Context and objective
The lack of evidence in a routine clinical setting has limited the widespread adoption of adalimumab biosimilars in the treatment of psoriasis. This study compared the persistence and safety of adalimumab biosimilars versus Humira in the treatment of psoriasis.
Method
We conducted a cohort study of new prevalent users using data from the SNDS, the British Association of Dermatologists’ Registry of Biologics and Immunomodulators (BADBIR) and the Spanish Registry of Systemic Psoriasis Treatments (BIOBADADERM). Adalimumab-naïve patients starting adalimumab biosimilars (new users) were compared to new Humira users. Patients switching from Humira to biosimilars (switchers) were compared to those who continued treatment with Humira. Patients were matched 1:1 based on duration of prior exposure to adalimumab to create equal-sized cohorts of biosimilar and Humira users. Secondary endpoints included treatment discontinuation and serious adverse events (SAEs). Hazard ratios (HRs) were calculated using Cox models. Meta-analyses using random effect models were performed to combine results from 3 databases.
Results
7,387 new biosimilar users and 3,654 switchers were matched and compared to Humira users. No difference was found between new biosimilar and Humira users in all-cause treatment discontinuation (HR: 0.99, 95% CI: 0.94-1.04). Switching from Humira to biosimilars was associated with a higher discontinuation rate than remaining on Humira (HR: 1.35, 95% CI: 1.19-1.52). Similar results were observed for treatment discontinuation due to ineffectiveness or adverse effects. SAE risks were similar between new biosimilar users and new Humira users (incidence ratio IRR: 0.91, 95% CI: 0.80-1.05) or between switchers and switchers. continued Humira users (IRR: 0.92, 95% CI: 0.83-1.01).
Conclusion
Adalimumab biosimilars may be considered viable alternatives to Humira for new patients, with comparable efficacy and safety. However, due to the higher likelihood of treatment discontinuation, patients switching from Humira to biosimilars may require closer monitoring and support.
Health
