Persistence of treatment in patients with ulcerative colitis who responded to tofacitinib therapy: data from the open-label, long-term extension study, OCTAVE open
Entity
UAM. Departamento de MedicinaPublisher
John Wiley & Sons, LtdDate
2022-02-13Citation
10.1111/apt.16848
Alimentary Pharmacology & Therapeutics 55.12 (2022): 1475-1591
ISSN
0269-2813 (print); 1365-2036 (online)DOI
10.1111/apt.16848Funded by
This study was sponsored by Pfizer. Medical writing support, under the guidance of the authors, was provided by Helen Findlow, PhD, CMC Connect, McCann Health Medical Communications and was funded by Pfizer Inc, New York, NY, USA in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med. 2015;163:461–464)Editor's Version
https://doi.org/10.1111/apt.16848Subjects
Tofacitinib; ulcerative colitis; MedicinaRights
© 2022 Pfizer IncEsta obra está bajo una licencia de Creative Commons Reconocimiento-NoComercial-SinObraDerivada 4.0 Internacional.
Abstract
Tofacitinib is an oral Janus kinase inhibitor for the treatment of ulcerative colitis (UC).
Aim:This post hoc analysis evaluated tofacitinib persistence in patients with UC in OCTAVE Open, an open-label, long-term extension study of patients receiving tofacitinib 5 or 10 mg twice daily.
Methods: Kaplan-Meier estimates for tofacitinib drug survival and reasons for discontinuations were evaluated. Baseline factors were analysed as predictors of persistence.
Results:This analysis included 603 patients: 280 entered OCTAVE Open with a clinical response (164 in remission and 116 not in remission), 220 were delayed responders, 75 were retreatment responders and 35 were dose escalation responders, treated for up to 7 years in OCTAVE Open. Of these, 118 (42.1%) responders, 121 (55.0%) delayed responders, 40 (53.3%) retreatment responders and 17 (48.6%) dose escalation responders discontinued tofacitinib with a median time to discontinuation of 5.6, 4.5, 4.0 and 4.4 years, respectively. The estimated 2- and 5-year drug survival rates in the responders (including patients in remission and not in remission) were 73.9% and 54.5%, respectively. Corresponding persistence values for delayed responders were 69.5% and 45.2%, for retreatment responders, 70.7% and 40.0%, and for dose escalation responders, 74.3% and 32.8%.
ConclusionIn: OCTAVE Open, a high proportion of patients maintained tofacitinib treatment, with the median survival by group ranging from 4.0 to 5.6 years although these analyses are post hoc and limited by sample size. Further research should focus on factors to enhance persistence with tofacitinib treatment in patients with UC
Files in this item
Google Scholar:Panaccione, Remo
-
Abreu, Maria T.
-
Lazariciu, Irina
-
Mundayat, Rajiv
-
Lawendy, Nervin
-
Salese, Leonardo
-
Woolcott, John C.
-
Sands, Bruce E.
-
Chaparro Sánchez, María
This item appears in the following Collection(s)
Related items
Showing items related by title, author, creator and subject.
-
Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial
Diago-Sempere, Elena; Bueno, José Luis; Sancho-López, Aránzazu; Muñez-Rubio, Elena; Torres, Ferrán; Malo de Molina, Rosa; Fernández-Cruz, Ana; Salcedo de Diego, Isabel; Velasco-Iglesias, Ana; Payares-Herrera, Concepción; Casas Flecha, Inmaculada; Avendaño Solá, Cristina; Duarte Palomino, Rafael; Ramos Martínez, Antonio; Ruiz-Antorán, Belén
2021-01-20