1. Long-Term Efficacy and Safety of Biosimilar CT-P10 Versus Innovator Rituximab in Rheumatoid Arthritis: 48-Week Results from a Randomized Phase III Trial
- Author
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Alfredo Berrocal Kasay, Thomas Linde, Piotr Wiland, Elia Chalouhi El-Khouri, Sang Joon Lee, Pavel Shesternya, Francisco Fidenci Cons Molina, Janusz Jaworski, Ihor Hospodarskyy, Paweł Hrycaj, Jose Chavez-Corrales, Mauricio Abello-Banfi, Marek Brzosko, Sergii Shevchuk, Seung Cheol Shim, Dae Hyun Yoo, Armando Calvo, D. Andersone, Sławomir Jeka, Chang-Hee Suh, Sung Young Lee, Francisco G. Medina-Rodriguez, Pedro Miranda, Marek Krogulec, Won Park, and Mariusz Piotrowski
- Subjects
rheumatoid arthritis ,Male ,drug safety ,double blind procedure ,clinical outcome ,Phases of clinical research ,immunogenicity ,law.invention ,Efficacy ,Arthritis, Rheumatoid ,Antibodies, Monoclonal, Murine-Derived ,antibody detection ,rituximab ,0302 clinical medicine ,infusion related reaction ,Randomized controlled trial ,law ,Pharmacology (medical) ,Original Research Article ,skin and connective tissue diseases ,C reactive protein ,adult ,General Medicine ,Middle Aged ,aged ,female ,priority journal ,drug withdrawal ,030220 oncology & carcinogenesis ,Rheumatoid arthritis ,Antirheumatic Agents ,Rituximab ,Female ,mental health ,Biotechnology ,medicine.drug ,Adult ,medicine.medical_specialty ,Adolescent ,Blood Sedimentation ,drug antibody ,malignant neoplasm ,Article ,methotrexate ,Drug Administration Schedule ,03 medical and health sciences ,Young Adult ,rhinitis ,male ,Double-Blind Method ,death ,Internal medicine ,pharmacodynamics ,medicine ,DAS28 ,Humans ,controlled study ,purl.org/pe-repo/ocde/ford#3.01.05 [https] ,human ,Patient Reported Outcome Measures ,Biosimilar Pharmaceuticals ,Aged ,030203 arthritis & rheumatology ,Pharmacology ,long term care ,treatment duration ,phase 3 clinical trial ,business.industry ,medicine.disease ,major clinical study ,Rheumatology ,drug efficacy ,Clinical trial ,multicenter study ,Methotrexate ,upper respiratory tract infection ,Short Form 36 ,Pharmacodynamics ,randomized controlled trial ,lower respiratory tract infection ,urinary tract infection ,business - Abstract
Objective The aim of this study was to investigate long-term clinical outcomes of extended treatment with CT-P10, a rituximab biosimilar, compared with rituximab reference products sourced from the USA and the EU (US-RTX and EU-RTX) in rheumatoid arthritis (RA) for up to 48 weeks. Methods In this multinational, randomized, double-blind trial, adults with active RA received up to two courses of CT-P10, US-RTX, or EU-RTX alongside methotrexate. Efficacy endpoints included Disease Activity Score 28-joint count (DAS28) and American College of Rheumatology (ACR) response rates. Pharmacokinetics, pharmacodynamics, immunogenicity, and safety were also assessed. Results Of 372 patients randomized to the study drug, 330 (88.7%) completed the second treatment course. Mean change from baseline to week 48 in DAS28-C-reactive protein was comparable in the CT-P10 and combined rituximab (US-RTX and EU-RTX) groups (− 2.7 and − 2.6, respectively). ACR20, ACR50, and ACR70 response rates at week 48 indicated no differences between groups (80.6%, 55.4%, and 31.7% vs. 79.8%, 53.9%, and 33.7% in the CT-P10 and combined rituximab groups, respectively). Similar improvements in the Health Assessment Questionnaire Disability Index and all medical outcomes in the Short Form 36-Item Health Survey, including physical and mental health, were seen in all groups. At week 48, antidrug antibodies were detected in 4.9%, 9.4%, and 8.6% of patients in the CT-P10, US-RTX, and EU-RTX groups, respectively. CT-P10 and rituximab displayed similar pharmacokinetic, pharmacodynamic, and safety profiles. Conclusion CT-P10 was similar to EU-RTX and US-RTX in terms of efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, and safety up to week 48. ClinicalTrials.gov identifier NCT02149121. Electronic supplementary material The online version of this article (10.1007/s40259-018-00331-4) contains supplementary material, which is available to authorized users.
- Published
- 2019