Evidence of association between tocilizumab and cutaneous vasculitis
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Evidence of association between tocilizumab and cutaneous vasculitis There is good evidence that tocilizumab is associated with cutaneous vasculitis, according to a review, presented in the recent WHO Pharmaceuticals Newsletter, of 16 such cases. The 16 reports of cutaneous vasculitis in association with tocilizumab were submitted to VigiBase between June 2012 and April 2019. In most cases, tocilizumab was given for the treatment of rheumatoid arthritis (RA). Tocilizumab was mostly administered IV, in most cases at a dose of 8 mg/kg. The dose was not reported in six cases. The median duration of therapy was 161 days. However, the time to onset of the reaction was only reported in 6 cases, indicating a median of 60 days, but the range was from 2 to 540 days. Interestingly, the number of men affected was substantially higher than the number of women affected (11 vs 5), even though RA is much more prevalent among women. Of the 16 cases, 13 were labelled as serious, with prolonged hospitalisation in 4 cases. There was only one report where the patient was rechallenged with tocilizumab, and the vasculitis recurred, providing strong evidence of causality. Six patients responded positively to dechallenge, adding further strength to the case for an association. In several cases, concomitant medications were taken that were suspected as contributing to the vasculitis, including methotrexate, rituximab and certolizumab. Based on the review of the 16 cases, there is good evidence that tocilizumab is associated with cutaneous vasculitis. Risk factors for the association are possibly male sex, duration of exposure of several months and higher dosage, such as 8 mg/kg monthly IV. WHO. Tocilizumab and Cutaneous Vasculitis. WHO Pharmaceuticals Newsletter : Sep 2020. Available from: URL: https://www.who.int/publications/i/ item/9789240010741
0114-9954/20/1823-0001/$14.95 Adis © 2020 Springer Nature Switzerland AG. All rights reserved
803502505
Reactions 26 Sep 2020 No. 1823
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