Razumab both safe and cost-effective for managing retinopathy by prematurity
India: A study published in the Indian Journal of Ophthalmology has concluded that Razumab may be safely used in managing ROP by retina physicians globally. They confirmed it to be safe and cost-effective. They also added that more data will be available to corroborate findings when the use becomes widespread.
In this study entitled, "Efficacy of a biosimilar ranibizumab monotherapy for the treatment of retinopathy of prematurity", researchers have evaluated the efficacy of biosimilar ranibizumab (Razumab) on outcomes of retinopathy of prematurity (ROP) for the first time.
The infants presenting with stage 3+ ROP either in zone 1 or zone 2 posterior or aggressive posterior ROP (APROP) were included in the study and received intravitreal razumab (0.25 mg/0.025 ml) monotherapy.
Follow-up was continued monthly till complete retinal vascularization was achieved, while retreatment with razumab was given when recurrent neovascularization was noted. In case of no recurrence but incomplete vascularization, laser photocoagulation was done to the residual avascular retina.
The study results could be summarised as follows:
- In total, there were 118 eyes of 59 infants.
- The median gestational age and median birth weight were 30 weeks and 1250 grams, respectively.
- Twenty-eight eyes constituting 24 %, had APROP in 14 babies.
- Stage 3 disease was seen in zone 1 in another 28 eyes constituting 24%, and the remaining 62 eyes, constituting 52%, had stage 3 ROP in zone 2 posterior region.
- Twenty-two eyes had complete ROP resolution and complete vascularization at 55 days median.
- Forty-two eyes constituting 35%, had recurrent neovascularization at a median of 51 days post-razumab.
- The cumulative incidence of recurrence of neovascularization (21%) peaked at seven weeks and was significantly higher in eyes with APROP (43%) than in eyes without APROP (13.4%).
They concluded that based on our study's results, the safety and effectiveness of Razumab treating ROP is confirmed, with about a third requiring reinjection at seven weeks following the first dose.
The study's drawbacks are its retrospective nature and lack of a comparison group with the innovator ranibizumab.
The study's advantages are the large sample size and the use of widefield retinal imaging to monitor ROP and make more objective decisions.
Further reading:
Prajapati V, Choudhary T, Chauhan W, Shah S, Handa R, Jahan B, Malviya S, Sengupta S. Efficacy of a biosimilar ranibizumab monotherapy for the treatment of retinopathy of prematurity. Indian J Ophthalmol. 2023 Feb;71(2):411-415. doi: 10.4103/ijo.IJO_973_22
