Background Abatacept (ABA), the first selective co-stimulation modulator approved and used for the treatment of moderate-to-severe polyarticular juvenile idiopathic arthritis (JIA), has a mechanism of action that is different from other biologic (b)DMARDs.
Objectives To describe the baseline (BL) characteristics and validated safety outcomes of patients (pts) with a diagnosis of JIA in a US healthcare claims database treated with IV ABA and those with a minimum of 12 months (M) of ABA treatment.
Methods Pts aged <18 years (yrs), diagnosed with JIA and in the Truven Health MarketScan® database between 1 Jan 2006 and 30 Sep 2014 were eligible for inclusion. Pts were required to have ≥180 days (d) of continuous health plan enrolment prior to a diagnosis of JIA based on two International Classification of Diseases, Ninth Revision, Clinical Modification codes (714.3x) within 90 d. BL characteristics and prior bDMARD use were analysed for two IV ABA-treated groups: a total cohort and a subgroup of pts with ≥12M of treatment. Three categories evaluated prior bDMARD use claims: biologic holiday (other bDMARD in history but not within 180 d of BL), biologic switcher (other bDMARD within 180 d of BL) and true initiator (no history of other bDMARD). Incidence rates (IR; number of events/person yrs [p-y] of exposure) per 100 p-y of exposure with 95% CI were calcuated for infections, malignancies and uveitis.
Results A total of 238 IV ABA-treated pts were identified with 89 pts having ≥12M of ABA treatment. The mean (SD) follow-up duration was 1.73 (1.28) yrs for the total IV ABA cohort and 2.28 (1.03) yrs for the ≥12-M subgroup. Most pts were female, and mean age was 12.4 yrs. Overall, the total IV ABA cohort was more likely to have a claim in the BL period for asthma and cardiovascular disease versus the ≥12-M subgroup; the ≥12-M subgroup was more likely to have uveitis (Table). The most frequent other bDMARD claim for the total IV ABA-treated pts in the biologic holiday group was etanercept (41.9%), and adalimumab for biologic switchers (34.5%). For the total IV ABA cohort, six hospitalized infection claims were reported with an IR (95% CI) of 2.4/100 p-y (0.9, 5.3) and an IR of 2.8/100 p-y (1.2, 5.9) for new-onset uveitis. There were no validated cases of malignancies in the follow-up period.
Conclusions Compared with an overall JIA population1, abatacept pts are slightly older, more likely to use additional prior biologics, and have a history of asthma or cardiovascular disease. The rates of hospitalized infection and new onset of uveitis in this study are within published ranges2,3 and are consistent with findings in the abatacept JIA registry.4
Simon, TA et al. Paediatric Rheumatology European Society Congress 2016; Poster P344.
Beukelman et al. Arthritis Res Ther 2016;18:210.
Foeldvari I et al. Arthritis Care Res 2016;68:46–54.
Lovell, DJ et al. Arthritis Rheumatol 2016;68(Suppl 10):495–6.
Disclosure of Interest T. Simon Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, S. Singhal Consultant for: Bristol-Myers Squibb, N. Ray Consultant for: Bristol-Myers Squibb, Z. Guo Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb