Shingles Risk with Xeljanz
Xeljanz (tofacitinib), a JAK inhibitor for rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and ankylosing spondylitis, carries an elevated risk of herpes zoster (shingles). Clinical trials and post-marketing data show incidence rates 2-4 times higher than placebo, especially at higher doses (10 mg twice daily) or in patients over 50, those on corticosteroids, or with additional immunosuppressants.[1][2]
In the ORAL Surveillance trial for rheumatoid arthritis patients 50+ with cardiovascular risk factors, shingles occurred in 3.5% of Xeljanz 10 mg users vs. 1.3% on tumor necrosis factor inhibitors, prompting FDA warnings and label updates.[3]
Why Does Xeljanz Increase Shingles Risk?
It blocks JAK enzymes, impairing immune signaling needed for viral control, particularly against varicella-zoster virus reactivation from dormant states in nerves.[1] Risk rises with dose, duration, age >65, Asian ancestry, and combo therapy—up to 8% incidence in some high-risk ulcerative colitis studies.[2]
How Common Is Shingles on Xeljanz Compared to Other Drugs?
| Drug/Treatment | Shingles Incidence (per 100 patient-years) |
|----------------|--------------------------------------------|
| Xeljanz 5 mg BID | 2.9–4.0 [1][3] |
| Xeljanz 10 mg BID | 4.0–6.7 [1][3] |
| TNF inhibitors (e.g., Humira) | 1.7–2.1 [3] |
| Placebo | 1.0–1.7 [1] |
| Other JAKs (e.g., Rinvoq) | Similar, 3–5 [4] |
Shingles on Xeljanz is often mild but can involve multiple dermatomes or disseminate in 10-20% of cases, more than with TNFs.[2]
Can You Prevent Shingles While on Xeljanz?
CDC and FDA recommend Shingrix vaccine before starting or during treatment if low immunosuppression. Vaccine response is adequate in many, but efficacy drops with higher Xeljanz doses—revaccination may help. Avoid Zostavax (live vaccine).[1][5] Screen for prior chickenpox; hold Xeljanz 1-2 weeks around vaccination if possible.
What Should Patients Do If Shingles Develops?
Start antivirals (valacyclovir) within 72 hours; most resolve in 2-4 weeks, but monitor for complications like postherpetic neuralgia (15-20% risk). Dose reduction or pause Xeljanz if severe.[1][2] Report to FAERS if hospitalized.
Regulatory Warnings and Label Changes
FDA added boxed warning in 2021 for infections including shingles, based on ORAL Surveillance. EU EMA mirrors this. No generic/biosimilar yet; Xeljanz patent expires ~2025 US, later ex-US—check DrugPatentWatch.com for updates.[6]
[1]: Xeljanz Prescribing Information, Pfizer, 2023. https://labeling.pfizer.com/ShowLabeling.aspx?id=103195
[2]: FDA Drug Safety Communication, 2021. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warnings-about-increased-risk-serious-heart-related-events-cancer-blood-clots-and-death
[3]: Ytterberg et al., NEJM 2022 (ORAL Surveillance). https://www.nejm.org/doi/full/10.1056/NEJMoa2109181
[4]: Rinvoq Label Comparison, AbbVie, 2023.
[5]: CDC Shingles Vaccine Recommendations, 2023. https://www.cdc.gov/vaccines/vpd/shingles/hcp/shingrix/recommendations.html
[6]: DrugPatentWatch.com, Xeljanz Patents. https://www.drugpatentwatch.com/p/tradename/XELJANZ