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Comparative Study
. 2020 Feb;79(2):285-291.
doi: 10.1136/annrheumdis-2019-216102. Epub 2019 Oct 31.

Comparative risk of serious infections among real-world users of biologics for psoriasis or psoriatic arthritis

Affiliations
Comparative Study

Comparative risk of serious infections among real-world users of biologics for psoriasis or psoriatic arthritis

Xintong Li et al. Ann Rheum Dis. 2020 Feb.

Abstract

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.

Keywords: interleukin inhibitors; psoriasis; psoriatic arthritis; serious infections; tumor necrosis factor alpha.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Patient selection process. IL,interleukin; TNF, tumour necrosis factor.
Figure 2
Figure 2
Kaplan-Meier curve showing the cumulative incidence of serious infection over time, by biologic class. IL,interleukin; TNF, tumour necrosis factor.

References

    1. Leonardi CL, Kimball AB, Papp KA, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (Phoenix 1). The Lancet 2008;371:1665–74. - PubMed
    1. Papp KA, Tyring S, Lahfa M, et al. A global phase lii randomized controlled trial of etanercept in psoriasis: safety, efficacy, and effect of dose reduction. Br J Dermatol 2005;152:1304–12. - PubMed
    1. Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis--results of two phase 3 trials. N Engl J Med 2014;371:326–38. - PubMed
    1. Griffiths CEM, Reich K, Lebwohl M, et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. The Lancet 2015;386:541–51. - PubMed
    1. Blauvelt A, Reich K, Tsai T-F, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study. J Am Acad Dermatol 2017;76:60–9. - PubMed

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