Biosimilar Gastroenterology Roundup: February

February 2018 saw a number of developments for biosimilars that treat inflammatory bowel disease (IBD), with new studies from around the globe adding to the body of data on these therapies.

New NOR-SWITCH Data Focuses on IBD Subgroup

At the European Crohn's and Colitis Organisation (ECCO)'s 13th annual congress in Vienna, Austria, researchers presented new data on the IBD subgroup (comprising patients with Crohn disease [CD] and ulcerative colitis [UC]) of the NOR-SWITCH trial. Participants (n = 380) who completed the original 52-week noninferiority trial entered a 26-week, open-label extension trial that assessed the safety of uninterrupted treatment with biosimilar infliximab (CT-P13, sold in the United States as Inflectra and in the European Union as Remsima) through week 78 compared with switching from the reference product to the biosimilar at week 52.

The primary endpoint of the extension was overall disease worsening during follow-up; the investigators found no difference between patients who remained on CT-P13 versus those who switched from the reference product to the biosimilar, and that the exploratory subgroup analyses of patients with CD and UC showed similarity between the groups in terms of efficacy, safety, and immunogenicity.

Patients Remain Wary of Switching

Other data presented at ECCO suggest that communicating with patients about a potential switch to a biosimilar of a reference product is important to a successful nonmedical switch; even in cases in which patients have experienced a switch to a biosimilar as an uncomplicated transition of treatment, patients say that they remain concerned about their therapy being switched again, especially according to a pharmacist’s decision rather than a prescriber’s.

Biosimilar Adalimumab Increased Access, but With Limited Efficacy

Real-world data on India’s first available biosimilar adalimumab, Exemptia, in 29 patients with UC show that the biosimilar has increased access to treatment, but it had limited efficacy when used for induction of remission in patients with UC that was refractory to treatment with steroids. Furthermore, 4 patients in the study developed tuberculosis-related adverse events, suggesting that the biosimilar should be prescribed with caution in populations who may have high rates of latent tuberculosis.

Biosimilar Infliximab Could Help Control Cachexia

Investigators presented data at ECCO that suggest that CT-P13 could benefit pediatric and adolescent patients with CD who have cachexia, which manifests as malabsorption, nutritional deficiencies, osteopenia, sarcopenia, and growth failure. In an animal model, CT-P13 significantly improved cachexia, lowered mortality, tempered weight loss, and preserved appetite (as did reference adalimumab). These findings suggest that drugs targeting tumor necrosis factor should be considered for the treatment of young patients with CD who have wasting conditions.

Anti-Drug Antibodies May Help Guide Decision-Making in Loss of Response

Antibodies toward infliximab are associated with lower infliximab trough concentrations and loss of response, and while treatment intensification can be effective for some patients with CD, a recent study of 103 patients showed that 37% did not response to intensification, and patients with higher anti-drug antibody levels were less likely to achieve therapeutic drug levels. According to S. Ben-Horin, MD, these data suggest the need to identify patients who will respond to dose optimization before undertaking costly and potentially harmful intervention in those who are unlikely to respond to treatment.

Immunomodulators Help Prevent Loss of Response

Loss of response may be preventable, according to 12-month data from the PANTS study, which investigated primary nonresponse, loss of response, and adverse drug reactions to infliximab among 1601 patients with CD. The study’s researchers found that the rate of primary nonresponse among patients receiving CT-P13, reference infliximab, and reference adalimumab was similar, and was associated with older age, higher body mass index, and low drug levels. Immunogenicity was associated with nonremission for all treatment groups, but the use of immunomodulators together with the biologic therapies reduced the risk of immunogenicity.