study did not report any source of funding. The authors declared no conflict of interests.

Source: Benucci M et al. Vaccination for SARS-CoV-2 in Patients With Psoriatic Arthritis: Can Therapy Affect the Immunological Response? Front Med. 2022;9:811829 (Feb 28). Doi: 10.3389/fmed.2022.811829

Key clinical point: Humoral response to BNT162b2 mRNA SARS-CoV-2 vaccine was reduced in patients with psoriatic arthritis (PsA) who received immunomodulatory treatment with antitumor necrosis factor (TNF) therapy, methotrexate, or interleukin 17 inhibitor compared with those without PsA.

Major finding: The median anti-SARS-CoV-2 spike receptor-binding domain immunoglobulin G (IgG) antibody level after 3 weeks of receiving the second dose of BNT162b2 mRNA SARS-CoV-2 vaccine was significantly higher in individuals without vs. with PsA (1,562.00 vs. 928.00 binding antibody units (BAU)/mL; P ≤ .001). The levels were, however, similar across anti-TNF therapy, secukinumab, or methotrexate treatment groups (P = .73).

Study details: Findings are from a prospective study including 110 patients with PsA in clinical remission who received immunomodulatory treatment and were matched with 96 healthy healthcare workers, all of whom had previously received two shots of the BNT162b2 mRNA SARS-CoV-2 vaccine.

Disclosures: The study did not report any source of funding. The authors declared no conflict of interests.

Source: Benucci M et al. Vaccination for SARS-CoV-2 in Patients With Psoriatic Arthritis: Can Therapy Affect the Immunological Response? Front Med. 2022;9:811829 (Feb 28). Doi: 10.3389/fmed.2022.811829

Key clinical point: Humoral response to BNT162b2 mRNA SARS-CoV-2 vaccine was reduced in patients with psoriatic arthritis (PsA) who received immunomodulatory treatment with antitumor necrosis factor (TNF) therapy, methotrexate, or interleukin 17 inhibitor compared with those without PsA.

Major finding: The median anti-SARS-CoV-2 spike receptor-binding domain immunoglobulin G (IgG) antibody level after 3 weeks of receiving the second dose of BNT162b2 mRNA SARS-CoV-2 vaccine was significantly higher in individuals without vs. with PsA (1,562.00 vs. 928.00 binding antibody units (BAU)/mL; P ≤ .001). The levels were, however, similar across anti-TNF therapy, secukinumab, or methotrexate treatment groups (P = .73).

Study details: Findings are from a prospective study including 110 patients with PsA in clinical remission who received immunomodulatory treatment and were matched with 96 healthy healthcare workers, all of whom had previously received two shots of the BNT162b2 mRNA SARS-CoV-2 vaccine.

Disclosures: The study did not report any source of funding. The authors declared no conflict of interests.

Source: Benucci M et al. Vaccination for SARS-CoV-2 in Patients With Psoriatic Arthritis: Can Therapy Affect the Immunological Response? Front Med. 2022;9:811829 (Feb 28). Doi: 10.3389/fmed.2022.811829

Key clinical point: Ustekinumab and a tumor necrosis factor inhibitor (TNFi) showed comparable efficacy, safety, and drug persistence after 1 year of treatment in real-world patients with psoriatic arthritis (PsA).

Major finding: After 1 year of treatment, ustekinumab vs. TNFi showed similar persistence (hazard ratio for stopping/switching treatment 0.82; 95% CI 0.60-1.13) and a similar proportion of patients achieving clinical low disease activity  on the Disease Activity Index for PsA  (odds ratio [OR] 0.80; 95% CI 0.57-1.10) and remission (OR 0.73; 95% CI 0.49-1.07), along with a similar safety profile.

Study details: Findings are from a 1-year analysis of the prospective, observational PsABio study including 893 patients with PsA who were prescribed first-line to third-line ustekinumab or TNFis.

Disclosures: PsABio study was sponsored by Janssen. The authors declared receiving grants, personal fees, consulting fees, research support, nonfinancial support, and honoraria from several sources, including Janssen. Three authors declared being employees or shareholders of Janssen or Johnson and Johnson, Janssen’s corporate parent.

