Background and importance Tofacitinib and baricitinib were recently approved for rheumatoid arthritis (RA) treatment. This was a breakthrough because of their oral administration and new mechanism of action.

Aim and objectives To analyse tofacitinib and baricitinib treatment for RA and adverse effects (AE) after starting treatment in a second level hospital.

Material and methods A retrospective observational study was conducted in all patients starting baricitinib and tofacitinib treatment until September 2019. The collected variables were sex, age, previous disease modifying antirheumatic drugs (DMARD) and biological treatments, and AEs detected (through review of electronic medical history).

Results Forty-seven patients were included (12.8% men; mean age 57±12.6 years). Twenty-six (53.2%) received baricitinib. All patients had been previously treated with any DMARD. Twenty-six (55.3%) patients had received any biologic agent, and the average number of previous biological treatments was 1.7. Twenty-four AEs were detected in 15 different patients (31.9%). Eight patients with baricitinib (30.8%) presented any of the following AEs: upper respiratory tract infection (4), fatigue (2), changes in blood pressure (2), skin and mucous lesions (2), oesophageal candidiasis (1), headache (1), anxiety (1), arthralgia (1) and hair loss (1). Six patients treated with tofacitinib (28.6%) presented any AEs: headache (2), fatigue (2), respiratory infection (1), herpes infection (1), joint swelling (1) changes in blood pressure (1), pruritus (1), insomnia (1) and blurred vision (1).

In two cases, baricitinib was suspended for no clinical improvement, and in four cases for AEs (two for skin and mucous lesions, one for hair loss and fatigue, and other for fatigue). Tofacitinib was suspended for inefficacy in four cases and one AE (insomnia), leading to a dose reduction in one patient.

Conclusion and relevance The population that started RA treatment with tofacitinib and baricitinib in our hospital were mostly middle aged women with at least one previous treatment with DMARD. More than half of the patients had received some biologic previously. In spite of the limitations of this study (probable underestimation of AEs because they were not always recorded on the clinal history), tofacitinib and baricitinib showed an acceptable profile of adverse reactions, similar to those described on both technical data sheets.

References and/or acknowledgements No conflict of interest.