Psoriatic Arthritis, Rheumatoid Arthritis
Conditions
Brief 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.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
1. Patients with a history of hypersensitivity to any ingredients of the product. 2. Patients with serious infection (eg, sepsis) or active infection including localized infection. 3. Patients with active tuberculosis. 4. Patients with severe hepatic function disorder. 5. Patients with an absolute neutrophil count (ANC) \<500 cells/mm3. 6. Patients with a lymphocyte count \<500 cells/mm3. 7. Patients with a hemoglobin concentration \<8 g/dL. 8. Pregnant or possibly pregnant women. 9. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events and Adverse Drug Reactions - Other Than Safety Analysis Population | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) | An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. AEs and ADRs for participants excluded from the safety analysis population were reported. The reason for exclusion included: not met the inclusion criteria/met exclusion criteria; off-label use; other significant protocol violation. |
| Number of Participants With Adverse Events by Their Causality to Xeljanz | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) | An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship. The causality of AEs to Xeljanz were assessed by physician according to the following criteria: certain, probable/likely, possible, unlikely, conditional/unclassified and unassessible/unclassifiable. One participant may experience more than one event hence, one participant may be included in more than one category specified below. Only participants with available causality assessment data are reported. |
| Number of Participants With Adverse Events According to Demographic Characteristics | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) | An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Number of participants with AEs classified according to the following demographic characteristics: sex: male and female; age: less than (\<) 40 years, greater than or equal to (\>=) 40 and \< 50 years and \>= 50 years and \<60 years; \>= 60 and \<70 years; geriatric (\>=65 years). Only participants with available demographic and AE assessment data are reported. |
| Number of Participants With Adverse Events According to Other Baseline Characteristics | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) | Other baseline characteristics included: indication; duration of the disease; severity of disease; radiologic progression; status of latent tuberculosis; herpes zoster vaccination; smoking; prior rheumatoid arthritis therapy; medical history; renal disorder; hepatic disorder; allergic history; concomitant medication; duration of administration. Only participants with available other baseline characteristics and AE assessment data are reported. |
| Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) | An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Logistic regression analysis of multivariate analysis was performed and presented an odds ratio with 95% confidence interval to identify the factors that affect occurrence of AEs in demography and baseline characteristics, or concomitant treatment status, etc. |
| Number of Geriatric Participants With Adverse Events and Adverse Drug Reactions | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) | An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. |
| Number of Participants With Adverse Events and Adverse Drug Reactions - Renal Disorder | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) | An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. Renal disorder was judged by the investigator. |
| Number of Participants With Adverse Events and Adverse Drug Reactions - Hepatic Disorder | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) | An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. Hepatic disorder was judged by the investigator. |
| Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) | An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Xeljanz was assessed by the physician. |
| Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) | An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. SADR was any SAE that is attributed to Xeljanz. Relatedness to Xeljanz was assessed by the physician. An unexpected AE was an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug. Unexpected ADRs were unexpected AEs that were, in the investigator's opinion, of causal relationship to the study treatment. |
| Duration of Adverse Events | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) | An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Only participants with available data are reported. |
| Number of Participants With Adverse Events by Their Severity | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) | The evaluation of AE severity was done according to the following categories: mild: not causing any significant problem to the participant. Administration of medicinal product continues without dose adjustment. Moderate: causes a problem that dose not interfere significantly with usual activities or the clinical status. Dose of the medical product is adjusted or other therapy is added due to the AE. Severe: causes a problem that interferes significantly with usual activities or the clinical status. The medicinal product is stopped due to the AE. Only participants with available severity assessment data are reported. |
