TITLE

Efficacy of golimumab plus methotrexate in methotrexate-naïve patients with severe active rheumatoid arthritis

AUTHOR(S)
Emery, Paul; Fleischmann, Roy; Hsia, Elizabeth; Xu, Stephen; Zhou, Yiying; Baker, Daniel
PUB. DATE
September 2014
SOURCE
Clinical Rheumatology;Sep2014, Vol. 33 Issue 9, p1239
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The purpose of this study was to assess the treatment benefit of golimumab + methotrexate (MTX) vs. MTX monotherapy in MTX-naïve patients with severe active rheumatoid arthritis (RA). This was a post hoc analysis of MTX-naïve RA patients in the GO-BEFORE trial who were randomized to receive placebo + MTX ( n = 160), golimumab 50 mg + MTX ( n = 159), or golimumab 100 mg + MTX ( n = 159). Subsets of patients with severe disease were identified using these baseline criteria: C-reactive protein (CRP) ≥1.5 mg/dL, CRP ≥3.0 mg/dL, swollen joint count (SJC) ≥10 and tender joint count (TJC) ≥12, SJC ≥ 20/TJC ≥ 12, 28-joint count Disease Activity Score using CRP (DAS28-CRP) >5.1, and anti-cyclic citrullinated peptide antibody-positive status. The treatment effect of golimumab + MTX vs. MTX alone was evaluated for these outcomes: the proportions of patients achieving ≥20, 50, and 70 % improvement in the American College of Rheumatology criteria; DAS28-CRP European League Against Rheumatism response; DAS28-CRP <2.6, clinically meaningful improvement in physical function; and change in van der Heijde-Sharp score ≤0 at week 52. Clinical response was greater in the golimumab + MTX groups vs. placebo + MTX for all of the outcomes evaluated. Furthermore, the treatment effect of golimumab + MTX was consistently greater among patients in the severe disease subsets when compared with the overall GO-BEFORE trial population. The treatment benefit of golimumab + MTX vs. MTX monotherapy was most pronounced within the subsets of patients with CRP ≥3.0 mg/dL and SJC ≥ 20/TJC ≥ 12. Following treatment with golimumab + MTX, improvements in RA signs/symptoms and in progression of structural damage were evident for the overall GO-BEFORE population, with the treatment effect more pronounced among patients with severe active disease.
ACCESSION #
97546131

 

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