Tremfya and Latent TB Risk
Tremfya (guselkumab), an IL-23 inhibitor for psoriasis and psoriatic arthritis, carries risks for patients with latent tuberculosis (TB) due to its immunosuppressive effects. The prescribing information requires screening for latent TB before starting treatment and, if positive, treating with anti-TB therapy first.[1]
Official Recommendations
- Screening mandate: Test all patients for active and latent TB via interferon-gamma release assays or tuberculin skin tests prior to initiating Tremfya.
- Latent TB protocol: Do not start Tremfya until latent TB is ruled out or adequately treated. Janssen (the manufacturer) advises completing standard prophylaxis (typically 3 months of isoniazid or equivalent) before dosing.
- Monitoring: During treatment, monitor for active TB symptoms like cough, fever, or weight loss, even in screened patients.[1][2]
Why the Concern Exists
Tremfya suppresses immune responses against TB, potentially reactivating latent infections. Clinical trials reported TB cases (0.2% incidence), mostly in high-prevalence regions, though rates were low overall. Post-marketing data shows rare reactivation in latent cases despite screening.[1]
What If Latent TB Is Detected
Patients with untreated latent TB should delay Tremfya until prophylaxis ends and re-testing confirms negativity. Treated patients can proceed if clinically stable, but ongoing vigilance is needed. Consult infectious disease specialists for complex cases, like drug-resistant TB strains.[2]
Comparison to Similar Drugs
| Drug | TB Screening Required? | Reactivation Risk Notes |
|------|-------------------------|-------------------------|
| Tremfya (guselkumab) | Yes, mandatory | Low trial incidence; screen/treat first |
| Stelara (ustekinumab, IL-12/23) | Yes | Similar risk profile |
| Skyrizi (risankizumab, IL-23) | Yes | Comparable warnings |
| TNF inhibitors (e.g., Humira) | Yes | Higher reactivation rates historically |
Tremfya's risk aligns with other biologics but is lower than TNF blockers.[1][3]
Patient Outcomes and Real-World Data
In registries like Psoriasis Longitudinal Assessment and Registry (PSOLAR), IL-23 inhibitors like Tremfya showed no excess TB events versus TNF inhibitors among screened patients. However, breakthrough reactivations occur rarely (e.g., 1-2 cases per 1,000 patient-years).[3]
Alternatives for Latent TB Patients