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AB0400 Intravenous Golimumab Inhibits Radiographic Progression and Maintains Clinical Efficacy and Safety in Patients with Active Rheumatoid Arthritis despite Methotrexate Therapy: 2-Year Results of A Phase 3 TRIAL of Intravenous Golimumab
  1. M.E. Weinblatt1,
  2. C.O. Bingham III2,
  3. A.M. Mendelsohn3,
  4. L. Kim3,
  5. K.H. Lo3,
  6. L. Noonan3,
  7. D. Baker3,
  8. R. Westhovens4
  9. on behalf of GO-FURTHER Investigators
  1. 1Brigham & Women's Hospital, Boston
  2. 2Johns Hopkins University, Baltimore
  3. 3Janssen Research & Development, LLC., Spring House, United States
  4. 4UZ Gasthuisberg, Leuven, Belgium

Abstract

Objectives To evaluate long-term clinical/radiographic efficacy of IV GLM 2mg/kg+MTX in active RA despite MTX through wk112.

Methods 592 pts with active RA (≥6/66 SJC, ≥6/68 TJC, CRP≥1.0mg/dL, RF and/or anti-CCP positive) despite ≥3 months of MTX (15-25mg/wk) participated in this multicenter, randomized, double-blind, placebo (PBO)-controlled study. Pts were randomized to IV GLM 2mg/kg or PBO at wks0&4 and q8wks; all pts continued stable MTX. PBO pts with <10% improvement in SJC+TJC at wk16 could early escape to IV GLM 2mg/kg (wks16&20, q8wks). All PBO pts received IV GLM 2mg/kg starting at wk24. Primary endpoint was wk14 ACR20. Radiographs of hands and feet at wks 0, 24 (wk16, early escape), 52, and 100 were scored by 2 independent readers and adjudicator (as needed) using the vdH-S score. Reading Session 2 included wk0, wk52, and wk100 scores. In general, analyses at wks 24, 52, and 100 were performed using ITT methodology, with imputation for missing data.

Results 82% of pts (486/592) continued through wk112; 106 pts d/c, mostly due to AEs (44pts) and few due to lack of efficacy (12pts). At wk14, significantly (p<0.001) larger proportions of GLM+MTX vs PBO+MTX pts had ACR20/50/70, DAS28-CRP good/moderate responses, and greater improvements in HAQ. Clinical improvements were maintained through wk100 (final efficacy visit), when ACR20/50/70 responses among all GLM+MTX-treated pts were 68.1%, 43.8%, and 23.5%, resp; DAS28-CRP moderate/good response was 81.9%; and median improvement from wk0 in HAQ was 0.5; 67.1% of GLM+MTX pts had improvement in HAQ ≥0.25 from baseline. GLM+MTX-treated pts continued to have significantly less radiographic progression based on vdH-S total and subscores vs PBO+MTX at wk24, and PBO+MTX$→ $GLM + MTX at wk52 and wk100. Pts randomized to PBO+MTX who began GLM at wk16/24 demonstrated marked slowing of radiographic progression from wk24-52 and from wk52-100. Through wk112 (final safety visit), the mean follow-up for all GLM-treated pts was 96wks. AEs and serious AEs occurred in 79% and 18%, resp, of GLM-treated pts (vs 49% and 2% at wk24). 3 cases of TB and 2 serious opportunistic infections (cryptococcal pneumonia, intervertebral discitis) were reported through wk112. 6pts (1.0%) died: 1 PBO+MTX and 5 (0.8%) GLM+MTX (pneumonia/MI, dehydration, abdominal TB, unknown x 2). Through wk112, the proportion of infusions with infusion reactions was 0.4% and the proportion of pts with infusion reactions was 3.9% (vs. 1.1% and 3.5%, respectively, at wk24).

Conclusions IV GLM+MTX significantly inhibited radiographic progression (vdH-S scores) at wks 24,52 and 100. Among PBO-treated pts who began GLM at wk16/24, marked slowing of radiographic progression, to rates similar to pts randomized to GLM, was observed from wk24-52 and from wk52-100. IV GLM+MTX also significantly improved and maintained RA signs/symptoms in pts with active RA despite ongoing MTX and continued to demonstrate an acceptable safety profile through wk112.

Disclosure of Interest M. Weinblatt: None declared, C. Bingham III: None declared, A. Mendelsohn Employee of: Janssen Research & Development, LLC., L. Kim Employee of: Janssen Research & Development, LLC., K. Lo Employee of: Janssen Research & Development, LLC., L. Noonan Employee of: Janssen Research & Development, LLC., D. Baker Employee of: Janssen Research & Development, LLC., R. Westhovens: None declared

DOI 10.1136/annrheumdis-2014-eular.2049

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