Psoriatic Arthritis ICYMI

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

For patients with psoriatic arthritis (PsA) whose condition doesn’t respond adequately to methotrexate, addition of the tumor necrosis factor (TNF) inhibitor adalimumab increased the likelihood of achieving minimum disease activity (MDA), compared with escalation of MTX dose, according to results from a phase 4, open-label study.

The new study is one of only a few to compare treatment protocols in a field that has seen new therapeutic options become available in recent years. That lack of evidence can leave patients and physicians uncertain about the next step if the initial results of treatment are disappointing.

“There are some gaps in our database and our understanding of psoriatic arthritis, compared to rheumatoid arthritis, where we have had many more studies over the years,” Arthur Kavanaugh, MD, told this news organization when asked to comment on the study.

The trial provides one answer, at least. “There was a clear-cut signal that it made more sense to add adalimumab at that early juncture where a person is not quite doing well enough on methotrexate to satisfy our goal of getting the patient to low disease activity. It gives us as clinicians some ammunition to speak to our insurance formulary people on this side of the Atlantic, or [for] people in the U.K. to go to their local regulatory board that approves medicines and be able to show them some actual practically derived evidence about this very common question that comes up in practice,” senior and corresponding author Philip Mease, MD, said in an interview. The study was published online in The Lancet Rheumatology.

“When a clinician and patient are making the decision to move on from methotrexate monotherapy, either because of lack of efficacy or safety issues, tolerability issues, it makes most sense to add on a biologic medication such as a TNF inhibitor at that juncture, rather than intensifying methotrexate therapy,” said Dr. Mease, who is director of rheumatology research at Swedish Medical Center/Providence St. Joseph Health and a clinical professor at the University of Washington, both in Seattle.

Physicians may be tempted to bump up the dose for patients who can tolerate MTX and who may be showing some improvement, but the new study should prompt a different strategy if MDA isn’t achieved, according to Oliver FitzGerald, MD, a professor at the Conway Institute for Biomolecular Research at University College Dublin, who was asked to comment on the study. “This study clearly shows that the early addition of adalimumab is the better choice, and it would change practice. That being said, there are clearly some patients who do respond sufficiently to increasing methotrexate, and it would be useful to be able to predict which patients might do that.” He added that the study focused on adalimumab and that the results might not apply to other biologics.

The study should encourage use of a quantitative treat-to-target measure like MDA, which is a composite measure of patient perspectives, Dr. Mease said. The American College of Rheumatology and National Psoriasis Foundation and Group for Research and Assessment of Psoriasis and Psoriatic Arthritis have recommended the use of MDA as a treat-to-target measure for PsA. The ACR and NPF recommend TNF inhibitors as first-line treatment, and GRAPPA includes it as a first-line option, whereas the European Alliance of Associations for Rheumatology recommends MTX only in the first line.

The study also suggests that there is value to using adalimumab on a weekly basis if an every-other-week schedule doesn’t produce the desired results. This strategy hasn’t been examined in PsA or even RA, according to Dr. Kavanaugh, who is a professor of medicine at the University of California, San Diego. “It did look like raising the dose might be an option for patients who are on every other week and are not doing quite as well as we would have hoped.”

The CONTROL study was a phase 4, two-part, open-label study. It included 245 patients in 14 countries who did not have MDA with MTX. In the first part of the study, patients were randomly assigned to receive weekly 15 mg MTX along with 40 mg adalimumab every other week, or escalation of MTX dose to 20-25 mg/week. MTX could be administered orally or intravenously. After 16 weeks (part 1), for patients who achieved MDA, current therapy was maintained or modified; for patients who did not achieve MDA, therapy was escalated over the following 16 weeks by giving adalimumab every week in the combination group or by adding adalimumab every other week in the MTX escalation arm.

Overall, 95% of the MTX plus adalimumab group completed part 1, as did 90% of the MTX escalation group. A total of 41% of the adalimumab group achieved MDA at 16 weeks versus 13% of the MTX group (P < .0001). The result held after accounting for sex and the interaction between sex and treatment (odds ratio, 4.6; 95% confidence interval, 2.4-8.9).

