Ankylosing Spondylitis, Psoriatic Arthritis, Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
Brief summary
The primary objective of this post-marketing observational study was to obtain data on the characteristics (patient age/gender; disease type, severity and duration; disease specific treatment history; current concomitant medications; other relevant medical history) of patients prescribed adalimumab (Humira®) for rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) as part of routine clinical care in Russia.
Detailed description
This is a non-interventional, observational study in which 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 exist that characterize patient types and adalimumab administration within the Russian population. Further, it is important to characterize the compliance, acceptability of patient self-injection, tolerability and safety profile of this therapy option with the routine clinical care. The total follow-up for each participant was planned to be 12 months, with approximately 6 follow-up visits occurring at average intervals of 2-3 months. However, since this was an observational study, follow-up was performed according to routine clinical practice; for 127 participants the follow-up period consisted of more than 12 months and the maximum observation period lasted 18.2 months. Follow-up visits were designated sequential visit numbers (Visit 1-6), regardless of the time point at which they occurred.
Interventions
None listed
Sponsors
Scientific Research Institute of Rheumatology, Moscow
Almedis
Abbott
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients for whom adalimumab therapy is indicated according to product label and who meet the following criteria: * Patients who are newly prescribed adalimumab therapy (no prior history of treatment with adalimumab) including patients with infliximab treatment history. * Patients who completed Abbott sponsored interventional trials and are continuing treatment with commercial adalimumab thereafter.
Exclusion criteria
The following patients will not be included in the study: * Patients who are being treated or will be treated with drugs at risk of interactions with adalimumab. * Hypersensitivity to adalimumab * Pregnancy * Lactation * Age below 18 * Infectious diseases including tuberculosis * Patients currently participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment | Baseline and at each follow-up visit (up to a maximum of 18.2 months). | Data on other medications (methotrexate, non-steroidal anti-inflammatory drugs \[NSAIDs\], corticosteroids and other medications) taken for the participant's condition (rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis) were collected at the Baseline visit and at each follow-up visit throughout the study. Overall data are presented. |
| Characteristics of Patients Prescribed Adalimumab: Marital Status | Baseline | Participants were asked to indicate their marital status at the Baseline visit. |
| Characteristics of Patients Prescribed Adalimumab: Disease Severity | Baseline | Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice. |
| Characteristics of Patients Prescribed Adalimumab: Duration of Disease | Baseline | Duration of disease was defined as the time from diagnosis until study entry. |
| Characteristics of Patients Prescribed Adalimumab: Education Level | Baseline | Participants were asked to indicate their highest education level at the Baseline visit: secondary school, vocational school or college, university graduate, current university student, or other. |
| Characteristics of Patients Prescribed Adalimumab: Occupation | Baseline | Participants were asked to indicate their occupation at the Baseline visit. |
| Characteristics of Patients Prescribed Adalimumab: Residence Status | Baseline | Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Missed or Delayed Injections | For the duration of the study (up to a maximum of 18.2 months). | Compliance with prescribed adalimumab therapy was assessed by the percentage of participants with missed injections and/or injections delayed by more than 7 days. |
| Duration of Treatment With Adalimumab | For the duration of the study (up to a maximum of 18.2 months). | Tolerability to adalimumab treatment was analyzed by the time on treatment until development of an adverse event leading to adalimumab discontinuation or until discontinuation from treatment for any other reason. |
| Patient's Acceptability of Self-injections | Data were collected at study follow-up visits (Visits 1-6) which occurred on average at 2-3 month intervals, up to a maximum of 18.2 months. | At each clinic visit participants were asked to rate the convenience of adalimumab injections. Possible options were convenient, inconvenient and unable to self-inject. The study follow-up period consisted of approximately 6 follow-up visits occurring at average intervals of 2-3 months, according to routine clinical practice. Acceptability data are reported by follow-up visit and by treatment regimen: 40 mg every other week or 40 mg once a week, as prescribed in accordance with local marketing authorization. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rheumatoid Arthritis Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia. | 126 |
| Psoriatic Arthritis Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia. | 35 |
| Ankylosing Spondylitis Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia. | 91 |
| Total | 252 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 1 |
| Overall Study | Lack of Efficacy | 2 | 0 | 1 |
| Overall Study | Other | 24 | 4 | 16 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 2 |
Baseline characteristics
| Characteristic | Rheumatoid Arthritis | Psoriatic Arthritis | Ankylosing Spondylitis | Total |
|---|---|---|---|---|
| Age Continuous | 47.0 years STANDARD_DEVIATION 13.7 | 42.4 years STANDARD_DEVIATION 12.6 | 36.2 years STANDARD_DEVIATION 10.6 | 42.5 years STANDARD_DEVIATION 13.4 |
| Region of Enrollment Russian Federation | 126 participants | 35 participants | 91 participants | 252 participants |
| Sex: Female, Male Female | 93 Participants | 18 Participants | 23 Participants | 134 Participants |
| Sex: Female, Male Male | 33 Participants | 17 Participants | 68 Participants | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 125 | 0 / 35 | 8 / 91 |
| serious Total, serious adverse events | 2 / 125 | 0 / 35 | 0 / 91 |
Outcome results
Primary
Characteristics of Patients Prescribed Adalimumab: Disease Severity
Disease severity was assessed by the physician as mild, moderate or severe, based on routine clinical practice.
