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- Title
Maintenance of antibody response to diphtheria/tetanus vaccine in patients aged 2–5 years with polyarticular-course juvenile idiopathic arthritis receiving subcutaneous abatacept.
- Authors
Brunner, Hermine I.; Tzaribachev, Nikolay; Cornejo, Gabriel Vega; Joos, Rik; Gervais, Elisabeth; Cimaz, Rolando; Calvo Penadés, Inmaculada; Cuttica, Rubén; Lutz, Thomas; Quartier, Pierre; Gandhi, Yash; Nys, Marleen; Wong, Robert; Martini, Alberto; Lovell, Daniel J.; Ruperto, Nicolino; for the Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation; Anton, Jordi; Espada, Graciela; Lauwerys, Bernard
- Abstract
Background: Patients with polyarticular-course juvenile idiopathic arthritis (pJIA), receiving disease-modifying anti-rheumatic drugs with immunosuppressive effects, may be at increased risk of vaccine-preventable infections. This substudy assessed protective antibody responses to diphtheria and tetanus vaccination given prior to study enrolment in patients with pJIA. Findings: This was a substudy of a 24-month, single-arm, open-label, multicenter, Phase III trial (NCT01844518) of subcutaneous abatacept in children with active pJIA (N = 219). Patients aged 2–5 years, with ≥2 continuous months of weekly weight-tiered (10–< 25 kg [50 mg], 25–< 50 kg [87.5 mg]) subcutaneous abatacept treatment (with/without methotrexate and/or low-dose corticosteroids), who received diphtheria/tetanus vaccine prior to enrolment, were eligible. Protective antibody levels to diphtheria/tetanus (> 0.1 IU/mL), and safety, were assessed. Overall, 29 patients were analyzed: 19 (65.5%), 1 (3.4%) and 9 (31.0%) patients had > 12, 6–12 and 2–< 6 months of abatacept exposure, respectively. All patients had protective antibody levels to tetanus and 26 (89.7%) patients had protective antibody levels to diphtheria. Of the 3 patients without protective antibody levels to diphtheria, each had an antibody level of 0.1 IU/mL, bordering the lower threshold of protection. Concomitant use of methotrexate and/or low-dose corticosteroids had no evident effect on antibody levels. No unexpected adverse events, including cases of diphtheria or tetanus, were reported during the 24-month period. Conclusions: Patients aged 2–5 years with pJIA who received 2–24 months of weekly subcutaneous abatacept, with or without concomitant methotrexate and/or low-dose corticosteroids, maintained effective diphtheria and tetanus vaccination protection without new safety signals. Trial registration: ClinicalTrials.gov (NCT01844518); registered May 1, 2013; https://clinicaltrials.gov/ct2/show/NCT01844518?term=NCT01844518&rank=1
- Subjects
JUVENILE idiopathic arthritis; ANTIBODY formation; DIPHTHERIA; TETANUS; MACROPHAGE activation syndrome; DIPHTHERIA vaccines
- Publication
Pediatric Rheumatology, 2020, Vol 18, Issue 1, p1
- ISSN
1546-0096
- Publication type
Article
- DOI
10.1186/s12969-020-0410-x