Among patients who achieved MDA at 16 weeks, 80% in the adalimumab group continued to have MDA at 32 weeks even after MTX had been withdrawn. Of those in the MTX escalation group, 67% continued to have MDA at 32 weeks with continued escalation of MTX.

Of the patients in the MTX escalation group who did not respond, 55% reached MDA following introduction of adalimumab every other week. Of those who did not respond to adalimumab, 30% reached MDA after switching to weekly adalimumab doses.

The study was open label, and patients who received adalimumab may have expected some improvement; that could have skewed the findings, Dr. Kavanaugh said. “I think that’s an important consideration as we interpret the data. The people who got the MTX arm probably had less of an expectation that they were going to do much better than those who switched to the adalimumab, as did the doctors taking care of them.”

The CONTROL study was funded by AbbVie. Dr. Mease has received research grants, consulted for, or received speaker honoraria from AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun Pharma, and UCB. Dr. FitzGerald has received grant support and honoraria from AbbVie. Dr. Kavanaugh has received research support from or consulted for AbbVie, Janssen, Pfizer, Lilly, Novartis, and UCB.

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

For patients with psoriatic arthritis (PsA) whose condition doesn’t respond adequately to methotrexate, addition of the tumor necrosis factor (TNF) inhibitor adalimumab increased the likelihood of achieving minimum disease activity (MDA), compared with escalation of MTX dose, according to results from a phase 4, open-label study.

The new study is one of only a few to compare treatment protocols in a field that has seen new therapeutic options become available in recent years. That lack of evidence can leave patients and physicians uncertain about the next step if the initial results of treatment are disappointing.

“There are some gaps in our database and our understanding of psoriatic arthritis, compared to rheumatoid arthritis, where we have had many more studies over the years,” Arthur Kavanaugh, MD, told this news organization when asked to comment on the study.

The trial provides one answer, at least. “There was a clear-cut signal that it made more sense to add adalimumab at that early juncture where a person is not quite doing well enough on methotrexate to satisfy our goal of getting the patient to low disease activity. It gives us as clinicians some ammunition to speak to our insurance formulary people on this side of the Atlantic, or [for] people in the U.K. to go to their local regulatory board that approves medicines and be able to show them some actual practically derived evidence about this very common question that comes up in practice,” senior and corresponding author Philip Mease, MD, said in an interview. The study was published online in The Lancet Rheumatology.

“When a clinician and patient are making the decision to move on from methotrexate monotherapy, either because of lack of efficacy or safety issues, tolerability issues, it makes most sense to add on a biologic medication such as a TNF inhibitor at that juncture, rather than intensifying methotrexate therapy,” said Dr. Mease, who is director of rheumatology research at Swedish Medical Center/Providence St. Joseph Health and a clinical professor at the University of Washington, both in Seattle.

Physicians may be tempted to bump up the dose for patients who can tolerate MTX and who may be showing some improvement, but the new study should prompt a different strategy if MDA isn’t achieved, according to Oliver FitzGerald, MD, a professor at the Conway Institute for Biomolecular Research at University College Dublin, who was asked to comment on the study. “This study clearly shows that the early addition of adalimumab is the better choice, and it would change practice. That being said, there are clearly some patients who do respond sufficiently to increasing methotrexate, and it would be useful to be able to predict which patients might do that.” He added that the study focused on adalimumab and that the results might not apply to other biologics.

The study should encourage use of a quantitative treat-to-target measure like MDA, which is a composite measure of patient perspectives, Dr. Mease said. The American College of Rheumatology and National Psoriasis Foundation and Group for Research and Assessment of Psoriasis and Psoriatic Arthritis have recommended the use of MDA as a treat-to-target measure for PsA. The ACR and NPF recommend TNF inhibitors as first-line treatment, and GRAPPA includes it as a first-line option, whereas the European Alliance of Associations for Rheumatology recommends MTX only in the first line.

The study also suggests that there is value to using adalimumab on a weekly basis if an every-other-week schedule doesn’t produce the desired results. This strategy hasn’t been examined in PsA or even RA, according to Dr. Kavanaugh, who is a professor of medicine at the University of California, San Diego. “It did look like raising the dose might be an option for patients who are on every other week and are not doing quite as well as we would have hoped.”

