AB0385 INTEGRATED SAFETY ANALYSIS ACROSS PHASE 3 CLINICAL STUDIES INCLUDING THE CONTROLLED AND UNCONTROLLED PERIODS FOR INTRAVENOUS GOLIMUMAB IN RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS, AND ANKYLOSING SPONDYLITIS

Abstract

Objectives: The GO‐FURTHER, GO‐VIBRANT, and GO‐ALIVE random‐ized controlled trials evaluated the efficacy and safety of intravenous (IV) golimumab (GLM) in patients with active rheumatoid arthritis (RA), psoriatic ar‐thritis (PsA), and ankylosing spondylitis (AS), respectively. This integrated analy‐sis assessed safety events across indications in patients who received IV GLM. Methods: Integrated safety data from 3 Phase 3, double‐blind, placebo (PBO)‐controlled trials were analyzed up to week (WK) 112 in RA patients and up to WK60 in PSA and AS patients. Patients received either IV PBO or IV GLM (2 mg/kg) at 0, 4, 12, and 20 WKS. PBO patients crossed over to IV GLM at WK24, except RA patients randomized to PBO who met early escape criteria crossed over at WK16 and AS patients randomized to PBO who crossed over at WK16. Cumulative adverse events (AEs) were reported by indication and pooled by treatment. Anti‐drug antibodies (ADAs) were evaluated. Results: Overall, 1248 patients were treated with IV GLM. A numerically greater proportion of patients with RA reported safety events than PSA or AS: SAEs (18.2 vs 5.2 vs 3.4), infections (49.1 vs 22.8 vs 32.8), serious infections (6.2 vs 2.2 vs 1.5), and infusion reactions (4.6 vs 0.9 vs 1.5). Overall incidence (per 100 patient‐years) of opportunistic infections, malignancy, active tubercu‐losis, and death was low (≤0.5). Infections were the most commonly reported type of SAE; the most frequent was pneumonia (10 [0.8%]). Incidence (per 100 patient‐years) of serious infections was similar among IV GLM patients with and without corticosteroid use (3.35 vs 3.37, respectively). Overall, 1 IV GLM patient (PsA) experienced a demyelination event. A numerically greater proportion of IV GLM patients discontinued due to an AE than PBO patients (5.0% vs 0.9%, respectively). Using a drug‐tolerant enzyme immunoassay, the incidence of ADAs was 22% through WK52 (primarily low titers). Conclusions: IV GLM demonstrated a consistent safety profile across indica‐tions in the PBO‐controlled (up to WK24) and uncontrolled study periods. More safety events occurred in RA patients, who represented the largest study population with older patients, longer disease duration, and more concomitant medication use.