Impact of Adalimumab (Humira®) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01754727

Acronym

IDEA

Enrollment

452

Registered

2012-12-21

Start date

2012-12-31

Completion date

2015-10-31

Last updated

2017-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis, Effectiveness, Post-marketing observational study (PMOS), Adalimumab, Humira®

Brief summary

The purpose of this study was to assess the proportion of AS patients achieving treatment response to adalimumab therapy.

Detailed description

This post-marketing observational study (PMOS) was performed in a multi-country, multi-center, single-arm format. Data were collected prospectively and retrospectively. Adult patients with diagnosis of AS who were assigned for treatment with adalimumab (Humira®) were eligible for participation. Each patient included in this study was to be observed during his/her adalimumab treatment for a maximum of 12 month period. During this period four follow-up visits were planned for observation of the patient and documentation of data. Ideally, these visits should have been performed approximately 3 (V1), 6 (V2), 9 (V3) and 12 (V4) months after the baseline visit (V0).

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Had ankylosing spondylitis (AS) and was eligible to start and/or continue adalimumab therapy according to the local product label and prescription guidelines, * Had been started on adalimumab therapy no more than one (1) month prior to the study enrollment * Had negative result of tuberculosis (TB) screening test or was receiving tuberculosis prophylaxis as per local guidelines * Provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations

Exclusion criteria

\- Had contraindications for the treatment with adalimumab

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12	Month 0 (baseline) and Month 12	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.

Secondary

Measure	Time frame	Description
Percentage of Participants Achieving At Least 2.0 Score Decrease in Ankylosing Spondylitis Disease Activity (ASDAS) Score From Baseline	Month 3, Month 6, Month 9 and Month 12	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.
Mean Change in the Number of Hospital Inpatient Days	12 months prior to month 0 (baseline) and 12 months prior to month 12	Difference in the number of hospital inpatient days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.
Mean Change in the Number of Hospitalizations	12 months prior to month 0 (baseline) and 12 months prior to month 12	Difference in the number of hospitalizations during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy.
Mean Change in the Number of Sick Leave Days	12 months prior to month 0 (baseline) and 12 months prior to month 12	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)
Percentage of Participants Achieving BASDAI 50	Month 3, Month 6 and Month 9	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.
Mean Change in the Number of Outpatient Visits to Each Kind of Health Care Provider	12 months prior to month 0 (baseline) and 12 months prior to month 12	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.
Mean Change From Baseline in BASDAI Score	Month 3, Month 6, Month 9, Month 12 and Month 12 Last Observation Carried Forward (LOCF)	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).
Mean Change From Baseline in Ankylosing Spondylitis Disease Activity (ASDAS) Score	Month 3, Month 6, Month 9 and Month 12	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.
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Score	Month 3, Month 6, Month 9 and Month 12	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.
Mean Change in the Number of Sick Leaves	12 months prior to month 0 (baseline) and 12 months prior to month 12	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).

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
Participants With Ankylosing Spondylitis Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.	450
Total	450

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adalimumab Treatment was not Documented	2

Baseline characteristics

Characteristic	Participants With Ankylosing Spondylitis
Age, Continuous	42.9 years STANDARD_DEVIATION 12.1
Gender Female	141 Participants
Gender Male	309 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 0
serious Total, serious adverse events	19 / 450

Outcome results

Primary

Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Month 12

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.

Time frame: Month 0 (baseline) and Month 12