Adalimumab biosimilar SB5 may be an effective treatment for noninfective uveitis, reducing both uveitis relapse and retinal vasculitis, according to research results published in the Asia-Pacific Journal of Ophthalmology.
Through a retrospective, nonrandomized study, researchers evaluated the efficacy of adalimumab biosimilar SB5 (Imraldi®, Biogen) in the treatment of patients with noninfectious uveitis. Medical records were reviewed from 2018 to 2020, and patients who were pregnant or who had a New York Heart Association functional class III and IV were excluded.
The primary study endpoint was SB5 efficacy in terms of uveitic relapse. Secondary endpoints included resolution of retinal vasculitis, impact of SB5 on visual acuity, influence on daily intake of glucocorticoids, overall cohort survival, and ocular complications and safety profile.
The total study cohort included 47 eyes from 26 patients (15 women) treated with SB5. Median treatment duration was 16.50 months (range, 14 months). In 5 and 21 cases, uveitis was unilateral and bilateral, respectively. Twelve eyes had anterior uveitis, 10 had posterior uveitis, and 25 had panuveitis.
Twenty-two patients began biologic treatment due to active uveitis; 4 were treated with SB5 as a result of uncontrolled systemic disease. Three patients in the cohort were not treated with a standard 40 mg every other week regimen.
Total uveitis relapses decreased from 121 relapses per 100 patients per year in the 12 months prior to SB5 therapy to 4 relapses per 100 patients per year in the first 12 months of treatment. An additional decrease from 115 relapses per 100 patients per year to 3 relapses per 100 patients per year was noted at the last follow-up. At this time, uveitis was inactive in 46 of 47 eyes.
Eyes affected by active retinal vasculitis decreased significantly during the study period, with results of post-hoc analyses demonstrating a significant decrease from baseline to 3 and 12 months. At the conclusion of the study period, 1 patient had no resolution of retinal vasculitis. At baseline, 6 eyes presented with uveitic macular edema; no eyes had uveitic macular edema at the final follow-up.
Mean best-corrected visual acuity (BCVA) increased from 7.7±3.41 at baseline to 8.9±2.46 at the last follow-up. Mean daily glucocorticoid daily dose decreased, from 18.33±10.33 mg to 5.75±2.29 mg at baseline and the final follow-up visit. Per investigators, this difference was statistically significant.
At the conclusion of the study, 2 participants had discontinued treatment with SB5: 1 due to prostatic carcinoma diagnosed after 6 months and 1 due to loss of efficacy.
Study limitations include those inherent to retrospective research, the relatively small sample size, and the lack of control group.
“[The] SB5 biosimilar is effective for the treatment of [noninfectious uveitis], either idiopathic or associated with systemic inflammatory diseases,” according to the researchers. “SB5 shows an excellent drug retention rate with a significant [glucocorticoid]-sparing effect. In this context, SB5 biosimilar may be a reliable additional weapon in the growing therapeutic armamentarium available for [noninfectious uveitis].”
Sota J, Gentileschi S, Vitale A, et al. Effectiveness of SB5, an adalimumab biosimilar, in patients with noninfectious uveitis: A real-life monocentric experience. Asia Pac J Ophthalmol. 2021;10(4):360-365. doi:10.1097/APO.000000000000380