Efficacy of golimumab in rheumatoid arthritis patients at high risk of a poor prognosis: Post hoc analysis of GO-FORTH study using cluster analysis

Author:

Asano Teita1ORCID,Ishii Yutaka1,Tsuchiya Hiroaki2,Masuda Junya1

Affiliation:

1. Immunology Infectious Disease Department, Medical Affairs Division, Janssen Pharmaceutical K.K. , Tokyo, Japan

2. Evidence Generation Department, Medical Affairs Division, Janssen Pharmaceutical K.K. , Tokyo, Japan

Abstract

ABSTRACT Objectives Our objective was to assess the efficacy of golimumab (GLM) in patients with poor prognostic factors (PPFs). Methods This is a post hoc analysis of GO-FORTH Phase 2/3 study. Cluster analysis was used to determine a patient population with high-risk patterns based on seven PPFs suggested by the European Alliance of Associations for Rheumatology recommendations and limited physical function. Radiographic progression, disease activity, and physical function and associated factors were evaluated over 52 weeks. Results Overall, 261 rheumatoid arthritis patients were classified into three clusters characterised by high disease activity, high C-reactive protein levels, and limited physical function at baseline. GLM showed suppression of progressive modified total sharp score and decreases in Disease Activity Score 28-joint counts with erythrocyte sedimentation rate and Health Assessment Questionnaire – Disease Index, in all the clusters. In Cluster C that showed almost all the PPF characteristics, a higher rate of change in modified total sharp score ≤0 was observed in GLM 100 mg group than in GLM 50 mg group (63.9% versus 46.5%). C-reactive protein concentration and physical limitation were associated with radiographic progression of Cluster C in GLM treatment. Conclusions GLM was effective in rheumatoid arthritis patients in a subpopulation at high risk of PPF in GO-FORTH study. A dose of 100 mg may be more beneficial in preventing radiographic progression in this population.

Publisher

Oxford University Press (OUP)

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