Ankylosing Spondylitis
Conditions
Keywords
Ankylosing Spondylitis
Brief summary
This study of adalimumab (Humira) will be conducted to clarify the following with regard to the treatment of ankylosing spondylitis with this drug: * Unknown adverse drug reactions (especially important adverse drug 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
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Patients with ankylosing spondylitis who are not responding well to conventional therapy and receive adalimumab will be enrolled in the 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 congestive cardiac failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reactions | 24 weeks | An adverse drug reaction (ADR) is an injury caused by taking a medication, in which a causative relationship can be shown. A serious adverse drug reaction is any untoward medical occurrence that at any dose; * Results in death * Life threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent of significant disability or incapacity |
| Number of Participants With Adverse Drug Reactions by Baseline Factors | 24 weeks | An adverse drug reaction (ADR) is an injury caused by taking a medication, in which a causative relationship can be shown. ADRs are reported by baseline characteristics. NSAID: non-steroidal anti-inflammatory drug DMARD: disease-modifying anti-rheumatic drug BASDAI: Bath Ankylosing Spondylitis Disease Activity Index |
| Number of Participants With Adverse Events | 24 weeks | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. |
| Number of Participants With Self-injection Errors | 24 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | 24 weeks (or last visit if earlier) | Participants were evaluated for improvement at weeks 12 and 24 of treatment or discontinuation of treatment or participation in the survey based on the clinical course from baseline using the following scale: 1\. Markedly improved, 2. Improved, 3.Not improved, 5. Not assessable |
| Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | Baseline and weeks 12 and 24 | The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale \[NRS\]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 where lower scores indicate less disease activity. |
| Number of Participants With Markedly Improved or Improved Rating | Weeks 12, 24, and at the last visit | Participants were evaluated for improvement at weeks 12 and 24 of treatment or discontinuation of treatment or participation in the survey based on the clinical course from baseline using the following scale: 1\. Markedly improved, 2. Improved, 3.Not improved, 5. Not assessable |
Countries
Japan
Participant flow
Recruitment details
Four hundred and three participants were registered at 195 sites in Japan. Survey forms were available for 400 participants from 194 sites.
Participants by arm
| Arm | Count |
|---|---|
| Adalimumab Participants with ankylosing spondylitis (AS) receiving treatment with adalimumab (Humira) as prescribed by their physician. | 396 |
| Total | 396 |
Baseline characteristics
| Characteristic | Adalimumab |
|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 15.6 |
| Age, Customized 15 to < 65 years | 344 Participants |
| Age, Customized ≥ 65 years | 52 Participants |
| Race/Ethnicity, Customized Japanese | 396 Participants |
| Region of Enrollment Japan | 396 participants |
| Sex: Female, Male Female | 130 Participants |
| Sex: Female, Male Male | 266 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 396 |
| other Total, other adverse events | 113 / 396 |
| serious Total, serious adverse events | 17 / 396 |
Outcome results
Primary
Number of Participants With Adverse Drug Reactions
An adverse drug reaction (ADR) is an injury caused by taking a medication, in which a causative relationship can be shown. A serious adverse drug reaction is any untoward medical occurrence that at any dose; * Results in death * Life threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent of significant disability or incapacity
Time frame: 24 weeks
Population: Safety analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adalimumab | Number of Participants With Adverse Drug Reactions | Adverse drug reactions | 101 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions | Serious adverse drug reactions | 15 Participants |
Primary
Number of Participants With Adverse Drug Reactions by Baseline Factors
An adverse drug reaction (ADR) is an injury caused by taking a medication, in which a causative relationship can be shown. ADRs are reported by baseline characteristics. NSAID: non-steroidal anti-inflammatory drug DMARD: disease-modifying anti-rheumatic drug BASDAI: Bath Ankylosing Spondylitis Disease Activity Index
Time frame: 24 weeks
Population: Safety analysis set; results are only included for participants with non-missing baseline data for each characteristic.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Concomitant drug-DMARDs: Absent | 42 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Age: 15 to < 65 years | 94 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Age: ≥ 65 years | 7 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Sex: Male | 66 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Sex: Female | 35 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Body Mass Index: < 18.5 kg/m² | 9 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Body Mass Index: 18.5 - < 25 kg/m² | 36 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Body Mass Index: 25 - 30 kg/m² | 25 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Body Mass Index: ≥ 30 kg/m² | 5 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Duration of illness: < 5 years | 34 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Duration of illness: 5 to < 10 years | 21 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Duration of illness: 10 to < 20 years | 20 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Duration of illness: > 20 years | 15 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Smoking history: Absent | 39 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Smoking history: Present | 35 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications: Absent | 39 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications: Present | 62 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications-renal disorder: Absent | 95 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications-renal disorder: Present | 6 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications-cardiovascular disorder: Absent | 86 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications-cardiovascular disorder: Present | 15 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications-liver disorder: Absent | 95 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications-liver disorder: Present | 6 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications-blood disorder: Absent | 97 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications-blood disorder: Present | 4 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications-respiratory