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

Table 2.

Studies estimating risk of lupus and vasculitis-like events in TNFi-treated patients

References Type of study Diseases evaluated Outcome studied TNFi agent Events on TNFi (n) Median time to event (months) Controls Estimation of risk
De Bandt et al. [58] Case series RA LLE INF, ETA 22 INF (9), ETA (4) None

  • Denominator based on unpublished company reports

  • INF 15/7700, 0.19%, ETA 7/3800, 0.18%
Flendrie et al. [59] Prospective cohort study RA

  • All cutaneous events including

  • LLE/VLE

 INF, ADAL, ETA LLE (1), VLE (5) For all cutaneous events (9) For vasculitis-cutaneous events (12) RA patients not on biologics

  • OR of a dermatology referral was calculated in TNFi users vs non-users

  • OR = 2.26 (95% CI: 1.46, 3.50)

  • LLE/VLE risk not calculated
Lee et al. [60] Observational clinical study (single centre) RA, AS, PsA

  • All cutaneous events including

  • LLE/VLE

 INF, ADAL, ETA

  • LLE (0)

  • VLE (1)

 Not specified None One patient developed leucocytoclastic vasculitis
Grönhagen et al. [61] Swedish population case control study (SCLE only) All SCLE Not specified (all) 4 2 months Swedish general population OR cases: controls 8.0 (95% CI: 1.6, 37.2)
Takase et al. [34] Observational single-centre UK-based study RA LLE/VLE INF, ADAL, ETA

  • LLE (3)

  • VLE (2)

  • LLE (26)

  • VLE (mean, 21.7)

 None Not formally assessed. 3/454 patients on first TNFi developed LLE (0.7%), 2/454 VLE (0.4%)
Moulis et al. [53] French pharmacovigilance study RA, AS, PsA, IBD LLE INF, ADAL, ETA 39 11 Postive control isoniazid, negative control paracetamol Association of TNFi and lupus: ROR 7.72 (95% CI: 5.50, 10.83) using disproportionality analysis
Jani et al. [55] Prospective observational study RA LLE/VLE INF, ADAL, ETA, CERT

  • LLE (54)

  • VLE (81)

  • LLE (14)

  • VLE (12)

 nbDMARD-treated cohort

  • LLE crude incidence rate: 10/10,000 patient-years in TNFi cohort

  • Adjusted HR for LLE in TNFi-treated cohort compared with nbDMARD: 1.86 (95% CI: 0.52, 6.58)

  • VLE crude incidence rate: 15/ 10 000 patient-years in TNFi cohort

  • Adjusted HR for VLE in TNFi-treated cohort compared with nbDMARD: 1.27 (95% CI: 0.40, 4.04)

ADAL, adalimumab; CERT, certolizumab pegol; ETA, etanercept; HR, hazard ratio; LLE, lupus-like event; nbDMARD, non-biologic DMARD; OR, odds ratio; ROR, reporting odds ratio; VLE, vasculitis-like events.