Source: Gossec L et al. Persistence and effectiveness of the IL-12/23 pathway inhibitor ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: 1-year results from the real-world PsABio Study. Ann Rheum Dis. 2022 (Feb 24). Doi: 10.1136/annrheumdis-2021-221640

Key clinical point: Ustekinumab and a tumor necrosis factor inhibitor (TNFi) showed comparable efficacy, safety, and drug persistence after 1 year of treatment in real-world patients with psoriatic arthritis (PsA).

Major finding: After 1 year of treatment, ustekinumab vs. TNFi showed similar persistence (hazard ratio for stopping/switching treatment 0.82; 95% CI 0.60-1.13) and a similar proportion of patients achieving clinical low disease activity  on the Disease Activity Index for PsA  (odds ratio [OR] 0.80; 95% CI 0.57-1.10) and remission (OR 0.73; 95% CI 0.49-1.07), along with a similar safety profile.

Study details: Findings are from a 1-year analysis of the prospective, observational PsABio study including 893 patients with PsA who were prescribed first-line to third-line ustekinumab or TNFis.

Disclosures: PsABio study was sponsored by Janssen. The authors declared receiving grants, personal fees, consulting fees, research support, nonfinancial support, and honoraria from several sources, including Janssen. Three authors declared being employees or shareholders of Janssen or Johnson and Johnson, Janssen’s corporate parent.

Source: Gossec L et al. Persistence and effectiveness of the IL-12/23 pathway inhibitor ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: 1-year results from the real-world PsABio Study. Ann Rheum Dis. 2022 (Feb 24). Doi: 10.1136/annrheumdis-2021-221640

Key clinical point: Ustekinumab and a tumor necrosis factor inhibitor (TNFi) showed comparable efficacy, safety, and drug persistence after 1 year of treatment in real-world patients with psoriatic arthritis (PsA).

Major finding: After 1 year of treatment, ustekinumab vs. TNFi showed similar persistence (hazard ratio for stopping/switching treatment 0.82; 95% CI 0.60-1.13) and a similar proportion of patients achieving clinical low disease activity  on the Disease Activity Index for PsA  (odds ratio [OR] 0.80; 95% CI 0.57-1.10) and remission (OR 0.73; 95% CI 0.49-1.07), along with a similar safety profile.

Study details: Findings are from a 1-year analysis of the prospective, observational PsABio study including 893 patients with PsA who were prescribed first-line to third-line ustekinumab or TNFis.

Disclosures: PsABio study was sponsored by Janssen. The authors declared receiving grants, personal fees, consulting fees, research support, nonfinancial support, and honoraria from several sources, including Janssen. Three authors declared being employees or shareholders of Janssen or Johnson and Johnson, Janssen’s corporate parent.

Source: Gossec L et al. Persistence and effectiveness of the IL-12/23 pathway inhibitor ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: 1-year results from the real-world PsABio Study. Ann Rheum Dis. 2022 (Feb 24). Doi: 10.1136/annrheumdis-2021-221640

Key clinical point: Methotrexate+leflunomide therapy was superior to methotrexate monotherapy at improving disease activity in patients with psoriatic arthritis (PsA); however methotrexate+leflunomide therapy was less well tolerated than methotrexate monotherapy.

Major finding: At week 16, PsA disease activity score improved significantly in the methotrexate+leflunomide vs. methotrexate monotherapy group (3.1 vs. 3.7; P = .025). Incidence of mild adverse events, such as nausea/vomiting (44% vs. 28%) and altered bowel habits (26% vs. 8%), was higher with methotrexate+leflunomide vs. methotrexate+placebo.

Study details: Findings are from the phase 3 COMPLETE-PsA trial including 78 patients with active PsA who were randomly assigned to receive 2 tablets/day of 10 mg leflunomide or placebo once/day, both with 25 mg/week methotrexate.

Disclosures: This study was supported by the Regional Junior Researcher Grant from the Sint Maartenskliniek, Nijmegen, and the Radboudumc, Nijmegen, The Netherlands. The authors declared serving as speakers or consultants or receiving payments, honoraria, consulting and speaker fees, and support for attending meetings from several sources.

Source: Mulder MLM et al. Comparing methotrexate monotherapy with methotrexate plus leflunomide combination therapy in psoriatic arthritis (COMPLETE-PsA): a double-blind, placebo-controlled, randomised, trial. Lancet Rheumatol. 2022 (Feb 28). Doi: 10.1016/S2665-9913(22)00028-5

Key clinical point: Methotrexate+leflunomide therapy was superior to methotrexate monotherapy at improving disease activity in patients with psoriatic arthritis (PsA); however methotrexate+leflunomide therapy was less well tolerated than methotrexate monotherapy.

