Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA, Rheumatoid Arthritis (RA
Conditions
Keywords
Treatment compliance and tolerability of Humira in patients, Eastern European countries, Rheumatoid Arthritis, Psoriatic Arthritis, Adalimumab, Ankylosing Spondylitis, Evaluation of clinical outcome
Brief summary
This is a non-interventional, post-marketing, observational study (PMOS) in which Humira (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No data currently exists to characterize patient populations being prescribed Humira in Eastern Europe. Further, it is important to establish the clinical outcome and tolerability of Humira in Eastern European patients, as well as their compliance with Humira treatment, in particular the acceptability of self-injection, which may influence all of the above in routine clinical practice.
Detailed description
This PMOS will be conducted in a prospective, single-arm, multicountry, multicenter format. The assignment of the patient to Humira is not decided in advance by this protocol but falls within the current practice. The prescription of Humira is clearly separated from the decision to include the patient in this study. No additional procedures (other than standard of care) shall be applied to the patients. As this study is observational in nature, its follow-up is not interventional and is left to the judgment of each physician within the 14-17 months period (including tuberculosis (TB) screening and prophylaxis, if indicated), which defines the survey for each patient. The TB screening period per patient will be 1-4 weeks and, if applicable, the TB prophylactic treatment period before Humira administration will be 1 month in accordance with local guidelines. For indicative purposes, follow-up of patients should entail approximately 7 patient visits during this period. These visits will take place at average intervals of 3 months, apart from the first visit following TB screening. The first visit following introduction of Humira and final visits are required because of intercurrent events. If treatment with Humira is discontinued, the standard practice is to review the patient after a period of 70 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment. If the physician decides to permanently discontinue Humira before the end of the planned observational period of 13 months, the reason for discontinuation and the new treatment regimen prescribed, if applicable, will be documented. The next routine follow-up visit will be the termination visit for this patient in the PMOS.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Adult patients with active RA, PsA or AS for whom Humira therapy is indicated according to the local product label and who meet the following criteria: * Are newly prescribed Humira therapy (no prior history of treatment with Humira), including patients with infliximab or etanercept treatment history OR * Completed Abbott sponsored interventional clinical trials and are continuing treatment with commercial Humira thereafter.
Exclusion criteria
* Patients who are being treated or will be treated with drugs at risk of interactions with Humira (see Humira Summary of Product Characteristics) * Patients currently participating in another clinical trial * Patients with diagnosis of active tuberculosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcome (Disease Activity Score [DAS28] Decrease ≥1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA | Baseline, 3 months | DAS28 score was calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR) level, and the participant's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. A positive clinical outcome was defined as a DAS28 decrease by 1.2 or more after 3 months of Humira therapy relative to baseline. |
| Clinical Outcome (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] Decrease ≥50%) After 3 Months of Humira Therapy Relative to Baseline in Participants With PsA and AS | Baseline, 3 months | BASDAI score was calculated using a questionnaire with 6 questions that the participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive clinical outcome was defined as a 50% or more decrease in BASDAI score after 3 months of Humira therapy relative to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compliance With the Humira Administration Schedule at Month 13 (End of Study) | Month 13 | Compliance with the Humira therapy was assessed by the number of missed injections among participants. Documentation of injections missed or delayed by more than 7 days was made at each study visit. |
| Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy | Baseline, 4, 7 and 13 months | HAQ-DI score was calculated using the standard questionnaire covering 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale from 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function. |
| Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the last dose of physician-prescribed therapy. Mean (standard deviation [SD]) duration of therapy was 49.0 (16.0) weeks. | Tolerability was measured by AEs and SAEs, collected during the course of the study. See the Reported Adverse Event section for details. |
| Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy | From first treatment until study discontinuation, up to 13 months. | Tolerability was evaluated by assessing the mean duration (in weeks) of treatment with Humira until the development of an adverse event leading to treatment discontinuation or until early discontinuation for any other reason. |
| Participant Acceptability of Self-injection at Month 13 (End of Study) | 13 months | Participant acceptability of self-injection was assessed by the percentage of participants able to appropriately execute self-injection after initial training in the medical center, per investigator's opinion and documentation of necessity of re-training. Those participants able to self-inject also reported their experience of self-injection as convenient or inconvenient. |
Countries
Croatia, Hungary, Israel, Poland, Romania, Slovakia, Ukraine
Participant flow
Recruitment details
Investigational sites in 7 countries participated in this study: Croatia, Hungary, Israel, Poland, Romania, Slovakia and Ukraine.
