학술논문
Response to Treatment with Intravenous Golimumab or Infliximab in Rheumatoid Arthritis Patients: PROMIS Results from the Real-World Observational Phase 4 AWARE Study
Original Research
Original Research
Document Type
Report
Author
Source
Rheumatology and Therapy. June 2023, Vol. 10 Issue 3, p659, 20 p.
Subject
Language
English
Abstract
Author(s): Clifton O. III Bingham [sup.1] , Shawn Black [sup.2] , Natalie J. Shiff [sup.2] [sup.3] , Stephen Xu [sup.4] , Wayne Langholff [sup.5] , Jeffrey R. Curtis [sup.6] Author [...]
Introduction To assess changes in the Patient-Reported Outcomes Measurement Information System (PROMIS.sup.®) 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 [greater than or equal to] 3, [greater than or equal to] 5, or [greater than or equal to] 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 ([greater than or equal to] 3-point improvement in T-scores) in all PROMIS-29 domains and respective SFs, and the proportions of patients with [greater than or equal to] 3, [greater than or equal to] 5, or [greater than or equal to] 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. ClinicalTrials.gov registration number NCT02728934.
Introduction To assess changes in the Patient-Reported Outcomes Measurement Information System (PROMIS.sup.®) 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 [greater than or equal to] 3, [greater than or equal to] 5, or [greater than or equal to] 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 ([greater than or equal to] 3-point improvement in T-scores) in all PROMIS-29 domains and respective SFs, and the proportions of patients with [greater than or equal to] 3, [greater than or equal to] 5, or [greater than or equal to] 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. ClinicalTrials.gov registration number NCT02728934.