Major finding: At week 16, PsA disease activity score improved significantly in the methotrexate+leflunomide vs. methotrexate monotherapy group (3.1 vs. 3.7; P = .025). Incidence of mild adverse events, such as nausea/vomiting (44% vs. 28%) and altered bowel habits (26% vs. 8%), was higher with methotrexate+leflunomide vs. methotrexate+placebo.

Study details: Findings are from the phase 3 COMPLETE-PsA trial including 78 patients with active PsA who were randomly assigned to receive 2 tablets/day of 10 mg leflunomide or placebo once/day, both with 25 mg/week methotrexate.

Disclosures: This study was supported by the Regional Junior Researcher Grant from the Sint Maartenskliniek, Nijmegen, and the Radboudumc, Nijmegen, The Netherlands. The authors declared serving as speakers or consultants or receiving payments, honoraria, consulting and speaker fees, and support for attending meetings from several sources.

Source: Mulder MLM et al. Comparing methotrexate monotherapy with methotrexate plus leflunomide combination therapy in psoriatic arthritis (COMPLETE-PsA): a double-blind, placebo-controlled, randomised, trial. Lancet Rheumatol. 2022 (Feb 28). Doi: 10.1016/S2665-9913(22)00028-5

Key clinical point: Methotrexate+leflunomide therapy was superior to methotrexate monotherapy at improving disease activity in patients with psoriatic arthritis (PsA); however methotrexate+leflunomide therapy was less well tolerated than methotrexate monotherapy.

Major finding: At week 16, PsA disease activity score improved significantly in the methotrexate+leflunomide vs. methotrexate monotherapy group (3.1 vs. 3.7; P = .025). Incidence of mild adverse events, such as nausea/vomiting (44% vs. 28%) and altered bowel habits (26% vs. 8%), was higher with methotrexate+leflunomide vs. methotrexate+placebo.

Study details: Findings are from the phase 3 COMPLETE-PsA trial including 78 patients with active PsA who were randomly assigned to receive 2 tablets/day of 10 mg leflunomide or placebo once/day, both with 25 mg/week methotrexate.

Disclosures: This study was supported by the Regional Junior Researcher Grant from the Sint Maartenskliniek, Nijmegen, and the Radboudumc, Nijmegen, The Netherlands. The authors declared serving as speakers or consultants or receiving payments, honoraria, consulting and speaker fees, and support for attending meetings from several sources.

Source: Mulder MLM et al. Comparing methotrexate monotherapy with methotrexate plus leflunomide combination therapy in psoriatic arthritis (COMPLETE-PsA): a double-blind, placebo-controlled, randomised, trial. Lancet Rheumatol. 2022 (Feb 28). Doi: 10.1016/S2665-9913(22)00028-5

Key clinical point: Findings from the CONTROL trial support adding adalimumab over escalating methotrexate in patients with psoriatic arthritis (PsA) who respond inadequately to the initial methotrexate dose.

Major finding: At week 16, a significantly higher proportion of patients achieved minimal disease activity after adding adalimumab to methotrexate vs. escalating methotrexate dose (41% vs. 13%; P < .0001), with the efficacy being maintained through 32 weeks by 80% of adalimumab responders despite methotrexate withdrawal at 16 weeks. No new safety signals were identified.

Study details: Findings are from the phase 4 CONTROL trial including 245 patients with active PsA with an inadequate response to methotrexate. They were randomly assigned to receive 15 mg/week adalimumab+methotrexate or have a methotrexate dose escalated up to 25 mg/week for 16 weeks; responders either maintained or modified their current therapy and nonresponders had their therapy escalated until 32 weeks.

Disclosures: This study was funded by AbbVie. Four authors declared being employees or stockholders of AbbVie and other authors reported ties with various sources including AbbVie.

Source: Coates LC et al. Comparison between adalimumab introduction and methotrexate dose escalation in patients with inadequately controlled psoriatic arthritis (CONTROL): a randomised, open-label, two-part, phase 4 study. Lancet Rheumatol. 2022 (Feb 25). Doi: 10.1016/S2665-9913(22)00008-X

Key clinical point: Findings from the CONTROL trial support adding adalimumab over escalating methotrexate in patients with psoriatic arthritis (PsA) who respond inadequately to the initial methotrexate dose.