The CONTROL study was a phase 4, two-part, open-label study. It included 245 patients in 14 countries who did not have MDA with MTX. In the first part of the study, patients were randomly assigned to receive weekly 15 mg MTX along with 40 mg adalimumab every other week, or escalation of MTX dose to 20-25 mg/week. MTX could be administered orally or intravenously. After 16 weeks (part 1), for patients who achieved MDA, current therapy was maintained or modified; for patients who did not achieve MDA, therapy was escalated over the following 16 weeks by giving adalimumab every week in the combination group or by adding adalimumab every other week in the MTX escalation arm.

Overall, 95% of the MTX plus adalimumab group completed part 1, as did 90% of the MTX escalation group. A total of 41% of the adalimumab group achieved MDA at 16 weeks versus 13% of the MTX group (P < .0001). The result held after accounting for sex and the interaction between sex and treatment (odds ratio, 4.6; 95% confidence interval, 2.4-8.9).

Among patients who achieved MDA at 16 weeks, 80% in the adalimumab group continued to have MDA at 32 weeks even after MTX had been withdrawn. Of those in the MTX escalation group, 67% continued to have MDA at 32 weeks with continued escalation of MTX.

Of the patients in the MTX escalation group who did not respond, 55% reached MDA following introduction of adalimumab every other week. Of those who did not respond to adalimumab, 30% reached MDA after switching to weekly adalimumab doses.

The study was open label, and patients who received adalimumab may have expected some improvement; that could have skewed the findings, Dr. Kavanaugh said. “I think that’s an important consideration as we interpret the data. The people who got the MTX arm probably had less of an expectation that they were going to do much better than those who switched to the adalimumab, as did the doctors taking care of them.”

The CONTROL study was funded by AbbVie. Dr. Mease has received research grants, consulted for, or received speaker honoraria from AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun Pharma, and UCB. Dr. FitzGerald has received grant support and honoraria from AbbVie. Dr. Kavanaugh has received research support from or consulted for AbbVie, Janssen, Pfizer, Lilly, Novartis, and UCB.

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

For patients with psoriatic arthritis (PsA) whose condition doesn’t respond adequately to methotrexate, addition of the tumor necrosis factor (TNF) inhibitor adalimumab increased the likelihood of achieving minimum disease activity (MDA), compared with escalation of MTX dose, according to results from a phase 4, open-label study.

The new study is one of only a few to compare treatment protocols in a field that has seen new therapeutic options become available in recent years. That lack of evidence can leave patients and physicians uncertain about the next step if the initial results of treatment are disappointing.

“There are some gaps in our database and our understanding of psoriatic arthritis, compared to rheumatoid arthritis, where we have had many more studies over the years,” Arthur Kavanaugh, MD, told this news organization when asked to comment on the study.

The trial provides one answer, at least. “There was a clear-cut signal that it made more sense to add adalimumab at that early juncture where a person is not quite doing well enough on methotrexate to satisfy our goal of getting the patient to low disease activity. It gives us as clinicians some ammunition to speak to our insurance formulary people on this side of the Atlantic, or [for] people in the U.K. to go to their local regulatory board that approves medicines and be able to show them some actual practically derived evidence about this very common question that comes up in practice,” senior and corresponding author Philip Mease, MD, said in an interview. The study was published online in The Lancet Rheumatology.

“When a clinician and patient are making the decision to move on from methotrexate monotherapy, either because of lack of efficacy or safety issues, tolerability issues, it makes most sense to add on a biologic medication such as a TNF inhibitor at that juncture, rather than intensifying methotrexate therapy,” said Dr. Mease, who is director of rheumatology research at Swedish Medical Center/Providence St. Joseph Health and a clinical professor at the University of Washington, both in Seattle.

