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AB0267 Five-year safety and efficacy of golimumab in patients with active rheumatoid arthritis despite prior treatment with methotrexate: final study results of the phase 3, randomized placebo-controlled go-forward trial
  1. E. Keystone1,
  2. M. C. Genovese2,
  3. S. Hall3,
  4. P. C. Miranda4,
  5. S.-C. Bae5,
  6. C. Han6,
  7. T. Gathany6,
  8. Y. Zhou7,
  9. S. Xu7,
  10. E. C. Hsia8
  1. 1Mount Sinai Hospital, Toronto, Canada
  2. 2Stanford Univ, Palo Alto, United States
  3. 3Monash Univ, Cabrini Med Cent., Malvern, Australia
  4. 4Univ de Chile, Santiago, Chile
  5. 5Hanyang Univ Hospital for Rheumatic Diseases, Seoul, Korea, Republic Of
  6. 6Janssen Global Services, LLC, Malvern
  7. 7Janssen R&D, LLC, Spring House
  8. 8Janssen R&D, LLC/U Penn, Spring House/Philadelphia, United States

Abstract

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

Methods Pts were randomized to placebo(PBO)+MTX, GLM 100mg+PBO, GLM 50mg+MTX, or GLM 100mg+MTX q4w. PBO+MTX pts crossed over to GLM+MTX at wks 16 (blinded early escape) or 24 (crossover). Pts continued treatment at wk52 (start of long-term extension). After the last pt completed wk52 and unblinding occurred, MTX and corticosteroid use could be adjusted, and a one-time GLM dose increase (50 to 100mg) or decrease (100 to 50mg) was permitted based on investigator judgment. 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 A total of 444 pts were randomized; 313 pts continued treatment through wk252, and 131 pts withdrew (64 for AE, 25 for lack of efficacy, 1 protocol violation, 6 lost to follow-up, 32 for other reasons, 3 deaths). 301 completed the safety follow-up through wk268. Efficacy results are presented in the table. At wk256, 76.0% of all pts had an ACR20, 89.5% had a DAS28-CRP EULAR response, and 68.5% had improvement in HAQ-DI ≥0.25. Changes from baseline in mean total vdH-S scores were small; 54% of pts randomized to GLM+MTX had no radiographic progression (ΔvdH-S≤0). The most common AEs were upper respiratory tract infection (32.9%), nasopharyngitis (17.1%), and bronchitis (17.1%); 9.2% of pts had an injection-site reaction. Through wk268, 172/434 pts (39.6%) had an SAE; 14.1% of pts discontinued study agent due to AEs. The rates of serious infections, malignancies, and death were 11.5%, 6.2%, and 1.8%, respectively. Of 429 pts with available samples, 33 (7.7%) were positive for antibodies to GLM.

Conclusions The retention rate was high (70.5%), and improvements in signs/symptoms of RA and in physical function with GLM+MTX therapy were maintained long-term. Radiographic progression appeared controlled with small changes in mean vdH-S scores observed through 5yrs. The long-term safety of GLM is consistent with other anti-TNFα agents.

Disclosure of Interest E. Keystone Grant/research support from: Janssen R&D, LLC, M. Genovese Grant/research support from: Janssen R&D, LLC, S. Hall Grant/research support from: Janssen R&D, LLC, P. Miranda Grant/research support from: Janssen R&D, LLC, S.-C. Bae 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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