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
Authors: A. Kavanaugh, D. van der Heijde, I. McInnes, P. Mease, G. G. Krueger, D. Gladman, Y. Zhou, J. D. Lu, Z. Xu, L. Noonan, A. Beutler
Journal: Annals of the Rheumatic Diseases (2013)

<h3>Objectives</h3> Safety, efficacy, &amp; radiographic progression in GLM-treated pts from long-term extension of GO-REVEAL is presented. <h3>Methods</h3> 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 &lt;10% improvement in SJ&amp;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&amp;completer analyses using ACR response criteria, DAS28-CRP, PASI, HAQ, enthesitis/dactylitis assessments, NAPSI scores, &amp; PsA-modified Sharp/van der Heijde Score (SHS). Safety evaluations included all pts who received at least one GLM dose thru 5yrs. <h3>Results</h3> Of 405 pts rand, 335 cont'd in the study at wk104, &amp; 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 &amp; efficacy at wk256 are provided(Table). ACR&amp;PASI responses were similar in pts tx with or without MTX; changes from BL in SHS scores were minimal&amp;numerically less in pts tx with GLM &amp; MTXvs GLM alone. 88%, &amp; 21% GLM-tx pts experienced AE &amp; SAE, resp. 12% of pts d/c GLM due to AE, &amp; 5% &amp; 4% pts experienced malignancy (incl NMSC),&amp; serious infection, resp. Antibodies to GLM were detected in 6% of pts. <h3>Conclusions</h3> Pt attrition thru 5yrs of GLM tx was low. GLM tx resulted in long-term maintenance of clinically meaningful responses in arthritic &amp; skin components of PsA, improved physical function, &amp; arrest of radiographic progression. No apparent differences between long-term safety&amp;efficacy of 2 GLM doses administered q4wks were observed, however, interpretation of the data is limited due to tx changes allowed across rand grps. <h3>Disclosure of Interest</h3> 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