| Number of Participants With Adverse Events by Their Outcome | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) | An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The outcomes of AE included recovered, recovered with sequelae, recovering, not recovered and unknown. One participant may experience more than one event hence one participant may be included in more than one category specified below. Only participants with available outcome assessment are reported. |
| Number of Participants With Adverse Events by Their Seriousness Criteria | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) | An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The seriousness criteria for AEs included 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. Only participants with available seriousness assessment data are reported. |
| Number of Participants With Adverse Events by Their Action Taken With Regard to Xeljanz | From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years) | An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship. The action taken with regard to the medicinal product included: permanently discontinued, temporarily discontinued or delayed, dose reduced, dose increased, no change, not applicable. Only participants with available action taken assessment data are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in DAS28 (CRP) | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) | DAS28 is a modified version of the original Disease Activity Score (DAS). It is a quantitative measure of disease activity used to monitor the treatment or RA. DAS28-3 ( C-reactive protein \[CRP\]) was calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity. |
| Number of Participants With EULAR Response | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) | European League Against Rheumatism (EULAR) response is a DAS-based response criteria that classifies individual participants as none, moderate, or good responders, depending on the extent of change and the level of disease activity reached. Participants with improvement in DAS28 from baseline \>1.2 and DAS28 based EULAR \<=3.2 were good responders; participants with improvement in DAS28 from baseline \>0.6 and \<=1.2 and DAS28 based EULAR \>3.2 and \<=5.1 were moderate responders; participants with improvement in DAS28 from baseline \<=0.6 and DAS28-based EULAR \>5.1 were none responders. |
| Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Month 6 | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) | ACR20 response: ≥20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and CRP. |
| Number of Participants With Effectiveness | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) | The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment. No change and aggravated were classified as ineffective. |
| Number of Participants With Effectiveness by Demographic Characteristics | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) | The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment. |
| Number of Participants With Improved Effectiveness - Multivariate Logistic Regression Analysis | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) | The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment. Logistic regression analysis of multivariate analysis was performed and presented as odds ratios with 95% confidence interval to identify the factors that affected classified overall assessment (effective/ineffective) in demography and baseline characteristics of the participants. |
| Change From Baseline in DAS28 (ESR) | From Baseline to 6 months after treatment (through study completion, up to approximately 6 years) | DAS28 is a modified version of the original Disease Activity Score (DAS). It is a quantitative measure of disease activity used to monitor the treatment or RA. DAS28 (erythrocyte sedimentation rate \[ESR\]) was calculated from: DAS28 (ESR) = 0.56\*√(tender joint counter \[TJC\] 28) + 0.28\*√(swollen joint count \[SJC\] 28) + 0.014\*VAS+ 0.70\*ln(ESR), where VAS = visual analogue scale. Total score range: 0-9.4, higher score=more disease activity. |
Countries
South Korea
Participant flow
Recruitment details
This was a study conducted in Korea. The investigator enrolled participants to whom Xeljanz was prescribed for the first time according to the local product document and who agreed to participate in this study. Xeljanz was administered according to the Dosage and Administration of the approved labeling. Xeljanz was medicated by the investigator's prescription under usual clinical practice.
Participants by arm
| Arm | Count |
|---|---|
| Post-Marketing Surveillance: Xeljanz Participants with moderately to severely active rheumatoid arthritis (RA) who had an inadequate response or intolerance to methotrexate were observed during this post-marketing surveillance (PMS) study. The entire study period was approximately 6 years. | 1,009 |
| Total | 1,009 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Experienced off-label use against Xeljanz local product document | 21 |
| Overall Study | Not met the inclusion/exclusion criterion | 9 |
| Overall Study | Other significant protocol violation | 2 |
Baseline characteristics
| Characteristic | Post-Marketing Surveillance: Xeljanz | — |
|---|---|---|
| Age, Continuous Mean | 55.04 Years STANDARD_DEVIATION 12.64 | — |
| Age, Customized < 40 years | 126 Participants | — |
| Age, Customized >= 40 years and < 50 years | 195 Participants | — |
| Age, Customized >= 50 years and < 60 years | 305 Participants | — |
| Age, Customized >= 60 years and < 70 years | 258 Participants | — |
| Age, Customized >= 70 years | 125 Participants | — |
| Allergic history, Yes/No No | 984 Participants | — |
| Allergic history, Yes/No Yes | 25 Participants | — |
| Concomitant medication, Yes/No No | 12 Participants | — |
