Rheumatology Practice Changers 2014

Bret S. Stetka, MD; Stephen A. Paget, MD


December 18, 2014

In This Article

Editor's Note: Between biomarkers, the biome, and promising new and cheaper therapies, the past year has brought major advances in the understanding and management of rheumatologic disease. Based primarily on Medscape Medical News coverage and input from our expert advisors, the following are notable important advances in the field of rheumatology from 2014, starting with the continued parade of biosimilars.

Biosimilars Have Arrived

In 2014, biosimlilars continued to have a major impact on rheumatology. Biosimilar drugs are agents that are, as the name suggests, similar to US Food and Drug Administration (FDA)-licensed biological products. As of 2013, rheumatologic biosimilars have been available in many European countries, whereas the first application to the FDA for an approval—for a biosimilar of infliximab—was submitted in August of this year.

There were important presentations about biosimilars at this year's European League Against Rheumatism (EULAR) Annual Scientific Meeting in Paris and also at the annual American College of Rheumatology (ACR) meeting in Boston. A phase 3, double-blind, active-comparator clinical trial[1] looked at a biosimilar of infliximab (BOW015) compared with reference infliximab (Remicade®) and found that the two agents were very similar in terms of performance. The ACR-20 scores at week 16—the study's primary endpoint—were 89.9% and 86.4% in the biosimilar and reference compound group, respectively, well within the necessary equivalence margin of 23%.

Another study,[2] presented at both the EULAR and ACR meetings, was a randomized, double-blind, phase 3 equivalence trial that compared a biosimilar etanercept, HD203, with the reference etanercept Enbrel®, in combination with methotrexate in patients with rheumatoid arthritis (RA). The proportion of patients reaching the primary endpoint—ACR20 scores at week 24—did not significantly differ between the two groups, nor did the safety profiles. Hence, the results demonstrate the equivalence between the two medications.

Two additional biosimilar studies were presented at the EULAR meeting as posters. The first[3] found that the infliximab biosimilar CTP-13 results in similar structural progression as the originator compound in patients with RA, whereas the other[4] reported similar pharmacokinetic and safety profiles between a potential rituximab biosimilar and rituximab.

In all, there are seven biosimilars of adalimumab, of which five are in phase 3 trials; four of etanercept, all in phase 3 studies; four of infliximab, again all in phase 3; and three of rituximab, with two in phase 3. Both Celltrion and Hospira have a biosimilar infliximab in Europe, and they have just filed a new drug application with the FDA, with a possible April advisory meeting. It's clear that in rheumatology, biosimilars are here to stay.


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