Biosimilar Performs as Well as Adalimumab

VBCR - December 2015, Volume 4, No 6 - Rheumatoid Arthritis
Phoebe Starr

San Francisco, CA—Although no biosimilar copy of a biologic therapy specific to rheumatoid arthritis (RA) has been approved by the US Food and Drug Administration, studies continue to be encouraging. A biosimilar version of adalimumab (ABP 501) was as safe and effective as the original product in patients with moderate to severe RA, with similar immunogenicity in a phase 3 study presented at the annual meeting of the American College of Rheumatology (ACR).1

ABT 501 met the primary end point of clinical equivalency compared with adalimumab: ACR20 (20% symptom reduction according to ACR criteria) at week 24 was 74.6% in the ABP 501 arm versus 72.4% in the adalimumab group.

Lead author Stanley Cohen, MD, Metroplex Clinical Research Center, Dallas, TX, said: “Results of this study combined with previous results of analytical and functional evaluation confirm that ABP 501 is similar to adalimumab.”

Even though biologics are theoretically attractive, the rheumatology community is not completely on board (see comment from ACR below).

The phase 3 study enrolled 526 patients with moderate to severe RA with an inadequate response to methotrexate. Patients were randomized to receive adalimumab 40 mg subcutaneously (SC) or ABP 501 40 mg SC every 2 weeks until week 22. Safety was assessed up to week 26.

Patients eligible for the study had to have active RA for at least 3 months, be positive for rheumatoid factor or anti–cyclic citrullinated peptide at baseline, and on a stable dose of methotrexate for at least 8 weeks. No previous exposure to adalimumab was allowed, and neither were 2 or more prior biologic therapies for RA.

About 25% had previously been treated with a biologic. Mean swollen joint count was 14, mean tender joint count was 24, and mean disease activity score with C-reactive protein was 5.7.

The study treatment was completed by 92% in the ABP 501 arm and 95.8% in the adalimumab arm.

In addition to similar ACR20 responses at week 24 in both groups, equivalence between the 2 products was also demonstrated in ACR50 and ACR70 (ie, at least a 50% reduction in symptoms and a 70% reduction, respectively, according to ACR criteria) at week 24. ACR50 response rates were 49.2% for both groups; ACR70 was achieved in 26% of the ABP 501 group versus 22.9% of the adalim­umab group.

Adverse events were reported in 50% of the ABP 501 group and 54.6% of the adalimumab group. The rates of grade 3 and higher adverse events (ie, serious adverse events) were 3.8% and 5%, respectively.

Injection site reactions were reported in 2.3% of the ABP 501 patients and 5% of the adalimumab group. Immunogenicity was equivalent as well, with antidrug antibodies evident in 38.3% and 38.2% of patients in the 2 groups, respectively. Neutralizing antibodies were reported in 9.1% and 11.1% of the 2 groups, respectively.

Although more biologics are making inroads in RA, rheumatologists remain concerned about their possible high cost as well as their safety and efficacy.

In a press statement in March 2015, ACR President E. William St. Clair, MD, said “We agree that less expensive biologic therapies are needed and recognize that biosimilars provide an opportunity to reduce treatment costs; however close monitoring of possible differences in the safety and efficacy of biosimilars is needed as they enter the market. It is uncertain whether patients will respond to these drugs the same way they would to an original biologic, because biologics are very sensitive to manufacturing changes. Even minor differences in a biosimilar’s molecular structure, purity or other chemical properties could change the way a patient responds to the drug.”2

The study was sponsored by Amgen.

References

  1. Cohen SB, Genovese MC, Choy EH, et al. Randomized, double-blind, phase 3 study of efficacy and safety of ABP 501 compared with adalimumab in subjects with moderate to severe rheumatoid arthritis. Presented at: 2015 American College of Rheumatology Annual Meeting; November 7-11, 2015; San Francisco, CA. Abstract 2054.
  2. American College of Rheumatology. ACR releases new position statement on biosimilars: encourages strict oversight, scientific study & physician involvement [press release]. March 12, 2015. www.rheumatology.org/About-Us/Newsroom/Press-Release/ID/33/ACR-Releases-New-Position-Statement-on-Biosimilars-Encourages-Strict-Oversight-Scientific-Study-Physician-Involvement. Accessed November 21, 2015.
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