NCT04071405

Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients

Completed Results posted Last updated 3 September 2024

What this trial tests

trial testing Non-intervention in Ulcerative Colitis in 110 participants. Completed in 26 September 2022.

Timeline

12 May 2020

Primary endpoint
26 September 2022

26 September 2022

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	110
Start date	12 May 2020
Primary completion	26 September 2022
Estimated completion	26 September 2022
Sites	1 location across South Korea

Drugs / interventions tested

• Non-intervention (non-intervention) — full drug profile →

Conditions studied

• Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Adverse Events, Adverse Drug Reactions, Serious Adverse Events and Serious Adverse Drug Reactions Primary · From first dose of Xeljanz until 52 weeks

An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product which need not necessarily have causal relationship with product treatment or usage. Serious adverse event was any adverse event that resulted in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Adverse drug reaction (ADR) was any untoward medical occurrence attributed to Xeljanz. Serious ADR: any ADR resulting in any of fo

Adverse events

Group	Value	95% CI
Tofacitinib	40.19	30.82 – 50.11

Adverse drug reactions

Group	Value	95% CI
Tofacitinib	24.30	16.53 – 33.54

Serious adverse events

Group	Value	95% CI
Tofacitinib	7.48	3.28 – 14.20

Serious adverse drug reactions

Group	Value	95% CI
Tofacitinib	0.93	0.02 – 5.10

Number of Participants With Adverse Events, Adverse Drug Reactions, Serious Adverse Events and Serious Adverse Drug Reactions in Long Term Users Primary · From first dose of Xeljanz until 52 weeks

An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product which need not necessarily have causal relationship with product treatment or usage. A serious adverse event was any adverse event that resulted in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Xeljanz. Serious ADR: any ADR resulting in any

Adverse events

Group	Value	95% CI
Tofacitinib	27

Adverse drug reactions

Group	Value	95% CI
Tofacitinib	18

Serious adverse events

Group	Value	95% CI
Tofacitinib	3

Serious adverse drug reactions

Group	Value	95% CI
Tofacitinib	0

Percentage of Participants With Unexpected Adverse Events (AE), Unexpected Adverse Drug Reactions, Unexpected Serious Adverse Events (SAE), and Unexpected Serious Adverse Drug Reactions Primary · From first dose of Xeljanz until 52 weeks

Unexpected AE: any event that may be symptomatically, pathophysiologically related to event listed in labeling, but differed from labeled event because of greater severity or specificity. ADR: any untoward medical occurrence attributed to Xeljanz. All events that were not included in "Precautions for use" section of local product document were classified as "unexpected" adverse drug reactions. Serious ADR: any ADR resulting in any of following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant

Unexpected adverse events

Group	Value	95% CI
Tofacitinib	22.43	14.93 – 31.51

Unexpected adverse drug reactions

Group	Value	95% CI
Tofacitinib	12.15	6.63 – 19.88

Unexpected serious adverse events

Group	Value	95% CI
Tofacitinib	3.74	1.03 – 9.30

Unexpected serious adverse drug reactions

Group	Value	95% CI
Tofacitinib	0	0 – 0

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 Primary · From first dose of Xeljanz until 52 weeks

Unexpected AE: any event that may be symptomatically, pathophysiologically related to event listed in labeling, but differed from labeled event because of greater severity or specificity. ADR: any untoward medical occurrence attributed to Xeljanz. All events that were not included in "Precautions for use" section of local product document were classified as "unexpected" adverse drug reactions. Serious ADR: any ADR resulting in any of following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant

Unexpected adverse events

Group	Value	95% CI
Tofacitinib	13

Unexpected adverse drug reactions

Group	Value	95% CI
Tofacitinib	9

Unexpected serious adverse events

Group	Value	95% CI
Tofacitinib	1

Unexpected serious adverse drug reactions

Group	Value	95% CI
Tofacitinib	0

Percentage of Participants With Adverse Events of Special Interest Primary · From first dose of Xeljanz until 52 weeks

An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events of special interest were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. 95% CI was based on Clopper-Pearson method. This outcome measure is reported for all participants including long term users.

