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Epidemiological science
Comparative risk of serious infections among real-world users of biologics for psoriasis or psoriatic arthritis
  1. Xintong Li1,2,
  2. Kathleen M Andersen1,2,
  3. Hsien-Yen Chang1,3,
  4. Jeffrey R Curtis4,5,
  5. G Caleb Alexander1,2
  1. 1 Center for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, Maryland, USA
  2. 2 Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA
  3. 3 Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
  4. 4 Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama, USA
  5. 5 Epidemiology, University of Alabama at Birmingham, Birmingham, Alabama, USA
  1. Correspondence to Dr G Caleb Alexander, Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD 21205, USA; galexan9{at}


Objective To examine whether initiation of interleukin (IL)-17, IL-12/23 or tumour necrosis factor (TNF) inhibitor is associated with an increased risk of serious infection among real-world psoriasis (PsO) or psoriatic arthritis (PsA) patients.

Methods We assembled a retrospective cohort of commercially insured adults in the USA diagnosed with PsO or PsA between 2015 and 2018. Exposure was dispensation for IL-17 (ixekizumab or secukinumab), IL-12/23 (ustekinumab) or TNF (adalimumab, certolizumab pegol, etanercept, golimumab and infliximab). The outcome was infection requiring hospitalisation after biologic initiation. Incidence rates (IRs) per 100 person-years were computed, and hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated using Cox proportional hazards regression models, adjusted for inverse probability of treatment-weighted propensity scores.

Results A total of 11 560 new treatment episodes were included. Overall, 190 serious infections (2% of treatment episodes) were identified in 9264 person-years of follow-up. Class-specific IRs were similar among IL-17 and TNF, yet significantly lower for IL-12/23. After adjustment for propensity scores, there was no increased risk with IL-17 compared with either TNF (HR=0.89, 95% CI 0.48 to 1.66) or IL-12/23 (HR=1.12, 95% CI 0.62 to 2.03). By contrast, IL-23/23 were associated with a lower risk of infections than TNF (HR=0.59, 95% CI 0.39 to 0.90).

Conclusions Relative to TNF and IL-17, IL-12/23 inhibitors were associated with a reduced risk of serious infection in biologic-naïve patients with PsO or PsA. In biologic-experienced individuals, there was no difference in infection risk across TNF, IL-17 or IL-12/23 inhibitors.

  • interleukin inhibitors
  • tumor necrosis factor alpha
  • psoriasis
  • psoriatic arthritis
  • serious infections

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  • Handling editor Josef S Smolen

  • Presented at This work had been presented at the 35th International Conference on Pharmacoepidemiology & Therapeutic Risk Management in Philadelphia, PA, USA on August 2019.

  • Contributors XL, GCA and JRC initiated the study design and H-YC and KMA helped with implementation. H-YC and JRC provided statistical expertise and XL conducted the primary statistical analysis. All authors contributed to refinement of the study protocol and approved the final manuscript.

  • Funding This study was funded by internal resources in the Center for Drug Safety and Effectiveness at the Johns Hopkins Bloomberg School of Public Health.

  • Competing interests GCA is past Chair of FDA’s Peripheral and Central Nervous System Advisory Committee, has served as a paid advisor to IQVIA, and is a consultant and holds equity in Monument Analytics, a healthcare consultancy whose clients include the life sciences industry as well as plaintiffs in opioid litigation; and is a member of OptumRx’s National P&T Committee. This arrangement has been reviewed and approved by Johns Hopkins University in accordance with its conflict of interest policies.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement No data are available.