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. 2018 Jan 8;57(11):1896–1907. doi: 10.1093/rheumatology/kex434

Table 1.

Lupus and vasculitis-like events on TNFi agents reported to the UK regulatory agency

Drug (licensing date UK for RA) Earliest reported event to MHRA Reported LLE cases (n) Reported vasculitis cases (n)
Infliximab (2002) 23 July 1999

  • Lupus-like syndrome (63)

  • SLE (32)

  • Cutaneous lupus (3)

  • Vasculitis (29)

  • ANCA-+ve vasculitis (2)

  • Cerebral vasculitis (2)

  • Vasculitic rash (8)

  • Granulomatosis with Polyangiitis (1)

  • Bechet’s syndrome (1)

  • DM (1)
Etanercept (2002) 30 September 1999

  • Lupus-like syndrome (7)

  • SLE (15)

  • Cutaneous lupus (13)

  • Lupus vasculitis (2)

  • Vasculitis (21)

  • Necrotising vasculitis (2)

  • Granulomatosis with Polyangiitis (1)

  • Bechet’s syndrome (1)
Adalimumab (2007) 24 March 2000

  • Lupus-like syndrome (25)

  • SLE (25)

  • Cutaneous lupus (11)

  • Vasculitis (24)

  • Cutaneous vasculitis (11)

  • Necrotising vasculitis (2)

  • Gastrointestinal vasculitis (2)

  • Cerebral vasculitis (2)

  • Granulomatosis with Polyangiitis (1)

  • Bechet’s syndrome (5)
Certolizumab (2010) 25 February 2010

  • Lupus-like syndrome (3)

  • Cutaneous lupus (1)

  • Vasculitis (1)

  • Skin vasculitis (1)

  • Panniculitis (1)
Golimumab (2011) 3 December 2010

  • Lupus-like syndrome (3)

  • SLE (6)

  • Vasculitis (3)

  • Skin vasculitis (1)

Figures from Drug Analysis Prints 31/5/2017 report, MHRA (includes biosimilars as not listed separately). The Drug Analysis Prints give a complete listing of all UK spontaneous suspected adverse drug reactions reported through the Yellow Card Scheme to the MHRA and the Government’s independent scientific committee on medicines safety, the Commission on Human Medicines. There is a high-level grouping by System Organ Class (the highest level in Medical Dictionary for Regulatory Activities) that groups together reactions that affect similar systems/organs in the body, followed by a more detailed breakdown, as outlined above. LLE, lupus-like events; MHRA, Medicines and Healthcare Products Regulatory Agency.