Occurrence of adverse events associated with the initiation of methotrexate and biologics for the treatment of psoriasis in routine clinical practice

Abstract

Background: Limited information exists on the risk of adverse events (AEs) attributed to methotrexate (MTX) and biologics for the treatment of psoriasis/psoriatic arthritis (PsA/PsO) in heterogeneous clinical practice and beyond the duration of clinical trials.

Methods: An observational study of 6294 adults with incident PsA/PsO who initiated MTX or biologics in Stockholm from 2006-2021 was conducted. The risk of kidney, liver, hematological, serious infectious, and major gastrointestinal AEs was quantified and compared between therapies using incidence rates, absolute risks, and adjusted hazard ratios (HRs) from propensity-score weighted Cox regression.

Results: Median follow-up was 4.3 (2–7) years. Users of MTX had a higher risk of anemia (HR 1.79 [95% CI, 1.48–2.16]), particularly mild-moderate anemias (1.93;1.49–2.50), and mild (1.46;1.03–2.06) and moderate-severe liver AEs (2.22;1.19–4.15) compared to biologics. Chronic kidney disease incidence did not differ between therapies (affecting 1.5% of the population in 5 years; HR:1.03;0.48–2.22). Acute kidney injury, serious infections, and major gastrointestinal AEs showed low absolute risks and no clinically meaningful differences between both therapies.

Conclusion: The use of MTX for psoriasis patients in routine care was associated with a higher risk of anemia and liver AEs than biologics, but similar risks of kidney, serious infections, and major gastrointestinal AEs.

Keywords:

• psoriasis
• methotrexate
• biologics
• safety
• adverse events

Ethical statement

The Regional Ethical Review Board in Stockholm approved the study.

Author contributions

F.M. and J.J.C. had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: F.M., J.J.C., and J.L Acquisition, analysis, or interpretation of data: F.M., JJC., A.K., J.L and L.S. Statistical analysis: F.M. and J.J.C Drafting of the article: All authors, Critical revision of the article for important intellectual content: All authors. Supervision: J.J.C.

Disclosure statement

J.J.C. received institutional funding from AstraZeneca, Astellas, Amgen, and ViforPharma outside this study. AK received consultation and advisory board membership from Janssen-Cilag AB, Novartis, Amgen, AbbVie. LS is an employee of Amgen. JL served paid speaker for Janssen-Cilag AB, Novartis, AbbVie and Galderma. FM had no disclosures to report.

Data availability statement

The SCREAM project contains sensitive personal data that as per GDPR regulations cannot be publicly shared. We however welcome collaborative project proposals that abide to GDPR, national and institutional regulations for data sharing and data access. For enquiries, please contact [email protected].

Correction Statement

This article has been republished with minor changes. These changes do not impact the academic content of the article.

Additional information

Funding

This study was supported by a grant from Amgen to Karolinska Institutet. In addition, we acknowledge grant support from the Swedish Research Council and the Karolinska Institutet research funds.