Efficacy of Golimumab in Rheumatoid Arthritis Patients at High Risk of a Poor Prognosis: Post-Hoc Analysis of GO-FORTH Study using Cluster Analysis.

Objectives: 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 EULAR recommendations and limited physical function. Radiographic progression, disease activity, and physical function and associated factors were evaluated over 52 weeks.

Results: Overall, 261 RA patients were classified into three clusters characterised by high disease activity, high CRP levels, and limited physical function at baseline. GLM showed suppression of progressive modified total sharp score (mTSS) 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 ΔmTSS≤0 was observed in GLM 100 mg group than in GLM 50 mg group (63.9% vs 46.5%). CRP concentration and physical limitation were associated with radiographic progression of cluster C in GLM treatment.

Conclusions: GLM was effective in RA 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. Short title: Impact of poor prognostic factors on GLM efficacy.