Session Information
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Reference Adalimumab is not available in our country but biosimilar ZRC 3197 is(1). This is lower priced and as healthcare is primarily self funded in India, it is now a practical option for many children with JIA and uveitis. This is the first study to analyse the use, safety and efficacy of ZRC 3197 in pediatric rheumatology patients.
Methods: Records of 29 children, who have been given ZRC3197 from Dec ‘14 till 15th June ‘16 were analysed to assess i.)Use, safety and efficacy in children with JIA ii.) Use, safety and efficacy in children with Uveitis. A predesigned proforma captured the demographic details, medications, 74 joint count and SUN classification for uveitis.
Results: 29 children (16 males) have received ZRC 3197 to date. Indications: JIA: (n=15) ERA 12, IBD and Psoriatic arthritis 1 each, PJIA 1.Median age at commencing ZRC 3197: 14.66yrs.(10.08-23.66) Uveitis (n=14); idiopathic:4, PJIA:4, OJIA:4,ERA:1,Behcets with uveitis:1.Median age at commencing ZRC 3197:8.66yrs.(5.16-20.16) All patients were on methotrexate/ and/or oral steroids/topical steroid eye drops. Median duration of therapy with ZRC3197:6 mths (0.5-17 mths) Safety: Prebiologic screen: Tuberculosis screening positive in 4: 2 drug anti tubercular therapy(ATT) for latent TB given to 3; 1 treated for TB disease. Post biologic: 1 child had multi dermatomal herpes zoster after 1 dose and drug was discontinued. Efficacy: a.)In 13 children with JIA, (2 patients’s follow up <3 mo) ZRC3197 was effective in all domains noted at 3mo.and 6mo.of use(Table1) as determined by the Wilcoxon Signed Ranks test. Median duration to achieve inactive disease in 12 children was 3 weeks (2-32weeks), 3 were still active at last follow up, none flared till last follow up. Table1: Efficacy of ZRC 3197 in children with JIA
| Pre ZRC 3197 | After 3 mo. | After 6 mo. | |
| n=15 | n=13 | n=9 | |
| Median Swollen joint count(range) (P Value) | 2(0-4) | 0(0-2) (p=0.003) | 0(0-1) (p=0.03) |
| Median Tender joint count(range) P value | 2(0-3) | 0(0-1) (p=0.004) | 0(0-1) (p=0.024) |
| Median Joints with limited range of movement(range) P value | 1(0-3) | 0(0-1) (p=0.004) | 0(0-2) (p=0.05) |
| Median ESR(range) (p value) | 58(6-120) | 8(3-22) (p=0.002) | 10(4-42) (p=0.008) |
| Median CRP(range) P value | 20(3-99) | 3(3-17) (p=0.003) | 3(3-3) (p=0.012) |
| Median Patient/parent global VAS 0-100(range) P value | |
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b.)In children with uveitis, ZRC 3197 was effective(Table 2), median duration to achieve inactivity per SUN in 10 children was 4 weeks(2-24weeks). Table 2: Efficacy of ZRC 3197 in Pediatric Uveitis
| n=14 | n=10 | n=8 | |
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Conclusion: ZRC 3197 is a safe and rapidly effective agent for children with JIA and uveitis resistant to methotrexate. This is the first report of the use of ZRC3197 in children.
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To cite this abstract in AMA style:
Agarwal M, Shivpuri A, Mittal S, Khosla A, Sawhney S. Use, Safety and Efficacy of Zrc 3197, a Biosimilar Candidate for Reference Adalimumab (Humira) from a Tertiary Pediatric Rheumatology Centre in India [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/use-safety-and-efficacy-of-zrc-3197-a-biosimilar-candidate-for-reference-adalimumab-humira-from-a-tertiary-pediatric-rheumatology-centre-in-india/. Accessed .« Back to 2016 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/use-safety-and-efficacy-of-zrc-3197-a-biosimilar-candidate-for-reference-adalimumab-humira-from-a-tertiary-pediatric-rheumatology-centre-in-india/