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FRI0132 Long Term Safety of Intravenous Golimumab and Comparison with Subcutaneous Golimumab in Rheumatoid Arthritis: Results Through 2 Years
  1. R. Westhovens1,
  2. E. Keystone2,
  3. C.O. Bingham3,
  4. E.C. Hsia4,
  5. L. Kim5,
  6. Y. Zhou5,
  7. A. Mendelsohn5,
  8. M. Weinblatt6
  1. 1UZ Gasthuisberg, Leuven, Belgium
  2. 2U of Toronto, Toronto, Canada
  3. 3Johns Hopkins University, Baltimore
  4. 4Janssen R & D, LLC/U of Penn, Spring House/Phila
  5. 5Janssen R & D, LLC, Spring House
  6. 6Brigham & Women's Hospital, Boston, United States

Abstract

Objectives To describe the safety profile of IV GLM in RA (MTX nonresponders) from the Ph3 GO-FURTHER trial. AE rates of interest are indirectly compared to those observed in the SC GLM GO-FORWARD trial in a similar pt population.

Methods In GO-FURTHER, pts with active RA despite MTX were randomized to MTX + IV PBO or GLM 2mg/kg at wks 0, 4, and q8wks. In GO-FORWARD, pts with active RA despite MTX were randomized to SC PBO+MTX or SC GLM 100mg+PBO, GLM 50 mg+MTX, or GLM 100 mg+MTX administered q4wks. Observed safety findings through wk 112 for GO-FURTHER and wk 104 in GO-FORWARD are reported; incidence rates/100 pt-yrs are reported for AEs of interest from data through the August 15, 2012 cut-off (120-day safety update) in GO-FURTHER and from the wk160 CSR in GO-FORWARD. Comparison of targeted safety events between IV and SC GLM are reported. Pts who received ≥1 administration were included.

Results Baseline demographic and disease characteristics were similar in GO-FURTHER and GO-FORWARD. 584 pts received IV GLM, with a mean follow-up of 95.9 wks. 434 pts received SC GLM, with a mean follow-up of 89.9 wks. Overall AEs observed in GO-FURTHER and GO-FORWARD are summarized (Table). Similar proportions of pts in GO-FURTHER (wk 112) and GO-FORWARD (wk 104) had an AE (79.1% and 89.4%, respectively), an SAE (18.2% and 22.6%, respectively), or discontinued due to an AE (7.0% and 9.4%, respectively). Infections/infestations were the most common type of AE in both trials. Rates of selected SAEs per 100 pt-years through the August 15, 2012 cut-off in GO-FURTHER and wk 160 in GO-FORWARD showed no difference in AE rates or significant SAEs between GLM IV and SC in RA pts previously treated with MTX with the exception of patients with ALT abnormalities (>1 - <3 x ULN). Similar differences were noted through all ALT tertiles (≥3 - <5 x ULN; ≥5 x ULN) (Table). Incidence of nonserious infusion reactions (median 30 minute infusions) remained low regardless of infusion length, and no serious infusion reactions, requiring study discontinuation, were reported. NMSC (incidence/100 pt-yrs of f/u: 0.10[95% CI: 0.00,0.58] vs. 0.81 [95%CI: 0.37,1.54] for GLM IV vs GLM SC) and lymphoma rates were numerically lower in GO-FURTHER vs. GO-FORWARD.

Conclusions Overall safety profile of IV GLM in pts with RA despite MTX observed through wk 112 in GO-FURTHER was similar to that for SC GLM in a similar pt population (GO-FORWARD). Rates/100 pt-yrs (through August 15, 2012 in GO-FURTHER and wk 160 in GO-FORWARD) for events of interest such as malignancies and serious infections in GO-FURTHER were comparable to or lower than rates in GO-FORWARD.

Disclosure of Interest R. Westhovens Grant/research support from: Janssen R & D, LLC, E. Keystone Grant/research support from: Janssen R & D, LLC, C. Bingham Grant/research support from: Janssen R & D, LLC, E. Hsia Employee of: Janssen R & D, LLC, L. Kim Employee of: Janssen R & D, LLC, Y. Zhou Employee of: Janssen R & D, LLC, A. Mendelsohn Employee of: Janssen R & D, LLC, M. Weinblatt Grant/research support from: Janssen R & D, LLC

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