Biosimilars Update: FDA Panel Voted to Approve Biosimilars for Etanercept & Adalimumab at July Meeting

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July 15, 2016 • By

The Rheumatologist

During the July meeting of the U.S. Food and Drug Administration’s Arthritis Advisory Committee in Silver Spring, Md., the FDA voted to approve two new biosimilars for use by rheumatologists

Etanercept Biosimilar

GP2015, a proposed biosimilar of etanercept(Enbrel), was evaluated at the FDA‘s Arthritis Advisory Committee meeting.1 The panel voted unanimously to recommend approval of GP2015.

The treatment’s proposed indications were:

  1. Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage and improving physical function in patients with moderate to severe active rheumatoid arthritis (RA) in combination with methotrexate (MTX) or as monotherapy;
  2. Reducing signs and symptoms of moderate to severe active polyarticular juvenile idiopathic arthritis in patients aged two years and older;
  3. Reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis in combination with MTX in patients who do not respond adequately to MTX alone;
  4. Reducing signs and symptoms in patients with active ankylosing spondylitis; and
  5. Treating patients 18 years of age or older with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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Etanercept-Methotrexate Combination Therapy Initiators Have Greater Adherence and Persistence Than Triple Therapy Initiators With Rheumatoid Arthritis

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Arthritis Care & Research
Volume 67, Issue 12, pages 1656–1663, December 2015

Machaon Bonafede et al.

Objective
To estimate adherence and persistence with etanercept plus methotrexate (ETN-MTX) combination therapy and MTX, hydroxychloroquine, and sulfasalazine triple therapy at 1 year following treatment initiation in adults with rheumatoid arthritis (RA).

Methods
This retrospective analysis used data from the Truven Health MarketScan Commercial and Medicare Supplemental databases from January 2009 to July 2013. Adherence was defined as having percentage of days covered >80% for all drugs within each regimen. Persistence was defined as no treatment gap >45 days for any drug and no addition or switching to other disease-modifying antirheumatic drugs. Multiple logistic regression models were employed in the analyses to control for potential confounders.

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Biosimilar Drugs for RA Studied in Multiple Trials

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The Rheumatologist

August 17, 2015 • By

Etanercept Biosimilars

A number of Phase 3 trials are ongoing for etanercept biosimilars.1One evaluation identified three trials in rheumatoid arthritis (RA) patients and one in psoriasis patients. The psoriatic arthritis trial evaluated PASI as a primary endpoint and the following secondary endpoints: PASI50, PASI75, PASI90, PASI score, laboratory values, ECG, adverse events (AEs), injection site reactions and immunogenicity. The RA trials are evaluating ACR20 as the primary endpoint. Secondary endpoints include ACR50, ACR70, DAS28, AEs, serious AEs, safety and immunogenicity.

Epratuzumab Results Disappointing, but Adalimumab Promising

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The Rheumatologist

August 19, 2015 • By

Epratuzumab is a monoclonal antibody targeting CD22, which modulates B cells. Epratuzumab is thought to bind to CD22, resulting in diminishedsystemic lupus erythematosus (SLE)–related hyperactivity of B cells without depleting them.

In each study, patients (n = 786 for EMBODY 1; n = 788 for EMBODY 2) received placebo or treatment with 2,400 mg epratuzumab over four, 12-week treatment cycles administered as 600 mg every week for four weeks or 1,200 mg every two weeks for four weeks. Patients were all receiving corticosteroids at the beginning of the studies, along with either epratuzumab or placebo. Immunosuppressant and antimalarial drugs were given per their standard therapy regimen.

Adalimumab Effective in Juvenile ERA
In other drug news, adalimumab was recently studied in a Phase 3, multicenter, randomized, double-blind trial in patients age 6 years to younger than 18 years withenthesitis-related arthritis (ERA) for 12 weeks (n = 46).2 Patients received 24 mg/m2 adalimumab (maximum dose of 40 mg every other week) or placebo, followed by adalimumab for up to 192 weeks in an open-label design. If a predefined worsening occurred, early escape to the open-label adalimumab treatment period was available at Week 4. Adverse events were evaluated throughout the study. The primary endpoint was the percentage change from baseline at Week 12 in the number of active joints with arthritis (AJC). At baseline, the mean patient age was 12.9 years, with a mean duration of ERA symptoms being 2.6 years. The mean AJC was 7.8 and the mean enthesitis count was 8.1.

At Week 12, there was a 63% reduction in the number of joints with active disease in the adalimumab-treated patients compared with placebo-treated patients (12% reduction). By Week 52, there was an 89% reduction from baseline in the number of joints with active disease. (All patients had been receiving adalimumab after Week 12.) By Week 52, 35% of patients had stopped taking non-steroidal antiinflammatory drugs, 15% had stopped taking corticosteroids, and 11% were no longer taking other disease modifying antirheumatic drugs (e.g., sulfasalazine or methotrexate).

The most common adverse effects were upper respiratory infections, injection site pain, gastroenteritis, ALT elevations, abdominal pain nausea and syncope. Serious adverse events included worsening of ERA and appendicitis.

Michele B. Kaufman, PharmD, CGP, RPh, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

  1. UCB. News release: UCB announces Phase 3 clinical trial program for epratuzumab in systemic lupus erythematosus did not meet primary endpoint. 2015 July 28.
  2. Burgos-Varga R, Tse SML, Horneff G, et al. Adalimumab in pediatric enthesitis-related arthritis A randomized, double-blind, placebo-controlled, multicenter study of adalimumab in pediatric patients with enthesitis-related arthritis.Arthritis Care Res (Hoboken). 2015 Jul 20. doi: 10.1002/acr.22657. [Epub ahead of print]