Ankylosing Spondylitis, Crohn's Disease, Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis
Conditions
Keywords
Postmarketing Drug Surveillance
Brief summary
Patients who take Humira as prescribed by physicians as per Korean label will be enrolled and observed in normal medical practice setting for not less than 3 months following first dose of Humira. Information on demographics, diagnosis and medical history, results of tuberculosis skin test, results of chest X-ray, Humira treatment information, concomitant medication, physician's global assessment for effectiveness, disease activity assessment for rheumatoid arthritis, disease activity assessment for Crohn's Disease, disease activity assessment for Psoriasis and adverse events will be recorded on case report forms.
Interventions
None listed
Sponsors
Eisai Co., Ltd.
AbbVie (prior sponsor, Abbott)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (19 years and above) with one of the following indications: * Moderately to severely active rheumatoid arthritis or * active and progressive psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate or * severe active ankylosing spondylitis who have had an inadequate response to conventional therapy or * severely active Crohn's disease who have had no response, intolerance or contraindication to corticosteroid therapy or immunosuppressants or * moderately to severely active psoriasis patients who have had no response, have intolerance or have contraindication to systemic therapies including cyclosporine, methotrexate or photochemotherapy (PUVA). * Patients who give verbal or written authorization to use their personal and health data.
Exclusion criteria
\- Patients with known hypersensitivity to adalimumab or any of its excipients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | From Baseline until up to 70 days after the 3 month study period (total of 160 days). | An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician's Global Assessment for Effectiveness | After 3-month treatment | The investigator's overall assessment for effectiveness was recorded as 'Improved', 'No change', 'Aggravated,' or 'Not assessable'. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea. | 1,698 |
| Total | 1,698 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Use of Humira outside the approved label | 81 |
Baseline characteristics
| Characteristic | Adalimumab |
|---|---|
| Age Continuous | 41.80 years STANDARD_DEVIATION 13.89 |
| Indication Ankylosing spondylitis | 925 participants |
| Indication Crohn's disease | 73 participants |
| Indication Psoriasis | 1 participants |
| Indication Psoriatic arthritis | 47 participants |
| Indication Rheumatoid arthritis | 652 participants |
| Region of Enrollment Korea, Republic of | 1,698 participants |
| Sex: Female, Male Female | 729 Participants |
| Sex: Female, Male Male | 969 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,698 |
| serious Total, serious adverse events | 47 / 1,698 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information.
Time frame: From Baseline until up to 70 days after the 3 month study period (total of 160 days).
Population: Safety analysis population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab | Number of Participants With Adverse Events (AEs) | Moderate adverse event | 58 participants |
| Adalimumab | Number of Participants With Adverse Events (AEs) | Any adverse event | 171 participants |
| Adalimumab | Number of Participants With Adverse Events (AEs) | Any adverse drug reaction | 116 participants |
| Adalimumab | Number of Participants With Adverse Events (AEs) | Serious adverse events | 47 participants |
| Adalimumab | Number of Participants With Adverse Events (AEs) | Mild adverse event | 115 participants |
| Adalimumab | Number of Participants With Adverse Events (AEs) | Severe adverse event | 7 participants |
| Adalimumab | Number of Participants With Adverse Events (AEs) | Discontinued adalimumab due to adverse event | 30 participants |
| Adalimumab | Number of Participants With Adverse Events (AEs) | Adverse events related to adalimumab | 120 participants |
| Adalimumab | Number of Participants With Adverse Events (AEs) | Unexpected adverse drug reaction | 21 participants |
Secondary
Physician's Global Assessment for Effectiveness
The investigator's overall assessment for effectiveness was recorded as 'Improved', 'No change', 'Aggravated,' or 'Not assessable'.
Time frame: After 3-month treatment
Population: Effectiveness evaluation was performed in 1,471 participants who received adalimumab for at least 3 months and in whom investigator's assessment at 3 months was available. No participants were available in the Psoriasis group for effectiveness evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adalimumab | Physician's Global Assessment for Effectiveness | Improved | 478 participants |
| Adalimumab | Physician's Global Assessment for Effectiveness | No change | 52 participants |
| Adalimumab | Physician's Global Assessment for Effectiveness | Aggravated | 11 participants |
| Adalimumab | Physician's Global Assessment for Effectiveness | Not assessable | 0 participants |
| Psoriatic Arthritis | Physician's Global Assessment for Effectiveness | No change | 2 participants |
| Psoriatic Arthritis | Physician's Global Assessment for Effectiveness | Aggravated | 1 participants |
| Psoriatic Arthritis | Physician's Global Assessment for Effectiveness | Not assessable | 0 participants |
| Psoriatic Arthritis | Physician's Global Assessment for Effectiveness | Improved | 37 participants |
| Ankylosing Spondylitis | Physician's Global Assessment for Effectiveness | Aggravated | 3 participants |
| Ankylosing Spondylitis | Physician's Global Assessment for Effectiveness | No change | 41 participants |
| Ankylosing Spondylitis | Physician's Global Assessment for Effectiveness | Not assessable | 0 participants |
| Ankylosing Spondylitis | Physician's Global Assessment for Effectiveness | Improved | 790 participants |
| Crohn's Disease | Physician's Global Assessment for Effectiveness | Not assessable | 0 participants |
| Crohn's Disease | Physician's Global Assessment for Effectiveness | No change | 6 participants |
| Crohn's Disease | Physician's Global Assessment for Effectiveness | Improved | 50 participants |
| Crohn's Disease | Physician's Global Assessment for Effectiveness | Aggravated | 0 participants |