Honap et al. UC Study | Xeljanz® (tofacitinib citrate)

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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.

Honap et al: Effectiveness of XELJANZ (tofacitinib citrate) in patients with biologic-refractory UC

Real World Evidence for Ulcerative Colitis

Study Design

Study Results

StudyDesign¹

Study Objective¹

Honap S, et al carried out an observational, retrospective study to which was conducted to evaluate the effectiveness and adverse events of tofacitinib, and the factors associated with tofacitinib treatment failure, in patients with UC in a real-world cohort¹.

This study was not sponsored by Pfizer.

Study Population¹

134 patients with moderate–severe UC from four UK tertiary referral IBD centers (Guy’s and St Thomas’, King’s College, Oxford University, Royal Devon and Exeter)

Biologic-refractory (83%)‡
- 83% of patients had received prior biologic therapy
- 44% had received an anti-TNF only, 3% had received vedolizumab only and 36% had received both

Baseline characteristics

	XELJANZ (N=134)
Male sex, n (%)	86 (64)
Age (years), median (range)	37 (16-81*)
Montreal E3† (extensive disease or pancolitis), n (%)	66 (49)
Disease duration (years), median (IQR)	5.5 (2.2-12.0)
Baseline corticosteroid treatment, n (%)	68 (45)

Tofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
*In total, 4 patients were under 18 in this study (One 16 year old and three 17 year olds)

Study method

Retrospective, observational cohort study, with a duration of 6 months (26 weeks)
Disease activity was assessed using the SCCAI or PMS depending on the study site^‡¶
Clinical response: reduction in SCCAI or PMS of ≥3
Clinical remission: SCCAI ≤2 or PMS ≤1
Corticosteroid-free remission: remission with no concurrent corticosteroid use at that time irrespective of baseline corticosteroid status

Study Endpoints

Effectiveness: Clinical response, clinical remission and corticosteroid-free remission at week 8, week 16 and week 26; disease activity at week 8, week 16 and week 26
Safety: Adverse events, lipid profile, lab parameters

Study Limitations

Small sample size limits the power of statistical analyses
Results may be affected by selection bias due to incomplete follow-up for all patients
Cross-site heterogeneity, given that no disease activity score (PMS, SCCAI^†) was used commonly across sites
No control or comparator population
Specific geographical population may not be representative of the worldwide population (eg, patient characteristics, healthcare access)
Efficacy outcomes are rated on the basis of clinical subjective assessment
Interpretation bias due to the retrospective design
Limited data on endoscopy

Scroll left to view table

StudyResults¹

Clinical response was observed in 74% (95% CI: 65%–81%) of patients taking XELJANZ at week 8
Clinical response was observed in 66% (95% CI: 56%–75%) at week 16
Clinical remission was observed in 51% (95% CI: 41%–61%) at week 16
Steroid-free remission was observed in 49% (95% CI: 39%–58%) of patients at week 16

Percentage of patients achieving: Response, Remission, Corticosteriod-free remission

Adapted from Honap S, et al. J Crohns Colitis. 2020;14(10):1385-1393

Explore More

Regulatory Updates for JAK inhibitors with James Galloway

Visit the page to gain more insight into the updated regulatory guidance on JAK inhibitors from an expert rheumatologist's perspective

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TOUR Registry

Learn more about real-world evidence in UC: TOUR Registry

CV=cardiovascular; JAK=Janus kinase; MTX=methotrexate; ORAL=Oral Rheumatoid Arthritis Trial; RA=rheumatoid arthritis; RCT=randomized controlled trial; RWE=real-world evidence; STAR-RA=Safety of TofAcitinib in Routine care patients with Rheumatoid Arthritis; US=United States; HR=hazard ratio; PS=propensity score; bDMARD=biologic disease-modifying antirheumatic drug; HZ=herpes zoster; IHD=ischemic heart disease; MI=myocardial infarction; MTX=methotrexate

References

1. Honap S, et al. J Crohns Colitis. 2020;14(10):1385-1393.

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-4565. May 2023

Real-World Evidence: UC

Honap S, et al.TOUR Registry

ORAL Surveillance study in Ulcerative Colitis | Professor Charlie Lees

In this video, Professor Charlie Lees, consultant gastroenterologist at the Edinburgh IBD Unit talks about the ORAL Surveillance study and its implications for the use of tofacitinib in the treatment of ulcerative colitis. He offers an overview of the study design and a summary of the results, before offering his own clinical interpretation and how this affects his prescribing decisions specifically with UC patients.

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