POS0590 SAFETY AND EFFICACY OF BIOLOGICS IN ELDERLY PATIENTS WITH RHEUMATOID ARTHRITIS IN A REAL WORLD STUDY: USE OF INTRAVENOUS GOLIMUMAB AND INFLIXIMAB IN ADULTS WITH RHEUMATOID ARTHRITIS ≥65 YEARS OF AGE
Authors: J. Schechtman, A. Broadwell, S. Kafka, S. Black, S. Xu, W. Langholff, S. Schwartzman
Journal: Annals of the Rheumatic Diseases (2021)

Background: AWARE is a real-world evidence-based (RWE) study evaluating the safety and efficacy of IV golimumab (GLM) and infliximab (IFX) in adults with RA. Objectives: Evaluate safety and efficacy of IV GLM and IFX in elderly AWARE participants. Methods: AWARE, a prospective non-interventional study (88 US sites), enrolled patients (pts) initiating either IV GLM or IFX. Pt management was at the discretion of treating rheumatologists. In a post hoc analysis, pts were grouped by age (&lt;65/≥65/≥75 yrs). Adverse events (AEs) were collected through the Week (W) 52 database lock (DBL; completed W52 or discontinued study) and at the end-of-study DBL (W104). The primary endpoint was proportion of pts with ≥1 infusion reaction through W52. Change from baseline in Clinical Disease Activity Index (CDAI) scores at Months 6 and 12 were secondary endpoints evaluated in bionaïve pts, including those with IFX dose escalation. Results: 1270 pts were enrolled (685 IV GLM; 585 IFX). 1047 (82%) pts were female; mean age was 60 yrs (57% &lt;65 yrs, 43% ≥65 yrs, and 7% ≥75 yrs). Mean disease durations were 9 yrs (IV GLM) and 7 yrs (IFX). Comorbidities were generally similar between IV GLM and IFX groups but more common among pts ≥65 vs &lt;65 yrs. Through W52, 66% of IV GLM pts and 62% of IFX pts discontinued the study. Discontinuation due to lack of efficacy was generally similar across age groups within treatment groups, although somewhat higher for IV GLM (29%) vs IFX (19%). For both treatments, AEs and discontinuations due to AE through W52 were more common in pts ≥65 vs &lt;65 yrs (Table 1). Consistent with general trends observed in elderly individuals, 1 rates of serious AEs (SAEs) and serious infections increased with age for both IV GLM and IFX; however, increases were more notable in IFX- than IV GLM-treated pts ≥65 yrs. The incidence of serious infections was highest in pts ≥75 yrs for both treatments, although small sample size may limit data interpretation. No increase in opportunistic infections, including Varicella, was observed in pts ≥65 vs &lt;65 yrs. Infusion reactions were more common in pts &lt;65 yrs in both treatment groups, and more prevalent in IFX- than IV GLM-treated pts within each age group through W52. Generally similar safety results were seen between W52 and W104 for each treatment group (data not shown). Both IV GLM and IFX in bionaïve pts showed improvement in CDAI scores across age groups, which was maintained over time (Figure 1). Table 1. % of pts with ≥1 AE through W52 DBL IV GLM IFX &lt;65 yrs ≥65 yrs ≥75 yrs &lt;65 yrs ≥65 yrs ≥75 yrs Patients, n 351 334 91 370 215 46 Discontinued due to AE 8.5% 12.6% 16.5% 15.1% 17.7% 21.7% AE 52.4% 58.4% 57.1% 63.5% 66.5% 71.7% Most common AEs (≥5% of pts in either treatment group) Nausea 3.7% 3.3% 3.3% 8.4% 6.0% 2.2% Worsening of RA 5.4% 4.5% 3.3% 7.3% 7.0% 4.3% Upper respiratory tract infection 5.7% 5.1% 4.4% 6.2% 5.6% 2.2% Pruritis 1.4% 2.4% 3.3% 6.8% 2.8% 2.2% Sinusitis 7.1% 3.3% 0% 3.8% 3.7% 2.2% Urinary tract infection 4.8% 5.1% 5.5% 4.3% 5.1% 6.5% SAE 7.7% 16.8% 20.9% 9.7% 18.6% 26.1% Infection 30.5% 27.2% 27.5% 32.2% 28.8% 32.6% Serious infection 3.7% 6.3% 7.7% 3.5% 7.9% 15.2% Neoplasms benign, malignant and unspecified 0.6% 2.7% 1.1% 0.8% 2.3% 6.5% Latent tuberculosis 0.3% 0% 0 0.3% 0% 0% Opportunistic infection 1.4% 1.8% 4.4% 1.9% 1.4% 4.3% Infusion reaction 5.1% 2.7% 1.1% 17.3% 8.8% 8.7% Death 0.3% 2.4% 2.2% 0% 2.3% 6.5% Conclusion: Elderly RA pts receiving IV GLM or IFX in this RWE study demonstrated similar safety and efficacy as reported in Phase 3 trials. 2,3 The higher rates of AEs, discontinuations due to AE, and SAEs (mainly serious infections) observed in pts ≥65 yrs are in line with increased safety events seen in elderly vs younger individuals in the general population. Rates of AEs, SAEs, and infusion reactions were higher for IFX vs IV GLM. Infusion reactions were more common in pts &lt;65 vs ≥65 yrs for both GLM and IFX, but more prevalent with IFX. References: [1]Castle SC. Clin Infect Dis 2000;31:578–85. [2]Lipsky PE, et al. N Engl J Med 2000;343:1594-602. [3]Weinblatt ME, et al. Ann Rheum Dis 2013;72:381-9. Disclosure of Interests: Joy Schechtman: None declared, Aaron Broadwell Speakers bureau: Amgen, AbbVie, Eli Lilly, Horizon, Janssen, Mallinckrodt, Novartis, Pfizer, Radius, Sanofi/Regeneron, and UCB, Consultant of: AbbVie, Amgen, Aurinia, Celegene, Eli Lilly, Janssen, Novartis, Pfizer, and Sandoz, Shelly Kafka Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Research &amp; Development, LLC, Shawn Black Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Research &amp; Development, LLC, Stephen Xu Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Research &amp; Development, LLC, Wayne Langholff Shareholder of: Johnson &amp; Johnson, Employee of: Janssen Research &amp; Development, LLC, Sergio Schwartzman Shareholder of: Amgen, Boston Scientific, Gilead, Medtronic, and Pfizer, Speakers bureau: AbbVie, Janssen, Eli Lily, Novartis, Pfizer, Regeneron, Sanofi, and UCB, Consultant of: AbbVie, Gilead, Eli Lilly, Janssen, Myriad, Novartis, Regeneron, Samsung, Sanofi, and UCB