Pre-assignment details
Out of 809 participants recruited, 789 were included in the statistical evaluation dataset (SES). 20 participants were not included due to no documented Humira therapy and/or missing primary diagnosis.
Participants by arm
| Arm | Count |
|---|---|
| Rheumatoid Arthritis (RA) Participants with active rheumatoid arthritis | 431 |
| Psoriatic Arthritis (PsA) Participants with active psoriatic arthritis | 124 |
| Ankylosing Spondylitis (AS) Participants with active ankylosing spondylitis | 234 |
| Total | 789 |
Baseline characteristics
| Characteristic | Rheumatoid Arthritis (RA) | Psoriatic Arthritis (PsA) | Ankylosing Spondylitis (AS) | Total |
|---|---|---|---|---|
| Age Continuous | 54.0 years STANDARD_DEVIATION 11.5 | 47.8 years STANDARD_DEVIATION 12.4 | 41.5 years STANDARD_DEVIATION 13 | 49.3 years STANDARD_DEVIATION 13.3 |
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score High Disease Activity (BASDAI score ≥4) | NA participants | 53 participants | 217 participants | 270 participants |
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score Low Disease Activity (BASDAI score <4) | NA participants | 7 participants | 10 participants | 17 participants |
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score Missing | NA participants | 64 participants | 7 participants | 71 participants |
| Disease Activity Score (DAS28) High Disease Activity (score ≥5.1) | 376 participants | NA participants | NA participants | 376 participants |
| Disease Activity Score (DAS28) Low Disease Activity (score ≥2.6 and <3.2) | 1 participants | NA participants | NA participants | 1 participants |
| Disease Activity Score (DAS28) Missing | 17 participants | NA participants | NA participants | 17 participants |
| Disease Activity Score (DAS28) Moderate Disease Activity (score ≥3.2 and <5.1) | 37 participants | NA participants | NA participants | 37 participants |
| Sex: Female, Male Female | 360 Participants | 61 Participants | 60 Participants | 481 Participants |
| Sex: Female, Male Male | 71 Participants | 63 Participants | 174 Participants | 308 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 431 | 0 / 124 | 0 / 234 | 0 / 789 |
| serious Total, serious adverse events | 18 / 431 | 4 / 124 | 5 / 234 | 27 / 789 |
Outcome results
Primary
Clinical Outcome (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] Decrease ≥50%) After 3 Months of Humira Therapy Relative to Baseline in Participants With PsA and AS
BASDAI score was calculated using a questionnaire with 6 questions that the participant completes by marking answers on a 10-centimeter visual analog scale with responses that range from 0 (none) to 10 (very severe) and measures severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. The final BASDAI score ranges from 0 to 10. A positive clinical outcome was defined as a 50% or more decrease in BASDAI score after 3 months of Humira therapy relative to baseline.
Time frame: Baseline, 3 months
Population: Clinical Outcome Analysis Set (COS): all participants in the SES, who had a non-missing assessment of clinical outcome at baseline and not less than one follow-up visit with a non-missing assessment of clinical outcome. In addition, patients with unclear visit schedule were excluded from the COS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis (RA) | Clinical Outcome (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] Decrease ≥50%) After 3 Months of Humira Therapy Relative to Baseline in Participants With PsA and AS | Missing | 2 participants |
| Rheumatoid Arthritis (RA) | Clinical Outcome (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] Decrease ≥50%) After 3 Months of Humira Therapy Relative to Baseline in Participants With PsA and AS | Positive (BASDAI Decrease ≥50%) | 24 participants |
| Rheumatoid Arthritis (RA) | Clinical Outcome (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] Decrease ≥50%) After 3 Months of Humira Therapy Relative to Baseline in Participants With PsA and AS | Negative (BASDAI Decrease <50% or No Decrease) | 26 participants |
| Ankylosing Spondylitis (AS) | Clinical Outcome (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] Decrease ≥50%) After 3 Months of Humira Therapy Relative to Baseline in Participants With PsA and AS | Missing | 12 participants |
| Ankylosing Spondylitis (AS) | Clinical Outcome (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] Decrease ≥50%) After 3 Months of Humira Therapy Relative to Baseline in Participants With PsA and AS | Positive (BASDAI Decrease ≥50%) | 138 participants |
| Ankylosing Spondylitis (AS) | Clinical Outcome (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] Decrease ≥50%) After 3 Months of Humira Therapy Relative to Baseline in Participants With PsA and AS | Negative (BASDAI Decrease <50% or No Decrease) | 66 participants |
Primary
Clinical Outcome (Disease Activity Score [DAS28] Decrease ≥1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA
DAS28 score was calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR) level, and the participant's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. A positive clinical outcome was defined as a DAS28 decrease by 1.2 or more after 3 months of Humira therapy relative to baseline.
