Trial Outcomes & Findings for Impact of Adalimumab (Humira®) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice (NCT NCT01754727)

NCT ID: NCT01754727

Last Updated: 2017-03-06

Results Overview

The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline as observed.

• Recruitment status: COMPLETED
• Target enrollment: 452 participants
• Primary outcome timeframe: Month 0 (baseline) and Month 12
• Results posted on: 2017-03-06

Participant Flow

A total of 452 participants were enrolled: 450 were in the main analysis set (MAS) population; 2 were excluded from MAS, as adalimumab treatment was not documented within this study.

Participant milestones

Measure	Participants With Ankylosing Spondylitis Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
Overall Study STARTED	452
Overall Study COMPLETED	450
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Participants With Ankylosing Spondylitis Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
Overall Study Adalimumab Treatment was not Documented	2

Baseline Characteristics

Age (continuous) measure analysis accounts for main analysis set (MAS) population (all participants who received at least 1 dose of study drug) with evaluable data.

Baseline characteristics by cohort

Measure	Participants With Ankylosing Spondylitis n=450 Participants Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
Age, Continuous	42.9 years STANDARD_DEVIATION 12.1 • n=447 Participants • Age (continuous) measure analysis accounts for main analysis set (MAS) population (all participants who received at least 1 dose of study drug) with evaluable data.
Gender Female	141 Participants n=450 Participants
Gender Male	309 Participants n=450 Participants

PRIMARY outcome

Timeframe: Month 0 (baseline) and Month 12

Population: Analysis included all participants who received at least one dose of adalimumab with evaluable data.

The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline as observed.

Outcome measures

Measure	Participants With Ankylosing Spondylitis n=351 Participants Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12	78.9 percentage of participants

SECONDARY outcome

Timeframe: Month 3, Month 6 and Month 9

Population: Analysis included all participants who received at least one dose of adalimumab with evaluable data.

The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms). The BASDAI 50 score captures patients with 50% reduction in the BASDAI score compared to baseline.

Outcome measures

Measure	Participants With Ankylosing Spondylitis n=425 Participants Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
Percentage of Participants Achieving BASDAI 50 Month 3 (N=425)	52.5 percentage of participants
Percentage of Participants Achieving BASDAI 50 Month 6 (N=395)	68.1 percentage of participants
Percentage of Participants Achieving BASDAI 50 Month 9 (N=367)	76.0 percentage of participants

SECONDARY outcome

Timeframe: Month 3, Month 6, Month 9 and Month 12

Population: Analysis included all participants who received at least one dose of adalimumab with evaluable data.

The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Higher scores indicate higher disease activity. Clinically important improvement is defined as a change >= 1.1 units, and major improvement is defined as a change >= 2.0 units.

Outcome measures

Measure	Participants With Ankylosing Spondylitis n=424 Participants Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
Percentage of Participants Achieving At Least 2.0 Score Decrease in Ankylosing Spondylitis Disease Activity (ASDAS) Score From Baseline Month 3 (N=424)	44.3 percentage of participants
Percentage of Participants Achieving At Least 2.0 Score Decrease in Ankylosing Spondylitis Disease Activity (ASDAS) Score From Baseline Month 6 (N=393)	54.5 percentage of participants
Percentage of Participants Achieving At Least 2.0 Score Decrease in Ankylosing Spondylitis Disease Activity (ASDAS) Score From Baseline Month 9 (N=364)	63.5 percentage of participants
Percentage of Participants Achieving At Least 2.0 Score Decrease in Ankylosing Spondylitis Disease Activity (ASDAS) Score From Baseline Month 12 (N=349)	64.8 percentage of participants

SECONDARY outcome

Timeframe: 12 months prior to month 0 (baseline) and 12 months prior to month 12

Population: Analysis included all participants who received at least one dose of adalimumab with evaluable data.

Difference in the number of hospital inpatient days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.

