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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:
These risks are considered class effects and relevant across all approved indications of JAKi in inflammatory and dermatologic diseases.
Tursi, et al carried out an observational, retrospective, multicenter study which was conducted to investigate the effectiveness and safety of XELJANZ in UC patients in Italy1.
This study was not sponsored by Pfizer.
166 patients who completed at least XELJANZ induction treatment between September 1, 2021 and October 1, 2022 were included.
Inclusion criteria:
Adult patients with an established UC diagnosis based on standard endoscopic, radiology, and histological criteria
Patients presented with moderate-to-severe active UC
| XELJANZ (N=166) |
|
| Male sex, n (%) | 98 (59.0) |
| Median age at diagnosis, years (IQR) | 42 (39–45) |
| Median disease duration prior to XELJANZ, years (IQR) | 8 (7–10) |
| Current smokers, n (%) | 24 (14.5) |
| Presence of comorbidities, n (%) | 61 (36.7) |
| Presence of rheumatoid diseases, n (%) | 10 (6.0) |
| Median Mayo score (IQR) | 7 (7–8) |
| Median Mayo endoscopic score (IQR) | 3 (3–3) |
| Extent of disease, n (%): | |
| Proctitis | 6 (3.6) |
| Left-sided colitis(distal colitis included) | 58 (34.9) |
| Pancolitis | 102 (61.4) |
| Indications for therapy with XELJANZ, n (%): | |
| Naïve patients (first line) | 6 (3.6) |
| Failure of anti-TNFα treatment (second line) |
71 (42.8) |
| Failure of anti-TNFα plus anti-integrin or anti-IL 12/23 treatment (third line) |
75 (45.2) |
| Failure of anti-TNFα plus anti-integrin plus anti-IL 12/23 treatment (fourth line) |
14 (8.4) |
| Median creatine phosphokinase level, UI/L (IQR) | 97.5 (80.0–121.0) |
| Median cholesterol level, mg/dL (IQR) | 176.0 (157.5–196.0) |
| Median LDL level, mg/dL (IQR) | 105.0 (79.7–128.5) |
| Median triglycerides level, mg/dL (IQR) | 112.0 (85.0–145.0) |
| Median CRP, mg/L (IQR) | 7 (5–8) |
| Median calprotectin, µg/g (IQR) | 821 (670–900) |
Continuous non-parametric variables were examined as median (IQR)
Categorical variables were examined as numbers (%)
Chi-square test was used to compare categorical variables
Mann-Whitney test was used for continuous variables
Due to varying lengths of follow-up, the predictive value of clinical parameters was assessed using time-to-event methods for censored observations
The duration of follow-up was calculated from the date of starting therapy to the date of the event or censorship
Time-to-event analysis used Kaplan-Meier estimates for the cumulative incidence curves
P-values of <0.05 were considered to be statistically significant
Specific geographic population may not be representative of the worldwide population (e.g., patient characteristics, healthcare access)
There is no control or comparator population
In a retrospective, observational, multicenter study of UC patients in Italy receiving XELJANZ treatment (N=166), with a median follow-up of 24 weeks:
36.7% of patients achieved clinical remission at week 8 follow-up
Clinical remission was maintained by 45.2% of patients at the end of follow-up
Clinical remission was obtained by:
- 66.7% of patients naïve to biologic therapy (first-line therapya)
- 52.1% of patients who failed one or more anti-TNFα treatment (second-line therapya)
- 41.3% of patients who failed anti-TNFα and anti-integrin or anti-IL 12/23 treatment (third-line therapya)
- 21.4% of patients who failed anti-TNFα, anti-integrin and anti-IL 12/23 treatment (fourth-line therapya)
Lines of therapy may be predictors for clinical remission
a: XELJANZ treatment was defined as first-, second-, third- or fourth-line therapy in this study. XELJANZ is categorised as first-line therapy when administered to biologic-naïve patients. In cases where patients exhibit resistance or refractoriness to steroids or have previously failed one or more anti-TNF-α treatments, XELJANZ is considered as second-line therapy. As for patients who have failed anti-TNF-α and anti-integrin or anti-IL12/23 treatments, XELJANZ is classified as third-line therapy. Finally, in situations where patients have experienced failure with anti-TNF-α, anti-integrin, and anti-IL12/23 treatments, XELJANZ is categorised as fourth-line therapy1.
Adapted from Tursi A, et al. Expert Opin Pharmacother. 2023:1–8.
- In none (0) of the patients treated with XELJANZ as first-line therapyf
- In 9/27 (33.3%) patients treated as second linef
- In 14/27 (51.9%) patients treated as third-linef
- In 4/27 (14.8%) patients treated as fourth-line therapyf, (p=0.294, not statistically significant)
a: Mucosal healing was defined as a Mayo subscore for endoscopy ≤11.
b: P<0.0001.
c: Mayo score 01.
d: Optimisation rate was considered as the persistence on 10 mg BID up to 8 weeks following the 8-week induction course, or increased from 5 mg to 10 mg BID during follow-up1.
e: XELJANZ was used in 12/27 (44.4%) patients resistant/refractory to steroid therapy1.
f: XELJANZ treatment was defined as first-, second-, third- or fourth-line therapy in this study. XELJANZ is categorised as first-line therapy when administered to biologic-naïve patients. In cases where patients exhibit resistance or refractoriness to steroids or have previously failed one or more anti-TNF-α treatments, XELJANZ is considered as second-line therapy. For patients who have failed anti-TNF-α and anti-integrin or anti-IL12/23 treatments, XELJANZ is classified as third-line therapy. Finally, in situations where patients have experienced failure with anti-TNF-α, anti-integrin, and anti-IL12/23 treatments, XELJANZ is categorised as fourth-line therapy1.
- A statistically significantf,g mild and transient increase of CPK levels was observed during the study period: from a median value of 97.5 (80.0-121.0) UI/L at baseline to 128 (90.0-178.7) UI/L at week 8 and 119 (97.7-151.5) UI/L at 16-week follow-up
a: A single dermatome was involved, and the infection resolved within four weeks1.
b: This patient did not receive the herpes zoster vaccine, which was largely embraced by the population, with >95% enrollment, following the introduction of the recombinant vaccine in Italy in March 20211.
c: Two cases of gastrointestinal infection were Clostridioides difficile and Campylobacter coli. Both cases were treated with oral antibiotic therapy without XELJANZ discontinuation1.
d: This case of renal vein thrombosis occurred in a 19-year-old female patient with a long-lasting history of steroid-resistant pancolitis, failure to infliximab and vedolizumab, and under concomitant treatment with azathioprine 100 mg and corticosteroids. This AE occurred after approximately seven weeks of XELJANZ therapy and was associated with severe clinical worsening of her colitis and hospitalisation. It resolved after initiating anticoagulation therapy, and no further complications occurred after discharge1.
e: Two patients treated with statins, one with a low-fat diet, and one with nutraceutical treatment1.
f: Friedman test1
g: P<0.0061
Visit the page to gain more insight into the updated regulatory guidance on JAK inhibitors from an expert rheumatologist's perspective
Learn more about real-world evidence in UC: TOUR Registry
UC: ulcerative colitis; IQR:Interquatile range; anti-IL=anti-interleukin; anti-TNFα=anti-tumor necrosis factor alpha; CRP=C-reactive protein; LDL=low-density lipoprotein; AE: Adverse Event; CPK=creatine phosphokinase; MACE=major cardiovascular adverse events; VTE=venous thrombosis event.
References
1. Tursi, A, et al. Expert Opinion on Pharmacotherapy, 24(14), 1649–1656.
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