Major finding: At week 16, a significantly higher proportion of patients achieved minimal disease activity after adding adalimumab to methotrexate vs. escalating methotrexate dose (41% vs. 13%; P < .0001), with the efficacy being maintained through 32 weeks by 80% of adalimumab responders despite methotrexate withdrawal at 16 weeks. No new safety signals were identified.

Study details: Findings are from the phase 4 CONTROL trial including 245 patients with active PsA with an inadequate response to methotrexate. They were randomly assigned to receive 15 mg/week adalimumab+methotrexate or have a methotrexate dose escalated up to 25 mg/week for 16 weeks; responders either maintained or modified their current therapy and nonresponders had their therapy escalated until 32 weeks.

Disclosures: This study was funded by AbbVie. Four authors declared being employees or stockholders of AbbVie and other authors reported ties with various sources including AbbVie.

Source: Coates LC et al. Comparison between adalimumab introduction and methotrexate dose escalation in patients with inadequately controlled psoriatic arthritis (CONTROL): a randomised, open-label, two-part, phase 4 study. Lancet Rheumatol. 2022 (Feb 25). Doi: 10.1016/S2665-9913(22)00008-X

Key clinical point: Findings from the CONTROL trial support adding adalimumab over escalating methotrexate in patients with psoriatic arthritis (PsA) who respond inadequately to the initial methotrexate dose.

Major finding: At week 16, a significantly higher proportion of patients achieved minimal disease activity after adding adalimumab to methotrexate vs. escalating methotrexate dose (41% vs. 13%; P < .0001), with the efficacy being maintained through 32 weeks by 80% of adalimumab responders despite methotrexate withdrawal at 16 weeks. No new safety signals were identified.

Study details: Findings are from the phase 4 CONTROL trial including 245 patients with active PsA with an inadequate response to methotrexate. They were randomly assigned to receive 15 mg/week adalimumab+methotrexate or have a methotrexate dose escalated up to 25 mg/week for 16 weeks; responders either maintained or modified their current therapy and nonresponders had their therapy escalated until 32 weeks.

Disclosures: This study was funded by AbbVie. Four authors declared being employees or stockholders of AbbVie and other authors reported ties with various sources including AbbVie.

Source: Coates LC et al. Comparison between adalimumab introduction and methotrexate dose escalation in patients with inadequately controlled psoriatic arthritis (CONTROL): a randomised, open-label, two-part, phase 4 study. Lancet Rheumatol. 2022 (Feb 25). Doi: 10.1016/S2665-9913(22)00008-X

Previous studies exploring vaccination responses in the setting of certain disease-modifying therapies noted that B-cell–depleting agents and fingolimod were associated with poorer vaccination responses, as measured by antibody titers. Another prospective study explored mitigating strategies for people with MS treated with fingolimod and concluded that discontinuation of disease-modifying therapy improved the humoral response generated after SARS-CoV-2 vaccination (Achiron et al). Specifically, 20 people with MS treated with fingolimod therapy, who received the third dose of BNT162b2 (Pfizer-BioNTech) vaccine after not developing a humoral immunoglobulin (Ig) G immune response to the previous two doses, were randomly assigned to the fingolimod-continuation or fingolimod-discontinuation group. In this cohort, 80% vs. 20% of patients in the fingolimod-discontinuation vs. fingolimod-continuation group developed a positive humoral response against SARS-CoV-2 at 1 month after the third vaccine dose, with a significantly higher median G titer in the fingolimod-discontinuation vs. fingolimod-continuation group (202.3 vs. 26.4 binding antibody units/mL; P = .022). Certain B-cell–depleting agents adversely influence serum Ig levels, and other B-cell–"impacting" agents appear to not. In one study, extended ofatumumab treatment in a group of people with MS (N = 1969) for up to 3.5 years was both well tolerated and not associated with new risks. In this study, 83.8% and 9.7% of patients experienced at least one AE and one serious AE, respectively. Systemic injection-related reactions, infections, and cancers were reported in 24.8%, 54.3%, and 0.3% of patients, respectively. In most patients, the mean serum IgG and IgM levels were stable and above the lower limit of normal, and the risk for serious infections remained low, as seen with Ig deficiencies (Hauser et al).