Time frame: Baseline
Population: Safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Disease Severity | Moderate | 44 participants |
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Disease Severity | Mild | 0 participants |
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Disease Severity | Severe | 81 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Disease Severity | Moderate | 14 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Disease Severity | Mild | 2 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Disease Severity | Severe | 19 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Disease Severity | Mild | 0 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Disease Severity | Severe | 60 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Disease Severity | Moderate | 31 participants |
Primary
Characteristics of Patients Prescribed Adalimumab: Duration of Disease
Duration of disease was defined as the time from diagnosis until study entry.
Time frame: Baseline
Population: Safety set
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Duration of Disease | 71.70 months | Full Range 81.91 |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Duration of Disease | 103.50 months | Full Range 110.02 |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Duration of Disease | 50.90 months | Full Range 79.47 |
Primary
Characteristics of Patients Prescribed Adalimumab: Education Level
Participants were asked to indicate their highest education level at the Baseline visit: secondary school, vocational school or college, university graduate, current university student, or other.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Education Level | Current university student | 5 participants |
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Education Level | University degree | 64 participants |
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Education Level | Secondary school | 21 participants |
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Education Level | Vocational school/college | 34 participants |
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Education Level | Other | 2 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Education Level | University degree | 19 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Education Level | Secondary school | 2 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Education Level | Vocational school/college | 9 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Education Level | Current university student | 5 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Education Level | Other | 0 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Education Level | Other | 1 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Education Level | Current university student | 8 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Education Level | Secondary school | 5 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Education Level | University degree | 51 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Education Level | Vocational school/college | 26 participants |
Primary
Characteristics of Patients Prescribed Adalimumab: Marital Status
Participants were asked to indicate their marital status at the Baseline visit.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Marital Status | Missing | 0 participants |
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Marital Status | Single | 32 participants |
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Marital Status | Married | 94 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Marital Status | Missing | 0 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Marital Status | Married | 24 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Marital Status | Single | 11 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Marital Status | Single | 21 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Marital Status | Married | 69 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Marital Status | Missing | 1 participants |
Primary
Characteristics of Patients Prescribed Adalimumab: Occupation
Participants were asked to indicate their occupation at the Baseline visit.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Occupation | Other | 15 participants |
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Occupation | Student | 7 participants |
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Occupation | Self-employed | 8 participants |
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Occupation | Civil servant | 10 participants |
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Occupation | Blue collar worker | 13 participants |
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Occupation | Retired | 21 participants |
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Occupation | White collar worker | 52 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Occupation | Blue collar worker | 5 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Occupation | Civil servant | 5 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Occupation | White collar worker | 13 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Occupation | Self-employed | 1 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Occupation | Student | 4 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Occupation | Retired | 4 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Occupation | Other | 3 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Occupation | Student | 4 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Occupation | Civil servant | 12 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Occupation | Other | 14 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Occupation | Retired | 4 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Occupation | Self-employed | 9 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Occupation | White collar worker | 38 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Occupation | Blue collar worker | 10 participants |
Primary
Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment
Data on other medications (methotrexate, non-steroidal anti-inflammatory drugs \[NSAIDs\], corticosteroids and other medications) taken for the participant's condition (rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis) were collected at the Baseline visit and at each follow-up visit throughout the study. Overall data are presented.
