Gayle van der Kraaij1, Celine Busard2, Juul van den Reek3, Stef Menting4, Annelie Musters2, Barbara Hutten5, Menno de Rie2, Wouter Ouwerkerk6, Sun-Jine van Bezooijen7, Errol Prens7, Theo Rispens8, Annick de Vries9, Elke de Jong3, Wim de Kort10, Jo Lambert11, Martijn van Doorn7, Phyllis Spuls12. 1. Department of Dermatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. Electronic address: g.e.vanderkraaij@amsterdamumc.nl. 2. Department of Dermatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. 3. Department of Dermatology, Radboud UMC, Radboud University, Nijmegen, The Netherlands. 4. Department of Dermatology, OLVG, Amsterdam, The Netherlands. 5. Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, Amsterdam, The Netherlands. 6. Department of Dermatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands; National Heart Centre Singapore, Singapore, Singapore. 7. Department of Dermatology, Erasmus MC, Rotterdam, The Netherlands. 8. Department of Blood Cell Research, Sanquin Research and Landsteiner Laboratory, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands. 9. Diagnostic Services, Sanquin, Amsterdam, The Netherlands. 10. Department of Dermatology, Amphia Hospital, Breda, The Netherlands. 11. Department of Dermatology, Ghent University Hospital, Ghent, Belgium. 12. Department of Dermatology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands; Amsterdam Public Health, Infection and Immunity, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
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.
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.
Authors: Francesco Bellinato; Paolo Gisondi; Elena Mason; Paolo Ricci; Martina Maurelli; Giampiero Girolomoni Journal: Dermatol Ther (Heidelb) Date: 2022-04-27