Tofacitinib in the treatment of ulcerative colitis
ÖGGH · 2022 · Austria
Source and licence
- Authors
- Maximilian Kutschera, Gottfried Novacek, Walter Reinisch et al.
- Title
- Tofacitinib in the treatment of ulcerative colitis
- Journal
- Wiener Klinische Wochenschrift, 2022
- Licence
- CC BY 4.0
- Changes
- Verbatim excerpts; formatting adapted
Full text retrieved 2026-10-27 from Europe PMC · PMC9713195
Licence statement of the original publication
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This page reproduces excerpts of the original publication; the original is authoritative. It has not been reviewed by a physician, does not state a recommendation of Medelix and does not replace medical advice. The guideline may have been updated since.
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Recommendations
Verbatim, with grade of recommendation or strength of consensus where given.
Efficacy in OCTAVE Induction 1 and 2
- Recommendation 1The recommended tofacitinib dosage in UC induction treatment is 10 mg b.i. d. over 8 weeks.
Non-response at week 8 of induction treatment
- Recommendation 2In patients, in whom no sufficient treatment success is determined by week 8 of induction treatment with tofacitinib 10 mg b.i. d., the induction dose of 10 mg b.i. d. can be extended by another 8 weeks (i.e. 16 weeks in total).
- Recommendation 3Treatment success and decisions regarding continued or discontinued tofacitinib therapy should be evaluated after 8–16 weeks. In the event of treatment response and concomitant corticosteroid treatment, cortisone is to be gradually reduced.
Sustained response in long-term treatment
- Recommendation 4Maintenance therapy with tofacitinib 10 mg b.i. d. is to be as short as possible. In the event of clinical and biomarker remission under 10 mg b.i. d., the attempt should be made to reduce the dosage to 5 mg b.i. d.
Dose escalation in OCTAVE Open after loss of response in OCTAVE Sustain
- Recommendation 5A tofacitinib dose increase to 10 mg b.i. d. can improve response in patients who lost response after switching to maintenance therapy with tofacitinib 5 mg b.i. d.
Time to loss of efficacy after treatment discontinuation and response after treatment resumption
- Recommendation 6Renewed induction treatment with tofacitinib 10 mg b.i. d. can be given in the event of treatment discontinuation and loss of response.
Severe infections
- Recommendation 7The risk-benefit profile of tofacitinib treatment is to be carefully examined in older patients and those at an increased risk of infection, e.g., diabetes mellitus.
Opportunistic infections
- Recommendation 8Opportunistic infections under tofacitinib are possible. In the event of pneumonia, consideration should be given to the presence of atypical pathogens.
Herpes zoster infections
- Recommendation 9As tofacitinib treatment leads to a dose-dependent increase in the risk for HZ, a prophylactic vaccination is recommended.
Vaccinations
- Recommendation 10Shingrix®, the first inactivated vaccine against HZ infections, was approved in Europe in 2018 [20]. Serological testing for anti-varicella zoster virus (VZV) antibodies is not required when applying this vaccine. Shingrix® can also be applied under ongoing tofacitinib treatment.
- Recommendation 11Live-attenuated vaccines are not to be applied concomitantly with tofacitinib [1]. These vaccines are to be given at least 4 weeks prior to tofacitinib treatment or in accordance with the current vaccination recommendations regarding the administration of immunomodulating agents.
Malignoma
- Recommendation 12In patients with a previous cancerous condition (excluding successfully treated non-melanoma skin cancer), the risks and benefits of tofacitinib treatment are to be considered prior to treatment. Patients under ongoing treatment for malignant disease are not to be treated with tofacitinib.
VTE risk under tofacitinib in ulcerative colitis
- Recommendation 13In patients with UC and known risk factors for VTEs, tofacitinib is to be applied with caution regardless of dosage (see also Recommendations 4 and 5). Over the course of tofacitinib treatment, patients are to be informed upfront and regularly about changes and early symptoms, such as swelling, pressure pain, etc., of the VTE risk.