Time frame: Baseline and at each follow-up visit (up to a maximum of 18.2 months).
Population: Safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment | Methotrexate | 96 participants |
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment | NSAIDs | 73 participants |
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment | Corticosteroids | 48 participants |
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment | Other medications | 82 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment | Other medications | 18 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment | Methotrexate | 23 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment | Corticosteroids | 9 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment | NSAIDs | 16 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment | Other medications | 65 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment | NSAIDs | 72 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment | Corticosteroids | 16 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Other Disease Specific Treatment | Methotrexate | 20 participants |
Primary
Characteristics of Patients Prescribed Adalimumab: Residence Status
Participants were asked to indicate their residence status within the Russian Federation at the Baseline visit.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Residence Status | Permanent | 113 participants |
| Rheumatoid Arthritis | Characteristics of Patients Prescribed Adalimumab: Residence Status | Temporary | 13 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Residence Status | Permanent | 33 participants |
| Psoriatic Arthritis | Characteristics of Patients Prescribed Adalimumab: Residence Status | Temporary | 2 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Residence Status | Permanent | 88 participants |
| Ankylosing Spondylitis | Characteristics of Patients Prescribed Adalimumab: Residence Status | Temporary | 3 participants |
Secondary
Duration of Treatment With Adalimumab
Tolerability to adalimumab treatment was analyzed by the time on treatment until development of an adverse event leading to adalimumab discontinuation or until discontinuation from treatment for any other reason.
Time frame: For the duration of the study (up to a maximum of 18.2 months).
Population: Safety set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Rheumatoid Arthritis | Duration of Treatment With Adalimumab | 52.10 weeks |
| Psoriatic Arthritis | Duration of Treatment With Adalimumab | 52.90 weeks |
| Ankylosing Spondylitis | Duration of Treatment With Adalimumab | 52.30 weeks |
Secondary
Patient's Acceptability of Self-injections
At each clinic visit participants were asked to rate the convenience of adalimumab injections. Possible options were convenient, inconvenient and unable to self-inject. The study follow-up period consisted of approximately 6 follow-up visits occurring at average intervals of 2-3 months, according to routine clinical practice. Acceptability data are reported by follow-up visit and by treatment regimen: 40 mg every other week or 40 mg once a week, as prescribed in accordance with local marketing authorization.
Time frame: Data were collected at study follow-up visits (Visits 1-6) which occurred on average at 2-3 month intervals, up to a maximum of 18.2 months.
Population: The number of participants analyzed (251) represents the total number of participants in the safety set. The number of participants with available data at each follow-up visit were: Visit 1: 249; Visit 2: 246; Visit 3: 237; Visit 4: 205; Visit 5: 179; Visit 6: 135.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis | Patient's Acceptability of Self-injections | Visit 6: 40 mg every other week | 105 participants |
| Rheumatoid Arthritis | Patient's Acceptability of Self-injections | Visit 4: 40 mg every other week | 155 participants |
| Rheumatoid Arthritis | Patient's Acceptability of Self-injections | Visit 6: 40 mg once a week | 1 participants |
| Rheumatoid Arthritis | Patient's Acceptability of Self-injections | Visit 1: 40 mg once a week | 0 participants |
| Rheumatoid Arthritis | Patient's Acceptability of Self-injections | Visit 6: Missing regimen data | 0 participants |
| Rheumatoid Arthritis | Patient's Acceptability of Self-injections | Visit 3: 40 mg once a week | 0 participants |
| Rheumatoid Arthritis | Patient's Acceptability of Self-injections | Visit 1: 40 mg every other week | 168 participants |
| Rheumatoid Arthritis | Patient's Acceptability of Self-injections | Visit 4: 40 mg once a week | 0 participants |
