A phase III, multicentre, randomised, double-blind, active-controlled, parallel-group trial comparing safety and efficacy of HD203, with innovator etanercept, in combination with methotrexate, in patients with rheumatoid arthritis: the HERA study

Annals of the Rheumatic Diseases
Sang-Cheol BaeHERA Study Investigators

Abstract

To evaluate equivalence in efficacy for rheumatoid arthritis (RA) and compare the safety of the biosimilar HD203 with innovator etanercept (ETN) plus methotrexate (MTX) (ClinicalTrials.gov NCT01270997). Patients with active RA received 25 mg HD203 or ETN subcutaneously twice-weekly with MTX for 48 weeks in a phase III, multicentre, randomised, double-blind, parallel-group design. The primary end point was the proportion of patients achieving the American College of Rheumatology 20% response (ACR20) at week 24 for per-protocol study completer set (PPS). Secondary end points included ACR response criteria, ACRn, European League against Rheumatism (EULAR) response, change in Disease Activity Score 28 (DAS28), patient-reported outcomes, safety and immunogenicity. Of the 294 randomised patients (HD203, n=147; ETN, n=147), 233 comprised the 24-week PPS (n=115 and 118, respectively). ACR20 at week 24 was achieved by 83.48% and 81.36% of PPS patients, respectively, demonstrating equivalent efficacy within predefined margins of ±20% (treatment difference 2.12%, 95% CI -7.65% to 11.89%). Outcomes for secondary end points were consistent with the primary efficacy findings. Groups were comparable for overall incidences of treatment-emergen...Continue Reading

References

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Citations

Aug 28, 2016·Annals of the Rheumatic Diseases·Jonathan Kay, John D Isaacs
Mar 18, 2017·Current Opinion in Rheumatology·Stanley Cohen, Jonathan Kay
Feb 28, 2018·Immunotherapy·Sizheng ZhaoRobert J Moots
Apr 24, 2018·Expert Review of Clinical Immunology·Wolf-Henning Boehncke, Nicolo Costantino Brembilla
Oct 20, 2018·International Journal of Rheumatic Diseases·Prasan Deep RathLyndon Llamado
Sep 13, 2019·Journal of Clinical Pharmacology·Misaki SuzukiSriram Krishnaswami
Jun 15, 2017·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Vibeke StrandLisa Marshall
Jan 25, 2018·Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG·Sascha GerdesMarc A Radtke
Nov 10, 2018·Current Rheumatology Reports·Laura ChadwickRobert J Moots
Feb 9, 2018·Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG·Sascha GerdesMarc A Radtke
May 1, 2016·Annals of the Rheumatic Diseases·Francesca MeacciMaurizio Benucci
Oct 13, 2020·Critical Reviews in Biotechnology·Muhammad Safwan AkramAli K Yetisen
Sep 18, 2020·International Journal of Clinical Practice·Raouf Hajji

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