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THU0202 Five-Year Safety and Efficacy of Golimumab in Patients with Active Rheumatoid Arthritis Despite Previous Anti-Tumor Necrosis Factor Therapy: Final Study Results of the Phase 3, Randomized, Placebo-Controlled Go-After Trial
  1. J. S. Smolen1,
  2. J. Kay2,
  3. R. Landewé3,
  4. E. L. Matteson4,
  5. N. Gaylis5,
  6. J. Wollenhaupt6,
  7. F. T. Murphy7,
  8. C. Han8,
  9. T. Gathany8,
  10. S. Xu9,
  11. Y. Zhou9,
  12. E. C. Hsia10,
  13. M. K. Doyle9
  1. 1Medical Univ of Vienna; Hietzing Hospital, Vienna, Austria
  2. 2UMass Memorial Medical Center, Worcester, United States
  3. 3Univ of Amsterdam; Atrium Medical Center, Heerlen, Netherlands
  4. 4Mayo Clinic College of Med, Rochester
  5. 5Arthritis & Rheumatic Disease Specialties, Aventura, United States
  6. 6Schoen Klinik Hamburg Eilbek, Hamburg, Germany
  7. 7Altoona Center for Clinical Research, Altoona
  8. 8Janssen Global Services, LLC, Malvern
  9. 9Janssen R&D, LLC, Spring House
  10. 10Janssen R&D, LLC/U Penn, Spring House/Philadelphia, United States

Abstract

Background GO-AFTER was the first multicenter, randomized, placebo (PBO)-controlled trial of the safety/efficacy of an anti-TNFα agent, GLM, in pts with active RA despite prior anti-TNFα therapy.

Objectives Final safety/efficacy results through 5yrs are reported.

Methods Pts were randomized (1:1:1) to PBO, GLM 50mg, or GLM 100mg q4w. At wk16, pts with inadequate treatment response entered double-blind early escape: PBO to GLM 50mg or GLM 50mg to 100mg. At wk24 (start of long-term extension), pts still receiving PBO switched to GLM 50mg, all other pts continued current treatment. After the last pt completed the wk24 visit, unblinding occurred, and a one-time GLM dose increase (50 to 100mg) or decrease (100 to 50mg) was permitted at investigator’s discretion. The last GLM injection was at wk252. Observed efficacy results (ACR20/50/70, DAS28-CRP, CDAI) by randomized treatment group and cumulative safety data are reported through wks 256 and 268, respectively. Efficacy data from 1 site (16 pts) were excluded (protocol violations).

Results 461 pts were randomized, and 459 received study agent; 183 pts continued treatment through wk252, and 276 pts withdrew (86 for AE, 107 for lack of efficacy, 9 lost to follow-up, 69 for other reasons, 5 deaths). 178 completed the safety follow-up through wk268. Efficacy results are shown in the table. Of pts with available data at wk256, 60.3% had an ACR20, 42.3% had an ACR50, 21.7% had an ACR70, 84.3% had DAS28-CRP EULAR response, 29.0% had DAS28-CRP <2.6, and 16.0% had CDAI≤2.8. The most common AEs were upper respiratory tract infection(27.1%), sinusitis(17.1%), and nasopharyngitis(16.9%). Through wk268, 151/431 pts had an SAE, with similar rates among dose groups (50mg only, 50 and 100mg, 100mg only) Rates of serious infections, malignancies, and death were 13.9%, 4.6%, and 2.1%, respectively. 12.3% of pts had ≥1 injection-site reaction. Of 388 pts with available samples, 31 (8.0%) tested positive for antibodies to GLM.

Conclusions GLM efficacy was maintained through 5yrs among pts with refractory RA who continued treatment. The long-term safety of GLM is consistent with other anti-TNFα agents.

Disclosure of Interest J. Smolen Grant/research support from: Janssen R&D, LLC, J. Kay Grant/research support from: Janssen R&D, LLC, R. Landewé Grant/research support from: Janssen R&D, LLC, E. Matteson Grant/research support from: Janssen R&D, LLC, N. Gaylis Grant/research support from: Janssen R&D, LLC, J. Wollenhaupt Grant/research support from: Janssen R&D, LLC, F. Murphy 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, S. Xu Shareholder of: Johnson & Johnson, Employee of: Janssen R&D, LLC, Y. Zhou Shareholder of: Johnson & Johnson, Employee of: Janssen R&D, LLC, E. Hsia Shareholder of: Johnson & Johnson, Employee of: Janssen R&D, LLC, M. Doyle Employee of: Janssen R&D, LLC

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