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SAT0270 5 Year Safety, Efficacy, and Radiographic Data in Patients with Active Psoriatic Arthritis Treated with Golimumab: Long-Term Extension Results of the Randomized, Placebo-Controlled Study Go-Reveal
  1. A. Kavanaugh1,
  2. D. van der Heijde2,
  3. I. McInnes3,
  4. P. Mease4,
  5. G. G. Krueger5,
  6. D. Gladman6,
  7. Y. Zhou7,
  8. J. D. Lu7,
  9. Z. Xu7,
  10. L. Noonan7,
  11. A. Beutler7
  1. 1U of California, San Diego, La Jolla, United States
  2. 2Leiden U Med Ctr, Leiden, Netherlands
  3. 3U of Glasgow, Glasgow, United Kingdom
  4. 4Swedish Med Ctr and U of Washington, Seattle
  5. 5U of Utah, SLC, United States
  6. 6U of Toronto, Toronto, Canada
  7. 7Janssen R&D, LLC, Spring House, United States

Abstract

Objectives Safety, efficacy, & radiographic progression in GLM-treated pts from long-term extension of GO-REVEAL is presented.

Methods 405 PsA pts (≥3 SJ, ≥3 TJ counts) were rand to SC PBO (Grp1, n=113), GLM50mg (Grp2, n=146), or GLM100mg (Grp3, n=146) q4wks thru wk20. Concomitant MTX at baseline (BL) was allowed but not required. At wk16, pts with <10% improvement in SJ&TJ were eligible for rescue tx. All pts received GLM from wk24 forward. After wk52, pts could change GLM dose based on investigator judgment. The last GLM inj was at wk252; efficacy was assessed at wk256 based on rand grp&completer analyses using ACR response criteria, DAS28-CRP, PASI, HAQ, enthesitis/dactylitis assessments, NAPSI scores, & PsA-modified Sharp/van der Heijde Score (SHS). Safety evaluations included all pts who received at least one GLM dose thru 5yrs.

Results Of 405 pts rand, 335 cont’d in the study at wk104, & 279 pts (69%) cont’d GLM thru wk252. 29% of Grp2 pts dose escalated to GLM100mg; 25% of Grp3 pts decreased dose from 100mg to 50mg. BL characteristics of pts who cont’d in the study at wk104 & efficacy at wk256 are provided(Table). ACR&PASI responses were similar in pts tx with or without MTX; changes from BL in SHS scores were minimal&numerically less in pts tx with GLM & MTXvs GLM alone. 88%, & 21% GLM-tx pts experienced AE & SAE, resp. 12% of pts d/c GLM due to AE, & 5% & 4% pts experienced malignancy (incl NMSC),& serious infection, resp. Antibodies to GLM were detected in 6% of pts.

Conclusions Pt attrition thru 5yrs of GLM tx was low. GLM tx resulted in long-term maintenance of clinically meaningful responses in arthritic & skin components of PsA, improved physical function, & arrest of radiographic progression. No apparent differences between long-term safety&efficacy of 2 GLM doses administered q4wks were observed, however, interpretation of the data is limited due to tx changes allowed across rand grps.

Disclosure of Interest A. Kavanaugh Grant/research support from: Janssen Research and Development, LLC, D. van der Heijde Grant/research support from: Janssen Research and Development, LLC, I. McInnes Grant/research support from: Janssen Research and Development, LLC, P. Mease Grant/research support from: Janssen Research and Development, LLC, G. G. Krueger Grant/research support from: Janssen Research and Development, LLC, D. Gladman Grant/research support from: Janssen Research and Development, LLC, Y. Zhou Employee of: Janssen Research and Development, LLC, J. D. Lu Employee of: Janssen Research and Development, LLC, Z. Xu Employee of: Janssen Research and Development, LLC, L. Noonan Employee of: Janssen Research and Development, LLC, A. Beutler Employee of: Janssen Research and Development, LLC

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