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Cutaneous Lymphoma Associated with JAK Inhibitors: A Pharmacovigilance Analysis of the FAERS Database and Literature

Lu Lu1, Jindi Feng1, Huimin He1

  • 1Department of Dermatology, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, National Clinical Research Center for Dermatologic and Immunologic Diseases, Beijing, China.

Acta Dermato-Venereologica
|January 9, 2026
PubMed

Insights

Janus kinase (JAK) inhibitors are linked to a potential risk of cutaneous lymphoma. This study identified 24 cases, with baricitinib showing the highest risk signal, emphasizing pharmacovigilance.

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Dermatology
  • Oncology

Background:

  • Janus kinase (JAK) inhibitors are increasingly used for various conditions.
  • Concerns exist regarding the potential association between JAK inhibitor use and cutaneous lymphoma.
  • Robust pharmacovigilance is crucial for identifying drug-related adverse events.

Purpose of the Study:

  • To investigate the risk of cutaneous lymphoma associated with JAK inhibitors.
  • To analyze clinical characteristics and identify risk signals using the FAERS database.
  • To evaluate specific JAK inhibitors for their association with cutaneous lymphoma.

Main Methods:

  • Comprehensive search of the FDA Adverse Event Reporting System (FAERS) database.
  • Inclusion of cases reported between January 2004 and September 2023.
  • Application of disproportionality and Bayesian analyses to detect safety signals.

Main Results:

  • Twenty-four cases of cutaneous lymphoma linked to JAK inhibitors (tofacitinib, ruxolitinib, baricitinib, upadacitinib, abrocitinib) were identified.
  • The majority of affected patients (64%) were 60 years or older, with a mean onset of 8.64 months.
  • Baricitinib exhibited the highest reporting odds ratio (23.91) and other significant statistical signals for cutaneous lymphoma.

Conclusions:

  • The use of JAK inhibitors is associated with an increased risk of cutaneous lymphoma.
  • Pharmacovigilance is essential for monitoring the safety of JAK inhibitors and understanding associated risks.
  • Further research is needed to elucidate the mechanisms and clinical implications of this association.

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