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Effectiveness and persistence of acitretin, ciclosporin, fumaric acid esters and methotrexate for patients with moderate-to-severe psoriasis: a cohort study from BADBIR

Alabas, Oras A; Mason, Kayleigh J; Yiu, Zenas Z N; Hampton, Philip J; Reynolds, Nick J; Owen, Caroline M; Bewley, Anthony; Laws, Philip M; Warren, Richard B; Lunt, Mark; Smith, Catherine H; Griffiths, Christopher E M; Study Group, BADBIR

Effectiveness and persistence of acitretin, ciclosporin, fumaric acid esters and methotrexate for patients with moderate-to-severe psoriasis: a cohort study from BADBIR Thumbnail


Authors

Oras A Alabas

Zenas Z N Yiu

Philip J Hampton

Nick J Reynolds

Caroline M Owen

Anthony Bewley

Philip M Laws

Richard B Warren

Mark Lunt

Catherine H Smith

Christopher E M Griffiths

BADBIR Study Group



Abstract

Background Real-world data evaluating effectiveness and persistence of systemic therapies for patients with psoriasis are limited. Objectives To determine the effectiveness and persistence of acitretin, ciclosporin, fumaric acid esters (FAEs) and methotrexate in patients with moderate-to-severe psoriasis. Methods Data from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR), a prospective, multicentre pharmacovigilance register of patients with moderate-to-severe psoriasis receiving biologic and/or conventional systemic therapies, were analysed. Eligible patients were ≥ 16 years of age receiving a first course of acitretin, ciclosporin, FAEs or methotrexate between 2007 and 2021 with ≥ 6 months’ follow-up. Effectiveness was defined as achieving absolute Psoriasis Area and Severity Index (aPASI) ≤ 2 reported ≥ 4 weeks after treatment start date until date of cessation. To identify baseline clinical variables associated with treatment effectiveness, we used multivariable logistic regression models estimating the adjusted odds ratio (aOR) of achieving aPASI ≤ 2. To describe drug persistence associated with ineffectiveness, occurrence of adverse events or other reasons for discontinuation, survival estimates with 95% confidence intervals (CIs) were obtained using a flexible parametric model. Results were obtained using multiple imputed data. Results In total, 5430 patients were included in the analysis. Overall, 1023 (19%) patients were receiving acitretin, 1401 (26%) patients were on ciclosporin, 347 (6%) patients were on FAEs, and 2659 (49%) patients were receiving methotrexate at registration. The proportion of patients who achieved aPASI ≤ 2 was lower for those treated with acitretin [n = 118 (21%)] compared with those receiving ciclosporin [n = 233 (34%)], FAEs [n = 43 (29%)] and methotrexate [n = 372 (32%)]. Factors associated with ineffectiveness included prior experience to previous nonbiologic systemic therapies (acitretin) (aOR 0.64, 95% CI 0.42–0.96), male sex (methotrexate) (aOR 0.58, 95% CI 0.46–0.74), comorbidities (aOR 0.70, 95% CI 0.51–0.97) and alcohol consumption (≤ 14 units per week) (ciclosporin) (aOR 0.70, 95% CI 0.50–0.98). Persistence associated with all reasons for discontinuation showed better survival for methotrexate compared with acitretin, ciclosporin and FAEs cohorts at 12 months [survival estimate 46.1 (95% CI 44.0–48.3), 31.9 (95% CI 29.4–34.7), 30.0 (95% CI 27.5–32.4) and 35.0 (95% CI 29.9–40.9), respectively]. Conclusions The real-world effectiveness and persistence of acitretin, ciclosporin, FAEs and methotrexate were generally low. Previous nonbiologic systemic therapies, male sex, comorbidities and alcohol consumption were risk factors associated with treatment ineffectiveness.

Citation

Alabas, O. A., Mason, K. J., Yiu, Z. Z. N., Hampton, P. J., Reynolds, N. J., Owen, C. M., …Study Group, B. (2023). Effectiveness and persistence of acitretin, ciclosporin, fumaric acid esters and methotrexate for patients with moderate-to-severe psoriasis: a cohort study from BADBIR. British Journal of Dermatology, 188(5), 618–627. https://doi.org/10.1093/bjd/ljad004

Journal Article Type Article
Acceptance Date Jan 3, 2023
Online Publication Date Jan 6, 2023
Publication Date 2023-05
Publicly Available Date May 30, 2023
Journal British Journal of Dermatology
Print ISSN 0007-0963
Electronic ISSN 1365-2133
Publisher Wiley
Peer Reviewed Peer Reviewed
Volume 188
Issue 5
Pages 618–627
DOI https://doi.org/10.1093/bjd/ljad004
Keywords Dermatology
Publisher URL https://academic.oup.com/bjd/advance-article/doi/10.1093/bjd/ljad004/6972416

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