Hudesman, David P. http://orcid.org/0000-0001-8318-5271
Torres, Joana http://orcid.org/0000-0003-2895-5821
Salese, Leonardo http://orcid.org/0000-0002-8168-1076
Woolcott, John C. http://orcid.org/0000-0001-7445-8696
Mundayat, Rajiv http://orcid.org/0000-0002-0005-0169
Su, Chinyu http://orcid.org/0000-0001-7703-4901
Mosli, Mahmoud H. http://orcid.org/0000-0002-6975-1297
Allegretti, Jessica R. http://orcid.org/0000-0002-1175-1024
Clinical trials referenced in this document:
Documents that mention this clinical trial
PTU-001 Tofacitinib, an oral jak inhibitor, in the treatment of ulcerative colitis: open-label, long-term extension study
https://doi.org/10.1136/gutjnl-2018-bsgabstracts.123
Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance
https://doi.org/10.1136/ard-2022-223715
Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs
https://doi.org/10.1007/s40744-022-00507-z
Next generation of small molecules in inflammatory bowel disease
https://doi.org/10.1136/gutjnl-2016-312912
Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program
https://doi.org/10.1007/s40271-022-00603-w
Impact of Concomitant Corticosteroids on Tofacitinib Induction Efficacy and Infection Rates in Ulcerative Colitis
https://doi.org/10.1007/s10620-022-07794-0
Documents that mention this clinical trial
PTU-001 Tofacitinib, an oral jak inhibitor, in the treatment of ulcerative colitis: open-label, long-term extension study
https://doi.org/10.1136/gutjnl-2018-bsgabstracts.123
Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance
https://doi.org/10.1136/ard-2022-223715
Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs
https://doi.org/10.1007/s40744-022-00507-z
Next generation of small molecules in inflammatory bowel disease
https://doi.org/10.1136/gutjnl-2016-312912
Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program
https://doi.org/10.1007/s40271-022-00603-w
Impact of Concomitant Corticosteroids on Tofacitinib Induction Efficacy and Infection Rates in Ulcerative Colitis
https://doi.org/10.1007/s10620-022-07794-0
Documents that mention this clinical trial
PTU-001 Tofacitinib, an oral jak inhibitor, in the treatment of ulcerative colitis: open-label, long-term extension study
https://doi.org/10.1136/gutjnl-2018-bsgabstracts.123
Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance
https://doi.org/10.1136/ard-2022-223715
Tofacitinib as a maintenance therapy in patients with ulcerative colitis stratified by OCTAVE Sustain baseline Mayo endoscopic subscore
https://doi.org/10.1186/s12876-022-02508-2
Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs
https://doi.org/10.1007/s40744-022-00507-z
Next generation of small molecules in inflammatory bowel disease
https://doi.org/10.1136/gutjnl-2016-312912
Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program
https://doi.org/10.1007/s40271-022-00603-w
AODWE-004 Maintenance of quality of life improvement in a phase 3 study of tofacitinib for patients with moderately to severely active ulcerative colitis
https://doi.org/10.1136/gutjnl-2017-314472.239
Documents that mention this clinical trial
PTU-001 Tofacitinib, an oral jak inhibitor, in the treatment of ulcerative colitis: open-label, long-term extension study
https://doi.org/10.1136/gutjnl-2018-bsgabstracts.123
Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance
https://doi.org/10.1136/ard-2022-223715
Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs
https://doi.org/10.1007/s40744-022-00507-z
Next generation of small molecules in inflammatory bowel disease
https://doi.org/10.1136/gutjnl-2016-312912
Long-Term Improvement in the Patient-Reported Outcomes of Rectal Bleeding, Stool Frequency, and Health-Related Quality of Life with Tofacitinib in the Ulcerative Colitis OCTAVE Clinical Program
https://doi.org/10.1007/s40271-022-00603-w
Funding for this research was provided by:
Pfizer
Article History
Accepted: 20 September 2022
First Online: 7 November 2022
Declarations
:
: This study was sponsored by Pfizer. Medical writing support was funded by Pfizer Inc.
: David P. Hudesman has received research support from Janssen and Pfizer Inc; consulting fees from UCB; and personal fees from AbbVie, Bristol-Myers Squibb, Janssen, Pfizer Inc, Samsung, and Takeda. Joana Torres has received advisory board fees from Arena, Galapagos, Janssen, and Pfizer Inc; research support from AbbVie and Janssen; and lecture fees from Galapagos and Janssen. Leonardo Salese, John C. Woolcott, Rajiv Mundayat, and Chinyu Su are employees and stockholders of Pfizer Inc. Mahmoud H. Mosli has received research support from Takeda; and lecture fees from AbbVie, Hikma, Janssen, Pfizer Inc, and Takeda. Jessica R. Allegretti has received consulting fees from Artugen, Bacainn, Bristol-Myers Squibb, Celgene, Finch Therapeutics, Iterative Scopes, Janssen, Morphic, Pandion, and Pfizer Inc; and research support from Merck.
: Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See for more information.
: All studies were conducted in compliance with the Declaration of Helsinki and the International Council for Harmonisation Good Clinical Practice Guidelines. Study protocols were approved by the Institutional Review Boards and/or independent Ethics Committees at each of the investigational centers participating in the studies, or a central Institutional Review Board.
: All patients provided written informed consent.
: Not applicable.
: LS, JCW, RM, and CS contributed to the design of the post hoc analyses. RM performed the statistical analysis of the data. All authors contributed to the drafting and editing of the manuscript, and approved the final version of the article, including the authorship list.