Time frame: Baseline, 3 months
Population: Clinical Outcome Analysis Set (COS): all participants in the SES, who had a non-missing assessment of clinical outcome at baseline and not less than one follow-up visit with a non-missing assessment of clinical outcome. In addition, patients with unclear visit schedule were excluded from the COS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis (RA) | Clinical Outcome (Disease Activity Score [DAS28] Decrease ≥1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA | Missing | 56 participants |
| Rheumatoid Arthritis (RA) | Clinical Outcome (Disease Activity Score [DAS28] Decrease ≥1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA | Positive (DAS28 Decrease ≥1.2) | 251 participants |
| Rheumatoid Arthritis (RA) | Clinical Outcome (Disease Activity Score [DAS28] Decrease ≥1.2) After 3 Months of Humira Therapy Relative to Baseline in Participants With RA | Negative (DAS28 Decrease <1.2 or No Decrease) | 78 participants |
Secondary
Compliance With the Humira Administration Schedule at Month 13 (End of Study)
Compliance with the Humira therapy was assessed by the number of missed injections among participants. Documentation of injections missed or delayed by more than 7 days was made at each study visit.
Time frame: Month 13
Population: Participants in the SES with evaluable values. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis (RA) | Compliance With the Humira Administration Schedule at Month 13 (End of Study) | None | 403 participants |
| Rheumatoid Arthritis (RA) | Compliance With the Humira Administration Schedule at Month 13 (End of Study) | 1 Injection Missed | 11 participants |
| Rheumatoid Arthritis (RA) | Compliance With the Humira Administration Schedule at Month 13 (End of Study) | 2 Injections Missed | 0 participants |
| Rheumatoid Arthritis (RA) | Compliance With the Humira Administration Schedule at Month 13 (End of Study) | 3 or More Injections Missed | 14 participants |
| Ankylosing Spondylitis (AS) | Compliance With the Humira Administration Schedule at Month 13 (End of Study) | 1 Injection Missed | 5 participants |
| Ankylosing Spondylitis (AS) | Compliance With the Humira Administration Schedule at Month 13 (End of Study) | 2 Injections Missed | 3 participants |
| Ankylosing Spondylitis (AS) | Compliance With the Humira Administration Schedule at Month 13 (End of Study) | 3 or More Injections Missed | 4 participants |
| Ankylosing Spondylitis (AS) | Compliance With the Humira Administration Schedule at Month 13 (End of Study) | None | 109 participants |
| Ankylosing Spondylitis (AS) | Compliance With the Humira Administration Schedule at Month 13 (End of Study) | 2 Injections Missed | 8 participants |
| Ankylosing Spondylitis (AS) | Compliance With the Humira Administration Schedule at Month 13 (End of Study) | 1 Injection Missed | 7 participants |
| Ankylosing Spondylitis (AS) | Compliance With the Humira Administration Schedule at Month 13 (End of Study) | 3 or More Injections Missed | 8 participants |
| Ankylosing Spondylitis (AS) | Compliance With the Humira Administration Schedule at Month 13 (End of Study) | None | 210 participants |
| All Participants (RA, PsA, AS) | Compliance With the Humira Administration Schedule at Month 13 (End of Study) | 3 or More Injections Missed | 26 participants |
| All Participants (RA, PsA, AS) | Compliance With the Humira Administration Schedule at Month 13 (End of Study) | 1 Injection Missed | 23 participants |
| All Participants (RA, PsA, AS) | Compliance With the Humira Administration Schedule at Month 13 (End of Study) | None | 722 participants |
| All Participants (RA, PsA, AS) | Compliance With the Humira Administration Schedule at Month 13 (End of Study) | 2 Injections Missed | 11 participants |
Secondary
Participant Acceptability of Self-injection at Month 13 (End of Study)
Participant acceptability of self-injection was assessed by the percentage of participants able to appropriately execute self-injection after initial training in the medical center, per investigator's opinion and documentation of necessity of re-training. Those participants able to self-inject also reported their experience of self-injection as convenient or inconvenient.