Physicians may be tempted to bump up the dose for patients who can tolerate MTX and who may be showing some improvement, but the new study should prompt a different strategy if MDA isn’t achieved, according to Oliver FitzGerald, MD, a professor at the Conway Institute for Biomolecular Research at University College Dublin, who was asked to comment on the study. “This study clearly shows that the early addition of adalimumab is the better choice, and it would change practice. That being said, there are clearly some patients who do respond sufficiently to increasing methotrexate, and it would be useful to be able to predict which patients might do that.” He added that the study focused on adalimumab and that the results might not apply to other biologics.

The study should encourage use of a quantitative treat-to-target measure like MDA, which is a composite measure of patient perspectives, Dr. Mease said. The American College of Rheumatology and National Psoriasis Foundation and Group for Research and Assessment of Psoriasis and Psoriatic Arthritis have recommended the use of MDA as a treat-to-target measure for PsA. The ACR and NPF recommend TNF inhibitors as first-line treatment, and GRAPPA includes it as a first-line option, whereas the European Alliance of Associations for Rheumatology recommends MTX only in the first line.

The study also suggests that there is value to using adalimumab on a weekly basis if an every-other-week schedule doesn’t produce the desired results. This strategy hasn’t been examined in PsA or even RA, according to Dr. Kavanaugh, who is a professor of medicine at the University of California, San Diego. “It did look like raising the dose might be an option for patients who are on every other week and are not doing quite as well as we would have hoped.”

The CONTROL study was a phase 4, two-part, open-label study. It included 245 patients in 14 countries who did not have MDA with MTX. In the first part of the study, patients were randomly assigned to receive weekly 15 mg MTX along with 40 mg adalimumab every other week, or escalation of MTX dose to 20-25 mg/week. MTX could be administered orally or intravenously. After 16 weeks (part 1), for patients who achieved MDA, current therapy was maintained or modified; for patients who did not achieve MDA, therapy was escalated over the following 16 weeks by giving adalimumab every week in the combination group or by adding adalimumab every other week in the MTX escalation arm.

Overall, 95% of the MTX plus adalimumab group completed part 1, as did 90% of the MTX escalation group. A total of 41% of the adalimumab group achieved MDA at 16 weeks versus 13% of the MTX group (P < .0001). The result held after accounting for sex and the interaction between sex and treatment (odds ratio, 4.6; 95% confidence interval, 2.4-8.9).

Among patients who achieved MDA at 16 weeks, 80% in the adalimumab group continued to have MDA at 32 weeks even after MTX had been withdrawn. Of those in the MTX escalation group, 67% continued to have MDA at 32 weeks with continued escalation of MTX.

Of the patients in the MTX escalation group who did not respond, 55% reached MDA following introduction of adalimumab every other week. Of those who did not respond to adalimumab, 30% reached MDA after switching to weekly adalimumab doses.

The study was open label, and patients who received adalimumab may have expected some improvement; that could have skewed the findings, Dr. Kavanaugh said. “I think that’s an important consideration as we interpret the data. The people who got the MTX arm probably had less of an expectation that they were going to do much better than those who switched to the adalimumab, as did the doctors taking care of them.”

The CONTROL study was funded by AbbVie. Dr. Mease has received research grants, consulted for, or received speaker honoraria from AbbVie, Amgen, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Sun Pharma, and UCB. Dr. FitzGerald has received grant support and honoraria from AbbVie. Dr. Kavanaugh has received research support from or consulted for AbbVie, Janssen, Pfizer, Lilly, Novartis, and UCB.

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

Exposure to air pollution – even short term – may play a role in triggering psoriasis flares, according to new research from Italy, which found a significant association between exposure to higher levels of air pollution prior to patients presenting for psoriasis flares at medical visits, compared with visits unrelated to flares.

“We found that higher concentration of different air pollutants was associated with psoriasis flares in patients living in an industrialized city of the Po Valley” in Verona, Italy, report the authors of the study, published in JAMA Dermatology.

The findings underscore the need for clinicians to “consider environmental/external triggers in patients with chronic inflammatory diseases experiencing flares,” first author Francesco Bellinato, MD, of the Section of Dermatology and Venereology, University of Verona, Italy, told this news organization.

