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This is an independent study (ISR) financed by a Pfizer Independent Medical Grant (ID: 66,519,171). Pfizer had no access to clinical data and was not involved in study design, statistical analysis, and manuscript writing.

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

Publicat a:American Journal Of Gastroenterology. 118 (7): 1237-1247 - 2023-07-01 118(7), DOI: 10.14309/ajg.0000000000002145

Autors: Chaparro, M; Acosta, D; Gisbert, JP; Rodríguez, C; Vicuña, M; Mesonero, F; Barreiro-de Acosta, M; Fernández-Clotet, A; Martínez, AH; Arroyo, M; Vera, I; Ruiz-Cerulla, A; Sicilia, B; Tapia, MJC; Villafranca, CM; Castro-Poceiro, J; Cadilla, JM; Sierra-Ausín, M; Morón, JMV; Lidón, RV; Bermejo, F; Royo, V; Calafat, M; Gonález-Muñoza, C; Carnerero, EL; Marcos, NM; Torrealba, L; Alonso-Galán, H; Benítez, JM; Nieto, YB; Palomares, MTDL; García, MJ; Muñoz, JF; González, EMA; Calvet, X; Hernández-Camba, A; Domínguez, REM; Menchén, L; Calle, JLP; Piqueras, M; Sadornil, CD; Botella, B; Martínez-Pérez, TD; Ramos, L; Rodríguez-Grau, MC; San Miguel, E; Forcelledo, JLF; Salazar, PMF; García-Sepulcre, M; Gutiérrez, A; Llaó, J; Abizanda, ES; Boscá-Watts, M; Iyo, E; Keco-Huerga, A; Bonil, CM; González, EP; Pérez-Galindo, P; Varela, P

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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.

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