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FRI0178 Five-year safety and efficacy of golimumab in methotrexate-naïve patients with rheumatoid arthritis: final study results of the phase 3, randomized, placebo-controlled go-before trial
  1. P. Emery1,
  2. R. M. Fleischmann2,
  3. I. Strusberg3,
  4. P. Durez4,
  5. P. Nash5,
  6. E. Amante6,
  7. M. Churchill8,
  8. W. Park7,
  9. B. Pons-Estel9,
  10. C. Han10,
  11. T. Gathany10,
  12. Y. Zhou11,
  13. S. Xu11,
  14. E. C. Hsia12
  1. 1Univ of Leeds, Leeds, United Kingdom
  2. 2Univ of Texas, SWMC, Dallas, United States
  3. 3Inst Reumatológico Strusberg, Córdoba, Argentina
  4. 4Univ Catholique de Louvain, Brussels, Belgium
  5. 5Univ of Queensland, Brisbane, Australia
  6. 6Univ of the Philippines, Manila, Philippines
  7. 7INHA Univ Hospital, Incheon, Korea, Republic Of
  8. 8Arthritis Cent of Nebraska, Lincoln, United States
  9. 9Inst Cardiovascular de Rosario, Santa Fe, Argentina
  10. 10Janssen Global Services, LLC, Malvern
  11. 11Janssen R&D, LLC, Spring House
  12. 12Janssen R&D, LLC/U Penn, Spring House/Philadelphia, United States

Abstract

Objectives Final 5yr safety and efficacy results of subcutaneous golimumab (GLM)+/-MTX evaluated in a phase 3 trial (GO-BEFORE) of MTX-naïve pts with rheumatoid arthritis (RA) are reported.

Methods Pts were randomized to PBO+MTX, GLM 100mg+PBO, GLM 50mg+MTX, or GLM 100mg+MTX q4w. PBO+MTX pts crossed over to GLM+MTX at wks 28 (blinded early escape) or 52 (pts with ≥1 swollen/tender joint). Pts continued treatment at wk52 (start of long-term extension). After the last pt completed wk52 and unblinding occurred, PBO+MTX pts could switch to GLM 50mg+MTX, MTX and corticosteroid use could be adjusted, and a one-time GLM dose change (50 → 100mg or 100 → 50mg) was permitted at investigator’s discretion. The last GLM injection was at wk252. Observed efficacy results (ACR20/50/70, DAS28-CRP, HAQ-DI, radiographic) by randomized treatment group and cumulative safety data are reported through wks 256 and 268, respectively.

Results Of 637 randomized pts, 3 were never treated; 419 continued treatment through wk252, and 215 withdrew (111 for AE, 23 for lack of efficacy, 20 lost to follow-up, 53 for other reasons, 8 deaths). 402 completed the safety follow-up through wk268. Efficacy results are presented in the table. At wk 256, 84.3% of all pts had an ACR20, 93.9% had DAS28-CRP EULAR response, and 80.6% had improvement in HAQ-DI ≥0.25. Mean changes from baseline in total vdH-S score were small and 64% of pts randomized to GLM+MTX had no radiographic progression (ΔvdH-S≤0). The most common AEs were upper respiratory tract infection(29.4%), nausea(19.6%), bronchitis(16.6%), and increased alanine aminotransferase(16.1%); 11.9% of pts had an injection-site reaction. Through wk268, 204/616(33.1%) pts had an SAE; 17.5% of pts discontinued study agent due to AEs. Overall rates of serious infections, malignancies, and death were 12.2%, 3.4%, and 1.9%, resp. Of 595 pts with available samples, 58(9.7%) were positive for antibodies to GLM.

Conclusions The retention rate was high(66.1%) through 5yrs. GLM+MTX therapy resulted in maintained improvements in signs/symptoms of RA and in physical function, and inhibited structural damage progression long-term. No new safety signals were detected through 5years in MTX-naïve RA pts.

Disclosure of Interest P. Emery Grant/research support from: Janssen R&D, LLC, R. Fleischmann Grant/research support from: Janssen R&D, LLC, I. Strusberg Grant/research support from: Janssen R&D, LLC, P. Durez Grant/research support from: Janssen R&D, LLC, P. Nash Grant/research support from: Janssen R&D, LLC, E. Amante Grant/research support from: Janssen R&D, LLC, M. Churchill Grant/research support from: Janssen R&D, LLC, W. Park Grant/research support from: Janssen R&D, LLC, B. Pons-Estel Grant/research support from: Janssen R&D, LLC, C. Han Shareholder of: Johnson & Johnson, Employee of: Janssen Global Services, LLC, T. Gathany Shareholder of: Johnson & Johnson, Employee of: Janssen Global Services, LLC, Y. Zhou Shareholder of: Johnson & Johnson, Employee of: Janssen R&D, LLC, S. Xu Shareholder of: Johnson & Johnson, Employee of: Janssen R&D, LLC, E. Hsia Shareholder of: Johnson & Johnson, Employee of: Janssen R&D, LLC

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