He and his coauthors conducted a case-crossover and cross-sectional longitudinal study that involved a retrospective analysis of data in 957 patients in Verona with chronic plaque psoriasis, who were evaluated every 3-4 months at an outpatient dermatology clinic for a median of 2.7 years.

Over the study period, disease flares, defined as an increase in the Psoriasis Area and Severity Index (PASI) of 5 or more points from the previous visit, occurred in 369 patients (38.6%), consistent with known flare rates in psoriasis. Participants in the study (mean age, 61) had median PASI scores of 12 during visits for psoriatic flares compared with PASI scores of 1 during control (no flare) visits (P < .001).

Evaluations of mean concentrations of several air pollutants within 10 miles of the patients over 4,398 visits showed that concentrations were significantly higher in the 60 days prior to the psoriasis flare, compared with control visits that were not related to flares (P < .05), after adjusting for factors including seasonality (by trimester, to adjust for weather conditions and UV/sunlight exposure) and the type of systemic psoriasis treatments patients were receiving (conventional or biological).

Increases in air pollutant levels prior to flares were observed among the 35.8% of patients who had a flare of at least a 50% increase in the PASI score, as well among the 47.2% of patients who had at least a 100% increase in PASI, compared with control visits not involving flares. In addition, mean and area-under-the-curve concentrations of air pollutants were higher in the 60 days before the visits among those with PASI 5 or greater, compared with those with PASI scores below 5, the authors add.

Dr. Bellinato noted that the associations were not limited to any particular subgroup. “The associations with air pollution and flares were observed in the entire population,” he said in an interview.

Vehicle, industry emissions

The pollutants that were measured were those mainly associated with fossil fuel combustion from vehicle and industry emissions, including carbon monoxide, nitrogen dioxide, other nitrogen oxides, benzene, coarse particulate matter (2.5-10.0 μm in diameter) and fine particulate matter (less than 2.5 μm in diameter).

They note that the risk of having a PASI score of 5 or greater was elevated even at thresholds of exposure that are largely considered safe. “Indeed, the risk for having a PASI score of 5 or greater was 40% to 50% higher at exposures as low as 20 μg/m³” of coarse particulate matter and 15 μg/m³ of fine particulate matter in the 60-day period prior to the visits, they write.

The authors referred to evidence linking air pollution with a worsening of a variety of inflammatory cutaneous diseases, including atopic dermatitis and acne, as well as photoaging. Psoriasis flares are known to be triggered by a variety of environmental factors, including infections or certain drugs; however, evidence of a role of air pollution has been lacking. Potential mechanisms linking the exposures to flares include the possibility that exhaust particles can activate skin resident T-cells, “resulting in abnormal production of proinflammatory cytokines including tumor necrosis factor α (TNF-α) and interleukins (ILs), including IL-1α, IL-1β, IL-6, and IL-8.8,” the authors write.

Their results, though inferring a causal relationship, fall short of showing a clear dose–response relationship between higher pollutant levels and an increased risk of psoriasis flares, possibly the result of a smaller sample size of subjects exposed to higher levels of pollution, they add.

Limitations of the study included the definition of flare, which used a clinical score that could be affected by other measurements, they point out, while strengths of the study included the large cohort of patients followed for over 7 years and the availability of daily measurements of air pollutants.

While the study suggests that environmental air pollutant fluctuations may affect psoriasis course,” the authors concluded, “further study is needed to examine whether these findings generalize to other populations and to better understand the mechanisms by which air pollution may affect psoriasis disease activity.”

Dr. Bellinato and four coauthors had no disclosures; the remaining authors had disclosures that included receiving personal fees from pharmaceutical companies that were outside of the submitted work.

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

Exposure to air pollution – even short term – may play a role in triggering psoriasis flares, according to new research from Italy, which found a significant association between exposure to higher levels of air pollution prior to patients presenting for psoriasis flares at medical visits, compared with visits unrelated to flares.

“We found that higher concentration of different air pollutants was associated with psoriasis flares in patients living in an industrialized city of the Po Valley” in Verona, Italy, report the authors of the study, published in JAMA Dermatology.