Group	Value	95% CI
Tofacitinib	1.87	0.23 – 6.59

Number of Participants With Adverse Events of Special Interest in Long Term Users Primary · From first dose of Xeljanz until 52 weeks

An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events of special interest were defined as serious or non-serious AEs which were of scientific and medical concern specific to the investigational product. This outcome measure was analyzed only in long term users.

Group	Value	95% CI
Tofacitinib	2

Number of Participants With Adverse Events by Their Severity Primary · From first dose of Xeljanz until 52 weeks

An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were categorized as per the severity: mild: did not cause any significant problem to the participant, administration of medicinal product continued without dose adjustment; moderate: caused a problem that did not interfere significantly with usual activities or the clinical status, dose of the medicinal product was adjusted or other therapy was added due to the AE; severe: caused a problem that

Mild

Group	Value	95% CI
Tofacitinib	35

Moderate

Group	Value	95% CI
Tofacitinib	11

Severe

Group	Value	95% CI
Tofacitinib	4

Number of Participants With Adverse Events by Their Severity in Long Term Users Primary · From first dose of Xeljanz until 52 weeks

An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were categorized as per the severity: mild: did not cause any significant problem to the participant, administration of medicinal product continued without dose adjustment; moderate: caused a problem that did not interfere significantly with usual activities or the clinical status, dose of the medicinal product was adjusted or other therapy was added due to the AE; severe: caused a problem that

Mild

Group	Value	95% CI
Tofacitinib	24

Moderate

Group	Value	95% CI
Tofacitinib	4

Severe

Group	Value	95% CI
Tofacitinib	1

Number of Participants With Adverse Events by Their Outcomes Primary · From first dose of Xeljanz until 52 weeks

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AE outcomes were categorized as: recovered; recovered with sequelae; recovering; not recovered; unknown. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure is reported for all participants including long term users.

Recovered

Group	Value	95% CI
Tofacitinib	33

Recovered with sequelae

Group	Value	95% CI
Tofacitinib	0

Recovering

Group	Value	95% CI
Tofacitinib	13

Not recovered

Group	Value	95% CI
Tofacitinib	6

Unknown

Group	Value	95% CI
Tofacitinib	1

Number of Participants With Adverse Events by Their Outcomes in Long Term Users Primary · From first dose of Xeljanz until 52 weeks

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AE outcomes were categorized as: recovered; recovered with sequelae; recovering; not recovered; unknown. One participant may experience more than one event; hence, one participant may be included in more than one category specified below. This outcome measure was analyzed only in long term users.

Recovered

Group	Value	95% CI
Tofacitinib	21

Recovered with sequelae

Group	Value	95% CI
Tofacitinib	0

Recovering

Group	Value	95% CI
Tofacitinib	7

Not recovered

Group	Value	95% CI
Tofacitinib	3

Unknown

Group	Value	95% CI
Tofacitinib	1

Number of Participants With Adverse Events by Their Seriousness Primary · From first dose of Xeljanz until 52 weeks

An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events were classified as per their seriousness as following: results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect, other important medical event. One participant may experience more than one event; hence, one participant may be incl

Results in death

Group	Value	95% CI
Tofacitinib	0

Life-threatening

Group	Value	95% CI
Tofacitinib	0

Requires inpatient hospitalization or prolongation of hospitalization

Group	Value	95% CI
Tofacitinib	8

Results in persistent or significant disability/incapacity

Group	Value	95% CI
Tofacitinib	0

Results in congenital anomaly/birth defect

Group	Value	95% CI
Tofacitinib	0

Other important medical event

Group	Value	95% CI
Tofacitinib	0

Non-Serious

Group	Value	95% CI
Tofacitinib	41

Number of Participants With Adverse Events by Their Seriousness in Long Term Users Primary · From first dose of Xeljanz until 52 weeks

An adverse event was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Adverse events were classified as per their seriousness as following: results in death, was life-threatening, required inpatient hospitalization or prolongation of hospitalization, resulted in persistent or significant disability/incapacity, results in congenital anomaly/birth defect, other important medical event. One participant may experience more than one event; hence, one participant may be in

Results in death

Group	Value	95% CI
Tofacitinib	0

Is life-threatening

Group	Value	95% CI
Tofacitinib	0

Requires inpatient hospitalization or prolongation of hospitalization.

Group	Value	95% CI
Tofacitinib	3

Results in persistent or significant disability/incapacity

Group	Value	95% CI
Tofacitinib	0

Results in congenital anomaly/birth defect

Group	Value	95% CI
Tofacitinib	0

Other important medical event

Group	Value	95% CI
Tofacitinib	0

Non-Serious

Group	Value	95% CI
Tofacitinib	26

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of Xeljanz until 52 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tofacitinib

Serious: 8/107 (7%)

Deaths: 0/107

Serious adverse events (7 terms)

Reaction	System	Tofacitinib
Colitis ulcerative	Gastrointestinal disorders	—
Abdominal pain	Gastrointestinal disorders	—
Pouchitis	Gastrointestinal disorders	—
Drug ineffective	General disorders	—
Anal abscess	Infections and infestations	—
COVID-19	Infections and infestations	—
Cytomegalovirus colitis	Infections and infestations	—

Other adverse events (53 terms — click to expand)

Reaction	System	Tofacitinib
Anaemia	Blood and lymphatic system disorders	—
Colitis ulcerative	Gastrointestinal disorders	—
Hyperlipidaemia	Metabolism and nutrition disorders	—
Pyrexia	General disorders	—
Myalgia	Musculoskeletal and connective tissue disorders	—
Headache	Nervous system disorders	—
Aspartate aminotransferase increased	Investigations	—
Blood cholesterol increased	Investigations	—
Rash	Skin and subcutaneous tissue disorders	—
Abdominal pain	Gastrointestinal disorders	—
Constipation	Gastrointestinal disorders	—
Dyspepsia	Gastrointestinal disorders	—
Gastritis erosive	Gastrointestinal disorders	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—
Oral pain	Gastrointestinal disorders	—
Pancreatitis acute	Gastrointestinal disorders	—
Proctalgia	Gastrointestinal disorders	—
Chest discomfort	General disorders	—
Drug ineffective	General disorders	—
Loss of therapeutic response	General disorders	—
Pain	General disorders	—
Anal abscess	Infections and infestations	—
COVID-19	Infections and infestations	—
Clostridium difficile infection	Infections and infestations	—
Cytomegalovirus colitis	Infections and infestations	—
Gastroenteritis	Infections and infestations	—
Periodontitis	Infections and infestations	—
Spinal column injury	Injury, poisoning and procedural complications	—
Alanine aminotransferase increased	Investigations	—
Blood creatinine increased	Investigations	—
Transaminases increased	Investigations	—
Vitamin D decreased	Investigations	—
Weight increased	Investigations	—
Hypercholesterolaemia	Metabolism and nutrition disorders	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—
Increased appetite	Metabolism and nutrition disorders	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Essential thrombocythaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Dizziness	Nervous system disorders	—

Most-reported serious reactions: Colitis ulcerative, Abdominal pain, Pouchitis, Drug ineffective, Anal abscess, COVID-19, Cytomegalovirus colitis.

Data from ClinicalTrials.gov NCT04071405 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety and effectiveness of tofacitinib in Korean adult patients with ulcerative colitis: post-marketing surveillance study.
   Yoon H, Ye BD, Kang SB, Lee KM, et al · · 2024 · cited 4× · PMID 39160459 · DOI 10.1186/s12876-024-03336-2
2. Analysis of Mandatory Post-Marketing Surveillance Studies Supports Revised Regulatory Requirements in Korea.
   Wolter K, Jeong SH, Woo JW, Kim E, et al · · 2026 · PMID 42046371 · DOI 10.1002/pds.70382