| Rheumatoid Arthritis | Patient's Acceptability of Self-injections | Visit 2: Missing regimen data | 2 participants |
| Rheumatoid Arthritis | Patient's Acceptability of Self-injections | Visit 4: Missing regimen data | 2 participants |
| Rheumatoid Arthritis | Patient's Acceptability of Self-injections | Visit 3: Missing regimen data | 4 participants |
| Rheumatoid Arthritis | Patient's Acceptability of Self-injections | Visit 5: 40 mg every other week | 137 participants |
| Rheumatoid Arthritis | Patient's Acceptability of Self-injections | Visit 2: 40 mg once a week | 1 participants |
| Rheumatoid Arthritis | Patient's Acceptability of Self-injections | Visit 5: 40 mg once a week | 0 participants |
| Rheumatoid Arthritis | Patient's Acceptability of Self-injections | Visit 5: Missing regimen data | 0 participants |
| Rheumatoid Arthritis | Patient's Acceptability of Self-injections | Visit 3: 40 mg every other week | 177 participants |
| Rheumatoid Arthritis | Patient's Acceptability of Self-injections | Visit 2: 40 mg every other week | 172 participants |
| Psoriatic Arthritis | Patient's Acceptability of Self-injections | Visit 5: 40 mg once a week | 0 participants |
| Psoriatic Arthritis | Patient's Acceptability of Self-injections | Visit 4: Missing regimen data | 0 participants |
| Psoriatic Arthritis | Patient's Acceptability of Self-injections | Visit 1: 40 mg once a week | 0 participants |
| Psoriatic Arthritis | Patient's Acceptability of Self-injections | Visit 3: 40 mg once a week | 0 participants |
| Psoriatic Arthritis | Patient's Acceptability of Self-injections | Visit 6: 40 mg once a week | 0 participants |
| Psoriatic Arthritis | Patient's Acceptability of Self-injections | Visit 4: 40 mg every other week | 3 participants |
| Psoriatic Arthritis | Patient's Acceptability of Self-injections | Visit 2: 40 mg once a week | 0 participants |
| Psoriatic Arthritis | Patient's Acceptability of Self-injections | Visit 2: 40 mg every other week | 7 participants |
| Psoriatic Arthritis | Patient's Acceptability of Self-injections | Visit 6: Missing regimen data | 0 participants |
| Psoriatic Arthritis | Patient's Acceptability of Self-injections | Visit 5: 40 mg every other week | 1 participants |
| Psoriatic Arthritis | Patient's Acceptability of Self-injections | Visit 1: 40 mg every other week | 10 participants |
| Psoriatic Arthritis | Patient's Acceptability of Self-injections | Visit 3: Missing regimen data | 0 participants |
| Psoriatic Arthritis | Patient's Acceptability of Self-injections | Visit 2: Missing regimen data | 0 participants |
| Psoriatic Arthritis | Patient's Acceptability of Self-injections | Visit 6: 40 mg every other week | 1 participants |
| Psoriatic Arthritis | Patient's Acceptability of Self-injections | Visit 4: 40 mg once a week | 0 participants |
| Psoriatic Arthritis | Patient's Acceptability of Self-injections | Visit 3: 40 mg every other week | 7 participants |
| Psoriatic Arthritis | Patient's Acceptability of Self-injections | Visit 5: Missing regimen data | 0 participants |
| Ankylosing Spondylitis | Patient's Acceptability of Self-injections | Visit 3: 40 mg every other week | 49 participants |
| Ankylosing Spondylitis | Patient's Acceptability of Self-injections | Visit 3: 40 mg once a week | 0 participants |
| Ankylosing Spondylitis | Patient's Acceptability of Self-injections | Visit 3: Missing regimen data | 0 participants |
| Ankylosing Spondylitis | Patient's Acceptability of Self-injections | Visit 4: 40 mg every other week | 45 participants |
| Ankylosing Spondylitis | Patient's Acceptability of Self-injections | Visit 4: 40 mg once a week | 0 participants |
| Ankylosing Spondylitis | Patient's Acceptability of Self-injections | Visit 4: Missing regimen data | 0 participants |
| Ankylosing Spondylitis | Patient's Acceptability of Self-injections | Visit 5: 40 mg every other week | 39 participants |
| Ankylosing Spondylitis | Patient's Acceptability of Self-injections | Visit 5: 40 mg once a week | 0 participants |
| Ankylosing Spondylitis | Patient's Acceptability of Self-injections | Visit 5: Missing regimen data | 1 participants |
| Ankylosing Spondylitis | Patient's Acceptability of Self-injections | Visit 6: 40 mg every other week | 27 participants |
| Ankylosing Spondylitis | Patient's Acceptability of Self-injections | Visit 6: 40 mg once a week | 0 participants |
| Ankylosing Spondylitis | Patient's Acceptability of Self-injections | Visit 6: Missing regimen data | 0 participants |
