N/A N=1,041

Korean Post-marketing Surveillance for Xeljanz

Rheumatoid Arthritis · Psoriatic Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT02984020 ↗

Enrolled (actual)

1,041

Serious AEs

4.0%

Results posted

Aug 2024

Primary outcome: Primary: Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) — 261; 148; 40; 20 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Jun 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)	261; 148; 40; 20; 21; 16	—
PRIMARY Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs	99; 31; 11; 1	—
PRIMARY Duration of Adverse Events	26	—
PRIMARY Number of Participants With Adverse Events by Their Severity	201; 82; 7	—
PRIMARY Number of Participants With Adverse Events by Their Outcome	200; 1; 43; 38; 7	—
PRIMARY Number of Participants With Adverse Events by Their Seriousness Criteria	2; 1; 40; 0; 0; 0	—
PRIMARY Number of Participants With Adverse Events by Their Action Taken With Regard to Xeljanz	45; 35; 14; 188; 4	—
PRIMARY Number of Participants With Adverse Events by Their Causality to Xeljanz	1; 9; 101; 134; 17; 25	—
PRIMARY Number of Participants With Adverse Events According to Demographic Characteristics	36; 225; 35; 48; 79; 63	—
PRIMARY Number of Participants With Adverse Events According to Other Baseline Characteristics	261; 0; 55; 47; 25; 35	—
PRIMARY Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis	261	<0.0001 sig
PRIMARY Number of Geriatric Participants With Adverse Events and Adverse Drug Reactions	67; 43	—
PRIMARY Number of Participants With Adverse Events and Adverse Drug Reactions - Renal Disorder	6; 5	—
PRIMARY Number of Participants With Adverse Events and Adverse Drug Reactions - Hepatic Disorder	13; 7	—
PRIMARY Number of Participants With Adverse Events and Adverse Drug Reactions - Other Than Safety Analysis Population	14; 9	—
SECONDARY Change From Baseline in DAS28 (ESR)	-2.35	—
SECONDARY Change From Baseline in DAS28 (CRP)	-2.42	—
SECONDARY Number of Participants With EULAR Response	404; 446; 53	—
SECONDARY Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Month 6	209	—
SECONDARY Number of Participants With Effectiveness	853; 36; 14	—
SECONDARY Number of Participants With Effectiveness by Demographic Characteristics	128; 725; 110; 162; 256; 219	—
SECONDARY Number of Participants With Improved Effectiveness - Multivariate Logistic Regression Analysis	853	0.0053 sig

Summary

The objective of this study is to identify any problems and questions with respect to the safety and efficacy of Xeljanz during the post-marketing period as required by the regulation of MFDS.

Eligibility Criteria

Inclusion Criteria

To be included in the study all patients will have received at least 1 dose of Xeljanz for the treatment of the following indication as per local labelling. Moderately to severely active RA in adult patients who have had an inadequate response or intolerance to previous therapy with at least 1 biological DMARD. Or Active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to previous antirheumatic drugs (DMARDs)

Exclusion Criteria

Patients with a history of hypersensitivity to any ingredients of the product.
Patients with serious infection (eg, sepsis) or active infection including localized infection.
Patients with active tuberculosis.
Patients with severe hepatic function disorder.
Patients with an absolute neutrophil count (ANC) <500 cells/mm3.
Patients with a lymphocyte count <500 cells/mm3.
Patients with a hemoglobin concentration <8 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.

According to Contraindication on label, the investigator should discontinue the patient's treatment if the laboratory test results are as below Patients with an absolute neutrophil count (ANC) <500 cells/mm3 Patients with a hemoglobin level <8 g/dL

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02984020). 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.