POS0947 LONG-TERM GOLIMUMAB PERSISTENCE: 5-YEAR TREATMENT RETENTION DATA POOLED FROM FIVE PHASE III CLINICAL TRIALS IN PATIENTS WITH RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS, AND ANKYLOSING SPONDYLITIS

Abstract

BackgroundTumor necrosis factor-alpha inhibitors (TNFi), such as golimumab (GLM), are widely prescribed for treatment of chronic immune-mediated rheumatic diseases, such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Long-term persistence of GLM response in these diseases has previously been described from individual randomized controlled trials.1-5 While treatment retention is considered an important factor for disease progression, health care utilization, and overall quality of life, and has previously been described, the probability of retention on GLM treatment in these trials has not been evaluated.ObjectivesTo evaluate probability of GLM treatment retention over a 5-year period in adult patients with immune-mediated rheumatic diseases, by indication and line of therapy, using pooled data from five Phase III randomized controlled clinical trials.MethodsUsing data prospectively collected from five Phase III studies, this post-hoc analysis evaluated subcutaneous (SC) GLM (50 mg or 100 mg every 4 weeks) for up to 5 years in participants with RA (GO-BEFORE,1,6 GO-AFTER2,7 and GO-FORWARD3,8), PsA (GO-REVEAL4,9), and AS (GO-RAISE5,10). Four of the five studies (GO-BEFORE, GO-FORWARD, GO-REVEAL and GO-RAISE) were pooled to examine 1st-line GLM therapy, while the remaining study (GO-AFTER) was used to examine 2nd-line (i.e., ≥ 1 line) GLM therapy in participants who had previously received and discontinued at least one other TNFi (etanercept, adalimumab, or infliximab) for any reason. Log-rank tests were performed to estimate retention rates by indication and line of therapy. Similarly, Kaplan-Meier analysis was used to estimate the probability of GLM retention over time.ResultsAmong the 2228 participants enrolled in the 5 trials, 1797 participants had received GLM as1st-line treatment (RA = 1050; PsA = 394; AS = 353) and 431 participants had received GLM as 2nd-line treatment. Compared to the pooled 1st-line GLM analysis cohort, more participants receiving 2nd-line GLM were female (78.7% vs 62.2%), were > 50 years (61.5% vs 41.2%), and had a longer disease duration (median of 9.2 years vs 3.7 years). In the pooled 1st-line studies, GLM treatment retention remained high over five years, with an overall probability of retention of 87.8% (95% confidence interval [CI], 86.2–89.2) at Year 1 (Week 52), 80.9% (79.0–82.6) at Year 2 (Week 104), 77.3% (75.3–79.2) at Year 3 (Week 156), 73.5% (71.4–75.5) at Year 4 (Week 208) and 69.8% (67.6–71.9) at Year 5 (Week 252). GLM retention rates were similar across the four 1st-line GLM studies with no notable differences observed by indication over time (Figure 1, panel A). Treatment retention was better in participants using GLM as a 1st-line therapy compared to 2nd-line therapy (Figure 1, panel B), with a probability of retention at 5 years (Week 252) with 2nd-line therapy of 41.6% (95% CI: 36.8-46.3).Figure 1.ConclusionIn this post-hoc analysis of prospectively collected clinical trial data, the probability of 1st-line GLM treatment retention at 5-years was consistently high across all rheumatic indications (RA, PsA and AS). Probability of long-term GLM treatment retention with 2nd-line therapy, while lower than 1st-line therapy, also remained favorable. Collectively, these data support the value of GLM as a 1st- or 2nd-line therapy in these chronic immune-mediated rheumatic diseases.References[1]Emery P, et al. Arthritis Rheum 2009;60:2272-83.[2]Smolen JS, et al. Lancet 2009;374:210-21.[3]Keystone EC, et al. J Rheumatol. 2015;43:298-306.[4]Kavanaugh A, et al. Ann Rheum Dis. 2014;73:1689-94[5]Inman RD, et al. Arthritis Rheum 2008;58:3402-12.[6]Emery P, et al. Arthritis Care Res. 2016;68:744-52.[7]Smolen JS, et al. Arthritis Res Ther. 2015;17:14.[8]Keystone EC, et al. Ann Rheum Dis 2009;68:789-96.[9]Kavanaugh A, et al. Arthritis Rheum 2009;60:976-86.[10]Deodhar A, et al. Ann Rheum Dis. 2015;74:757-61.Disclosure of InterestsCindy Weinstein Shareholder of: Merck & Co., Inc., Kenilworth, NJ, USQA, Employee of: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Marinella Govoni Shareholder of: Merck & Co., Inc., Kenilworth, NJ, USA, Employee of: MSD Italy, a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Jianxin Lin Shareholder of: Merck & Co., Inc., Kenilworth, NJ, USA, Employee of: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Alan Meehan Shareholder of: Merck & Co., Inc., Kenilworth, NJ, USA, Employee of: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, Zaina Qureshi Shareholder of: Merck & Co., Inc., Kenilworth, NJ, USA, Employee of: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA