Use of tofacitinib as first or second-line therapy is associated with better outcomes in patients with ulcerative colitis: data from a real-world study

ABSTRACT

Background

Data regarding the real-world (RW) use of tofacitinib (TOF) in patients with ulcerative colitis (UC) are limited. We aimed to investigate TOF’s RW efficacy and safety in Italian UC patients.

Research design and methods

A retrospective assessment of clinical and endoscopic activity was performed according to the Mayo score. The primary endpoints were to evaluate the effectiveness and safety of TOF.

Results

We enrolled 166 patients with a median follow-up of 24 (IQR 8–36) weeks. Clinical remission was achieved in 61/166 (36.7%) and 75/166 (45.2%) patients at 8-week and 24-week follow-ups, respectively. The optimization was requested in 27 (16.3%) patients. Clinical remission was achieved more frequently when TOF was used as a first/second line rather than a third/fourth line treatment (p = 0.007). Mucosal healing was reported in 46% of patients at the median follow-up time. Colectomy occurred in 8 (4.8%) patients. Adverse events occurred in 12 (5.4%) patients and severe in 3 (1.8%). One case of simple Herpes Zoster and one of renal vein thrombosis were recorded.

Conclusions

Our RW data confirm that TOF is effective and safe in UC patients. It performs remarkably better when used as the first/second line of treatment.

KEYWORDS:

• Ulcerative colitis
• tofacitinib
• real life
• remission
• safety

Declaration of interest

A Tursi, G Mocci and A Papa have served as consultants for Janssen;

E Savarino has served as a speaker for AbbVie, AGPharma, Alfasigma, Dr Falk, EG Stada Group, Fresenius Kabi, Grifols, Janssen, Innovamedica, Malesci, Pfizer, Reckitt Benckiser, Sandoz, SILA, Sofar, Takeda, Unifarco; has served as consultant for Alfasigma, Amgen, Biogen, Bristol-Myers Squibb, Celltrion, Diadema Farmaceutici, Dr Falk, Fresenius Kabi, Janssen, Merck & Co, Reckitt Benckiser, Regeneron, Sanofi, Shire, SILA, Sofar, Synformulas GmbH, Takeda, Unifarco; he received research support from Pfizer, Reckitt Benckiser, SILA, Sofar, Unifarco.

G Maconi has served as speaker and/or advisory board fees for AlfaSigma, Arena, Janssen, Gilead, Roche.

D Pugliese received speaker fees from AbbVie, MSD, Takeda, Janssen, and Pfizer;

Fr S has served as lecturer for Sanofi.

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

Conception and design: A. Tursi, G. Mocci, and A. Papa;

Collection of data: A. Tursi, G. Mocci, L. Cingolani, E. Savarino, R. Pica, A. Cocco, M. Zippi, D. Napolitano, E. Schiavoni, D. Pugliese, F. Scaldaferri, F. Costa, M. Marzo, M. Serio, A. Scarcelli, L. Bolognini, E. Bendia, G. Maconi, R. Cannatelli, S. Piergallini, G. Bodini, F. Calabrese, A. Ferronato, G. Pranzo, W. Elisei, R. Monterubbianesi, R. Faggiani, S. Rodinò, L. Sebkova, L. Grossi, F. Gaiani, G. dè Angelis, R. Lorenzetti, L. Allegretta, A.I. Cazzato, S. Scorza, N. Della Valle, R. Sacco, G. Forti, R. Colucci, P. Tonti, V. Neve, G. Rocco, C. Sacchi, C. Zampaletta, C. Pagnini, M.G. Graziani, M.C. Di Paolo, F.M. Onidi, P. Usai Satta and A. Papa.

Analysis and interpretation of data: A. Tursi, G. Mocci, E. Savarino, W. Elisei, M. Picchio, and A. Papa;

Final approval of the version to be published: A. Tursi, G. Mocci, L. Cingolani, E. Savarino, R. Pica, A. Cocco, M. Zippi, D. Napolitano, E. Schiavoni, D. Pugliese, F. Scaldaferri, F. Costa, M. Marzo, M. Serio, A. Scarcelli, L. Bolognini, E. Bendia, G. Maconi, R. Cannatelli, S. Piergallini, G. Bodini, F. Calabrese, A. Ferronato, G. Pranzo, W. Elisei, R. Monterubbianesi, R. Faggiani, S. Rodinò, L. Sebkova, L. Grossi, F. Gaiani, G. dè Angelis, R. Lorenzetti, L. Allegretta, A.I. Cazzato, S. Scorza, N. Della Valle, R. Sacco, G. Forti, R. Colucci, P. Tonti, V. Neve, G. Rocco, C. Sacchi, C. Zampaletta, C. Pagnini, M.G. Graziani, M.C. Di Paolo, F.M. Onidi, P. Usai Satta, M. Picchio, and A. Papa

Additional information

Funding

This paper was not funded.