Revista de la Facultad de Ciencias Medicas (Cordoba, Argentina) · 2026
[Real-world evidence on the use of generic tofacitinib in patients with rheumatoid arthritis].
Аннотация на английскомСтатьяНазвание и аннотация: Перевод в очереди
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Di Giuseppe Luis Angel, Burgos Mariana Andrea, Posadas Martínez Maria Lourdes, Vargas Casalles Alfredo Lieber, Alvarez Karina Elena, Buela Gabriela, Puga Maria Celeste, Soriano Guppy Enrique Roberto, Rosa Javier Eduardo
Аннотация
OBJECTIVE: To describe the clinical outcomes of using generic tofacitinib in patients with rheumatoid arthritis (RA) who either initiated it de novo or underwent a non-medical switch from the original formulation.
METHODS: Retrospective cohort of adults with RA who either initiated generic tofacitinib (JANVAX®) or switched from original tofacitinib (XELJANZ®). Patients were followed until treatment discontinuation, death, or end of follow-up (12 months). Effectiveness was assessed using the DAS28-ESR scale via mixed-effects models. The switch group was evaluated at 0, 6, and 12 months; the initiation group at 0, 3, 6, and 12 months. The occurrence of adverse events was assessed for safety.
RESULTS: A total of 42 RA patients were included (24 in the switch group and 18 in the initiation group). Nine patients discontinued treatment. In the switch group, DAS28-ESR remained stable (2.96; 3.08; 3.10; p = 0.70). In the initiation group, improvement was significant (5.3, 3.42, 3.49, 3.31; p < 0.001). No major cardiovascular events (MACE) were reported. There was one death of unknown cause, three serious infections, one pulmonary embolism, and one diagnosis of malignancy during follow-up.
CONCLUSIONS: The non-medical switch to generic tofacitinib and treatment initiation were associated with a good clinical response in terms of effectiveness, with no evidence of new safety concerns. However, the limited sample size calls for further studies to confirm these findings.
METHODS: Retrospective cohort of adults with RA who either initiated generic tofacitinib (JANVAX®) or switched from original tofacitinib (XELJANZ®). Patients were followed until treatment discontinuation, death, or end of follow-up (12 months). Effectiveness was assessed using the DAS28-ESR scale via mixed-effects models. The switch group was evaluated at 0, 6, and 12 months; the initiation group at 0, 3, 6, and 12 months. The occurrence of adverse events was assessed for safety.
RESULTS: A total of 42 RA patients were included (24 in the switch group and 18 in the initiation group). Nine patients discontinued treatment. In the switch group, DAS28-ESR remained stable (2.96; 3.08; 3.10; p = 0.70). In the initiation group, improvement was significant (5.3, 3.42, 3.49, 3.31; p < 0.001). No major cardiovascular events (MACE) were reported. There was one death of unknown cause, three serious infections, one pulmonary embolism, and one diagnosis of malignancy during follow-up.
CONCLUSIONS: The non-medical switch to generic tofacitinib and treatment initiation were associated with a good clinical response in terms of effectiveness, with no evidence of new safety concerns. However, the limited sample size calls for further studies to confirm these findings.