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

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

Tumour necrosis factor inhibitor monotherapy vs combination with MTX in the treatment of PsA: a systematic review of the literature

“…At week 104, similar PASI 50, 75 and 90 responses were seen irrespective of baseline MTX use (monotherapy 81% vs. MTX 88%, 64% vs. 62% and 44% vs. 38%, respectively, for golimumab 50 mg; 83% vs. 89%, 73% vs. 71% and 51% vs. 42%, respectively, for 100 mg) [22]. At week 256, PASI responses were similar in patients treated with and without MTX [23,24].…”

“…In GO-REVEAL, patients receiving MTX at baseline demonstrated numerically less progression at week 104 than patients not receiving MTX despite having more radiographic damage at baseline (mean change from baseline in 10 modified Sharp/van der Heijde score [SHS] -0.78 vs. 0.03 for golimumab 50 mg every 4 weeks and -0.65 vs. 0.00 for 100 mg) [22]. A similar pattern was seen at week 256 [23,24].…”

“…It should be noted that these studies were not sufficiently powered to answer this question and no statistically tests were conducted. Some data suggest that concomitant MTX may reduce structural progression, with numerically less progression at weeks 104 and 256 in patient receiving MTX and golimumab in GO-REVEAL [22][23][24] and a greater difference in radiographic progression at 1 year between infliximab and placebo groups with concomitant MTX in IMPACT 2 [29]. No significant differences in other outcomes have been reported, other than some benefit of MTX for skin symptoms at week 12 in patients with severe skin symptoms receiving etanercept 50 mg twice weekly (but not 50 mg once weekly) in PRESTA [19].…”

“…The ADEPT adalimumab trial found no differences for ACR20, ACR50 or ACR70 at weeks 12 and 48 [16,17]. Similarly, the GO-REVEAL golimumab trial reported no effect of concomitant MTX on ACR20, 50 or 70 at 14 weeks [21], 2 years [22] or 5 years [23,24]. 9…”

“…Two articles reported on two RCTs of etanercept [18,19], and a conference abstract reported a post-hoc analysis of pooled data from these trials [20]. Two articles and two conference abstracts reported on the GO-REVEAL trial of golimumab [21][22][23][24]. Five articles reported on two trials (IMPACT and IMPACT 2) of infliximab [25][26][27][28][29].…”