Background/Purpose: Subcutaneous (SC) golimumab (GLM) is currently approved for adult patients (pts) with RA, PsA, and AS. The GO-ALIVE study was designed to evaluate the safety and efficacy of IV GLM in adult pts with active AS.

Methods: GO-ALIVE is a Phase 3, multicenter, randomized, double-blind, placebo (PBO)-controlled trial. Pts (≥18 yrs) had a diagnosis of definite AS (per modified New York criteria) and BASDAI ≥4, total back pain visual analogue scale ≥4, and CRP ≥0.3mg/dL. Pts were randomized (1:1) to IV GLM 2mg/kg at weeks (wks) 0, 4, and every 8 wks or PBO at wks 0, 4, and 12, with crossover to GLM at wk16 through wk52. Up to 20% of pts could have had a prior anti-TNF agent (other than GLM), and up to 10% of pts could have complete ankylosis of the spine. The primary endpoint was ASAS20 at wk16. Other assessments included BASDAI, BASFI, and enthesitis (UCSF index). Missing data were imputed using LOCF. Pts were monitored for adverse events (AEs). Efficacy and safety data through wk52/wk60 are reported here.

Results: 208 pts were randomized and received study agent (PBO: 103; GLM: 105); 5.8% had complete ankylosis of the spine. 17 pts (PBO, n=4; PBO to GLM, n=5; GLM, n=8) discontinued study agent through week 60. At wk 16, greater proportions of pts in the GLM group as compared to PBO had ASAS20 (73% vs 26%), ASAS40 (48% vs 9%), ASAS partial remission (16% vs 4%), and BASDAI50 (41% vs 15%) and GLM pts had greater mean improvements in BASFI (-2.4 vs. -0.5). After crossover to GLM at wk16, clinical efficacy in the PBO group approached that in the GLM group as early as wk20. Efficacy was maintained through week 52 with comparable response levels in the two treatment groups. At wk52, 69.5% of GLM pts and 65.0% of PBO → GLM pts had an ASAS20 response; 56.2% and 51.5%, respectively, had an ASAS40 response, and 24.8% and 24.3%, respectively, achieved ASAS partial remission. BASDAI 50/70 was achieved by 56.2%/33.3% of GLM pts and 55.3%/35.0% of PBO→GLM pts at wk52. Mean changes in BASFI and BASMI at wk52 were similar to wk16 and comparable between the treatment groups. Among pts with enthesitis at baseline, mean decreases in enthesitis score were similar for GLM (n=87; -3.8) and PBO→GLM (n=85; -3.6) pts at wk52. Through wk60, 204 pts received ≥1 administration of GLM. Of these, 55.4% had ≥1 adverse event (AE), including 3.4% who had a serious AE (SAE). Infections were the most common type of AE (32.8%). One pt who screened negative for tuberculosis was diagnosed with pulmonary TB. There were no deaths, malignancies, or opportunistic infections.

Conclusion: Response to IV GLM 2mg/kg was maintained through wk52 and comparable between patients who were randomized to GLM versus those who switched to GLM at wk 16. Through wk60, the safety profile was consistent with other anti-TNFs, including SC GLM.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-and-efficacy-of-intravenous-golimumab-in-adult-patients-with-active-ankylosing-spondylitis-results-through-1-year/