The findings underscore the need for clinicians to “consider environmental/external triggers in patients with chronic inflammatory diseases experiencing flares,” first author Francesco Bellinato, MD, of the Section of Dermatology and Venereology, University of Verona, Italy, told this news organization.

He and his coauthors conducted a case-crossover and cross-sectional longitudinal study that involved a retrospective analysis of data in 957 patients in Verona with chronic plaque psoriasis, who were evaluated every 3-4 months at an outpatient dermatology clinic for a median of 2.7 years.

Over the study period, disease flares, defined as an increase in the Psoriasis Area and Severity Index (PASI) of 5 or more points from the previous visit, occurred in 369 patients (38.6%), consistent with known flare rates in psoriasis. Participants in the study (mean age, 61) had median PASI scores of 12 during visits for psoriatic flares compared with PASI scores of 1 during control (no flare) visits (P < .001).

Evaluations of mean concentrations of several air pollutants within 10 miles of the patients over 4,398 visits showed that concentrations were significantly higher in the 60 days prior to the psoriasis flare, compared with control visits that were not related to flares (P < .05), after adjusting for factors including seasonality (by trimester, to adjust for weather conditions and UV/sunlight exposure) and the type of systemic psoriasis treatments patients were receiving (conventional or biological).

Increases in air pollutant levels prior to flares were observed among the 35.8% of patients who had a flare of at least a 50% increase in the PASI score, as well among the 47.2% of patients who had at least a 100% increase in PASI, compared with control visits not involving flares. In addition, mean and area-under-the-curve concentrations of air pollutants were higher in the 60 days before the visits among those with PASI 5 or greater, compared with those with PASI scores below 5, the authors add.

Dr. Bellinato noted that the associations were not limited to any particular subgroup. “The associations with air pollution and flares were observed in the entire population,” he said in an interview.

Vehicle, industry emissions

The pollutants that were measured were those mainly associated with fossil fuel combustion from vehicle and industry emissions, including carbon monoxide, nitrogen dioxide, other nitrogen oxides, benzene, coarse particulate matter (2.5-10.0 μm in diameter) and fine particulate matter (less than 2.5 μm in diameter).

They note that the risk of having a PASI score of 5 or greater was elevated even at thresholds of exposure that are largely considered safe. “Indeed, the risk for having a PASI score of 5 or greater was 40% to 50% higher at exposures as low as 20 μg/m³” of coarse particulate matter and 15 μg/m³ of fine particulate matter in the 60-day period prior to the visits, they write.

The authors referred to evidence linking air pollution with a worsening of a variety of inflammatory cutaneous diseases, including atopic dermatitis and acne, as well as photoaging. Psoriasis flares are known to be triggered by a variety of environmental factors, including infections or certain drugs; however, evidence of a role of air pollution has been lacking. Potential mechanisms linking the exposures to flares include the possibility that exhaust particles can activate skin resident T-cells, “resulting in abnormal production of proinflammatory cytokines including tumor necrosis factor α (TNF-α) and interleukins (ILs), including IL-1α, IL-1β, IL-6, and IL-8.8,” the authors write.

Their results, though inferring a causal relationship, fall short of showing a clear dose–response relationship between higher pollutant levels and an increased risk of psoriasis flares, possibly the result of a smaller sample size of subjects exposed to higher levels of pollution, they add.

Limitations of the study included the definition of flare, which used a clinical score that could be affected by other measurements, they point out, while strengths of the study included the large cohort of patients followed for over 7 years and the availability of daily measurements of air pollutants.

While the study suggests that environmental air pollutant fluctuations may affect psoriasis course,” the authors concluded, “further study is needed to examine whether these findings generalize to other populations and to better understand the mechanisms by which air pollution may affect psoriasis disease activity.”

Dr. Bellinato and four coauthors had no disclosures; the remaining authors had disclosures that included receiving personal fees from pharmaceutical companies that were outside of the submitted work.

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

Exposure to air pollution – even short term – may play a role in triggering psoriasis flares, according to new research from Italy, which found a significant association between exposure to higher levels of air pollution prior to patients presenting for psoriasis flares at medical visits, compared with visits unrelated to flares.

“We found that higher concentration of different air pollutants was associated with psoriasis flares in patients living in an industrialized city of the Po Valley” in Verona, Italy, report the authors of the study, published in JAMA Dermatology.

The findings underscore the need for clinicians to “consider environmental/external triggers in patients with chronic inflammatory diseases experiencing flares,” first author Francesco Bellinato, MD, of the Section of Dermatology and Venereology, University of Verona, Italy, told this news organization.

He and his coauthors conducted a case-crossover and cross-sectional longitudinal study that involved a retrospective analysis of data in 957 patients in Verona with chronic plaque psoriasis, who were evaluated every 3-4 months at an outpatient dermatology clinic for a median of 2.7 years.

Over the study period, disease flares, defined as an increase in the Psoriasis Area and Severity Index (PASI) of 5 or more points from the previous visit, occurred in 369 patients (38.6%), consistent with known flare rates in psoriasis. Participants in the study (mean age, 61) had median PASI scores of 12 during visits for psoriatic flares compared with PASI scores of 1 during control (no flare) visits (P < .001).

Evaluations of mean concentrations of several air pollutants within 10 miles of the patients over 4,398 visits showed that concentrations were significantly higher in the 60 days prior to the psoriasis flare, compared with control visits that were not related to flares (P < .05), after adjusting for factors including seasonality (by trimester, to adjust for weather conditions and UV/sunlight exposure) and the type of systemic psoriasis treatments patients were receiving (conventional or biological).

Increases in air pollutant levels prior to flares were observed among the 35.8% of patients who had a flare of at least a 50% increase in the PASI score, as well among the 47.2% of patients who had at least a 100% increase in PASI, compared with control visits not involving flares. In addition, mean and area-under-the-curve concentrations of air pollutants were higher in the 60 days before the visits among those with PASI 5 or greater, compared with those with PASI scores below 5, the authors add.

Dr. Bellinato noted that the associations were not limited to any particular subgroup. “The associations with air pollution and flares were observed in the entire population,” he said in an interview.

Vehicle, industry emissions

The pollutants that were measured were those mainly associated with fossil fuel combustion from vehicle and industry emissions, including carbon monoxide, nitrogen dioxide, other nitrogen oxides, benzene, coarse particulate matter (2.5-10.0 μm in diameter) and fine particulate matter (less than 2.5 μm in diameter).

They note that the risk of having a PASI score of 5 or greater was elevated even at thresholds of exposure that are largely considered safe. “Indeed, the risk for having a PASI score of 5 or greater was 40% to 50% higher at exposures as low as 20 μg/m³” of coarse particulate matter and 15 μg/m³ of fine particulate matter in the 60-day period prior to the visits, they write.

The authors referred to evidence linking air pollution with a worsening of a variety of inflammatory cutaneous diseases, including atopic dermatitis and acne, as well as photoaging. Psoriasis flares are known to be triggered by a variety of environmental factors, including infections or certain drugs; however, evidence of a role of air pollution has been lacking. Potential mechanisms linking the exposures to flares include the possibility that exhaust particles can activate skin resident T-cells, “resulting in abnormal production of proinflammatory cytokines including tumor necrosis factor α (TNF-α) and interleukins (ILs), including IL-1α, IL-1β, IL-6, and IL-8.8,” the authors write.

Their results, though inferring a causal relationship, fall short of showing a clear dose–response relationship between higher pollutant levels and an increased risk of psoriasis flares, possibly the result of a smaller sample size of subjects exposed to higher levels of pollution, they add.

Limitations of the study included the definition of flare, which used a clinical score that could be affected by other measurements, they point out, while strengths of the study included the large cohort of patients followed for over 7 years and the availability of daily measurements of air pollutants.

While the study suggests that environmental air pollutant fluctuations may affect psoriasis course,” the authors concluded, “further study is needed to examine whether these findings generalize to other populations and to better understand the mechanisms by which air pollution may affect psoriasis disease activity.”

Dr. Bellinato and four coauthors had no disclosures; the remaining authors had disclosures that included receiving personal fees from pharmaceutical companies that were outside of the submitted work.

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