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5PSQ-097 Health alert of tofacitinib and pharmaceutical intervention
  1. I Sánchez Lobón,
  2. R Pla Pasán,
  3. A Ganfornina Andrades,
  4. V Manzano Martin,
  5. M Saldaña Valderas,
  6. MJ Huertas Fernández
  1. Puerta Del Mar University Hospital, Pharmacy, Cádiz, Spain


Background and Importance Tofacitinib is a selective inhibitor of the janus kinase family indicated for the treatment of various rheumatological pathologies such as rheumatoid arthritis (RA) and psoriatic arthritis (PsA) and used, off label, in pathologies such as alopecia areata (AA).

The Spanish Medicines and Medical Devices Agency (AEMPS) released in July 2021 a safety alert stating that patients over 65 years of age, smokers or ex-smokers and with cardiovascular risk factors or with a predisposition to the development of neoplasms, should not receive treatment with tofacitinib unless no other available therapeutic alternative can be used, based in the results from the ORAL Surveillance clinical trial. Health policy in Andalucía establishes the need to follow-up on the application of the safety notes issued by the AEMPS regarding prescriptions of drugs.

Aim and Objectives Evaluate the pharmaceutical intervention on the review of tofacitinib prescriptions to ensure their adaptation to the criteria established by the AEMPS, according to the Andalusian regional regulations.

Material and Methods Retrospective review of tofacitinib prescription in a tertiary hospital. All patients on treatment with tofacitinib from July 2021 to February 2022 were included. Variables collected were age, sex, risk factors included in the health alert and continuation or discontinuation of treatment.

Results A total of 71 patients receiving tofacitinib treatment were included (mean age: 41 ± 16; sex: 74.6% women). The treatment was discontinued in 25.4% (18/71) of the patients due to inefficacy, adverse reactions or presenting at least one risk factor. However, 74.6% (53/71) of the patients continued treatment, with 43.4% (23/53) having at least one risk factor. Results were shown to the Pharmacy Commission, where the pharmacist developed a protocol regarding tofacitinib safety issues.

Conclusion and Relevance This is the first experience in our hospital regarding the global monitoring of safety notes released by the AEMPS, endorsed by autonomic regulation. Despite the presence of risk factors, tofacitinib was not withdrawn nor justified in a high percentage of patients. This finding underlines the relevance of systematic patients follow-up and the need to develop protocols agreed by the pharmacists and involved physicians.

Conflict of Interest No conflict of interest

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