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Real-World Evidence of Tofacinitib in Ulcerative Colitis: Short-Term and Long-Term Effectiveness and Safety

2022; Lippincott Williams & Wilkins; Volume: 118; Issue: 7 Linguagem: Inglês

10.14309/ajg.0000000000002145

1572-0241

María Chaparro, Diana Acosta, Cristina Rodríguez, Francisco Mesonero, M Vicuña, Manuel Barreiro‐de Acosta, A Fernández-Clotet, Álvaro Hernández Martínez, M Arroyo, Isabel Vera, Alexandra Ruiz‐Cerulla, Beatriz Sicilia, M J Cabello Tapia, Carmen Muñoz Villafranca, Jesús Castro‐Poceiro, J Martínez Cadilla, Mónica Sierra‐Ausín, Juan María Vázquez Morón, Raquel Vicente Lidón, Fernando Bermejo, Vanesa Royo, Margalida Calafat, Carlos González‐Muñoza, Eduardo Leo Carnerero, Noemí Manceñido, Leyanira Torrealba, Horacio Alonso‐Galán, J M Benítez, Yolanda Ber, M T Diz-Lois Palomares, María José García, José Fernando Muñoz, Edisa María Armesto González, Xavier Calvet, Alejandro Hernández-Camba, Rosa Eva Madrigal Domínguez, Luís Menchén, J L Pérez Calle, Marta Piqueras, Carmen Dueñas Sadornil, Belén Botella, Teresa Martínez-Pérez, Laura Ramos, M C Rodríguez-Grau, Elena San Miguel, José Luis Fernández Forcelledo, Paola María Fradejas Salazar, Marifé García-Sepulcre, Ana Gutiérrez, Jordina Llaó, Eva Sesé Abizanda, Marta Maia Boscá-Watts, Eduardo Iyo, Alma Keco‐Huerga, Carmen Martínez Bonil, Elena Peña González, Pablo Pérez‐Galindo, Pilar Varela, Javier P. Gisbert,

Chronic Lymphocytic Leukemia Research

INTRODUCTION: The objective of this study was to assess the durability, short-term and long-term effectiveness, and safety of tofacitinib in ulcerative colitis (UC) in clinical practice. METHODS: This is a retrospective multicenter study including patients with UC who had received the first tofacitinib dose at least 8 weeks before the inclusion. Clinical effectiveness was based on partial Mayo score. RESULTS: A total of 408 patients were included. Of them, 184 (45%) withdrew tofacitinib during follow-up (mean = 18 months). The probability of maintaining tofacitinib was 67% at 6 m, 58% at 12 m, and 49% at 24 m. The main reason for tofacitinib withdrawal was primary nonresponse (44%). Older age at the start of tofacitinib and a higher severity of clinical activity were associated with tofacitinib withdrawal. The proportion of patients in remission was 38% at week 4, 45% at week 8, and 47% at week 16. Having moderate-to-severe vs mild disease activity at baseline and older age at tofacitinib start were associated with a lower and higher likelihood of remission at week 8, respectively. Of 171 patients in remission at week 8, 83 (49%) relapsed. The probability of maintaining response was 66% at 6 m and 54% at 12 m. There were 93 adverse events related to tofacitinib treatment (including 2 pulmonary thromboembolisms [in patients with risk factors] and 2 peripheral vascular thrombosis), and 29 led to tofacitinib discontinuation. DISCUSSION: Tofacitinib is effective in both short-term and long-term in patients with UC. The safety profile is similar to that previously reported.