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You are here: Home / Articles / FDA Approves Rituximab Biosimilar; Plus New Safety Data for Filgotinib in RA Patients

FDA Approves Rituximab Biosimilar; Plus New Safety Data for Filgotinib in RA Patients

January 7, 2019 • By Michele B. Kaufman, PharmD, BCGP

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FDA Approves Rituximab Biosimilar
In late November, the U.S. Food and Drug Administration (FDA) approved Truxima (rituximab-abbs), which is the first treatment biosimilar to Rituxan (rituximab).1 At present, the treatment is approved for use in adults with CD20-positive, B-cell non-Hodgkin’s lymphoma. Truxima can be used as a single agent or in combination with chemotherapy.

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In Europe, Truxima is approved for treating follicular lymphoma, diffuse large B cell non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, severe rheumatoid arthritis (RA) and granulomatosis with polyangiitis and microscopic polyangiitis.2 U.S. approval of Truxima for these other indications may also be on the horizon.

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New Safety Data for Filgotinib in RA Patients
CHICAGO—The Phase 3 study, FINCH-2, examined the use of filgotinib vs. placebo in adults with active RA who had an inadequate response to biologic disease-modifying anti-rheumatic drugs (DMARDs) [NCT02873936].3 Filgotinib is a selective, oral, JAK1 inhibitor. The results of the study were presented at the 2018 ACR/ARHP Annual Meeting.

During the study, patients (N=448) were randomized 1:1:1 to receive either 200 mg of filgotinib (n=147), 100 mg of filgotinib (n=153) or placebo (n=148) once daily for 24 weeks. The primary efficacy endpoint was the proportion of patients who achieved an ACR20 response at Week 12.

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To participate, patients had to be taking stable doses of conventional synthetic DMARDs. The majority of study patients were female (80%), had a mean age of 56 years and had an RA disease duration of 12.4 years. Additionally, 23.4% of all patients had used at least three prior biologic DMARDs.

At Week 12, more patients taking filgotinib achieved ACR20 responses compared with placebo-treated patients (66% for 200 mg filgotinib; 58% for 100 mg filgotinib; 31% for placebo), which was clinically and statistically significant. Additionally, the reduction from baseline in Health Assessment Questionnaire Disability Index was greater for filgotinib-treated patients than placebo-treated patients.

Important secondary endpoints, such as FACIT-Fatigue and SF-36, were also met by filgotinib-treated patients. At Weeks 12 and 24, ACR50, ACR70, DAS28(CRP)≤ 3.2 and clinical remission—defined as DAS28(CRP) of less than 2.6—were also assessed and significantly improved in filgotinib-treated patients compared with placebo-treated patients.

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Adverse and serious adverse events were similar for filgotinib- and placebo-treated patients. Four cases of uncomplicated herpes zoster occurred, two cases in each of the filgotinib-treated groups. No new cases of active tuberculosis or opportunistic infections, gastrointestinal perforation, malignancy or death occurred.

This study showed that filgotinib was a safe and effective treatment for patients with highly active RA and prior intolerance or inadequate response to biologic DMARDs.

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Filed Under: Biologics & Biosimilars, DMARDs & Immunosuppressives, Drug Updates Tagged With: biosimilar, FDA, filgotinib, Rheumatoid Arthritis (RA), rituximab, rituximab-abbs, U.S. Food and Drug Administration (FDA)Issue: February 2019

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