Background/Purpose: The use of biologic response modifiers(BRMs) is associated with an increased risk of infections.
We also use biosimilars for two reasons:1. originator not available, like Adalimumab, or 2. prohibitive cost of originator molecule.
This study was undertaken to
- Study the usage of BRMs at our centre
- Study the adverse events in biologics and biosimilars over a longitudinal follow up
Methods: All patients who received a BRM from 1st January 2006 to 31st December 2019 were included. The pre BRM screening, diagnosis along with adverse events, were retrospectively collected
Results: Demographics: Total 340 children received 417 BRMs. M:f:213:127
Median age at commencing first cycle of a BRM: 11.66 yrs(IQR 7.54-15.29)
Median duration of follow up:40months(IQR22-64)
Diagnosis: JIA(ERA:163,SJIA:65,PJIA:43,OJIA:23,UJIA:6,Psoriatic arthritis:1,Extended OJIA:2,) Uveitis:5,CTDs(SLE:23,Overlap syndrome:1)Vasculitis(Kawasaki disease:2, Takayasu’s aortoarteritis:3,Behcet’s disease:1)Others(IBD associated arthritis:1,MAGIC syndrome:1)
Screening protocol: Chest X ray, USG abdomen, Mantoux test, HIV and HbsAg were done for all.
Table 1: Screening prior to biologics
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Symptomatic tuberculosis disease 4 children( Post Infliximab-1, post Adalimumab-3) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
50 adverse events were seen during long term follow as detailed in table 2
|
Conclusion:
- BRMs(both biologic and biosimilars) can be safely used for prolonged periods of time even in regions where there is a high background incidence of infections
- 54 adverse events occurred on exposure to a BRM in 417 episodes.99% recovered without sequelae.3/217 patients died(0.72% mortality)
- Annual screen for TB should be done to detect asymptomatic Mantoux conversion to prevent dissemination of disease Asymptomatic Mantoux converters(n=16, 9.2% of tested patients)were picked up with this protocol.
The post Long Term Safety of Biologics and Biosimilars in Pediatric Rheumatic Diseases: An Experience from a Single North Indian Centre appeared first on ACR Meeting Abstracts.