Literature DB >> 26267731

Efficacy of Adalimumab Compared With Methotrexate or Placebo Stratified by Baseline BMI in a Randomized Placebo-Controlled Trial in Patients With Psoriasis.

Ronald Prussick, Kristina Unnebrink, Wendell C Valdecantos.   

Abstract

INTRODUCTION: In the Comparative Study of Humira vs Methotrexate vs Placebo In Psoriasis Patients (CHAMPION) study, significantly more patients achieved ≥75% improvement in the Psoriasis Area and Severity Index (PASI75) and ≥90% improvement (PASI90) after 16 weeks of treatment with adalimumab (80 mg at week 0, then 40 mg every other week starting at week 1) compared with methotrexate (up to 25 mg/week orally) or placebo. In this exploratory analysis, the efficacy of adalimumab was evaluated in a subset of the CHAMPION patient population stratified by baseline body mass index (BMI).
METHODS: PASI responses and Dermatology Life Quality Index (DLQI) scores through 16 weeks of treatment were examined by baseline BMI category (<25 kg/m2 [normal], 25 to <30 kg/m2 [overweight], and ≥30 kg/m2 [obese]) in patients with psoriasis with a baseline PASI total score ≥12. Treatment differences between the adalimumab and the methotrexate or placebo groups were compared using Fisher's exact test for PASI responses and 1-way analysis of variance for DLQI scores.
RESULTS: In all BMI categories, adalimumab treatment led to significantly greater rates of PASI75/90 responses at weeks 12 and 16 compared with methotrexate or placebo (P<0.05 for all). In normal weight, overweight, and obese patients at week 16, the respective PASI75 response rates were 85.0%, 85.7%, and 61.3% with adalimumab; 43.3%, 29.3%, and 26.1% with methotrexate; and 28.6%, 16.7%, and 0% with placebo. PASI90 response rates were 70.0%, 53.6%, and 35.5% with adalimumab; 26.7%, 7.3%, and 8.7% with methotrexate; and 9.5%, 16.7%, and 0% with placebo. Across all BMI subgroups, the greatest decreases in DLQI scores from baseline occurred in the adalimumab group.
CONCLUSION: Significantly higher PASI75/90 response rates and more pronounced improvements in DLQI scores at week 16 were identified in patients treated with adalimumab, compared with methotrexate or placebo, regardless of baseline BMI category.

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Year:  2015        PMID: 26267731

Source DB:  PubMed          Journal:  J Drugs Dermatol        ISSN: 1545-9616            Impact factor:   2.114


  9 in total

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Journal:  Cochrane Database Syst Rev       Date:  2017-12-22

Review 2.  Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.

Authors:  Emilie Sbidian; Anna Chaimani; Ignacio Garcia-Doval; Liz Doney; Corinna Dressler; Camille Hua; Carolyn Hughes; Luigi Naldi; Sivem Afach; Laurence Le Cleach
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Review 3.  Adalimumab: A Review in Chronic Plaque Psoriasis.

Authors:  Celeste B Burness; Kate McKeage
Journal:  Drugs       Date:  2015-12       Impact factor: 9.546

4.  Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.

Authors:  Emilie Sbidian; Anna Chaimani; Ignacio Garcia-Doval; Liz Doney; Corinna Dressler; Camille Hua; Carolyn Hughes; Luigi Naldi; Sivem Afach; Laurence Le Cleach
Journal:  Cochrane Database Syst Rev       Date:  2021-04-19

5.  Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.

Authors:  Emilie Sbidian; Anna Chaimani; Sivem Afach; Liz Doney; Corinna Dressler; Camille Hua; Canelle Mazaud; Céline Phan; Carolyn Hughes; Dru Riddle; Luigi Naldi; Ignacio Garcia-Doval; Laurence Le Cleach
Journal:  Cochrane Database Syst Rev       Date:  2020-01-09

6.  AURIEL-PsO: a randomized, double-blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB11022 to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis.

Authors:  J Hercogová; K A Papp; V Chyrok; M Ullmann; P Vlachos; C J Edwards
Journal:  Br J Dermatol       Date:  2019-09-26       Impact factor: 9.302

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8.  Certolizumab Pegol in Japanese Patients with Moderate to Severe Plaque Psoriasis: Effect of Demographics and Baseline Disease Characteristics on Efficacy.

Authors:  Shinichi Imafuku; Yayoi Tada; Yoshinori Umezawa; Shinya Sakurai; Naoki Hoshii; Hidemi Nakagawa
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Review 9.  Obesity and response to anti-tumor necrosis factor-α agents in patients with select immune-mediated inflammatory diseases: A systematic review and meta-analysis.

Authors:  Siddharth Singh; Antonio Facciorusso; Abha G Singh; Niels Vande Casteele; Amir Zarrinpar; Larry J Prokop; Eduardo L Grunvald; Jeffrey R Curtis; William J Sandborn
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  9 in total

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