Switch From Remicade to Newer Biosimilar Safe, Study Finds

People with severe and difficult-to-treat sarcoidosis can safely switch from Remicade (infliximab) or its biosimilar Inflectra, to another biosimilar called Flixabi and maintain similar clinical benefits, a study reports.

Six months after switching, none of these patients had stopped using Flixabi or showed a worsening in lung function, but better physical abilities and disease activity scores, results showed.

The study, “Switching to an Infliximab Biosimilar Was Safe and Effective in Dutch Sarcoidosis Patients,” was published in the journal Cells.

Although corticosteroids are the first-line treatment for sarcoidosis, TNF-alpha inhibitors may be recommended for patients who are unresponsive or intolerant (refractory) to steroid treatments. Remicade is among the most common of these immune dampening treatments used off-label for sarcoidosis, and shown to safely and effectively improve lung function in refractory patients.

Several Remicade biosimilars are available, including Pfizer’s Inflectra and Samsung Bioepis’ Flixabi (sold as Renflexis in the U.S.). Biosimilars are medical products with similar properties — as well as comparable safety and effectiveness — to an original biological therapy, available at lower prices.

The Dutch Association of Pulmonologists favors patients using Remicade switch to more affordable biosimilars. A number of studies have shown this change to be safe, but most involved patients with autoimmune diseases that Remicade is specifically approved to treat, like rheumatoid arthritis and inflammatory bowel disease.

Researchers in the Netherlands investigated the safety and effectiveness of switching from off-label Remicade or Inflecta to Flixabi in people with severe refractory sarcoidosis.

Using retrospective patient hospital data, the team assessed discontinuation rates, adverse events, and changes in physical status, lung function, and inflammation within six months of changing treatments.

A total of 79 patients were included in the analysis, using either Remicade or Inflectra for an average of 4.4 years prior to switching treatments. They were on average 51.8 years old, 42% were female, and all had been diagnosed a mean of 9.8 years earlier.

Most patients (98.7%) were using infliximab at a dose of 5 mg/kg, with one patient on a 7.5 mg/kg dose. Doses remained the same for all patients after the switch, and most (76%) also kept their treatment intervals — 18 patients prolonged treatment intervals by one or two weeks, and one person shortened it by one week.

Within six months of switching, no treatment discontinuations were evident, a primary goal of this study. Five (6.3%) patients reported adverse effects after switching, including general malaise in two patients and joint pain or muscle strains in three. Three of these patients had also reported side effects on a prior infliximab treatment.

Two patients switched back to Remicade, and reported gains in quality of life. Data showed no significant changes in infliximab levels in the blood with the return switch, the study reported.

Regarding clinical outcomes, no differences were observed in patients’ lung function within six months after switching. But physical abilities, as assessed by the 36-Item Short Form Health Survey, significantly improved by seven points (on a scale of 100), while levels of inflammatory biomarker soluble interleukin-2 receptor were significantly lower. 

“We found that switching was safe and resulted in an overall persisting clinical benefit as reflected by physical functioning, lung function parameters, and inflammatory disease activity before and after the switch,” the investigators wrote.

Flixabi was approved in the European Union in 2016; Renflexis was approved in the U.S. in 2017.