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  • Incidence of facial nerve palsies stratified by DMARD treatment in patients with rheumatoid arthritis: data from the RABBIT register

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Incidence of facial nerve palsies stratified by DMARD treatment in patients with rheumatoid arthritis: data from the RABBIT register
  1. Yvette Meissner1,
  2. Martin Schäfer1,
  3. Matthias Schneider2,
  4. Elke Wilden3,
  5. Silke Zinke4,
  6. Angela Zink1 and
  7. Anja Strangfeld1
  1. 1 Epidemiology Unit, German Rheumatism Research Centre, Berlin, Germany
  2. 2 Rheumatology, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany
  3. 3 Rheumapraxis, Köln, Germany
  4. 4 Rheuma Praxis Berlin, Berlin, Germany
  1. Correspondence to Yvette Meissner; y.meissner{at}drfz.de

https://doi.org/10.1136/rmdopen-2020-001403

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    Key messages

    What is already known about this subject?

    • A safety signal regarding the occurrence of facial paralysis in patients receiving tocilizumab has been reported to the Pharmacovigilance Committee of the European Medicine Agency.1

    • Facial nerve palsies are rare events, and no information is available on the incidence in patients with rheumatoid arthritis or if DMARD treatment is associated with their occurrence.

    What does this study add?

    • The incidence rate of facial nerve palsies under tocilizumab was comparable to other biological treatments and higher compared to csDMARDs.

    • Patients with facial nerve palsy presented with a more severe course of the rheumatic disease, lower physical function and more comorbidities than patients without facial nerve palsy.

    How might this impact on clinical practice?

    • It is reassuring to physicians and patients that treatment with tocilizumab was not associated with an increased rate of facial nerve palsy compared to patients receiving other bDMARDs.

    INTRODUCTION

    Spontaneous reports of facial paralysis in patients receiving tocilizumab prompted the Pharmacovigilance Risk Assessment Committee of the European Medicine Agency to investigate this safety signal.1 A total of 6 facial pareses and 10 facial paralyses have been registered by healthcare professionals (1 paralyses was reported by a non-healthcare professional) in the EudraVigilance database, the spontaneous pharmacovigilance reporting system across the European Union, until 21 March 2020 (http://www.adrreports.eu).

    Facial nerve palsies (FNPs) are very rare events. About three quarters are of idiopathic origin and one quarter have a detectable cause and may be related to, for example, surgery, infections, stroke or selected malignancies like pons tumour.2 Reported annual incidences of idiopathic FNPs vary widely and range from 11 to 40, 20 to 25 or 12 to 53 events per 100 000 persons depending on the population investigated.2–4 Recently, a UK study based on data of general practices reported an overall incidence of 37.7/100 000 person-years.5 No data are available on the incidence in patients with rheumatoid arthritis (RA) or …

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