Safety of biologic therapy in combination with methotrexate in moderate to severe psoriasis: a cohort study from the BIOBADADERM registry

Br J Dermatol. 2023 Oct 17:ljad382. doi: 10.1093/bjd/ljad382. Online ahead of print.

ABSTRACT

BACKGROUND: Safety is an important consideration in decisions on treatment for patients with moderate to severe psoriasis and its study is the main purpose of the BIOBADADERM Registry. The combination of a biologic agent and a conventional systemic drug- generally methotrexate (MTX)-is a common treatment in clinical practice. However, there is a paucity of evidence from real-world practice on the safety of such combination regimens in psoriasis.

OBJECTIVES: The primary objective of this study was to ascertain whether the use of regimens combining biologic drugs with MTX in the management of moderate to severe psoriasis increases the risk of adverse events (AEs) or serious AEs (SAEs). We compared monotherapy with tumour necrosis factor (TNF), interleukin-17 and interleukin-23 inhibitors with the use of the same drugs in combination with MTX.

METHODS: Using data from the BIOBADADERM Registry, we compared biologic monotherapies with MTX combined therapies. We estimated crude and adjusted incidence rate ratios using a random effects Poisson regression with 95% confidence intervals for all AEs, SAEs, infections and serious infections, and several organ class systems.

RESULTS: We analysed data from 2,829 patients and 5,441 treatment cycles, a total of 12,853 patient-years. The combination of a biologic with MTX was not associated with statistically significant increases in overall risk of AEs or SAEs in any treatment group. No increase in the total number of infections or serious infections in patients receiving combined therapy was observed for any group. However, treatment with a TNF inhibitor plus MTX was associated with an increase in the incidence of gastrointestinal AEs.

CONCLUSIONS: The risk of AEs and SAEs was not significantly increased in patients with moderate to severe psoriasis receiving different classes of biologic drugs plus MTX compared to those on biologic monotherapy.

PMID:37846976 | DOI:10.1093/bjd/ljad382