4CPS-310 Tofacitinib effectiveness and safety results: real world data

Background and importance Tofacitinib is an oral JAK inhibitor indicated for the treatment of rheumatoid arthritis, psoriasis arthritis and ulcerative colitis. The efficacy and safety of tofacitinib have been shown in several randomised clinical trials. Aim and objectives To evaluate the effectiveness and safety of tofacitinib in all indications used in a real world cohort of patients in a third level hospital. Material and methods This was a retrospective observational study of patients who received tofacitinib from 2017 to March 2020. Demographic, clinical characteristics at baseline and outcomes analysed were: age, sex, diagnosis, number of days treated with tofacitinib, previous lines of treatment, objective response and adverse effects. Results 30 patients were treated with tofacitinib from 2017 to March 2020, 23 women and 7 men, with a median age of 55 (48–62) years; 40% of patients were overweight. 23 patients were diagnosed with rheumatoid arthritis, 3 patients with psoriasis arthritis, 1 patient with vitiligo, 1 patient with alopecia areata and 1 patient with polyarthritis. 50% of patients were pre-exposed to at least one biological agent and all of the patients were pre-exposed to methotrexate, leflunomide and/or hydroxychloroquine. Median time to stop tofacitinib was 307 (114–557) days. Reasons for stopping tofacitinib were: insufficient response (n=9), infection (n=1), headache (n=3), haematemesis (n=1) and pregnancy (n=1). 15 patients have continued treatment with tofacitinib with a good response. Elevation of liver enzymes, or changes in the levels of lymphocytes, neutrophils and haemoglobin have not been detected in any patient. 30% of patients had adverse events; more frequent adverse events were infections in 13% of patients and headache in 13% of patients. Conclusion and relevance The efficacy and safety of tofacitinib have been demonstrated in clinical trials. This retrospective analysis of real life data showed that tofacitinib was also effective and safe in a real life setting but only 50% of the patient cohort achieved a response with a dose of tofacitinib 5 mg twice daily. Due to the size of the group, these results should be interpreted with caution; future analysis in clinical practice is necessary. References and/or acknowledgements Conflict of interest No conflict of interest