Outcome measures

Measure	Participants With Ankylosing Spondylitis n=365 Participants Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
Mean Change in the Number of Hospital Inpatient Days	-19.6 Days Standard Deviation 45.0

SECONDARY outcome

Timeframe: 12 months prior to month 0 (baseline) and 12 months prior to month 12

Population: Analysis included all participants who received at least one dose of adalimumab with evaluable data.

Difference in the number of hospitalizations during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.

Outcome measures

Measure	Participants With Ankylosing Spondylitis n=376 Participants Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
Mean Change in the Number of Hospitalizations	-1.9 Number of admissions to hospital Standard Deviation 4.4

SECONDARY outcome

Timeframe: 12 months prior to month 0 (baseline) and 12 months prior to month 12

Population: Analysis included all participants who received at least one dose of adalimumab with evaluable data.

Difference in the number of sick leave days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only)

Outcome measures

Measure	Participants With Ankylosing Spondylitis n=235 Participants Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
Mean Change in the Number of Sick Leave Days	-27.3 Days Standard Deviation 66.3

SECONDARY outcome

Timeframe: 12 months prior to month 0 (baseline) and 12 months prior to month 12

Population: Analysis included all participants who received at least one dose of adalimumab with evaluable data.

Difference in the number of sick leaves during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only).

Outcome measures

Measure	Participants With Ankylosing Spondylitis n=237 Participants Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
Mean Change in the Number of Sick Leaves	-2.1 Number of sick leaves Standard Deviation 5.3

SECONDARY outcome

Timeframe: 12 months prior to month 0 (baseline) and 12 months prior to month 12

Population: Analysis included all participants who received at least one dose of adalimumab with evaluable data.

Difference in the number of outpatient visits to each kind of health care provider which includes general practitioner, rheumatologist, other specialists (ophthalmologist, gastroenterologist, dermatologist, physiatrist), physiotherapist and rheumatology nurse, during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.

Outcome measures

Measure	Participants With Ankylosing Spondylitis n=403 Participants Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider Overall (N=403)	-12.1 Number of visits Standard Deviation 23.1
Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider General practitioner (N=354)	-4.3 Number of visits Standard Deviation 8.7
Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider Rheumatologists (N=399)	-4.4 Number of visits Standard Deviation 8.3
Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider Ophthalmologist (N=313)	-1.1 Number of visits Standard Deviation 4.3
Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider Gastroenterologist (N=309)	-0.6 Number of visits Standard Deviation 3.1
Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider Dermatologist (N=311)	-0.4 Number of visits Standard Deviation 2.5
Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider Physiatrist (N=310)	-0.5 Number of visits Standard Deviation 1.9
Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider Physiotherapist (N=315)	-1.9 Number of visits Standard Deviation 10.6
Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider Rheumatology nurse (N=315)	-0.5 Number of visits Standard Deviation 7.5

SECONDARY outcome

Timeframe: Month 3, Month 6, Month 9, Month 12 and Month 12 Last Observation Carried Forward (LOCF)

Population: Analysis included all participants who received at least one dose of adalimumab with evaluable data.

The BASDAI score was determined using a simple, self-reported questionnaire that consists of 6 questions on disease activity. Each question is scored from 0 to 10 (0 = no symptoms, 10 = very severe symptoms).

Outcome measures

Measure	Participants With Ankylosing Spondylitis n=429 Participants Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
Mean Change From Baseline in BASDAI Score Month 3 (N=425)	-3.1 units on a scale Standard Deviation 2.3
Mean Change From Baseline in BASDAI Score Month 6 (N=395)	-3.8 units on a scale Standard Deviation 2.4
Mean Change From Baseline in BASDAI Score Month 9 (N=367)	-4.3 units on a scale Standard Deviation 2.3
Mean Change From Baseline in BASDAI Score Month 12 (N=351)	-4.4 units on a scale Standard Deviation 2.4
Mean Change From Baseline in BASDAI Score Month 12 LOCF (N=429)	-4.0 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: Month 3, Month 6, Month 9 and Month 12

Population: Analysis included all participants who received at least one dose of adalimumab with evaluable data.

