Skip to main content

ICYMI: Drug Safety Differences with New Novel Therapies in RA

Editor's note: This article originally appeared February 14, 2023, and is being shared again this week in case you missed it. 

Safety outcomes for targeted synthetic or biological disease-modifying antirheumatic drugs (b/ts DMARDs) used to treat rheumatoid arthritis (RA) were studied using data from the Anti-Rheumatic Therapies in Sweden (ARTIS) registry, showing that these newer agents are largely similar, but still have particular differences for specific infection or other adverse event (AE) risks.

This register-based cohort study included RA patients starting b/tsDMARD between January 2010 and December 2020. Safety outcomes included treatment discontinuation due to AE, MACE events, serious infection (SIE), herpes zoster, tuberculosis, non-steatosis liver disease, depression, suicide, hospitalisation and all-cause mortality. Drug exposures analyzed included tumour necrosis factor inhibitors (TNFi; adalimumab, certolizumab, etanercept, golimumab and infliximab); other bDMARDS (abatacept, anakinra, rituximab, sarilumab, tocilizumab) and janus kinase inhibitors (JAKi; baricitinib, tofacitinib and upadacitinib). Owing to limited exposure (<200 treatment episodes), anakinra (n=84) and upadacitinib (n=105) were excluded.

Notable Safety Findings

  • AE treatment discontiuations ranged from 18 on rituximab to 57 on tofacitinib (rates per 1000 person-years ranged), but few were for serious adverse events.
  • Cardiovascular events (MACE, MI, CVA) and serious infections were similar in JAKi and bDMARDs Treated patients.
  • JAKi had higher rates of hospital-treated herpes zoster (HR ~4.0 vs etanercept)
  • RA on b/tsDMARDs and doubled rate for SIE and tripled rate for herpes zoster
  • SIE rates were 30% higher with Infliximab and rituximab than etanercept
  • non-steatosis liver disease was low (1–3 per 1000 PYs) across all b/tsDMARDs (40% higher than the general population)
  • All b/tsDMARDs had similar rates for depression (2–5 per 1000 PYs) and (attempted) suicide (1–2 per 1000 PYs); but these were 10% and 40% higher than general population
  • Hospitalisation rates (for any cause) (162 per 1000 PYs) on b/tsDMARD was 80% higher than the general population. Significantly higher rates (vs etanercept) were observed on infliximab (18%), certolizumab pegol (15%) and rituximab (28%). The lowest rate was observed on tofacitinib (weighted HR=0.69 (0.49–0.96)).


If you are a health practitioner, you may to comment.

Due to the nature of these comment forums, only health practitioners are allowed to comment at this time.

The author has no conflicts of interest to disclose related to this subject