| Ankylosing Spondylitis | Patient's Acceptability of Self-injections | Visit 1: 40 mg every other week | 71 participants |
| Ankylosing Spondylitis | Patient's Acceptability of Self-injections | Visit 1: 40 mg once a week | 0 participants |
| Ankylosing Spondylitis | Patient's Acceptability of Self-injections | Visit 2: 40 mg every other week | 63 participants |
| Ankylosing Spondylitis | Patient's Acceptability of Self-injections | Visit 2: 40 mg once a week | 1 participants |
| Ankylosing Spondylitis | Patient's Acceptability of Self-injections | Visit 2: Missing regimen data | 0 participants |
| Missing | Patient's Acceptability of Self-injections | Visit 2: Missing regimen data | 0 participants |
| Missing | Patient's Acceptability of Self-injections | Visit 1: 40 mg once a week | 0 participants |
| Missing | Patient's Acceptability of Self-injections | Visit 5: Missing regimen data | 1 participants |
| Missing | Patient's Acceptability of Self-injections | Visit 5: 40 mg once a week | 0 participants |
| Missing | Patient's Acceptability of Self-injections | Visit 3: Missing regimen data | 0 participants |
| Missing | Patient's Acceptability of Self-injections | Visit 2: 40 mg every other week | 0 participants |
| Missing | Patient's Acceptability of Self-injections | Visit 5: 40 mg every other week | 0 participants |
| Missing | Patient's Acceptability of Self-injections | Visit 4: Missing regimen data | 0 participants |
| Missing | Patient's Acceptability of Self-injections | Visit 3: 40 mg once a week | 0 participants |
| Missing | Patient's Acceptability of Self-injections | Visit 2: 40 mg once a week | 0 participants |
| Missing | Patient's Acceptability of Self-injections | Visit 4: 40 mg once a week | 0 participants |
| Missing | Patient's Acceptability of Self-injections | Visit 4: 40 mg every other week | 0 participants |
| Missing | Patient's Acceptability of Self-injections | Visit 6: Missing regimen data | 1 participants |
| Missing | Patient's Acceptability of Self-injections | Visit 3: 40 mg every other week | 0 participants |
| Missing | Patient's Acceptability of Self-injections | Visit 1: 40 mg every other week | 0 participants |
| Missing | Patient's Acceptability of Self-injections | Visit 6: 40 mg once a week | 0 participants |
| Missing | Patient's Acceptability of Self-injections | Visit 6: 40 mg every other week | 0 participants |
Secondary
Percentage of Participants With Missed or Delayed Injections
Compliance with prescribed adalimumab therapy was assessed by the percentage of participants with missed injections and/or injections delayed by more than 7 days.
Time frame: For the duration of the study (up to a maximum of 18.2 months).
Population: Safety set; the analysis only includes participants with non-missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rheumatoid Arthritis | Percentage of Participants With Missed or Delayed Injections | No missed or delayed injections | 55.2 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With Missed or Delayed Injections | One missed or delayed injection | 21.6 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With Missed or Delayed Injections | Two missed or delayed injections | 9.6 percentage of participants |
| Rheumatoid Arthritis | Percentage of Participants With Missed or Delayed Injections | Three or more missed or delayed injections | 13.6 percentage of participants |
| Psoriatic Arthritis | Percentage of Participants With Missed or Delayed Injections | Three or more missed or delayed injections | 11.4 percentage of participants |
| Psoriatic Arthritis | Percentage of Participants With Missed or Delayed Injections | No missed or delayed injections | 57.1 percentage of participants |
| Psoriatic Arthritis | Percentage of Participants With Missed or Delayed Injections | Two missed or delayed injections | 20.0 percentage of participants |
| Psoriatic Arthritis | Percentage of Participants With Missed or Delayed Injections | One missed or delayed injection | 11.4 percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Missed or Delayed Injections | Three or more missed or delayed injections | 14.4 percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Missed or Delayed Injections | One missed or delayed injection | 21.1 percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Missed or Delayed Injections | Two missed or delayed injections | 7.8 percentage of participants |
| Ankylosing Spondylitis | Percentage of Participants With Missed or Delayed Injections | No missed or delayed injections | 56.7 percentage of participants |