Time frame: 13 months
Population: Participants in the SES with evaluable values. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis (RA) | Participant Acceptability of Self-injection at Month 13 (End of Study) | Able to Self-inject, Assessed as Convenient | 86.2 percentage of participants |
| Rheumatoid Arthritis (RA) | Participant Acceptability of Self-injection at Month 13 (End of Study) | Able to Self-inject, Assessed as Inconvenient | 7.2 percentage of participants |
| Rheumatoid Arthritis (RA) | Participant Acceptability of Self-injection at Month 13 (End of Study) | Unable to Self-inject With Need for Retraining | 0.5 percentage of participants |
| Rheumatoid Arthritis (RA) | Participant Acceptability of Self-injection at Month 13 (End of Study) | Unable to Self-inject Due to Disease Condition | 6.1 percentage of participants |
| Ankylosing Spondylitis (AS) | Participant Acceptability of Self-injection at Month 13 (End of Study) | Able to Self-inject, Assessed as Inconvenient | 0.8 percentage of participants |
| Ankylosing Spondylitis (AS) | Participant Acceptability of Self-injection at Month 13 (End of Study) | Unable to Self-inject With Need for Retraining | 0.0 percentage of participants |
| Ankylosing Spondylitis (AS) | Participant Acceptability of Self-injection at Month 13 (End of Study) | Unable to Self-inject Due to Disease Condition | 3.3 percentage of participants |
| Ankylosing Spondylitis (AS) | Participant Acceptability of Self-injection at Month 13 (End of Study) | Able to Self-inject, Assessed as Convenient | 95.9 percentage of participants |
| Ankylosing Spondylitis (AS) | Participant Acceptability of Self-injection at Month 13 (End of Study) | Unable to Self-inject With Need for Retraining | 0.4 percentage of participants |
| Ankylosing Spondylitis (AS) | Participant Acceptability of Self-injection at Month 13 (End of Study) | Able to Self-inject, Assessed as Inconvenient | 6.4 percentage of participants |
| Ankylosing Spondylitis (AS) | Participant Acceptability of Self-injection at Month 13 (End of Study) | Unable to Self-inject Due to Disease Condition | 0.9 percentage of participants |
| Ankylosing Spondylitis (AS) | Participant Acceptability of Self-injection at Month 13 (End of Study) | Able to Self-inject, Assessed as Convenient | 92.3 percentage of participants |
| All Participants (RA, PsA, AS) | Participant Acceptability of Self-injection at Month 13 (End of Study) | Unable to Self-inject Due to Disease Condition | 4.1 percentage of participants |
| All Participants (RA, PsA, AS) | Participant Acceptability of Self-injection at Month 13 (End of Study) | Able to Self-inject, Assessed as Inconvenient | 6.0 percentage of participants |
| All Participants (RA, PsA, AS) | Participant Acceptability of Self-injection at Month 13 (End of Study) | Able to Self-inject, Assessed as Convenient | 89.5 percentage of participants |
| All Participants (RA, PsA, AS) | Participant Acceptability of Self-injection at Month 13 (End of Study) | Unable to Self-inject With Need for Retraining | 0.4 percentage of participants |
Secondary
Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy
HAQ-DI score was calculated using the standard questionnaire covering 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale from 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.
