N/A
Completed N=110
Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients
Source: ClinicalTrials.gov NCT04071405 ↗Enrolled (actual)
110
Serious AEs
7.5%
Results posted
Sep 2024
Primary outcomePrimary: Percentage of Participants With Adverse Events, Adverse Drug Reactions, Serious Adverse Events and Serious Adverse Drug Reactions — 40.19; 24.30; 7.48; 0.93 Percentage of participants
Summary
As required for new medications approved by the Ministry of Food and Drug Safety, safety and efficacy information should be provided for a minimum of 90 patients treated in the setting of routine practice during 4 years following approval (until 19 September 2022). Out of all the enrolled patients, at least 18 cases (20%) will be followed up until the 52nd week to see the long term safety of Xeljanz.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events, Adverse Drug Reactions, Serious Adverse Events and Serious Adverse Drug Reactions |
40.19; 24.30; 7.48; 0.93 | — |
| PRIMARY Number of Participants With Adverse Events, Adverse Drug Reactions, Serious Adverse Events and Serious Adverse Drug Reactions in Long Term Users |
27; 18; 3; 0 | — |
| PRIMARY Percentage of Participants With Unexpected Adverse Events (AE), Unexpected Adverse Drug Reactions, Unexpected Serious Adverse Events (SAE), and Unexpected Serious Adverse Drug Reactions |
22.43; 12.15; 3.74; 0 | — |
| PRIMARY Number of Participants With Unexpected Adverse Events, Unexpected Adverse Drug Reactions, Unexpected Serious Adverse Events, and Unexpected Serious Adverse Drug Reactions in Long Term Users |
13; 9; 1; 0 | — |
| PRIMARY Percentage of Participants With Adverse Events of Special Interest |
1.87 | — |
| PRIMARY Number of Participants With Adverse Events of Special Interest in Long Term Users |
2 | — |
| PRIMARY Number of Participants With Adverse Events by Their Severity |
35; 11; 4 | — |
| PRIMARY Number of Participants With Adverse Events by Their Severity in Long Term Users |
24; 4; 1 | — |
| PRIMARY Number of Participants With Adverse Events by Their Outcomes |
33; 0; 13; 6; 1 | — |
| PRIMARY Number of Participants With Adverse Events by Their Outcomes in Long Term Users |
21; 0; 7; 3; 1 | — |
| PRIMARY Number of Participants With Adverse Events by Their Seriousness |
0; 0; 8; 0; 0; 0 | — |
| PRIMARY Number of Participants With Adverse Events by Their Seriousness in Long Term Users |
0; 0; 3; 0; 0; 0 | — |
| PRIMARY Number of Participants With Adverse Events by Action Taken |
8; 2; 2; 3; 35; 1 | — |
| PRIMARY Number of Participants With Adverse Events by Action Taken in Long Term Users |
0; 0; 1; 2; 26; 0 | — |
| PRIMARY Number of Participants With Adverse Events by Their Causality Assessment |
1; 0; 9; 22; 6; 13 | — |
| PRIMARY Number of Participants With Adverse Events by Their Causality Assessment in Long Term Users |
0; 0; 4; 11; 5; 11 | — |
| PRIMARY Number of Participants With Adverse Events by Their Other Causality Assessment |
13; 5; 2; 5 | — |
| PRIMARY Number of Participants With Adverse Events by Their Other Causality Assessment in Long Term Users |
6; 3; 1; 2 | — |
| SECONDARY Mayo Index, Mayo Score and Partial Mayo Score at Baseline, Week 8, Week 16 and Week 24 |
2.41; 1.57; 2.15; 2.56; 8.64; 6.13 | — |
| SECONDARY Mayo Index, Mayo Score and Partial Mayo Score at Week 8, Week 16, Week 24 and Week 52 for Long Term Users |
2.38; 1.48; 2.08; 2.55; 8.5; 5.95 | — |
| SECONDARY Number of Participants With Mucosal Healing at Week 8, Week 16 and Week 24 |
5; 2; 37; 27; 2; 0 | — |
| SECONDARY Number of Participants With Mucosal Healing at Week 8, Week 16, Week 24 and Week 52 for Long Term Users |
2; 0; 25; 16; 1; 0 | — |
| SECONDARY Number of Participants With Remission at Week 8, Week 16 and Week 24 |
34; 52; 42; 49; 34; 26 | — |
| SECONDARY Number of Participants With Remission at Week 8, Week 16, Week 24 and Week 52 for Long Term Users |
23; 25; 31; 28; 29; 18 | — |
| SECONDARY Number of Participants With Clinical Response at Week 8, Week 16 and Week 24 |
78; 22; 88; 12; 57; 43 | — |
| SECONDARY Number of Participants With Clinical Response at Week 8, Week 16, Week 24 and Week 52 for Long Term Users |
45; 15; 58; 2; 46; 14 | — |
| SECONDARY Number of Participants According to Final Effectiveness Evaluation by Investigator |
90; 9; 2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Adult ulcerative colitis patients with moderately to severely active disease who has received at least 1 dose of Xeljanz according to the local labeling
Exclusion Criteria
- Patients meeting any of the following criteria as per local labeling will not be included in the study.
- Patients with a history of hypersensitivity to any ingredients of this product.
- Patients with serious infection (sepsis, etc.) or active infection including localized infection.
- Patients with active tuberculosis.
- Patients with severe hepatic function disorder.
- Patients with an absolute neutrophil count (ANC) <1,000 cells/mm3.
- Patients with a lymphocyte count <500 cells/mm3.
- Patients with a hemoglobin level <9 g/dL.
- Pregnant or possibly pregnant women.
- Because of lactose contained in this drug, it should not be administered to patients with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.
Data sourced from ClinicalTrials.gov (NCT04071405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.