Erelzi Safe in AS, Eases Disease Activity in Rheumatoid Arthritis, Real-World Data Show

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by Joana Carvalho |

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Treatment with Erelzi (etanercept) is well-tolerated by people with ankylosing spondylitis (AS) and other rheumatic diseases, including rheumatoid arthritis (RA) and progressive psoriatic arthritis, an early analysis of a real-world study suggests.

The findings also indicated that Erelzi reduced disease activity in patients with RA, the only group with available efficacy data.

The research, “Etanercept Biosimilar GP 2015 (Erelzi) in Rheumatic Diseases: Interim Analysis of Real-World Data from COMPACT: A Multicentric, Prospective, Observational Cohort Study,” was presented at the 2019 American College of Rheumatology and Association of Rheumatology Professionals (ACR/ARP) Annual Meeting in Atlanta.

Sandoz’s Erelzi is a biosimilar to Amgen’s Enbrel. Like Enbrel, Erelzi is a TNF-alpha inhibitor that blocks a pro-inflammatory molecule called TNF-alpha.

A biosimilar has similar active properties, as well as comparable safety and efficacy to an original brand medication. Similar to generics, they are predicted to cost less than the reference therapies, depending on country and insurance plan. Companies may start producing biosimilars when the patent of the original brand product expires, after obtaining a license from its manufacturer.

Erelzi has been approved for the same indications for which Enbrel is available. These include AS, RA, psoriatic arthritis, juvenile idiopathic arthritis and plaque psoriasis.

An observational study called COMPACT is currently evaluating Erelzi’s safety and effectiveness in adults with rheumatic diseases.

A total 430 adults — including 256 with RA, 93 with AS, and 81 with psoriatic arthritis — were enrolled in the study through April 2019. The participants were recruited from different clinical centers in Germany, the United Kingdom, Spain, Poland, and Canada.

Among the total group of participants, 37.7% were switched from Enbrel to Erelzi while 7.4% were switched from other anti-TNF inhibitors. Of the remaining individuals, 46.3% had never received a biologic therapy and 8.6% were never given disease-modifying anti-rheumatic drug (DMARDs).

Concurrent medical conditions, called comorbidities, were more common in the group with RA (77.7%) than in people with AS (57%) or psoriatic arthritis (66.7%).

The results showed that treatment with Erelzi was generally safe and well-tolerated at week 12. Approximately a third (33.3%) of study participants experienced at least one adverse event. However, only 2.8% discontinued treatment due to Erelzi-related side effects. No deaths and no new safety concerns were reported during the study.

As for efficacy, assessed only in patients with RA, the therapy reduced disease activity and functional disabilities at week 12 of treatment. Disease activity was evaluated with DAS28 — the Disease Activity Score 28-joint count erythrocyte sedimentation rate — while functional disability was measured with the Health Assessment Questionnaire Disability Index.

“The interim analysis from the COMPACT study adds evidence to a growing body of research that confirms the safety and efficacy of biosimilar etanercept,” Marc Schmalzing, senior physician of the department of rheumatology and clinical immunology at the University of Wurzburg, in Germany, and a study investigator, said in a press release.

“In addition to the existing clinical research on Erelzi, we now can see how this biosimilar is performing in a real-world patient population setting with comorbidities and concomitant medications,” Schmalzing added.

Besides the COMPACT data, Sandoz — a division of Novartis focused on biosimilars and generics — also presented a study on the financial impact of switching patients with rheumatic diseases in the U.S. from a brand medication to a biosimilar of etanercept.

That study, “Long-term Financial Impact of Switching from Reference to Biosimilar Etanercept When Considering Short-term Formulary Management Costs in the US,” revealed that despite initial costs, switching from a reference product to a biosimilar led to substantial long-term savings for U.S. health systems.

These cost savings may be attained by taking advantage of integrated delivery networks (IDNs) while patients are transitioning from one medication to the other, the study showed.

For IDNs dealing with low administrative costs, pharmacy cost savings may reach up to $62.4 million over five years, assuming that up to 1,331 patients per year are receiving etanercept for AS, RA, or juvenile arthritis, the study found.

“This model shows that substantial pharmacy cost savings, about $10,000 per switched patient per year, far outweighed the relatively minor incremental administrative and labor costs associated with implementation of a formulary change,” said Edward Li, the study’s author and associate director of Health Economics and Outcomes Research (HEOR).

The lower costs also may allow greater access by people with ankylosing spondylitis (AS) and other rheumatic diseases, said Florian Bieber, global head of development at Sandoz.

“Interim data from the COMPACT study, along with long-term US cost savings modeling analysis, help build confidence in the value of biosimilars, which may enable more patients to access advanced biologic medicines earlier and offer significant savings for overburdened health system,” Bieber said.