| Concomitant medication, Yes/No Yes | 997 Participants | — |
| Duration of the disease, Continuous | 98.36 Months STANDARD_DEVIATION 80.77 | — |
| Duration of the disease, Customized >= 12 years | 214 Participants | — |
| Duration of the disease, Customized < 3 years | 219 Participants | — |
| Duration of the disease, Customized >= 3 years and < 6 years | 193 Participants | — |
| Duration of the disease, Customized >= 6 years and < 9 years | 146 Participants | — |
| Duration of the disease, Customized >= 9 years and < 12 years | 121 Participants | — |
| Duration of the disease, Customized Unknown | 116 Participants | — |
| Hepatic disorder, Yes/No No | 969 Participants | — |
| Hepatic disorder, Yes/No Yes | 40 Participants | — |
| Herpes zoster Vaccination, Yes/No/Unknown No | 407 Participants | — |
| Herpes zoster Vaccination, Yes/No/Unknown Unknown | 487 Participants | — |
| Herpes zoster Vaccination, Yes/No/Unknown Yes | 115 Participants | — |
| Indication, RA/PsA PsA | 0 Participants | — |
| Indication, RA/PsA RA | 1009 Participants | — |
| Prior rheumatoid arthritis therapy, Yes/No No | 119 Participants | — |
| Prior rheumatoid arthritis therapy, Yes/No Yes | 890 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Radiologic progression, Yes/No/Not assessed No | 290 Participants | — |
| Radiologic progression, Yes/No/Not assessed Not assessed | 213 Participants | — |
| Radiologic progression, Yes/No/Not assessed Yes | 506 Participants | — |
| Renal disorder, Yes/No No | 990 Participants | — |
| Renal disorder, Yes/No Yes | 19 Participants | — |
| Severity of disease activity, High/Moderate/Low/Not assessed High (DAS28 > 5.1) | 874 Participants | — |
| Severity of disease activity, High/Moderate/Low/Not assessed Low (DAS28 <= 3.2) | 0 Participants | — |
| Severity of disease activity, High/Moderate/Low/Not assessed Moderate (DAS28 > 3.2 and <= 5.1) | 135 Participants | — |
| Severity of disease activity, High/Moderate/Low/Not assessed Not assessed | 0 Participants | — |
| Sex: Female, Male Female | 852 Participants | — |
| Sex: Female, Male Male | 157 Participants | — |
| Smoking, Ex-smoking/Current smoking/Non-smoking/Unknown Current smoking | 57 Participants | — |
| Smoking, Ex-smoking/Current smoking/Non-smoking/Unknown Ex-smoking | 64 Participants | — |
| Smoking, Ex-smoking/Current smoking/Non-smoking/Unknown Non-smoking | 706 Participants | — |
| Smoking, Ex-smoking/Current smoking/Non-smoking/Unknown Unknown | 182 Participants | — |
| Status of latent tuberculosis, Yes/No/Unknown No | 770 Participants | — |
| Status of latent tuberculosis, Yes/No/Unknown Unknown | 13 Participants | — |
| Status of latent tuberculosis, Yes/No/Unknown Yes | 226 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 1,009 |
| other Total, other adverse events | 261 / 1,009 |
| serious Total, serious adverse events | 40 / 1,009 |
Outcome results
Primary
Duration of Adverse Events
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Only participants with available data are reported.
Time frame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Duration of Adverse Events | 26 Days |
Primary
Number of Geriatric Participants With Adverse Events and Adverse Drug Reactions
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz.
Time frame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Population: The population included geriatric participants (aged \>=65 years) in the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Number of Geriatric Participants With Adverse Events and Adverse Drug Reactions | Adverse Events | 67 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Geriatric Participants With Adverse Events and Adverse Drug Reactions | Adverse Drug Reactions | 43 Participants |
Primary
Number of Participants With Adverse Events According to Demographic Characteristics
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Number of participants with AEs classified according to the following demographic characteristics: sex: male and female; age: less than (\<) 40 years, greater than or equal to (\>=) 40 and \< 50 years and \>= 50 years and \<60 years; \>= 60 and \<70 years; geriatric (\>=65 years). Only participants with available demographic and AE assessment data are reported.
Time frame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Demographic Characteristics | Sex: Male | 36 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Demographic Characteristics | Sex: Female | 225 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Demographic Characteristics | Age: < 40 years | 35 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Demographic Characteristics | Age: >= 40 years and < 50 years | 48 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Demographic Characteristics | Age: >= 50 years and < 60 years | 79 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Demographic Characteristics | Age: >= 60 years and < 70 years | 63 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Demographic Characteristics | Age: >= 70 years | 36 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Demographic Characteristics | Geriatric (>= 65 years) | 67 Participants |
Primary
Number of Participants With Adverse Events According to Other Baseline Characteristics
Other baseline characteristics included: indication; duration of the disease; severity of disease; radiologic progression; status of latent tuberculosis; herpes zoster vaccination; smoking; prior rheumatoid arthritis therapy; medical history; renal disorder; hepatic disorder; allergic history; concomitant medication; duration of administration. Only participants with available other baseline characteristics and AE assessment data are reported.
