gms | German Medical Science

Introduction: The observation of SIMPONI within the Rheumatoide Arthritis: Beobachtung der Biologika Therapie (RABBIT) study aimed at further characterizing the long-term safety profile of originator golimumab (GLM) in a real-world setting among adults with rheumatoid arthritis (RA), with a particular focus on serious infections, malignancies, demyelinating disorders and all-cause mortality.

Methods: RABBIT is a non-interventional, observational, prospective cohort study consisting of patients with RA in Germany, who start any biologic (b-) or conventional synthetic (cs-) disease-modifying anti-rheumatic drug (DMARD) per their treating rheumatologist. For this analysis, patients enrolled from 01-Jan-2007 through 31-Dec-2016, and followed through 31-Oct-2021, regardless of treatment changes/discontinuations, were selected. Crude incidence rates (IR) of predefined outcomes in patients exposed to originator GLM compared to other bDMARDs, bionaïve csDMARDs and nonbionaïve csDMARDs were calculated. Hazard ratios for the respective outcomes under GLM therapy compared to the other DMARDs were determined by multivariable adjusted analyses. All treatment episodes of the exposure groups were included in the Andersen-Gill model, so patients could contribute to several exposure groups. Propensity score based inverse probability of treatment weighting was applied to adjust for confounding by indication. Drug exposure was defined as the time from the start of treatment to the occurrence of an event, end of therapy, death, follow-up or end of study, whichever occurred first. In the analyses reported here, exposure was based on an as-treated approach adding a 90-day risk window.

Results: A total of 10,287 participants (mean age 56–61 years and 73–76% female) were enrolled and had a total of 23,929 treatment episodes. Serious infections occurred at an IR of 17 per 1,000 PY in the GLM group compared to 20–41 per 1,000 PY across comparator groups (Table 1 [Tab. 1]). There was a significantly reduced risk of serious infection in the GLM group compared to other bDMARDs and nonbionaïve csDMARDs. The IR for overall malignancies in the GLM group was 10 per 1,000 PY compared to 11–21 per 1,000 PY in comparator groups, with no increased risk of malignancy in the regression model. With only 1 demyelinating disorder event in the GLM group, the regression model was not applied. Risk of all-cause mortality was not increased with GLM compared to all comparator groups.

Conclusion: Overall, results from the RABBIT study were consistent with the known safety profile for GLM. Risk of serious infections, malignant disease and all-cause mortality in RA is not increased with GLM compared to other bDMARDs and csDMARDs.

Disclosure: RABBIT is an independently run non-interventional observational registry that is supported by a joint, unconditional grant from AbbVie, Amgen, BMS, Celltrion, Fresenius Kabi, Galapagos, Hexal, Lilly, Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, Pfizer, Samsung Bioepis, Sanofi Aventis, VIATRIS SANTE and UCB and previously by Roche. Funding for the SIMPONI study was provided by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and Janssen Research & Development, LLC, Spring House, PA, USA.

Yvette Meissner, lecture honoraria from Pfizer. Martin Schäfer has no personal disclosures. Martine Phaneuf, Susanne Hohenberger, Zhiping Huang, Alan G. Meehan, Kelly Smith, Cindy Weinstein are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and may own stock/stock options in Merck & Co., Inc., Rahway, NJ, USA. Suzan Esslinger is an employee of Janssen Research & Development, LLC, Spring House, PA, USA and may hold stock/stock options in the company.