Adalimumab with methotrexate versus adalimumab monotherapy in psoriasis: First-year results of a single-blind randomized controlled trial

• Published in: Journal of investigative dermatology
• Main Authors: van der Kraaij, G E, Busard, C I, van den Reek, J, Menting, S P, Musters, A H, Hutten, B A, de Rie, M A, Ouwerkerk, W, van Bezooijen, J S, Prens, E, Rispens, T, de Vries, A, de Jong, E M G J, de Kort, W, Lambert, J, van Doorn, M B A, Spuls, Ph I
• Format: Journal Article
• Language: English
• Published: United States 08.03.2022
• ISSN: 1523-1747

Adalimumab is normally prescribed with methotrexate (MTX) in rheumatoid arthritis given the enhanced treatment effect and reduced antidrug antibody (ADA) formation compared to adalimumab monotherapy. In psoriasis, the long-term treatment effects and pharmacokinetic profile have not been investigated extensively. We conducted a randomized controlled trial to assess the efficacy, safety, pharmacokinetics and immunogenicity of adalimumab combined with MTX (ADL-MTX group) compared to adalimumab monotherapy (ADL group) in chronic plaque psoriasis. Thirty-one patients in the ADL-MTX group and 30 in the ADL group were analysed.After one year, a (non-significant) better drug survival was found in the ADL-MTX group (74.2% vs 58.6%; p=0.15). The Psoriasis Area and Severity Index (PASI)75 response in week 49 was 58.1% vs. 36.7% (p=0.13) and the median (IQR) serum trough concentrations were 6.8 (5.5-9.2) vs. 5.9 (3.5-8.8)mg/L (p=0.26) in the ADL-MTX and ADL group respectively. Fewer patients showed ADA in the ADL group (22.6% vs. 60.0%; p<0.01). No serious adverse events (SAEs) occurred. Combination therapy of adalimumab and MTX results in less patients showing ADA, with a trend towards a better PASI75 response, drug survival and higher serum trough concentrations compared to adalimumab monotherapy. Patient reported outcomes and adverse events were comparable between the groups.