The ASDAS tool is a self-administered questionnaire plus an objective laboratory evaluation. The questionnaire covers disease activity, back pain, and peripheral pain/swelling assessed on a visual analogue scale (from 0 (normal) to 10 (extreme pain or disability) cm) and duration of morning stiffness on a numerical rating scale (from 0 to 10, with 0 being none and 10 representing a duration of 2 hours or longer). The laboratory parameter is a measurement of C-reactive protein (mg/L) (CRP) or erythrocyte sedimentation rate (mm/h) (ESR). Data from five variables (disease activity, back pain, duration of morning stiffness, peripheral pain/swelling, and either CRP or ESR values) are combined to yield a score ranging from 0 to no defined upper limit. Higher scores indicate higher disease activity. Remission is defined as ASDAS score <1.3. Clinically important improvement is defined as a change >= 1.1 units, and major improvement is defined as a change >= 2.0 units.

Outcome measures

Measure	Participants With Ankylosing Spondylitis n=428 Participants Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score Month 12 (N=349)	-2.4 units on a scale Standard Deviation 1.3
Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score Month 3 (N=424)	-1.8 units on a scale Standard Deviation 1.3
Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score Month 6 (N=393)	-2.1 units on a scale Standard Deviation 1.3
Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score Month 9 (N=364)	-2.3 units on a scale Standard Deviation 1.2
Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score Month 12 LOCF (N=428)	-2.2 units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: Month 3, Month 6, Month 9 and Month 12

Population: Analysis included all participants who received at least one dose of adalimumab with evaluable data.

The BASFI is a numeric rating scale that uses self-reported patient evaluations to measure physical function impairment caused by AS. It is a ten questions, each question was scored on a numerical rating scale that ranged from 0 (no functional impairment) to 10 (maximal impairment). The mean of the ten questions was the total BASFI score. A higher score indicates more severe impairment of functioning.

Outcome measures

Measure	Participants With Ankylosing Spondylitis n=422 Participants Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score Month 3 (N=414)	-2.7 units on a scale Standard Deviation 2.4
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score Month 6 (N=381)	-3.5 units on a scale Standard Deviation 2.4
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score Month 9 (N=356)	-3.8 units on a scale Standard Deviation 2.3
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score Month 12 (N=339)	-4.0 units on a scale Standard Deviation 2.5
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score Month 12 LOCF (N=422)	-3.6 units on a scale Standard Deviation 2.6

Adverse Events

Participants With Ankylosing Spondylitis

Serious events: 19 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Participants With Ankylosing Spondylitis n=450 participants at risk Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
Blood and lymphatic system disorders ANAEMIA	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Blood and lymphatic system disorders LYMPHOCYTOSIS	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Ear and labyrinth disorders VERTIGO	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Gastrointestinal disorders COLITIS ULCERATIVE	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
General disorders ADMINISTRATION SITE RASH	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
General disorders DRUG INEFFECTIVE	0.44% 2/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Hepatobiliary disorders HEPATIC STEATOSIS	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Immune system disorders HYPERSENSITIVITY	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Infections and infestations CLOSTRIDIUM DIFFICILE INFECTION	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Infections and infestations CYSTITIS	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Infections and infestations GINGIVITIS	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Infections and infestations PNEUMONIA	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Infections and infestations PNEUMONIA PSEUDOMONAL	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Infections and infestations PULMONARY TUBERCULOSIS	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Infections and infestations TUBERCULOSIS	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Infections and infestations TUBERCULOUS PLEURISY	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Musculoskeletal and connective tissue disorders ANKYLOSING SPONDYLITIS	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Musculoskeletal and connective tissue disorders ARTHRITIS	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Nervous system disorders HYPERTONIA	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Psychiatric disorders ANXIETY	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Renal and urinary disorders NEPHROLITHIASIS	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Renal and urinary disorders RENAL COLIC	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Skin and subcutaneous tissue disorders DERMATITIS	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Skin and subcutaneous tissue disorders DERMATITIS ALLERGIC	0.44% 2/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Skin and subcutaneous tissue disorders RASH	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.
Vascular disorders HYPERTENSION	0.22% 1/450 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months. Non serious adverse events were not collected for this study.

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Information

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