Response to Treatment with Intravenous Golimumab or Infliximab in Rheumatoid Arthritis Patients: PROMIS Results from the Real-World Observational Phase 4 AWARE Study

Clifton O Bingham 3rd; Shawn Black; Natalie J Shiff; Stephen Xu; Wayne Langholff; Jeffrey R Curtis

doi:10.1007/s40744-023-00533-5

Response to Treatment with Intravenous Golimumab or Infliximab in Rheumatoid Arthritis Patients: PROMIS Results from the Real-World Observational Phase 4 AWARE Study

Rheumatol Ther. 2023 Jun;10(3):659-678. doi: 10.1007/s40744-023-00533-5. Epub 2023 Feb 23.

Authors

Clifton O Bingham 3rd¹, Shawn Black², Natalie J Shiff^{2

3}, Stephen Xu⁴, Wayne Langholff⁴, Jeffrey R Curtis⁵

Affiliations

¹ Johns Hopkins Division of Rheumatology, Johns Hopkins University, 5200 Eastern Ave, MFL Center Tower, Room 434A, Baltimore, MD, 21224, USA. cbingha2@jhmi.edu.
² Department of Immunology, Janssen Scientific Affairs, LLC, Horsham, PA, USA.
³ Department of Community Health and Epidemiology, College of Medicine, University of Saskatchewan, Saskatoon, SK, Canada.
⁴ Department of Biostatistics, Janssen Research & Development, Spring House, PA, USA.
⁵ Department of Medicine, Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA.

Abstract

Introduction: To assess changes in the Patient-Reported Outcomes Measurement Information System (PROMIS^®) outcomes related to social, mental, and physical well-being after approximately 1 year of intravenous (IV) golimumab or infliximab treatment in patients with rheumatoid arthritis (RA) using real-world evidence from AWARE.

Methods: AWARE was a prospective, noninterventional, multicenter, observational, U.S.-based phase 4 study of 1270 RA patients who initiated treatment with IV golimumab or infliximab. PROMIS-29 and PROMIS short form (SF) Fatigue 7a and Pain Interference 6b questionnaires were administered at baseline and infusions 2, 5, and 8 (approximately weeks 4, 28, and 52 for IV golimumab and weeks 2, 22, and 46 for infliximab). Mean changes from baseline in all PROMIS-29 domains and respective SFs and response rates for achieving ≥ 3, ≥ 5, or ≥ 10-point improvements were determined.

Results: Among all patients, baseline mean ± SD PROMIS T-scores were consistent between treatment groups and indicated worse physical function (38.2 ± 6.8 IV golimumab, 38.0 ± 6.9 infliximab), more pain interference (63.0 ± 7.6 IV golimumab, 63.9 ± 7.8 infliximab), and greater fatigue (58.4 ± 9.9 IV golimumab, 59.4 ± 10.0 infliximab) in these patients vs the general U.S. population (T-score = 50). Through the 8th infusion of either treatment, IV golimumab- and infliximab-treated patients achieved meaningful improvements (≥ 3-point improvement in T-scores) in all PROMIS-29 domains and respective SFs, and the proportions of patients with ≥ 3, ≥ 5, or ≥ 10-point improvements in T-scores increased from infusion 2 through infusion 8.

Conclusions: RA patients treated with IV golimumab or infliximab achieved comparable improvements across social, mental, and physical well-being PROMIS measures. Additionally, PROMIS detected meaningful clinical changes in patient-reported outcomes in both treatment groups.

Gov registration number: NCT02728934.

Keywords: Depression; Fatigue; Infliximab; Intravenous golimumab; Observational study; PROMIS; Pain interference; Patient-reported outcomes; Physical function; Rheumatoid arthritis.

Associated data

ClinicalTrials.gov/NCT02728934