The results, presented at the UEG (United European Gasroenterology) Week 2016 in Vienna, Austria, came from the NOR-SWITCH study in adult patients who had been switched to Inflectra treatment for 52 weeks for many conditions.
NOR-SWITCH (NCT02148640) was a randomized, double-blind, Phase 4 clinical trial to evaluate the safety and effectiveness of switching from Remicade to Inflectra in patients with ulcerative colitis, Crohn’s disease, rheumatoid arthritis, spondyloarthritis, psoriatic arthritis, and chronic plaque psoriasis.
All 481 participants had been on Remicade for at least six months before they were switched to the biosimilar.
In April, the U.S. Food and Drug Administration (FDA) approved Inflectra (a biosimilar of infliximab, developed by Celltrion) for all the same indications as Remicade (developed by Janssen). The drug is an FDA-approved biosimilar monoclonal antibody (mAb). It was approved by the European Medicines Agency in 2013 as Remsima. Inflectra is currently approved in more than 75 countries.
“We conducted this study to assess how switching to biosimilar infliximab affects patients who are stable on the originator biologic,” Jørgen Jahnsen, MD, PhD, professor of gastroenterology at the University of Oslo, said in a news release.
“The data shows that safety and efficacy are maintained post-switch and should give confidence to physicians looking to move their patients onto biosimilar infliximab for non-medical reasons such as cost. I am hopeful that switching will lead to financial savings that can in turn enable more patients to receive this life-changing medicine,” Jahnsen said.
The trial primary endpoint in NOR-SWITCH was disease worsening, which was seen in 26.2% of patients who remained on Remicade and in 29.6% of those switched to Inflectra. The results mean that the switch was considered to be a non-inferior.
The occurrence of disease worsening was fairly equal among specific clinical indications. Adverse events, including infusion reactions and development of anti-drug antibodies were also comparable.
Other studies presented at UEG Week added to the growing evidence of Inflectra’s biosimilarity.
A large study in Hungary showed that Inflectra was safe and effective to induce and maintain remission in 291 patients with inflammatory bowel diseases — 184 patients with Crohn’s disease (CD) and 107 ulcerative colitis (UC) patients. After 54 weeks, treatment with Inflectra lead to clinical remission in 47% of patients with CD and 53% of patients with UC.
Another smaller study was conducted in Prague using 119 patients with IBD (90 patients with CD and 29 with UC) who had never received anti-TNF therapy. Following 38 weeks of treatment with Inflectra, complete or partial remissions were observed in 84.1% of CD patients and 65.2% of UC patients. Effectiveness and safety studies determined that Inflectra was comparable to Remicade.
Concerning cost savings, Inflectra compared to Remicade and other anti-TNFs for patients with CD in nine European countries was more cost-effective.
“In all countries, biosimilar infliximab was dominant relative to originator infliximab-standard care strategy [and] the biosimilar infliximab-adalimumab-vedolizumab sequence dominated the originator infliximab-adalimumab-vedolizumab sequence,” the researchers wrote.
Other cost-saving analyses presented at UEG Week revealed that savings from using Inflectra (instead of Remicade) ranged from 1.35 million euros ($1.47 million) in Germany to 5.97 million euros ($6.52 million) in Spain in 2015. France showed no cost-savings.
“The NOR-SWITCH study builds on a wealth of data that support appropriate switching of patients to biosimilar infliximab, with new studies being presented all the time,” said Man Hoon Kim, Celltrion Healthcare’s president and CEO. “We are proud that our biosimilar may enable more people with chronic inflammatory conditions to benefit from infliximab.”
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