Live Attenuated Vaccines in Pediatric Rheumatic Diseases Are Safe: Multicenter, Retrospective Data Collection

Veronica Moshe ¹ Yosef Uziel ¹ Beata Onozo ² Andrea Kulcsar ³ Diána Tróbert-Sipos ⁴ JD Akikusa ⁵ Gecilmara Pileggi ⁶ Despoina Maritsi ⁷ Ozgur Kasapcopur ⁸ Mariana Rodrigues ⁹ Roubini Smerla ¹⁰ D. Rigante ¹¹ Balahan Makay ¹² Erato Atsali ¹³ Nico Wulffraat ¹⁴ Nataša Toplak ¹⁵

¹Pediatric Rheumatology Unit, Pres Working Party of Vaccination Study Group, ישראל
²County Central Hospital of Borsod-Abauj-Zemplen, Consultant of Clinical Immunology and Allergology, הונגריה
³Department of Special Immunization Services, South-Pest Central Hospital National Institute of Hematology and Infectious Diseases, הונגריה
⁴Budapest, Hungary, South-Pest Central Hospital National Institute of Hematology and Infectious Diseases, הונגריה
⁵Honorary Research Fellow, Murdoch Children’s Research Institute The Royal Children's Hospital Melbourne, Paediatric Rheumatologist & Paediatrician, אוסטרליה
⁶Clinical Research Unit, University Hospital Center - School of Medicine Ribeirão Preto - Sao Paulo University, ברזיל
⁷Consultant Paediatric Rheumatologist, Athens Medical School, National and Kapodistrian University of Athens, Greece, יוון
⁸Cerrahpasa Medical School, Istanbul University, תורכיה
⁹Paediatric Rheumatology Unit, São João University Hospital, ברזיל
¹⁰Paediatric Rheumatologist, University of Athens, יוון
¹¹Rome, Italy, Università Cattolica Sacro Cuore, Institute of Pediatrics, איטליה
¹²., Behcet Uz Children's Hospital, תורכיה
¹³., Attikon University Hospital, תורכיה
¹⁴Divisie Kinderen, Immuno, Hoogleraar Kindergeneeskunde, הולנד
¹⁵Medical Centre Ljubljana, Faculty of Medicine, University of Ljubljana, Bohoriceva, Rheumatology and Clinical Immunology, University Children's Hospital, סלובניה

Background For patients with rheumatic diseases who are receiving conventional or biologic disease modifying anti-rheumatic drugs (c-bDMARD), current practice and recommendation are to withhold vaccination with live-attenuated vaccines. This policy is due to lack of safety data and the (theoretical) risk of introducing an infectious disease in these patients. Currently, the evidence for this statement is low.

Objective: To collect retrospective data on patients with JIA and other rheumatic diseases who received live booster MMR/V while on c-bDMARD.

Methods: Data from 13 pediatric rheumatology centers in 10 countries were collected.

Results: 234 patients were reported; mean age 5±2.7 years, 67% girls and 211 had JIA. Among all patients, 47% were in remission. Disease activity was low in 37%, high in 8%, and moderate in 8%. MMR/V booster was given to 124 while on MTX, of whom 3 reported local mild side-effects. Among 71 on MTX + biologics, 9 reported mild, transient local skin reaction, fever or URTI. Among 39 on biologics, 1 reported fever. Disease activity, type, duration, sex, and age were not related to the outcome of the vaccination. No vaccinal infection-MMRV was reported. None of the patients experienced disease flare.

Conclusions: Live-attenuated MMR/V booster vaccine is probably safe for children with rheumatic diseases, on immunosuppressive therapies. This strengthens the 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.”