Time frame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Medical history: No | 52 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Indication: RA | 261 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Indication: PsA | 0 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Duration of the disease: < 3 years | 55 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Duration of the disease: >= 3 years and < 6 years | 47 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Duration of the disease: >= 6 years and < 9 years | 25 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Duration of the disease: >= 9 years and < 12 years | 35 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Duration of the disease: >= 12 years | 70 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Duration of the disease: Unknown | 29 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Severity of disease activity: High (DAS28 > 5.1) | 226 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Severity of disease activity: Moderate (DAS28 > 3.2 and <= 5.1) | 35 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Severity of disease activity: Low (DAS28 <= 3.2) | 0 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Severity of disease activity: Not assessed | 0 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Radiologic progression: Yes | 132 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Radiologic progression: No | 62 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Radiologic progression: Not assessed | 67 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Status of latent tuberculosis: Yes | 52 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Status of latent tuberculosis: No | 206 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Status of latent tuberculosis: Unknown | 3 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Herpes zoster Vaccination: Yes | 33 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Herpes zoster Vaccination: No | 125 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Herpes zoster Vaccination: Unknown | 103 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Smoking: Ex-smoking | 18 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Smoking: Current smoking | 16 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Smoking: Non-smoking | 188 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Smoking: Unknown | 39 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Prior rheumatoid arthritis therapy: Yes | 238 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Prior rheumatoid arthritis therapy: No | 23 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Medical history: Yes | 209 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Renal disorder: Yes | 6 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Renal disorder: No | 255 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Hepatic disorder: Yes | 13 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Hepatic disorder: No | 248 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Allergic history: Yes | 11 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Allergic history: No | 250 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Concomitant medication: Yes | 259 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Concomitant medication: No | 2 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Duration of administration: < 6 months | 75 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Duration of administration: >= 6 months and < 7 months | 135 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Duration of administration: >= 7 months | 39 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events According to Other Baseline Characteristics | Duration of administration: Unknown | 12 Participants |
Primary
Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. SADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Relatedness to Xeljanz was assessed by the physician.
Time frame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) | Adverse Events(AEs) | 261 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) | Adverse Drug Reactions(ADRs) | 148 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) | Serious Adverse Events(SAEs) | 40 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) | Serious Adverse Drug Reactions(SADRs) | 20 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) | Adverse Events of Special Interest | 21 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events (AEs), Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) | Adverse Drug Reactions of Special Interest | 16 Participants |
Primary
Number of Participants With Adverse Events and Adverse Drug Reactions - Hepatic Disorder
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. Hepatic disorder was judged by the investigator.
Time frame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Population: The population included participants with hepatic disorder in the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events and Adverse Drug Reactions - Hepatic Disorder | Adverse Events | 13 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events and Adverse Drug Reactions - Hepatic Disorder | Adverse Drug Reactions | 7 Participants |
Primary
Number of Participants With Adverse Events and Adverse Drug Reactions - Other Than Safety Analysis Population
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. AEs and ADRs for participants excluded from the safety analysis population were reported. The reason for exclusion included: not met the inclusion criteria/met exclusion criteria; off-label use; other significant protocol violation.
Time frame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Population: The population included participants excluded from the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events and Adverse Drug Reactions - Other Than Safety Analysis Population | Adverse Events | 14 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events and Adverse Drug Reactions - Other Than Safety Analysis Population | Adverse Drug Reactions | 9 Participants |
Primary
Number of Participants With Adverse Events and Adverse Drug Reactions - Renal Disorder
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. Renal disorder was judged by the investigator.
Time frame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Population: The population included participants with renal disorder in the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events and Adverse Drug Reactions - Renal Disorder | Adverse Events | 6 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events and Adverse Drug Reactions - Renal Disorder | Adverse Drug Reactions | 5 Participants |
Primary
Number of Participants With Adverse Events by Their Action Taken With Regard to Xeljanz
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship. The action taken with regard to the medicinal product included: permanently discontinued, temporarily discontinued or delayed, dose reduced, dose increased, no change, not applicable. Only participants with available action taken assessment data are reported.
