Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis
Brief summary
To clarify the following matters: * Unknown adverse reactions (especially clinically significant adverse reactions) * Incidence and conditions of occurrence of adverse reactions in the clinical setting * Factors that may affect the safety and effectiveness of Humira
Interventions
None listed
Sponsors
Abbott
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients prescribed and treated with Humira are included in this survey.
Exclusion criteria
* Contraindications according to the Package Insert: * Patients who have serious infections, * Patients who have tuberculosis, * Patients with a history of hypersensitivity to any ingredient of Humira, * Patients who have demyelinating disease or with a history of demyelinating disease, * Patients who have cardiac failure congestive.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Patients With Adverse Events | Baseline to Week 24 | Adverse events were assessed from the time treatment began until treatment ended after 24 weeks. Details about the adverse events and serious adverse events are presented with the adverse event section of the disclosure. This outcome is measured as a percentage of patients with adverse events. |
| Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4 | Week 4 | Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 4. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad). |
| Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12 | Week 12 | Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 12. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad). |
| Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24 | Week 24 | Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 24. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physicians' Overall Effectiveness Response Rating | Week 24 | Physicians' rated the level of overall patient improvement as markedly improved, improved, not changed, or not assessable by comparing clinical conditions at Week 24 or at discontinuation with baseline conditions. |
Countries
Japan
Participant flow
Recruitment details
The sponsor was required to include all patients diagnosed with rheumatoid arthritis and who were treated Humira in routine medical practice during the review period by the Pharmaceuticals and Medical Devices Agency (PMDA).
Pre-assignment details
The study was completed when the PMDA had completed their review. A total of 7972 patients were registered and case report forms were retrieved for 7891 patients; 151 patients were excluded from the analysis because the case report forms were either duplicated (n=150) or the patient was included in another survey (n=1).
Participants by arm
| Arm | Count |
|---|---|
| Humira Patients who received Humira for 24 weeks during the PMDA review period. | 7,740 |
| Total | 7,740 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 767 |
| Overall Study | Lack of Efficacy | 849 |
| Overall Study | Lost to Follow-up | 241 |
| Overall Study | Non-compliance | 274 |
| Overall Study | Other | 119 |
Baseline characteristics
| Characteristic | Humira |
|---|---|
| Age Continuous | 60.1 years STANDARD_DEVIATION 13 |
| Age, Customized >=20-<30 | 165 participants |
| Age, Customized <20 years | 26 participants |
| Age, Customized >=30-<40 | 461 participants |
| Age, Customized >=40-<50 | 828 participants |
| Age, Customized >=50-<60 | 1803 participants |
| Age, Customized >=60-<70 | 2515 participants |
| Age, Customized >=70-<80 | 1676 participants |
| Age, Customized >=80-<90 | 261 participants |
| Age, Customized >=90 | 4 participants |
| Age, Customized No data | 1 participants |
| Region of Enrollment Japan | 7740 participants |
| Sex: Female, Male Female | 6388 Participants |
| Sex: Female, Male Male | 1352 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 863 / 7,740 |
| serious Total, serious adverse events | 469 / 7,740 |
Outcome results
Primary
Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12
Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 12. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
Time frame: Week 12
Population: Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Humira | Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12 | 26.4 percentage of patients |
| Humira - Moderate Response | Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12 | 42.6 percentage of patients |
| Humira - No Response | Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12 | 31.1 percentage of patients |
| Effective Rate-Sum of Patients With Good or Moderate Response | Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 12 | 68.9 percentage of patients |
Primary
Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24
Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 24. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
Time frame: Week 24
Population: Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Humira | Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24 | 30.7 Percentage of Patients |
| Humira - Moderate Response | Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24 | 39.3 Percentage of Patients |
| Humira - No Response | Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24 | 29.9 Percentage of Patients |
| Effective Rate-Sum of Patients With Good or Moderate Response | Patient Effectiveness Response Rating and Effective Rate of Humira With DAS 28 at Week 24 | 70.1 Percentage of Patients |
Primary
Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4
Effectiveness was assessed according to European League Against Rheumatism (EULAR) response criteria. The investigator rated patient response as good, moderate, or none from baseline to Week 4. The DAS 28 index is a measure of activity derived from the number of swollen or tender joints, laboratory tests of inflammation, and patient assessment of global health (10 cm line ranging from very good to very bad).
Time frame: Week 4
Population: Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Humira | Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4 | 20.4 Percentage of patients |
| Humira - Moderate Response | Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4 | 45.7 Percentage of patients |
| Humira - No Response | Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4 | 33.9 Percentage of patients |
| Effective Rate-Sum of Patients With Good or Moderate Response | Patient Effectiveness Response Rating and Effective Rate of Humira With Disease Activity Score (DAS) 28 at Week 4 | 66.1 Percentage of patients |
Primary
Total Number of Patients With Adverse Events
Adverse events were assessed from the time treatment began until treatment ended after 24 weeks. Details about the adverse events and serious adverse events are presented with the adverse event section of the disclosure. This outcome is measured as a percentage of patients with adverse events.
Time frame: Baseline to Week 24
Population: The safety population included all patients who received at least one dose of Humira, had one set of case report forms, and were registered with PMDA during the review period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Humira | Total Number of Patients With Adverse Events | 27.8 Percentage of Patients |
Secondary
Physicians' Overall Effectiveness Response Rating
Physicians' rated the level of overall patient improvement as markedly improved, improved, not changed, or not assessable by comparing clinical conditions at Week 24 or at discontinuation with baseline conditions.
Time frame: Week 24
Population: Of the 7740 subjects treated, 938 patients were removed; 16 patients used Humira for another indication label, 812 patients had data missing at baseline or at least 1 other time point, and 254 patients were treated with Humira for less than 2 weeks. Patients may have been in more than 1 category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Humira | Physicians' Overall Effectiveness Response Rating | Markedly Improved | 29.1 Percentage of Patients |
| Humira | Physicians' Overall Effectiveness Response Rating | Improved | 45.2 Percentage of Patients |
| Humira | Physicians' Overall Effectiveness Response Rating | Not Changed | 19.6 Percentage of Patients |
| Humira | Physicians' Overall Effectiveness Response Rating | Not Assessable | 6.1 Percentage of Patients |