OcrV1, Main, Exploration, bibRecord, 000298

Safety and Efficacy of Various Dosages of Ocrelizumab in Japanese Patients with Rheumatoid Arthritis with an Inadequate Response to Methotrexate Therapy: A Placebo-controlled Double-blind Parallel-group Study

Identifieur interne : 000298 ( Main/Exploration ); précédent : 000297; suivant : 000299

Safety and Efficacy of Various Dosages of Ocrelizumab in Japanese Patients with Rheumatoid Arthritis with an Inadequate Response to Methotrexate Therapy: A Placebo-controlled Double-blind Parallel-group Study

Auteurs : Masayoshi Harigai [Japon] ; Yoshiya Tanaka ; Shingo Maisawa

Source :

Journal of rheumatology [ 0315-162X ] ; 2012.

RBID : Pascal:12-0160677

Descripteurs français

Pascal (Inist)
- Polyarthrite rhumatoïde, Ocrélizumab, Toxicité, Homme, Méthotrexate, Traitement, Etude double insu, Cellule β, Lymphocyte B, Essai clinique, Rhumatologie, Immunomodulateur, Antirhumatismal, Chronique, Anticancéreux.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Antineoplastic agent, Antirheumatic agent, B-Lymphocyte, Chronic, Clinical trial, Double blind study, Human, Immunomodulator, Methotrexate, Ocrelizumab, Rheumatoid arthritis, Rheumatology, Toxicity, Treatment, β Cell.

Abstract

Objective. To evaluate the safety and efficacy of ocrelizumab (OCR) in Japanese patients with rheumatoid arthritis (RA) with an inadequate response to methotrexate (MTX). Methods. RA patients with an inadequate response to MTX 6-8 mg/week received an infusion of 50, 200, or 500 mg OCR or placebo on Days 1 and 15 and were observed for 24 weeks. The double-blind period was prematurely terminated because of a possible risk for serious infection from OCR. Results. A total of 152 patients were randomized into the study. The incidence of infection was 37.7% (43/114) in the OCR groups combined, compared to 18.9% (7/37) in the placebo group. Serious infections occurred in 7 patients in the OCR groups combined; there were no serious infections in the placebo group. Among the serious infections, Pneumocystis jirovecia pneumonia occurred in 2 patients in the OCR 200 mg group. The American College of Rheumatology 20% response rates at Week 24 (the primary endpoi nt) of the OCR 50, 200, and 500 mg groups were 54.1 % (p = 0.0080), 55.6% (p = 0.0056), and 47.2% (p = 0.044), respectively, all significantly higher than that of the placebo group (25.0%). Conclusion. These results suggest inappropriate benefit-risk balance of OCR in this patient population. Because rituximab is not approved for treatment of RA in Japan, it will be necessary to investigate safety and efficacy of other anti-B cell therapies in Japanese patients with RA.

Affiliations:

Japon
Tokyo

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to stream PascalFrancis, to step Checkpoint: 000060
to stream Main, to step Merge: 000301
to stream Main, to step Curation: 000298

Le document en format XML

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<term>Immunomodulator</term>
<term>Methotrexate</term>
<term>Ocrelizumab</term>
<term>Rheumatoid arthritis</term>
<term>Rheumatology</term>
<term>Toxicity</term>
<term>Treatment</term>
<term>β Cell</term>
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<front><div type="abstract" xml:lang="en">Objective. To evaluate the safety and efficacy of ocrelizumab (OCR) in Japanese patients with rheumatoid arthritis (RA) with an inadequate response to methotrexate (MTX). Methods. RA patients with an inadequate response to MTX 6-8 mg/week received an infusion of 50, 200, or 500 mg OCR or placebo on Days 1 and 15 and were observed for 24 weeks. The double-blind period was prematurely terminated because of a possible risk for serious infection from OCR. Results. A total of 152 patients were randomized into the study. The incidence of infection was 37.7% (43/114) in the OCR groups combined, compared to 18.9% (7/37) in the placebo group. Serious infections occurred in 7 patients in the OCR groups combined; there were no serious infections in the placebo group. Among the serious infections, Pneumocystis jirovecia pneumonia occurred in 2 patients in the OCR 200 mg group. The American College of Rheumatology 20% response rates at Week 24 (the primary endpoi nt) of the OCR 50, 200, and 500 mg groups were 54.1 % (p = 0.0080), 55.6% (p = 0.0056), and 47.2% (p = 0.044), respectively, all significantly higher than that of the placebo group (25.0%). Conclusion. These results suggest inappropriate benefit-risk balance of OCR in this patient population. Because rituximab is not approved for treatment of RA in Japan, it will be necessary to investigate safety and efficacy of other anti-B cell therapies in Japanese patients with RA.</div>
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Safety and Efficacy of Various Dosages of Ocrelizumab in Japanese Patients with Rheumatoid Arthritis with an Inadequate Response to Methotrexate Therapy: A Placebo-controlled Double-blind Parallel-group Study

Safety and Efficacy of Various Dosages of Ocrelizumab in Japanese Patients with Rheumatoid Arthritis with an Inadequate Response to Methotrexate Therapy: A Placebo-controlled Double-blind Parallel-group Study

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri