TOUR registry | Xeljanz® (tofacitinib citrate)

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Adverse event reporting can be found at the bottom of the page

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XELJANZ® (tofacitinib citrate) Prescribing Information and Maxtrex (methotrexate) Prescribing Information. Adverse event reporting can be found at the bottom of the page.

Tofacitinib should only be used if no suitable treatment alternatives are available in patients:

65 years of age and older;
patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers);
patients with malignancy risk factors (e.g. current malignancy or history of malignancy)

These risks are considered class effects and relevant across all approved indications of JAKi in inflammatory and dermatologic diseases.

TOUR registry: Long MD, et al.

Real World Evidence for Ulcerative Colitis

Study Design

Study Results

StudyDesign¹

Study Objective¹

TOUR focuses on patient reported outcomes, including the SCCAI, evaluating bowel frequency, urgency and rectal bleeding, and the NIH PROMIS domains of anxiety, depression, and social satisfaction to evaluate the onset of symptom improvement
To describe the onset of clinical response and remission during the induction therapy based on PROs, including urgency and incontinence

The TOUR registry is funded by Pfizer.

Study Population¹

The TOUR study is a prospective cohort study conducted in 14 sites across the US (NCT03772145)
Adult patients with moderate to severe UC were enrolled (February 2019) if there was an intent to start XELJANZ

Sample: 96 patients initiated XELJANZ

Inclusion criteria:

>18 years old
Diagnosis of UC
On XELJANZ therapy in the setting of SOC therapy
Anticipation that the patient will be followed by the participating center for ≥12 months

Exclusion criteria:

Inability to use English language
Lack of internet access

Baseline characteristics

	XELJANZ (N=96)
Age (years), mean (range)	37.3 (18-76)
Male sex, n (%)	54 (56.3)
Disease duration (years), mean (range)	8.5 (0-50)
BMI (kg/m2), mean (range)	25.4 (14.8-43.9)
White, n (%)	81 (84.4)
Current smoker, n (%)	2 (2.1)
Montreal E3 (pancolitis), n (%)	50 (52)
Prior use of TNFi, n (%)	91 (94.8)
Prior use of ≥2 TNFi, n (%)	33 (34.4)
Prior use of ≥2 biologics, n (%)	64 (66.7)
Prior vedolizumab use, n (%)	56 (58.3)
Mayo endoscopy† score <3, n (%)	43 (44.8)
SCCAI>2, n (%)	78 (81.3)

Study method

A web-based platform was used to collect all patient-related information, daily PROs, and other study questionnaires
Specific questionnaires were sent electronically to the participating patients initially daily for 14 days after the start of XELJANZ and at days 28 and 56
The questionnaires included the SCCAI and PROMIS symptom scales for depression, anxiety, and social satisfaction
The SCCAI includes 6 variables: bowel frequency during the day and night, urgency of defecation, blood in the stool, general well-being, and extracolonic manifestations of UC
Daily SCCAI stool frequency, rectal bleeding, and urgency subscores were calculated based on the daily web-based diary entry
Changes from baseline in each of the subscores, day and night bowel frequency, urgency, and rectal bleeding were evaluated during the first 14 days of therapy and at day 28 and day 56
PROMIS symptom scales were collected at the start of therapy and days 14, 28, and 56

Study Endpoints

Primary outcome: Clinical response to therapy at day 56 defined by an SCCAI score of <5

Secondary outcome: clinical response to therapy defined by an SCCAI score of ≤2

Other outcomes: AEs including new onset of shingles, infections resulting in the need for antibiotic therapy, hospitalizations, and UC-related surgeries