disorder: Absent | 94 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications-respiratory disorder: Present | 7 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications-diabetes mellitus: Absent | 94 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications-diabetes mellitus: Present | 7 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications-uveitis: Absent | 89 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications-uveitis: Present | 12 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications-inflammatory bowel disease: Absent | 100 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications-inflammatory bowel disease: Present | 1 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications-psoriasis: Absent | 100 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Complications-psoriasis: Present | 1 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Past illnesses: Absent | 66 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Past illnesses: Present | 34 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Allergy history: Absent | 83 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Allergy history: Present | 12 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Adalimumab self-injection: Absent | 37 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Adalimumab self-injection: Present | 64 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Prior medication-NSAIDs: Absent | 20 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Prior medication-NSAIDs: Present | 81 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Prior medication-biological products: Absent | 81 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Prior medication-biological products: Present | 20 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Prior medication-adrenal corticosteroids: Absent | 67 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Prior medication-adrenal corticosteroids: Present | 34 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Concomitant drugs: Absent | 2 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Concomitant drugs: Present | 99 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Concomitant drug-NSAIDs: Absent | 32 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Concomitant drug-NSAIDs: Present | 69 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Concomitant drug-DMARDs: Present | 59 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Concomitant drug-methotrexate: Absent | 57 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Concomitant drug-methotrexate: Present | 44 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Concomitant drug-salazosulfapyridine: Absent | 78 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Concomitant drug-salazosulfapyridine: Present | 23 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Concomitant drug-adrenal corticosteroids: Absent | 63 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Concomitant drug-adrenal corticosteroids: Present | 38 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Concomitant therapy: Absent | 97 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Concomitant therapy: Present | 4 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Human leukocyte antigen B27 (HLA-B27): Negative | 28 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | Human leukocyte antigen B27 (HLA-B27): Positive | 37 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | BASDAI: < 4 | 27 Participants |
| Adalimumab | Number of Participants With Adverse Drug Reactions by Baseline Factors | BASDAI: ≥4 | 50 Participants |
Comparison: Agep-value: 0.0328Mann-Whitney U-test
Comparison: Sexp-value: 0.7128Fisher Exact
Comparison: Body mass indexp-value: 0.0465Mann-Whitney U-test
Comparison: Duration of illnessp-value: 0.8872Mann-Whitney U-test
Comparison: Smoking historyp-value: 0.0388Fisher Exact
Comparison: Complicationsp-value: 0.4855Fisher Exact
Comparison: Complications - Liver disorderp-value: 0.663Fisher Exact
Comparison: Complications - Renal disorderp-value: 0.2067Fisher Exact
Comparison: Complications - Cardiovascular disorderp-value: 0.8749Fisher Exact
Comparison: Complications - Blood disorderp-value: 0.482Fisher Exact
Comparison: Complications - Respiratory disorderp-value: 0.6355Fisher Exact
Comparison: Complications - Diabetes mellitusp-value: 0.8193Fisher Exact
Comparison: Complications - Uveitisp-value: 0.5723Fisher Exact
Comparison: Complications - Inflammatory bowel diseasep-value: 1Fisher Exact
Comparison: Complications - Psoriasisp-value: 1Fisher Exact
Comparison: Past Illnessesp-value: 0.0144Fisher Exact
Comparison: Allergy historyp-value: 1Fisher Exact
Comparison: Adalimumab self-injection statusp-value: 0.3928Fisher Exact
Comparison: Prior medications - NSAIDsp-value: 0.2735Fisher Exact
Comparison: Prior medications - Biological productsp-value: 0.8875Fisher Exact
Comparison: Prior medications - Adrenal corticosteroidsp-value: 0.254Fisher Exact
Comparison: Concomitant drugsp-value: 0.0226Fisher Exact
Comparison: Concomitant drug: NSAIDsp-value: 1Fisher Exact
Comparison: Concomitant drugs - DMARDsp-value: 0.2481Fisher Exact
Comparison: Concomitant drugs - Methotrexatep-value: 0.1558Fisher Exact
Comparison: Concomitant drugs - salazosulfapyridinep-value: 1Fisher Exact
Comparison: Concomitant drugs - Adrenal corticosteroidsp-value: 0.0094Fisher Exact
Comparison: Concomitant therapyp-value: 1Fisher Exact
Comparison: Human leukocyte antigen B27 (HLA-B27) test resultp-value: 0.8836Fisher Exact
Comparison: BASDAI at start of treatmentp-value: 1Fisher Exact
Primary
Number of Participants With Adverse Events
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, may have caused a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage.
Time frame: 24 weeks
Population: Safety analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adalimumab | Number of Participants With Adverse Events | Any adverse event | 125 Participants |
| Adalimumab | Number of Participants With Adverse Events | Serious adverse events | 17 Participants |
Primary
Number of Participants With Self-injection Errors
Time frame: 24 weeks
Population: Participants in the safety analysis set who self-injected adalimumab
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Adalimumab | Number of Participants With Self-injection Errors | 1 Participants |
Secondary
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) assesses disease activity by asking the participant to answer 6 questions (each on a 10 point numeric rating scale \[NRS\]) pertaining to symptoms experienced for the past week. For 5 questions (level of fatigue/tiredness, level of AS neck, back or hip pain, level of pain/swelling in joints, other than neck, back or hips, level of discomfort from any areas tender to touch or pressure, and level of morning stiffness), the response is from 0 (none) to 10 (very severe); for Question 6 (duration of morning stiffness), the response is from 0 (0 hours) to 10 (≥ 2 hours). The overall BASDAI score ranges from 0 to 10 where lower scores indicate less disease activity.