Practical points for clinicians who treat MS to include in discussions with people with MS about choice of disease-modifying therapy and ongoing treatment include the safety and tolerability of vaccinations, the limited effect of vaccination on relapse in MS, the effect of specific disease-modifying therapies on vaccination responses and vaccine efficacy, and the importance of Ig levels and ongoing monitoring of Ig levels in routine care.

Previous studies exploring vaccination responses in the setting of certain disease-modifying therapies noted that B-cell–depleting agents and fingolimod were associated with poorer vaccination responses, as measured by antibody titers. Another prospective study explored mitigating strategies for people with MS treated with fingolimod and concluded that discontinuation of disease-modifying therapy improved the humoral response generated after SARS-CoV-2 vaccination (Achiron et al). Specifically, 20 people with MS treated with fingolimod therapy, who received the third dose of BNT162b2 (Pfizer-BioNTech) vaccine after not developing a humoral immunoglobulin (Ig) G immune response to the previous two doses, were randomly assigned to the fingolimod-continuation or fingolimod-discontinuation group. In this cohort, 80% vs. 20% of patients in the fingolimod-discontinuation vs. fingolimod-continuation group developed a positive humoral response against SARS-CoV-2 at 1 month after the third vaccine dose, with a significantly higher median G titer in the fingolimod-discontinuation vs. fingolimod-continuation group (202.3 vs. 26.4 binding antibody units/mL; P = .022). Certain B-cell–depleting agents adversely influence serum Ig levels, and other B-cell–"impacting" agents appear to not. In one study, extended ofatumumab treatment in a group of people with MS (N = 1969) for up to 3.5 years was both well tolerated and not associated with new risks. In this study, 83.8% and 9.7% of patients experienced at least one AE and one serious AE, respectively. Systemic injection-related reactions, infections, and cancers were reported in 24.8%, 54.3%, and 0.3% of patients, respectively. In most patients, the mean serum IgG and IgM levels were stable and above the lower limit of normal, and the risk for serious infections remained low, as seen with Ig deficiencies (Hauser et al).

Practical points for clinicians who treat MS to include in discussions with people with MS about choice of disease-modifying therapy and ongoing treatment include the safety and tolerability of vaccinations, the limited effect of vaccination on relapse in MS, the effect of specific disease-modifying therapies on vaccination responses and vaccine efficacy, and the importance of Ig levels and ongoing monitoring of Ig levels in routine care.

Previous studies exploring vaccination responses in the setting of certain disease-modifying therapies noted that B-cell–depleting agents and fingolimod were associated with poorer vaccination responses, as measured by antibody titers. Another prospective study explored mitigating strategies for people with MS treated with fingolimod and concluded that discontinuation of disease-modifying therapy improved the humoral response generated after SARS-CoV-2 vaccination (Achiron et al). Specifically, 20 people with MS treated with fingolimod therapy, who received the third dose of BNT162b2 (Pfizer-BioNTech) vaccine after not developing a humoral immunoglobulin (Ig) G immune response to the previous two doses, were randomly assigned to the fingolimod-continuation or fingolimod-discontinuation group. In this cohort, 80% vs. 20% of patients in the fingolimod-discontinuation vs. fingolimod-continuation group developed a positive humoral response against SARS-CoV-2 at 1 month after the third vaccine dose, with a significantly higher median G titer in the fingolimod-discontinuation vs. fingolimod-continuation group (202.3 vs. 26.4 binding antibody units/mL; P = .022). Certain B-cell–depleting agents adversely influence serum Ig levels, and other B-cell–"impacting" agents appear to not. In one study, extended ofatumumab treatment in a group of people with MS (N = 1969) for up to 3.5 years was both well tolerated and not associated with new risks. In this study, 83.8% and 9.7% of patients experienced at least one AE and one serious AE, respectively. Systemic injection-related reactions, infections, and cancers were reported in 24.8%, 54.3%, and 0.3% of patients, respectively. In most patients, the mean serum IgG and IgM levels were stable and above the lower limit of normal, and the risk for serious infections remained low, as seen with Ig deficiencies (Hauser et al).

Practical points for clinicians who treat MS to include in discussions with people with MS about choice of disease-modifying therapy and ongoing treatment include the safety and tolerability of vaccinations, the limited effect of vaccination on relapse in MS, the effect of specific disease-modifying therapies on vaccination responses and vaccine efficacy, and the importance of Ig levels and ongoing monitoring of Ig levels in routine care.