Characterizing real world safety profile of oral Janus kinase inhibitors among adult atopic dermatitis patients: evidence transporting from the rheumatoid arthritis population

Abstract

Objective

To address potential safety concerns of Janus Kinase Inhibitors (JAK-Is), we characterized their safety profile in the atopic dermatitis (AD) patient population.

Methods

In this retrospective observational study, we used propensity score-based methods and a Poisson modeling framework to estimate the incidence of health outcomes of interest (HOI) for the AD patient. To that end, two mutually exclusive cohorts were created using a real world data resource: a rheumatoid arthritis (RA) cohort, where we directly quantify the safety risk of JAK-Is on HOIs, and an AD cohort, that comprises the target population of interest and to whom we transport the results obtained from the RA cohort. The RA cohort included all adults who filled at least one prescription for a JAK-I (tofacitinib, baricitinib, or upadacitinib) between 1 January 2017 and 31 January 2020. The AD cohort consisted of all adults diagnosed with AD during the same period. We first estimated the incidence rate of each HOI in the RA cohort, and then transported the results to the AD population.

Results

The RA and AD cohorts included 5,296 and 261,855 patients, respectively. On average, patients in the AD cohort were younger, more often male, more likely to be Asian, and had higher household income. They also had a lower prevalence of several comorbid conditions including hypertension, chronic kidney disease, obesity, and depression. Overall, the transported incidence rates of the HOIs to the AD cohort were lower than those obtained in the RA cohort by 13–50%.

Conclusion

We applied transportability methods to characterize the risk of the HOIs in the AD population and found absolute risks higher than that of the general population. Future work is needed to validate these conclusions in comparable populations.

Keywords:

• Janus kinase inhibitors
• atopic dermatitis
• rheumatoid arthritis
• transportability
• incidence

Transparency

Declaration of funding

This work was supported by a Sanofi iDEA Award (https://www.sanofi.us/en/innovation-and-science/partnering-initiatives/sanofi-idea-awards).

Declaration of financial/other relationships

MEMR, KK, AYL, and MD have no conflict of interest to declare. The other authors are Sanofi employees and may hold shares and/or stock options in the company. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

Study concept and design: MEMR, RL, KK, AYL, RLC, KC, and MD; analysis and interpretation of data: MEMR, RL, KK, AYL, RLC, and MD; drafting of the manuscript: MEMR, and RL; critical revision of the manuscript for important intellectual content: MEMR, RL, KK, AYL, RLC, LR, KC, and MD; statistical analysis: KK. All authors agree to be accountable for all aspects of the work.

Acknowledgements

No assistance in the preparation of this article is to be declared.

Data availability statement

Due to the nature of this research, participants of this study did not agree for their data to be shared publicly, so supporting data is not available.

Notes

i CLINFORMATICS is a trademark of OptumInsight, Inc.

ii Guidance Regarding Methods for De‐identification of Protected Health Information in Accordance with the Health Information Insurance Portability and Accountability Act (HIPAA) Privacy Rule (Dated as 4 September 2012, as first released on 26 November 2012).