MADRID, SPAIN — Live-attenuated booster vaccines are probably safe in pediatric patients with rheumatic diseases who receive immunosuppressive therapy, strengthening the new Pediatric Rheumatology European Society (PReS) recommendation that the decision to vaccinate pediatric rheumatology patients should be taken on a case-by-case basis, according to research presented at the European Congress of Rheumatology, held June 12-15, 2019, in Madrid, Spain.

This large, retrospective study of data collected from pediatric rheumatology centers was designed to obtain safety data that can be used to update and revise the traditional approach to immunization with rheumatic diseases, which is to withhold vaccination with live-attenuated vaccines in patients taking high-dose disease-modifying antirheumatic drugs (DMARDs), biological agents, or glucocorticosteroids because of the limited safety data available and the risk of introducing infectious diseases to the patient. Evidence for this approach is low, and the current study collected data from 13 pediatric rheumatology centers in 10 countries on patients with juvenile idiopathic arthritis (JIA) and other rheumatic diseases who received the live booster measles, mumps, and rubella (MMR) vaccine or MMR + varicella vaccine while taking DMARDs, biological agents, or glucocorticosteroids.

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Of a total 234 patients (70% girls, mean age 5±2.7 years), 206 had JIA (5% spondyloarthritis types, 8% systemic, 36% polyarticular, and 46% oligoarticular; 5% had JIA and uveitis), and 48% of these patients with JIA were in remission on medication. Disease activity was primarily low at 38%, moderate in 7%, and high in 2%, with 11 patients having juvenile dermatomyositis, 4 with isolated idiopathic uveitis, 3 with systemic and 2 with localized scleroderma, 1 with mevalonate kinase deficiency, 1 with familial Mediterranean fever, and 1 with chronic infantile neurological, cutaneous, and articular syndrome.

Among the 110 patients given the MMR + varicella booster while taking methotrexate, 3 reported mild adverse effects of local skin reactions/pain, and none experienced disease flares. Of the 76 given the booster while taking methotrexate and anti-tumor necrosis factor, 7 reported mild and transient adverse events (local skin reactions, fever, and upper respiratory tract infection). Among the 39 patients given the booster while taking anti-tumor necrosis factor only, one patient reported fever. Three patients received the booster while taking tocilizumab, 5 while taking canakinumab, and 7 taking anakinra. No association was found among disease activity, type, or duration, or age, sex, and vaccination outcomes. No vaccine infections related to rubella, mumps, measles, and varicella were reported.

Study investigators indicated support for the current PReS recommendation: “Vaccination of live-attenuated vaccines in patients on high-dose DMARD, high-dose glucocorticosteroids, or biological agents can be considered on a case-by-case basis, weighing the risk of infections against the hypothetical risk of inducing infection through vaccination.”

They concluded, “These data provide the basis for a large, prospective data collection study that is planned by the PReS vaccination study group. It will increase the current level of evidence for the safety of vaccinations in our pediatric rheumatology population.”

One study author reports connections to AbbVie Inc.; Enzyvant; Novartis Pharmaceuticals Corporation; and Roche.

Reference

Uziel Y, Bergonzo VM, Onozo B, et al. Live attenuated vaccines in pediatric rheumatic diseases are safe: multicenter, retrospective data collection. Presented at: Annual European Congress of Rheumatology; June 12-15, 2019; Madrid, Spain. Abstract OP0205.