Time frame: Baseline and weeks 12 and 24
Population: Efficacy analysis population with available BASDAI data at baseline and each timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adalimumab | Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 12 weeks | -1.9 units on a scale | Standard Deviation 2.2 |
| Adalimumab | Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | 24 weeks | -2.0 units on a scale | Standard Deviation 2.6 |
Secondary
Number of Participants With Markedly Improved or Improved Rating
Participants were evaluated for improvement at weeks 12 and 24 of treatment or discontinuation of treatment or participation in the survey based on the clinical course from baseline using the following scale: 1\. Markedly improved, 2. Improved, 3.Not improved, 5. Not assessable
Time frame: Weeks 12, 24, and at the last visit
Population: Efficacy analysis population; participants with available data at each timepoint
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adalimumab | Number of Participants With Markedly Improved or Improved Rating | 12 weeks | 257 Participants |
| Adalimumab | Number of Participants With Markedly Improved or Improved Rating | 24 weeks | 292 Participants |
| Adalimumab | Number of Participants With Markedly Improved or Improved Rating | Last observation | 333 Participants |
Secondary
Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors
Participants were evaluated for improvement at weeks 12 and 24 of treatment or discontinuation of treatment or participation in the survey based on the clinical course from baseline using the following scale: 1\. Markedly improved, 2. Improved, 3.Not improved, 5. Not assessable
Time frame: 24 weeks (or last visit if earlier)
Population: Efficacy analysis set; results are only included for participants with non-missing data for each baseline characteristic.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications-cardiovascular disorder: Present | 52 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications-liver disorder: Present | 25 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Concomitant therapy: Present | 13 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Age: 15 to < 65 years | 291 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Age: ≥ 65 years | 42 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Sex: Male | 232 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Sex: Female | 101 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Body Mass Index: < 18.5 kg/m² | 25 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Body Mass Index: 18.5 - < 25 kg/m² | 146 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Body Mass Index: 25 - 30 kg/m² | 51 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Body Mass Index: ≥ 30 kg/m² | 20 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Duration of illness: < 5 years | 113 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Duration of illness: 5 to < 10 years | 69 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Duration of illness: 10 to < 20 years | 64 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Duration of illness: > 20 years | 40 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Smoking history: Absent | 162 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Smoking history: Present | 98 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications: Absent | 139 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications: Present | 194 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications-renal disorder: Absent | 321 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications-renal disorder: Present | 12 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications-cardiovascular disorder: Absent | 281 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications-liver disorder: Absent | 308 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications-blood disorder: Absent | 324 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications-blood disorder: Present | 9 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications-respiratory disorder: Absent | 312 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications-respiratory disorder: Present | 21 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications-diabetes mellitus: Absent | 314 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications-diabetes mellitus: Present | 19 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications-uveitis: Absent | 298 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications-uveitis: Present | 35 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications-inflammatory bowel disease: Absent | 328 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications-inflammatory bowel disease: Present | 5 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications-psoriasis: Absent | 328 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Complications-psoriasis: Present | 5 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Past illnesses: Absent | 249 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Past illnesses: Present | 76 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Allergy history: Absent | 284 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Allergy history: Present | 39 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Adalimumab self-injection: Absent | 101 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Adalimumab self-injection: Present | 232 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Prior medication-NSAIDs: Absent | 51 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Prior medication-NSAIDs: Present | 282 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Prior medication-biological products: Absent | 272 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Prior medication-biological products: Present | 61 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Concomitant drugs: Absent | 22 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Prior medication-adrenal corticosteroids: Absent | 237 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Prior medication-adrenal corticosteroids: Present | 96 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Concomitant drugs: Present | 311 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Concomitant drug-NSAIDs: Absent | 104 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Concomitant drug-NSAIDs: Present | 229 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Concomitant drug-DMARDs: Absent | 157 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Concomitant drug-DMARDs: Present | 176 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Concomitant drug-methotrexate: Absent | 202 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Concomitant drug-methotrexate: Present | 131 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Concomitant drug-salazosulfapyridine: Absent | 262 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Concomitant drug-salazosulfapyridine: Present | 71 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Concomitant drug-adrenal corticosteroids: Absent | 245 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Concomitant drug-adrenal corticosteroids: Present | 88 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Concomitant therapy: Absent | 320 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Human leukocyte antigen B27 (HLA-B27): Negative | 83 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | Human leukocyte antigen B27 (HLA-B27): Positive | 121 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | BASDAI: < 4 | 87 Participants |
| Adalimumab | Percentage of Participants With Markedly Improved or Improved Rating at Last Visit by Baseline Factors | BASDAI: ≥4 | 162 Participants |