Time frame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Action Taken With Regard to Xeljanz | Permanently discontinued | 45 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Action Taken With Regard to Xeljanz | Temporarily discontinued or delayed | 35 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Action Taken With Regard to Xeljanz | Dose reduced | 14 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Action Taken With Regard to Xeljanz | No change | 188 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Action Taken With Regard to Xeljanz | Not applicable | 4 Participants |
Primary
Number of Participants With Adverse Events by Their Causality to Xeljanz
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship. The causality of AEs to Xeljanz were assessed by physician according to the following criteria: certain, probable/likely, possible, unlikely, conditional/unclassified and unassessible/unclassifiable. One participant may experience more than one event hence, one participant may be included in more than one category specified below. Only participants with available causality assessment data are reported.
Time frame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Causality to Xeljanz | Certain | 1 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Causality to Xeljanz | Probable/likely | 9 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Causality to Xeljanz | Possible | 101 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Causality to Xeljanz | Unlikely | 134 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Causality to Xeljanz | Conditional/unclassified | 17 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Causality to Xeljanz | Unaccessible/unclassifiable | 25 Participants |
Primary
Number of Participants With Adverse Events by Their Outcome
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The outcomes of AE included recovered, recovered with sequelae, recovering, not recovered and unknown. One participant may experience more than one event hence one participant may be included in more than one category specified below. Only participants with available outcome assessment are reported.
Time frame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Outcome | Recovered | 200 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Outcome | Recovered with sequelae | 1 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Outcome | Recovering | 43 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Outcome | Not recovered | 38 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Outcome | Unknown | 7 Participants |
Primary
Number of Participants With Adverse Events by Their Seriousness Criteria
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. The seriousness criteria for AEs included 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. Only participants with available seriousness assessment data are reported.
Time frame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Seriousness Criteria | Results in death | 2 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Seriousness Criteria | Is life-threatening | 1 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Seriousness Criteria | Requires inpatient hospitalization or prolongation of hospitalization | 40 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Seriousness Criteria | Results in persistent or significant disability/incapacity | 0 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Seriousness Criteria | Results in congenital anomaly/birth defect | 0 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Seriousness Criteria | Is an important medical event | 0 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Seriousness Criteria | Non-SAE | 238 Participants |
Primary
Number of Participants With Adverse Events by Their Severity
The evaluation of AE severity was done according to the following categories: mild: not causing any significant problem to the participant. Administration of medicinal product continues without dose adjustment. Moderate: causes a problem that dose not interfere significantly with usual activities or the clinical status. Dose of the medical product is adjusted or other therapy is added due to the AE. Severe: causes a problem that interferes significantly with usual activities or the clinical status. The medicinal product is stopped due to the AE. Only participants with available severity assessment data are reported.
Time frame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Severity | Mild | 201 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Severity | Moderate | 82 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events by Their Severity | Severe | 7 Participants |
Primary
Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. Logistic regression analysis of multivariate analysis was performed and presented an odds ratio with 95% confidence interval to identify the factors that affect occurrence of AEs in demography and baseline characteristics, or concomitant treatment status, etc.
Time frame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Adverse Events - Multivariate Logistic Regression Analysis | 261 Participants |
p-value: <0.000195% CI: [0.69, 0.86]Regression, Logistic
p-value: <0.000195% CI: [1.64, 3.59]Regression, Logistic
Primary
Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs
An AE was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) without regard to possibility of a causal relationship with product treatment or usage. SAE was any untoward medical occurrence that at any dose resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect. An ADR was any untoward medical occurrence attributed to Xeljanz in a participant who received Xeljanz. SADR was any SAE that is attributed to Xeljanz. Relatedness to Xeljanz was assessed by the physician. An unexpected AE was an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug. Unexpected ADRs were unexpected AEs that were, in the investigator's opinion, of causal relationship to the study treatment.
Time frame: From first dose for Xeljanz to 28 days after last dose (through study completion, up to approximately 6 years)
Population: The safety analysis set included all participants who had received at least 1 dose of Xeljanz according to local product document and had been assessed for safety information including AEs by investigator.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs | Unexpected Adverse Events | 99 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs | Unexpected Adverse Drug Reactions | 31 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs | Unexpected Serious Adverse Events | 11 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Unexpected AEs, Unexpected SAEs, Unexpected ADRs and Unexpected SADRs | Unexpected Serious Adverse Drug Reactions | 1 Participants |
Secondary
Change From Baseline in DAS28 (CRP)
DAS28 is a modified version of the original Disease Activity Score (DAS). It is a quantitative measure of disease activity used to monitor the treatment or RA. DAS28-3 ( C-reactive protein \[CRP\]) was calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count and CRP (mg/L). Total score range: 0 to 9.4, higher score indicated more disease activity.
