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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, et al.
(2022) JOURNAL OF INVESTIGATIVE DERMATOLOGY. 142(9). p.2375-2383.e6
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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.
Keywords
RHEUMATOID-ARTHRITIS, SYSTEMIC AGENTS, IMMUNOGENICITY, EFFICACY, COMBINATION, BIOLOGICS, MODERATE, IMPACT, PHARMACOKINETICS, ETANERCEPT

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MLA
van der Kraaij, Gayle, et al. “Adalimumab with Methotrexate vs. Adalimumab Monotherapy in Psoriasis : First-Year Results of a Single-Blind Randomized Controlled Trial.” JOURNAL OF INVESTIGATIVE DERMATOLOGY, vol. 142, no. 9, Elsevier Science INC, 2022, pp. 2375-2383.e6, doi:10.1016/j.jid.2022.01.033.
APA
van der Kraaij, G., Busard, C., van den Reek, J., Menting, S., Musters, A., Hutten, B., … Spuls, P. (2022). Adalimumab with methotrexate vs. adalimumab monotherapy in psoriasis : first-year results of a single-blind randomized controlled trial. JOURNAL OF INVESTIGATIVE DERMATOLOGY, 142(9), 2375-2383.e6. https://doi.org/10.1016/j.jid.2022.01.033
Chicago author-date
Kraaij, Gayle van der, Celine Busard, Juul van den Reek, Stef Menting, Annelie Musters, Barbara Hutten, Menno de Rie, et al. 2022. “Adalimumab with Methotrexate vs. Adalimumab Monotherapy in Psoriasis : First-Year Results of a Single-Blind Randomized Controlled Trial.” JOURNAL OF INVESTIGATIVE DERMATOLOGY 142 (9): 2375-2383.e6. https://doi.org/10.1016/j.jid.2022.01.033.
Chicago author-date (all authors)
van der Kraaij, Gayle, 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, and Phyllis Spuls. 2022. “Adalimumab with Methotrexate vs. Adalimumab Monotherapy in Psoriasis : First-Year Results of a Single-Blind Randomized Controlled Trial.” JOURNAL OF INVESTIGATIVE DERMATOLOGY 142 (9): 2375-2383.e6. doi:10.1016/j.jid.2022.01.033.
Vancouver
1.
van der Kraaij G, Busard C, van den Reek J, Menting S, Musters A, Hutten B, et al. Adalimumab with methotrexate vs. adalimumab monotherapy in psoriasis : first-year results of a single-blind randomized controlled trial. JOURNAL OF INVESTIGATIVE DERMATOLOGY. 2022;142(9):2375-2383.e6.
IEEE
[1]
G. van der Kraaij et al., “Adalimumab with methotrexate vs. adalimumab monotherapy in psoriasis : first-year results of a single-blind randomized controlled trial,” JOURNAL OF INVESTIGATIVE DERMATOLOGY, vol. 142, no. 9, pp. 2375-2383.e6, 2022.
@article{01GWS9PNHR445Y5EQF50NBCJGH,
  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.}},
  author       = {{van der Kraaij, Gayle and Busard, Celine and  van den Reek, Juul and  Menting, Stef and  Musters, Annelie and  Hutten, Barbara and  de Rie, Menno and  Ouwerkerk, Wouter and  Van Bezooijen, Sun-Jine and  Prens, Errol and  Rispens, Theo and  de Vries, Annick and  de Jong, Elke and  de Kort, Wim and Lambert, Jo and van Doorn, Martijn and Spuls, Phyllis}},
  issn         = {{0022-202X}},
  journal      = {{JOURNAL OF INVESTIGATIVE DERMATOLOGY}},
  keywords     = {{RHEUMATOID-ARTHRITIS,SYSTEMIC AGENTS,IMMUNOGENICITY,EFFICACY,COMBINATION,BIOLOGICS,MODERATE,IMPACT,PHARMACOKINETICS,ETANERCEPT}},
  language     = {{eng}},
  number       = {{9}},
  pages        = {{2375--2383.e6}},
  publisher    = {{Elsevier Science INC}},
  title        = {{Adalimumab with methotrexate vs. adalimumab monotherapy in psoriasis : first-year results of a single-blind randomized controlled trial}},
  url          = {{http://doi.org/10.1016/j.jid.2022.01.033}},
  volume       = {{142}},
  year         = {{2022}},
}
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