Background/Purpose: Spontaneous reports of nine facial paralyses and five facial pareses made by healthcare professionals from Europe have recently prompted EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) to consider a potentially increased risk of idiopathic facial nerve palsy for patients receiving tocilizumab. The objective was to assess whether this signal can be confirmed with data of a large data set with known denominators for various treatments, comparing the risk in patients with rheumatoid arthritis (RA) receiving tocilizumab with the risk in patients receiving other DMARDs.

Methods: The German register RABBIT is a prospective longitudinally followed cohort of RA patients with a new start of a DMARD after at least one conventional synthetic (cs)DMARD failure. For this analysis, patients were included who were enrolled with a biologic (b)DMARD start between 01/2007 and 04/2018. DMARD specific, unadjusted incidence ratios were calculated.

Results: Between 2007 and 2018, a total of 20 facial nerve palsies were observed in 11,963 RABBIT patients, of those, three were excluded due to obvious reasons (e.g. stroke) leaving 17 idiopathic facial nerve palsies. Three of them were observed in tocilizumab patients, leading to an incidence rate of 0.47 per 1,000 PY (95% CI: 0.10, 1.14), which is higher than the incidence rate observed in patients receiving conventional synthetic (cs)DMARDs (0.21, 95% CI: 0.04; 0.51) but does not stand out among the incidence rates observed for other biologicals (see figure). The overall incidence of an idiopathic facial nerve palsy among patients receiving (synthetic or biological) DMARDs was 0.37 (95% CI: 0.22, 0.57) which is higher than the incidence of idiopathic facial nerve palsies in the general population (with 20-25 cases per 100,000 [1]). Age and gender were roughly equally distributed among patients with and without idiopathic facial nerve palsies. Patients with idiopathic facial nerve palsies had longer disease duration, more frequently presented with joint erosions and with prior treatment with biologics (see table). They also had more comorbidities. In one patient with idiopathic facial nerve palsy receiving treatment with rituximab (original biologic) a Sjoegrens’ syndrome was reported as comorbidity, which is associated with an increased risk of neuropathies.

Conclusion: The overall incidence of idiopathic facial nerve palsies among RA patients receiving DMARDs was higher than the incidence in the general population. However, an increased risk for patients receiving tocilizumab compared to patients treated with other biologicals cannot be confirmed. The incidence of idiopathic facial nerve palsies is higher for patients receiving biologicals compared to patients receiving csDMARDs. This might be due to the higher disease activity. However, the small number of cases with an idiopathic facial nerve palsy is a limiting factor in analysing and interpreting these results.

References:  [1] Finsterer, J.: Management of peripheral facial nerve palsy. Eur Arch Otorhinolaryngol. 2008 265:743-752.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/no-confirmation-of-increased-risk-of-idiopathic-facial-nerve-palsy-under-tocilizumab/