Adalimumab with Methotrexate vs. Adalimumab Monotherapy in Psoriasis: First-Year Results of a Single-Blind Randomized Controlled Trial

Gayle van der Kraaij*, Celine Busard, Juul van den Reek, Stef Menting, Annelie Musters, Barbara Hutten, Menno de Rie, Wouter Ouwerkerk, Sun Jine van Bezooijen, Errol Prens, Theo Rispens, Annick de Vries, Elke de Jong, Wim de Kort, Jo Lambert, Martijn van Doorn, Phyllis Spuls

*Corresponding author for this work

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Abstract

Introduction: Adalimumab is normally prescribed with methotrexate (MTX) in rheumatoid arthritis given the enhanced treatment effect and reduced antidrug antibody formation compared with adalimumab monotherapy (ADL). In psoriasis, the long-term treatment effects and pharmacokinetic profile have not been investigated extensively. Methods: We conducted a randomized controlled trial to assess the efficacy, safety, pharmacokinetics, and immunogenicity of adalimumab combined with MTX 10 mg per week (ADL-MTX group) compared with that of ADL (ADL group) in chronic plaque psoriasis. Results: A total of 31 patients in the ADL-MTX group and 30 in the ADL group were analyzed. After 1 year, a (nonsignificant) better drug survival was found in the ADL-MTX group (74.2 vs. 58.6%, P = 0.15). The PASI 75 response in week 49 was 58.1 versus 36.7% (P = 0.13), and the median (interquartile range) serum-trough concentrations were 6.8 (5.5‒9.2) versus 5.9 (3.5‒8.8) mg/l (P = 0.26) in the ADL-MTX group and ADL group, respectively. Fewer patients showed antidrug antibodies in the ADL-MTX group (22.6 vs. 60.0%, P < 0.01). No serious adverse events occurred. Conclusion: Combination therapy of adalimumab and MTX results in fewer patients showing antidrug antibodies, with a trend toward a better PASI 75 response, drug survival, and higher serum-trough concentrations than ADL. Patient-reported outcomes and adverse events were comparable between the groups.

Original languageEnglish
Pages (from-to)2375-+
JournalJournal of Investigative Dermatology
Volume142
Issue number9
Early online date8 Mar 2022
DOIs
Publication statusPublished - 1 Sep 2022

Bibliographical note

Funding Information:
GvdK was involved in clinical trials for Janssen, AbbVie, Novartis, Pfizer, UCB, Leo Pharma, and Eli Lilly as a subinvestigator. JvdR carries/carried out clinical trials for AbbVie, Celgene, and Janssen and has received speaking fees from AbbVie, Janssen, BMS, and Eli Lilly and reimbursement for attending a symposium from Janssen, Pfizer, Celgene, and AbbVie. All funding is not personal but goes to the independent research fund of the department of dermatology of Radboud UMC (Nijmegen, The Netherlands). SJvB is currently employed at Janssen-Cilag BV. EP has served as a consultant, advisory board member, speaker, and/or principal investigator for AbbVie, Amgen, AstraZeneca, Baxter, Celgene, ChemoCentryx, Eli Lilly, Galderma, InflaRx, Janssen-Cilag, Leo Pharma, Novartis, Pfizer, Regeneron, Sandoz, and UCB and received investigator-initiated grant support (paid to the Erasmus University Rotterdam, Rotterdam, The Netherlands) from AbbVie, AstraZeneca, Celgene, CHDR, Kymera, Novartis, Regeneron, Pfizer, Janssen-Cilag, and UCB. TR received honoraria for presentations from Pfizer, AbbVie, and Regeneron and a research grant from Genmab. EdJ has received research grants for the independent research fund of the department of dermatology of the Radboud UMC from AbbVie, BMS, Pfizer, Novartis, Janssen Pharmaceutica, UCB, and Leo Pharma and has acted as consultant and/or paid speaker for and/or participated in research sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Amgen, Galapagos, Janssen Pharmaceutica, Novartis, Lilly, Celgene, Leo Pharma, Sanofi, UCB, and Almirall. All funding is not personal but goes to the independent research fund of the department of dermatology of Radboud UMC. MvD is a consultant and advisory board member for AbbVie and reports personal fees from Leopharma; grants and personal fees from Novartis; and personal fees from AbbVie, BMS, Celgene, Lilly, MSD, Pfizer, Sanofi-Genzyme, and Janssen-Cilag, outside the submitted work. PS has acted as a consultant for Sanofi and AbbVie (unpaid), received departmental independent research grants for TREAT NL registry from Pharma since December 2019, and received independent research grants in the past (>5 years ago). She is involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of, for example, psoriasis and atopic dermatitis, for which financial compensation is paid to the department/hospital, and is chief investigator of the systemic and phototherapy atopic eczema registry (TREAT NL) for adults and children. The remaining authors state no conflict of interest.

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