Study Limitations

Potential selection bias may have occurred because patients were required to have access to the internet for the data entries
CRP or calprotectin data were not captured, as they may have not been measured in a standardized fashion before the start of the therapy
Due to the pragmatic approach of TOUR registry in most cases, endoscopic evaluations were performed up to 6 months before start of XELJANZ therapy, limiting the evaluation of the impact of mucosal inflammation on study outcomes
Endoscopy was not required to confirm the status of remission. However, the SCCAI has been shown to correlate well with endoscopic disease activity and steroid-free clinical response and remission are clinically relevant end points
No control or comparator population; improvements on PROs may have been attributed to the possibility of regression towards the mean and placebo effect
Specific geographical population may have not been representative of the worldwide population (eg, patient characteristics and healthcare access)
Efficacy outcomes were rated on the basis of clinical subjective assessment
The short duration of the induction period limited ability to draw conclusions
Exact definitions of disease severity were still in development at time of study publication
Time since previous line of therapy was not mentioned; the washout period could have been different between patients
If XELJANZ was discontinued, the reason for discontinuation was captured and patients were censored at that time as not having completed the full treatment
Potential selection bias may have occurred because patients were required to have access to the internet for the data entries
CRP or calprotectin data were not captured, as they may have not been measured in a standardized fashion before the start of the therapy
Due to the pragmatic approach of TOUR registry in most cases, endoscopic evaluations were performed up to 6 months before start of XELJANZ therapy, limiting the evaluation of the impact of mucosal inflammation on study outcomes
Endoscopy was not required to confirm the status of remission. However, the SCCAI has been shown to correlate well with endoscopic disease activity and steroid-free clinical response and remission are clinically relevant end points
No control or comparator population; improvements on PROs may have been attributed to the possibility of regression towards the mean and placebo effect
Specific geographical population may have not been representative of the worldwide population (eg, patient characteristics and healthcare access)
Efficacy outcomes were rated on the basis of clinical subjective assessment
The short duration of the induction period limited ability to draw conclusions
Exact definitions of disease severity were still in development at time of study publication
Time since previous line of therapy was not mentioned; the washout period could have been different between patients
If XELJANZ was discontinued, the reason for discontinuation was captured and patients were censored at that time as not having completed the full treatmen

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StudyResults¹

In the TOUR prospective real-world study, tofacitinib resulted in a rapid and persistent improvement in UC disease activity PROs. The safety findings were consistent with the established safety profile of tofacitinib.

XELJANZ therapy resulted in stable response and remission rates UP TO day 56 in the whole cohort¹

Patients with higher disease activity at baseline had lower rates of CS-free response and remission with XELJANZ treatment¹

Mean SCCAI and its components decreased significantly from day 3 of XELJANZ initiation through to day 56 (induction period) compared with baseline¹

‡ Significance level compared with baseline

Improvement of patient-reported daily bowel frequency, bleeding, and urgency¹

Adapted from Long MD, et al. 2022.

In the TOUR Registry, mild to moderate adverse events occured in approximately 10% of Xeljanz-treated patients during the induction period¹

Table adapted from Long MD, et al. 2022.

†2 of 3 patients (66.7%) had been vaccinated with shingles vaccine (Shingrix®).

Explore More

Read about efficacy studies in UC

OCTAVE Induction 1 and 2 were two identical studies of patients with moderately to severely active disease to assess the efficacy and safety of XELJANZ in inducing remission

Go to study page

SCCAI = Simple Clincal Activity Index; SOC = standard of care; PROMIS = Patient-Reported Outcomes Measurement Information System; PRO = patient reported outcome; AE = adverse events; TOUR =The Tofacitinib Response in UC

References

1. Long MD, et al. Inflamm Bowel Dis. 2022; doi: 10.1093/ibd/izac121.

XELJANZ Risk Minimisation Programme (RMP) materials, including a Patient Alert Card, Prescriber Checklists and a Prescriber Brochure are available from https://www.medicines.org.uk/emc/. Patients treated with XELJANZ should be given the Patient Alert Card.

PP-XEL-GBR-4566. May 2023

Real-World Evidence: UC

Honap S, et al.TOUR registry

COVID-19 and Ulcerative Colitis (UC) Podcast

In this podcast Dr Peter Irving and Professor James Lindsay examine how COVID-19 has affected the management of Ulcerative Colitis (UC).

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