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Journal article
Incidence of Infusion Reactions and Clinical Effectiveness of Intravenous Golimumab Versus Infliximab in Patients with Rheumatoid Arthritis: The Real-World AWARE Study
Rheumatology and therapy, v 8(4), pp 1551-1563
01 Dec 2021
PMID: 34417735
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
Objective Evaluate tolerability and effectiveness of golimumab-IV versus infliximab in patients with rheumatoid arthritis (RA) in a real-world setting. Methods AWARE, a prospective, real-world, pragmatic, observational, multicenter, phase 4 study, enrolled RA patients when initiating golimumab-IV or infliximab. Treatment decisions were made by the treating rheumatologist. The approved doses for RA are 2 mg/kg at weeks 0, 4, then Q8W for golimumab-IV and 3 mg/kg at weeks 0, 2, 6, then Q8W (dose escalation permitted) for infliximab. A prespecified formal interim analysis was conducted. The primary endpoint was the incidence of infusion reactions (any adverse event that occurred during or within 1 h of infusion) through week 52. Major secondary endpoints were mean change from baseline in CDAI at months 6 and 12 in biologic-naive patients (non-inferiority margin in the CDAI = 6). Baseline characteristics were adjusted using propensity scores with inverse probability of treatment weights (IPTW). Results In the formal interim analysis (golimumab-IV, n = 479; infliximab, n = 354), the incidence of infusion reactions was significantly lower with golimumab-IV vs. infliximab (3.6 vs. 17.6%, p < 0.001, IPTW-adjusted). Among biologic-naive patients, mean changes from baseline in CDAI at month 6 (- 9.5 golimumab-IV vs. - 10.1 infliximab) and at month 12 (- 9.4 golimumab-IV vs. - 10.1 infliximab) demonstrated non-inferiority. Conclusions The proportion of patients with an infusion reaction was significantly lower with golimumab-IV vs. infliximab. Among biologic-naive patients, mean change from baseline in CDAI at months 6 and 12 was non-inferior for golimumab-IV vs. infliximab. Compared with fixed-dose golimumab-IV, infliximab dose escalation did not provide any greater improvements in CDAI for patients with RA.
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Details
- Title
- Incidence of Infusion Reactions and Clinical Effectiveness of Intravenous Golimumab Versus Infliximab in Patients with Rheumatoid Arthritis: The Real-World AWARE Study
- Creators
- Jeffrey R. Curtis - University of Alabama at BirminghamSoumya D. Chakravarty - Drexel UniversityShawn Black - Janssen Research & Development LLC, Spring House, PA, USAShelly Kafka - JanssenStephen Xu - Janssen Research & Development LLC, Spring House, PA, USAWayne Langholff - Janssen Research & Development LLC, Spring House, PA, USADennis Parenti - JanssenAndrew Greenspan - JanssenSergio Schwartzman - Cornell University
- Publication Details
- Rheumatology and therapy, v 8(4), pp 1551-1563
- Publisher
- Springer Nature
- Number of pages
- 13
- Grant note
- Janssen Scientific Affairs, LLC
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Rheumatology
- Web of Science ID
- WOS:000686884800001
- Scopus ID
- 2-s2.0-85113147564
- Other Identifier
- 991019167565604721
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- Collaboration types
- Industry collaboration
- Domestic collaboration
- Web of Science research areas
- Rheumatology