Time frame: Baseline, 4, 7 and 13 months
Population: SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented. n=number of participants with evaluable records at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis (RA) | Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy | Score at Baseline (n=314, 81, 106, 501) | 1.8 units on a scale | Standard Deviation 0.6 |
| Rheumatoid Arthritis (RA) | Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy | Score at 4 Months (n=232, 56, 76, 364) | 1.3 units on a scale | Standard Deviation 0.7 |
| Rheumatoid Arthritis (RA) | Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy | Score at 7 Months (n=211, 49, 63, 323) | 1.2 units on a scale | Standard Deviation 0.7 |
| Rheumatoid Arthritis (RA) | Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy | Score at 13 Months (n=174, 47, 31, 252) | 1.1 units on a scale | Standard Deviation 0.7 |
| Ankylosing Spondylitis (AS) | Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy | Score at 4 Months (n=232, 56, 76, 364) | 0.8 units on a scale | Standard Deviation 0.6 |
| Ankylosing Spondylitis (AS) | Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy | Score at 7 Months (n=211, 49, 63, 323) | 0.7 units on a scale | Standard Deviation 0.6 |
| Ankylosing Spondylitis (AS) | Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy | Score at 13 Months (n=174, 47, 31, 252) | 0.8 units on a scale | Standard Deviation 0.6 |
| Ankylosing Spondylitis (AS) | Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy | Score at Baseline (n=314, 81, 106, 501) | 1.5 units on a scale | Standard Deviation 0.6 |
| Ankylosing Spondylitis (AS) | Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy | Score at 7 Months (n=211, 49, 63, 323) | 0.7 units on a scale | Standard Deviation 0.6 |
| Ankylosing Spondylitis (AS) | Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy | Score at 4 Months (n=232, 56, 76, 364) | 0.7 units on a scale | Standard Deviation 0.5 |
| Ankylosing Spondylitis (AS) | Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy | Score at 13 Months (n=174, 47, 31, 252) | 0.6 units on a scale | Standard Deviation 0.5 |
| Ankylosing Spondylitis (AS) | Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy | Score at Baseline (n=314, 81, 106, 501) | 1.3 units on a scale | Standard Deviation 0.6 |
| All Participants (RA, PsA, AS) | Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy | Score at 13 Months (n=174, 47, 31, 252) | 1.0 units on a scale | Standard Deviation 0.7 |
| All Participants (RA, PsA, AS) | Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy | Score at 4 Months (n=232, 56, 76, 364) | 1.1 units on a scale | Standard Deviation 0.7 |
| All Participants (RA, PsA, AS) | Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy | Score at Baseline (n=314, 81, 106, 501) | 1.6 units on a scale | Standard Deviation 0.6 |
| All Participants (RA, PsA, AS) | Physical Function: Mean Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Baseline, and After 4, 7 and 13 Months of Humira Therapy | Score at 7 Months (n=211, 49, 63, 323) | 1.0 units on a scale | Standard Deviation 0.7 |
Secondary
Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy
Tolerability was evaluated by assessing the mean duration (in weeks) of treatment with Humira until the development of an adverse event leading to treatment discontinuation or until early discontinuation for any other reason.
Time frame: From first treatment until study discontinuation, up to 13 months.
Population: Participants in the SES who discontinued therapy and had evaluable records. SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rheumatoid Arthritis (RA) | Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy | 28.6 weeks | Standard Deviation 17.6 |
| Ankylosing Spondylitis (AS) | Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy | 29.7 weeks | Standard Deviation 19 |
| Ankylosing Spondylitis (AS) | Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy | 29.9 weeks | Standard Deviation 14.1 |
| All Participants (RA, PsA, AS) | Tolerability: Duration of Humira Therapy in Participants Who Discontinued Therapy | 29.2 weeks | Standard Deviation 16.7 |
Secondary
Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Tolerability was measured by AEs and SAEs, collected during the course of the study. See the Reported Adverse Event section for details.
Time frame: From the time participant gave authorization to use and disclose information (or gave informed consent) until 5 half-lives following the last dose of physician-prescribed therapy. Mean (standard deviation [SD]) duration of therapy was 49.0 (16.0) weeks.
Population: SES=participants fulfilling both of the following criteria: a primary diagnosis of specified rheumatic disease (RA, PsA, AS); at least one recorded Humira treatment is documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis (RA) | Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with Any SAE | 18 participants |
| Rheumatoid Arthritis (RA) | Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with Any AE | 78 participants |
| Ankylosing Spondylitis (AS) | Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with Any SAE | 4 participants |
| Ankylosing Spondylitis (AS) | Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with Any AE | 30 participants |
| Ankylosing Spondylitis (AS) | Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with Any AE | 36 participants |
| Ankylosing Spondylitis (AS) | Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with Any SAE | 5 participants |
| All Participants (RA, PsA, AS) | Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with Any SAE | 27 participants |
| All Participants (RA, PsA, AS) | Tolerability: Overall Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Number of Participants with Any AE | 144 participants |