Lymphocytes, neutrophils and hemoglobin
- Recommendation 14Lymphocytes, neutrophils and hemoglobin are to be controlled at baseline, after week 2 and week 6 of treatment and subsequently every 3 months. In dose-related abnormal laboratory results, such as lymphopenia, neutropenia and anemia, dose reduction or treatment discontinuation may become necessary.
Lipid values
- Recommendation 15Blood lipid levels are to be examined at certain time points after beginning treatment with tofacitinib. Statin treatment can be applied to lower elevated total cholesterol and LDL values in connection with tofacitinib to pretreatment levels [1].
Hepatic and renal function
- Recommendation 16No dose adaptation of tofacitinib is required in mild and moderate renal dysfunction and the daily dosage is to be halved in severe kidney impairment. In patients requiring dialysis, the dosage is to remain reduced after hemodialysis [1]. No dose adaptation is required in mild hepatic dysfunction (Child-Pugh score A) and the daily dosage is to be halved in moderate liver impairment (Child-Pugh score B). Tofacitinib is not to be applied in severe hepatic dysfunction (Child-Pugh score C).
Pregnancy and lactation
- Recommendation 17The incidence of congenital deformities and spontaneous miscarriages in clinical studies with tofacitinib seems to be largely consistent with the background risk in the normal population; however, in view of the results of preclinical studies, the lack of controlled clinical studies and the scarcity of prospective registry data, patients under ongoing tofacitinib treatment are advised against pregnancy. Women of childbearing age are to apply a reliable method of contraception during their tofacitinib treatment and for at least 4 weeks after their last intake of tofacitinib.
Efficacy in clinical practice
- Recommendation 18The real-world data are consistent with the available data from approval studies with regard to the efficacy and safety of tofacitinib in patients with UC. Furthermore, the real-world data do not demonstrate an increased risk of cardiovascular and thromboembolic events.
Tofacitinib and COVID-19 in patients with ulcerative colitis
- Recommendation 19Tofacitinib does not imply an increased risk of COVID-19 infection or severe courses in the event of infection. Planned tofacitinib therapy is not to be postponed and ongoing treatment is not to be interrupted.
Abstract
Ulcerative colitis (UC) is one of the main forms of inflammatory bowel disease (IBD). Despite the widening range of drug treatment options, primary nonresponse, secondary loss of response as well as adverse events call for additional treatment alternatives.
Tofacitinib is an oral small-molecule drug of the class of Janus kinase inhibitors which, in the European Union, was approved for the treatment of moderate to severe active UC in August 2018. This position paper, drawn up by the IBD Working Group of the Austrian Society of Gastroenterology and Hepatology, summarizes the mechanism of action, clinical development, marketing authorization status, efficacy and safety of tofacitinib. Also, by providing a synopsis of available data from both pivotal and post-marketing studies, clinical aspects of specific interest are highlighted and discussed.
The available body of evidence indicates that tofacitinib is an additional effective medication for the treatment of UC that exhibits a good safety profile. This position paper aims at optimizing the safe and effective use of tofacitinib in daily clinical practice.
Contents of the original publication
The section headings of the original.
- Introduction
- Tofacitinib in ulcerative colitis: clinical trial program
- OCTAVE Induction 1 and 2
- OCTAVE Sustain
- OCTAVE Open
- Tofacitinib: efficacy in clinical studies
- Efficacy in OCTAVE Induction 1 and 2
- Pretreatment with TNF-alpha inhibitors
- Non-response at week 8 of induction treatment
- Efficacy in OCTAVE sustain
- Efficacy in OCTAVE Open
- Tofacitinib: safety in clinical studies
- General safety profile
- AEs of special interest
- Severe infections
- Malignoma
- Non-melanoma skin cancer
- Major adverse cardiovascular events
- Venous thromboembolic events (VTEs) under tofacitinib
- Mortality
- Treatment management
- Monitoring of laboratory parameters
- Lipid values
- Hepatic and renal function
- Pregnancy and lactation
- Real-world experiences
- Efficacy in clinical practice
- Tofacitinib and COVID-19 in patients with ulcerative colitis
- Conclusion
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