Incidence of Infusion Reactions and Clinical Effectiveness of Intravenous Golimumab Versus Infliximab in Patients with Rheumatoid Arthritis: The Real-World AWARE Study.
Clinical disease activity index
Infliximab
Infusion reaction
Intravenous golimumab
Real-world evidence
Journal
Rheumatology and therapy
ISSN: 2198-6576
Titre abrégé: Rheumatol Ther
Pays: England
ID NLM: 101674543
Informations de publication
Date de publication:
Dec 2021
Dec 2021
Historique:
received:
03
06
2021
accepted:
27
07
2021
pubmed:
22
8
2021
medline:
22
8
2021
entrez:
21
8
2021
Statut:
ppublish
Résumé
Evaluate tolerability and effectiveness of golimumab-IV versus infliximab in patients with rheumatoid arthritis (RA) in a real-world setting. 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-naïve patients (non-inferiority margin in the CDAI = 6). Baseline characteristics were adjusted using propensity scores with inverse probability of treatment weights (IPTW). 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-naïve 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. The proportion of patients with an infusion reaction was significantly lower with golimumab-IV vs. infliximab. Among biologic-naïve 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. ClinicalTrials.gov identifier, NCT02728934.
Identifiants
pubmed: 34417735
doi: 10.1007/s40744-021-00354-4
pii: 10.1007/s40744-021-00354-4
pmc: PMC8572298
doi:
Banques de données
ClinicalTrials.gov
['NCT02728934']
Types de publication
Journal Article
Langues
eng
Pagination
1551-1563Informations de copyright
© 2021. The Author(s).
Références
Simponi ARIA. Package insert. Horsham: Janssen Biotech, Inc.; 2021.
Remicade: Package insert. Horsham, PA: Janssen Biotech, Inc.; 2020.
Bingham CO 3rd, Mendelsohn AM, Kim L, et al. Maintenance of clinical and radiographic benefit with intravenous golimumab therapy in patients with active rheumatoid arthritis despite methotrexate therapy: Week-112 efficacy and safety results of the open-label long-term extension of a phase III, double-blind, randomized, placebo-controlled trial. Arthritis Care Res (Hoboken). 2015;67:1627–36.
doi: 10.1002/acr.22556
Hsia EC, Ruley KM, Rahman MU. Infliximab (Remicade): from bench to clinical practice. A paradigm shift in rheumatology practice. APLAR J Rheumatol. 2006;9:107–18.
doi: 10.1111/j.1479-8077.2006.00185.x
Lipsky PE, van der Heijde DM, St Clair EW, Furst DE, Breedveld FC, Kalden JR, Smolen JS, Weisman M, Emery P, Feldmann M, Harriman GR, Maini RN, Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. Infliximab and methotrexate in the treatment of rheumatoid arthritis. N Engl J Med. 2000;343:1594–602.
doi: 10.1056/NEJM200011303432202
Maini R, St Clair EW, Breedveld F, Furst D, Kalden J, Weisman M, Smolen J, Emery P, Harriman G, Feldmann M, Lipskyet P, ATTRACT Study Group. Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. Lancet. 1999;354:1932–9.
doi: 10.1016/S0140-6736(99)05246-0
Weinblatt ME, Bingham CO 3rd, Mendelsohn AM, et al. Intravenous golimumab is effective in patients with active rheumatoid arthritis despite methotrexate therapy with responses as early as week 2: results of the phase 3, randomised, multicentre, double-blind, placebo-controlled GO-FURTHER trial. Ann Rheum Dis. 2013;72:381–9.
doi: 10.1136/annrheumdis-2012-201411
Zhuang Y, Xu Z, Frederick B, et al. Golimumab pharmacokinetics after repeated subcutaneous and intravenous administrations in patients with rheumatoid arthritis and the effect of concomitant methotrexate: an open-label, randomized study. Clin Ther. 2012;34:77–90.
doi: 10.1016/j.clinthera.2011.11.015
Blonde L, Khunti K, Harris SB, Meizinger C, Skolnik NS. Interpretation and impact of real-world clinical data for the practicing clinician. Adv Ther. 2018;35:1763–74.
doi: 10.1007/s12325-018-0805-y
Aletaha D, Nell VPK, Stamm T, et al. Acute phase reactants add little to composite disease activity indices for rheumatoid arthritis: validation of a clinical activity score. Arthritis Res Ther. 2005;7:R796-806.
doi: 10.1186/ar1740
Curtis JR, Yang S, Chen L, et al. Determining the minimally important difference in the clinical disease activity index for improvement and worsening in early rheumatoid arthritis patients. Arthritis Care Res (Hoboken). 2015;67:1345–53.
doi: 10.1002/acr.22606
Austin PC. A tutorial and case study in propensity score analysis: an application to estimating the effect of in-hospital smoking cessation counseling on mortality. Multivariate Behav Res. 2011;46:119–51.
doi: 10.1080/00273171.2011.540480
Weinblatt ME, Westhovens R, Mendelsohn AM, et al. Radiographic benefit and maintenance of clinical benefit with intravenous golimumab therapy in patients with active rheumatoid arthritis despite methotrexate therapy: results up to 1 year of the phase 3, randomised, multicentre, double blind, placebo controlled GO-FURTHER trial. Ann Rheum Dis. 2014;73:2152–9.
doi: 10.1136/annrheumdis-2013-203742
Baumfeld Andre E, Reynolds R, Caubel P, Azoulay L, Dreyer NA. Trial designs using real-world data: the changing landscape of the regulatory approval process. Pharmacoepidemiol Drug Saf. 2020;29:1201–12.
doi: 10.1002/pds.4932
Hernandez MV, Sanmarti R, Canete JD. The safety of tumor necrosis factor-alpha inhibitors in the treatment of rheumatoid arthritis. Expert Opin Drug Saf. 2016;15:613–24.
doi: 10.1517/14740338.2016.1160054