Time frame: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Population: The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Change From Baseline in DAS28 (CRP) | -2.42 Scores on a scale | Standard Deviation 1.1 |
Secondary
Change From Baseline in DAS28 (ESR)
DAS28 is a modified version of the original Disease Activity Score (DAS). It is a quantitative measure of disease activity used to monitor the treatment or RA. DAS28 (erythrocyte sedimentation rate \[ESR\]) was calculated from: DAS28 (ESR) = 0.56\*√(tender joint counter \[TJC\] 28) + 0.28\*√(swollen joint count \[SJC\] 28) + 0.014\*VAS+ 0.70\*ln(ESR), where VAS = visual analogue scale. Total score range: 0-9.4, higher score=more disease activity.
Time frame: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Population: The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Change From Baseline in DAS28 (ESR) | -2.35 Scores on a scale | Standard Deviation 1.11 |
Secondary
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Month 6
ACR20 response: ≥20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and CRP.
Time frame: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Population: The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Month 6 | 209 Participants |
Secondary
Number of Participants With Effectiveness
The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment. No change and aggravated were classified as ineffective.
Time frame: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Population: The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Effectiveness | Effective: Improved | 853 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Effectiveness | Ineffective: No change | 36 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Effectiveness | Ineffective: Aggravated | 14 Participants |
Secondary
Number of Participants With Effectiveness by Demographic Characteristics
The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment.
Time frame: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Population: The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment and with improved effectiveness.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Effectiveness by Demographic Characteristics | Age: >= 60 years and < 70 years | 219 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Effectiveness by Demographic Characteristics | Sex: Male | 128 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Effectiveness by Demographic Characteristics | Sex: Female | 725 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Effectiveness by Demographic Characteristics | Age: < 40 years | 110 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Effectiveness by Demographic Characteristics | Age: >= 40 years and < 50 years | 162 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Effectiveness by Demographic Characteristics | Age: >= 50 years and < 60 years | 256 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Effectiveness by Demographic Characteristics | Age: >= 70 years | 106 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Effectiveness by Demographic Characteristics | Geriatric (>= 65 years) | 200 Participants |
Secondary
Number of Participants With EULAR Response
European League Against Rheumatism (EULAR) response is a DAS-based response criteria that classifies individual participants as none, moderate, or good responders, depending on the extent of change and the level of disease activity reached. Participants with improvement in DAS28 from baseline \>1.2 and DAS28 based EULAR \<=3.2 were good responders; participants with improvement in DAS28 from baseline \>0.6 and \<=1.2 and DAS28 based EULAR \>3.2 and \<=5.1 were moderate responders; participants with improvement in DAS28 from baseline \<=0.6 and DAS28-based EULAR \>5.1 were none responders.
Time frame: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Population: The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Number of Participants With EULAR Response | Good | 404 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With EULAR Response | Moderate | 446 Participants |
| Post-Marketing Surveillance: Xeljanz | Number of Participants With EULAR Response | None | 53 Participants |
Secondary
Number of Participants With Improved Effectiveness - Multivariate Logistic Regression Analysis
The variables included DAS28, EULAR response, and ACR20 response. The investigator made the assessment of the overall effectiveness as improved, no change, or aggravated, based on each test results and clinical judgment. Logistic regression analysis of multivariate analysis was performed and presented as odds ratios with 95% confidence interval to identify the factors that affected classified overall assessment (effective/ineffective) in demography and baseline characteristics of the participants.
Time frame: From Baseline to 6 months after treatment (through study completion, up to approximately 6 years)
Population: The analysis set included all participants who received at least 1 dose of Xeljanz and were available for an effectiveness assessment and with improved effectiveness.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Post-Marketing Surveillance: Xeljanz | Number of Participants With Improved Effectiveness - Multivariate Logistic Regression Analysis | 853 Participants |
p-value: 0.005395% CI: [1.11, 1.82]Regression, Logistic