52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritis

التفاصيل البيبلوغرافية
العنوان: 52-week results of the phase 3 randomized study comparing SB4 with reference etanercept in patients with active rheumatoid arthritis
المؤلفون: Vira Tseluyko, Paul Emery, Piotr Leszczyński, Barbara Stasiuk, Wieslawa Porawska, Roma Milasiene, Soo Yeon Cheong, Aaron Alejandro Barrera Rodriguez, Anna Sylwestrzak, Vyacheslav Zhdan, Asta Baranauskaite, Jeehoon Ghil, Jiří Vencovský
المصدر: Rheumatology (Oxford, England)
بيانات النشر: Oxford University Press (OUP), 2017.
سنة النشر: 2017
مصطلحات موضوعية: Male, rheumatoid arthritis, 0301 basic medicine, medicine.medical_specialty, Time Factors, Arthritis, Etanercept, law.invention, Arthritis, Rheumatoid, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Rheumatology, Randomized controlled trial, law, Internal medicine, medicine, Humans, biologics, Pharmacology (medical), In patient, Biosimilar Pharmaceuticals, Benepali, Aged, 030203 arthritis & rheumatology, business.industry, Incidence (epidemiology), Middle Aged, Clinical Science, medicine.disease, Clinical disease, Radiography, Safety profile, Treatment Outcome, 030104 developmental biology, Antirheumatic Agents, Rheumatoid arthritis, Disease Progression, SB4, Female, biosimilar, business, medicine.drug
الوصف: Objective To compare the 52-week efficacy and safety of SB4 [an etanercept biosimilar] with reference etanercept (ETN) in patients with active RA. Methods In a phase 3, randomized, double-blind, multicentre study, patients with moderate to severe RA despite MTX treatment were randomized to receive 50 mg/week of s.c. SB4 or ETN up to week 52. Efficacy assessments included ACR response rates, 28-joint DAS, Simplified and Clinical Disease Activity Indices and changes in the modified total Sharp score (mTSS). Safety and immunogenicity were also evaluated. Results A total of 596 patients were randomized to receive either SB4 (n = 299) or ETN (n = 297) and 505 (84.7%) patients completed 52 weeks of the study. At week 52, the ACR20 response rates in the per-protocol set were comparable between SB4 (80.8%) and ETN (81.5%). All efficacy results were comparable between the two groups and they were maintained up to week 52. Radiographic progression was also comparable and the change from baseline in the mTSS was 0.45 for SB4 and 0.74 for ETN. The safety profile of SB4 was similar to that of ETN and the incidence of anti-drug antibody development up to week 52 was 1.0 and 13.2% in the SB4 and ETN groups, respectively. Conclusion Efficacy including radiographic progression was comparable between SB4 and ETN up to week 52. SB4 was well tolerated and had a similar safety profile to that of ETN. Trial registration number ClinicalTrials.gov NCT01895309, EudraCT 2012-005026-30
تدمد: 1462-0332
1462-0324
DOI: 10.1093/rheumatology/kex269
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e9c97b6023735e54eeea3c700bce0202
https://doi.org/10.1093/rheumatology/kex269
Rights: OPEN
رقم الانضمام: edsair.doi.dedup.....e9c97b6023735e54eeea3c700bce0202
قاعدة البيانات: OpenAIRE
الوصف
تدمد:14620332
14620324
DOI:10.1093/rheumatology/kex269