January 06, 2020
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Biosimilar switching 'feasible' in noninfectious uveitis

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Switching to a biosimilar would be a “feasible treatment choice,” and is associated with maintaining clinical efficacy in patients with noninfectious uveitis who previously received the reference biologic, according to data published in Frontiers in Pharmacology.

“Beyond the significant costs associated with the use of originators, the development of biosimilar products has recently accounted for considerable cost savings and a substantial favorable impact on the health care budget; from this perspective, the number of patients possibly benefiting from an early access to biological treatment could be increased,” Claudia Fabiani, PhD, of the University of Siena, in Italy, and colleagues wrote. “Nevertheless, introducing biosimilar agents to naive patients and switching from the originator to a biosimilar gives rise to different medical liability issues.”

“To date, studies addressing the consequences of the switch from originators to biosimilars have included patients with rheumatoid or psoriatic arthritis, spondyloarthritis and inflammatory bowel diseases,” they added. “Conversely, data related to patients with noninfectious uveitis are limited and the issue about ocular disease control after the switch is currently unexplored.”

To analyze changes in ocular inflammatory symptoms among individuals with noninfectious uveitis who switch from an anti-TNF-alpha originator drug to its biosimilar, Fabiani and colleagues retrospectively enrolled 37 consecutive patients, for a total of 62 involved eyes. The researchers assessed ocular flare frequency before and after switching, best corrected visual acuity (BCVA), central macular thickness (CMT), daily systemic corticosteroid intake and uveitic macular edema (UME) frequency at the switch and at follow-up, compared to the preceding 12 months.

Switching to a biosimilar would be a “feasible treatment choice,” and is associated with maintaining clinical efficacy in patients with noninfectious uveitis who previously received the reference biologic, according to data.

Among the included patients, 20, with a total of 33 involved eyes, were switched to Imraldi (SB5, Samsung Bioepis), a biosimilar to Humira (adalimumab, AbbVie); 10 patients with 16 eyes involved switched to Flixabi (SB2, Samsung Bioepis), a biosimilar to Remicade (infliximab, Janssen); five patients with nine involved eyes switched to Inflectra (infliximab-dyyb, Celltrion), another Remicade biosimilar; and two patients with four involved eyes total switched to Benepali (SB4, Samsung Bioepis), an Enbrel (etanercept, Amgen) biosimilar.

According to the researchers, there were 16 ocular flares during the 12 months preceding biosimilar switching, corresponding to 3.6 flares per 100 patients per 12 months. There were 14 flares after switching, which corresponds to two flares per 100 patients per 12 months.

There were no statistically significant differences in the frequency of flares, nor in the number of patients demonstrating ocular flares, between the 12 months preceding the switch and the study period thereafter. There were similarly no statistically significant changes recorded in the BCVA, CMT, frequency of UME and daily corticosteroid intake between biosimilar switching and last follow-up.

“Our results suggest an optimal maintenance of uveitis control following the switch from originators to biosimilars,” Fabiani and colleagues wrote. “In particular, the rate of uveitic flares observed during the 12 months preceding the switch and the subsequent follow-up period were comparable... with no statistically significant differences.

“The switch to biosimilars represents a feasible treatment choice associated with the maintenance of clinical efficacy in patients with noninfectious uveitis previously treated with the corresponding originator anti-TNF-alpha biologic agents,” they added. – by Jason Laday

Disclosure: The researchers report no relevant financial disclosures.