Adalimumab for the treatment of psoriasis in real life: a retrospective cohort of 119 patients at a single Spanish centre

• Published in: British journal of dermatology (1951) Vol. 169; no. 5; pp. 1141 - 1147
• Main Authors: López-Ferrer, A., Vilarrasa, E., Gich, I.J., Puig, L.
• Format: Journal Article
• Language: English
• Published: Oxford Blackwell Publishing Ltd 01.11.2013; Wiley-Blackwell
• Subjects: Adalimumab; Adolescent; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized - therapeutic use; Biological and medical sciences; Dermatologic Agents - therapeutic use; Dermatology; Humans; Male; Medical sciences; Middle Aged; Miscellaneous; Psoriasis - drug therapy; Psoriasis. Parapsoriasis. Lichen; Public health. Hygiene; Public health. Hygiene-occupational medicine; Retrospective Studies; Severity of Illness Index; Treatment Outcome; Young Adult; Human; Skin disease; Psoriasis; Dermatology; Antipsoriatic agent; Patient; Retrospective; Immunomodulator; Treatment; Cohort study; Spanish; Adalimumab; Public health
• ISSN: 0007-0963; 1365-2133
• DOI: 10.1111/bjd.12543

Summary Background Patients with moderate‐to‐severe psoriasis treated with adalimumab in daily clinical practice are different from those in clinical trials, and outcomes may differ in different geographical settings. Objectives To analyse the efficacy, retention of treatment and adverse events in a cohort of such patients at a referral centre in Barcelona, Spain. Methods Data from a cohort of 119 consecutive patients treated between January 2008 and March 2013 were retrospectively collected. Drug survival was analysed by the Kaplan–Meier method with log‐rank test and Cox regression. Results The mean duration of treatment was 25 months (median 22, range 2–60). The 75% improvement in Psoriasis Area and Severity Index (PASI 75) response rates at 16 weeks, 6 months and 1 year of treatment were 64%, 58% and 53%, respectively (intention‐to‐treat analysis). The corresponding PASI 90 values were 49%, 52% and 50%. Biologic‐naive patients (41%) had significantly higher PASI 75 and PASI 90 response rates at 6 months and 1 year. On multivariate analysis, only PASI 90 response at 6 months was significantly associated with treatment retention (P = 0·0009), with a hazard ratio of 7·3 (95% confidence interval 2·3–23·6). Forty‐eight adverse events (AEs) occurred in 29 patients, and were serious in eight (0·032 events per patient‐year). Paradoxical flares of psoriasis or arthritis were seen in five patients. Infections accounted for seven serious AEs, and were the reason for discontinuation in two patients. Conclusions PASI 90 response at 6 months was the only independent variable predicting drug survival on multivariate analysis. Infections, including de novo infection by Mycobacterium tuberculosis, accounted for seven serious AEs. What's already known about this topic? There are few reports on the use of adalimumab for the treatment of moderate‐to‐severe psoriasis in clinical practice according to the European Medicines Agency. Psoriasis Area and Severity Index (PASI) 75% response rates at 16 weeks and 6 months were approximately 60% in a previously published U.K. series. Male sex and the presence of arthritis have been associated with decreased drug survival in one study. What does this study add? Biologic‐naive status and efficacy parameters denoting a good or excellent response appear to be associated with a higher probability of drug survival. Combination treatment increased PASI response rates at 6 months and might provide an explanation for the relatively high rate of PASI 90 responders in our cohort. Infections, including de novo infection by Mycobacterium tuberculosis, accounted for most serious adverse events, and paradoxical flares of psoriasis and psoriatic arthritis were relatively frequent.