Originator to Biosimilar Infliximab: Uveitis Inflammation Recurrence Rates

Molecular Model of Infliximab, or Remicade, a monoclonal antibody against tumour necrosis factor alpha (TNF-α), which is used to treat autoimmune diseases
Researchers sought to describe the frequency of ocular flares in patients with non-infectious uveitis who switch from originator infliximab to biosimilar infliximab.

Patients with noninfectious uveitis (NIU) who switch from originator infliximab to biosimilar infliximab-abda suffer more ocular flares, with the majority occurring shortly after the switch, particularly within the first 3 months, according to findings published in the American Journal of Ophthalmology.

This retrospective case series was designed to describe the frequency of flares among patients with NIU after they switched from chimeric monoclonal antibody originator infliximab to biosimilar infliximab-abda for nonmedical reasons, such as price or insurance company coverage. Patients needed to have at least 3 months of follow-up data available to have been included in the study. Data collected included demographics, additional immunosuppressive therapy (IMT), infliximab dosing information, number of flares, and time to flare. The primary outcome was flare frequency. Flare was defined as inflammatory activity determined to be new or worsening by clinical exam, leakage on fluorescein angiography (FA), or increased macular edema on optical coherence tomography (OCT) as interpreted by a trained uveitis specialist.

Out of the total number of patients treated at the Cleveland Clinic who had switched to the biosimilar, 32 were excluded for being on infliximab for reasons other than uveitis, 8 for not having follow-up data after the switch, and 9 for having less than 3 months of follow-up. Seventeen patients (average age 43.6 years [SD 17.8], range 14-67) met criteria for inclusion, and most were women (n=13, 76.5%).

No statistical difference was found in the follow-up duration of originator compared with biosimilar infliximab (P =.307). Participants experienced statistically more flares per person-year on infliximab-abda than on originator infliximab (0.916 vs 0.19; P =.037). A repeated measures analysis of variance used to adjust for the covariates of age, sex, additional IMT, and uveitis location determined there was no statistically significant effect. Four of 6 participants (66.6%) flared in 90 days of switching to the biosimilar. Participants who flared on the originator were not more likely to flare on the biosimilar (OR 0.67; 95% CI, 0.14-3.17; P =1.00); indeed, the 1 participant who flared twice on originator infliximab went on to flare once on biosimilar infliximab-abda. The final average normalized dose for participants who flared on the biosimilar infliximab-abda but continued taking it was higher than those who remained inactive on the biosimilar (1.301 mg/kg/week vs 1.186 mg/kg/week), but this difference was not statistically significant (P =.417).

Despite the limitations of the small sample size, the heterogeneity of inflammatory eye disease, and the study’s retrospective design, the investigators concluded “the switch from originator infliximab to the biosimilar infliximab-abda appears to result in more uveitis flares. Providers need to be aware that a majority of these flares occur shortly after switching, especially within the first 90 days, and that increasing the dose of infliximab-abda may lead to future clinical quiescence in a majority of these patients.”

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.


Deaner JD, Srivastava SK, Hajj-Ali RA, et al. Recurrence rates of inflammation after switching from originator infliximab to biosimilar infliximab-abda for non-infectious uveitis. Am J Ophthalmol. [published online, Aug 11, 2020]. doi: 10.1016/j.ajo.2020.08.005.