Does Sotyktu Raise Infection Risk?
Yes, Sotyktu (deucravacitinib), a TYK2 inhibitor for moderate-to-severe plaque psoriasis, increases infection risk. Clinical trials showed higher rates of infections like upper respiratory tract infections (22.6% vs. 15.4% placebo) and nasopharyngitis.[1][2] Serious infections occurred in 1.8% of patients, including cases of herpes zoster and pneumonia.[1]
Common Infections Reported in Trials
- Upper respiratory infections: Most frequent, often mild.
- Herpes zoster (shingles): 1.4% incidence vs. 0.3% placebo.
- Urinary tract infections: Slightly elevated.
Rates were higher with longer use, but no new infection types emerged beyond placebo.[1][3]
Why Does It Increase Risk?
Sotyktu selectively inhibits TYK2, reducing type I interferon signaling and dampening immune responses against viruses and bacteria. This mirrors risks with other JAK inhibitors like Xeljanz, flagged by FDA for serious infections, thrombosis, and malignancy.[2][4]
Who Faces Higher Risk?
Patients with comorbidities (e.g., diabetes, immunosuppression history) or on corticosteroids see amplified risk. Avoid in active infections; screen for tuberculosis before starting.[1][3] Elderly patients had more urinary tract infections in trials.[1]
What Do Real-World Reports and Labels Say?
Post-marketing data through 2023 confirms trial findings, with FDA label warning of "increased risk of infections" and advising monitoring.[2] No major spikes in opportunistic infections like those with broader immunosuppressants (e.g., biologics).[4]
How Does It Compare to Other Psoriasis Treatments?
| Treatment | Infection Risk Profile |
|-----------|------------------------|
| Sotyktu | Moderate; mainly respiratory/viral (OR ~1.5 vs. placebo) |
| Methotrexate | Higher bacterial risk; hepatotoxicity common |
| Biologics (e.g., Humira) | Elevated serious infections (3-5%); TB screening required |
| JAK inhibitors (e.g., Olumiant) | Similar to Sotyktu; black box for infections/thrombosis |
Sotyktu has a lower serious infection rate than some IL-17/IL-23 inhibitors in head-to-head data.[3][5]
Patient Tips and Monitoring
Doctors recommend vaccinations (e.g., shingles, pneumococcal) before starting, avoiding live vaccines during treatment, and prompt reporting of fever or persistent cough. Discontinue if serious infection develops.[1][2]
[1]: Sotyktu Prescribing Information (BMS, 2023)
[2]: FDA Label for Deucravacitinib
[3]: POETYK PSO-1 Trial (NEJM, 2022)
[4]: FDA JAK Class Warning (2021)
[5]: DrugPatentWatch.com - Sotyktu Safety Data