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Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice

Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01768858
Acronym
Adherence
Enrollment
96
Registered
2013-01-16
Start date
2013-02-05
Completion date
2017-08-13
Last updated
2019-01-28

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

Conditions

Ankylosing Spondylitis, Crohn´s Disease, Plaque Psoriasis, Psoriatic Arthritis, Rheumatoid Arthritis, Ulcerative Colitis

Keywords

Arthritis, Morbus Crohn, Adherence, Spondylitis, Ulcerative colitis, Monoclonals, Rheumatoid, Antibodies, Ankylosing, Plaque psoriasis, Psoriatic, Crohn´s disease, Antirheumatic Agents

Brief summary

The purpose of this non-interventional, multicenter, post-marketing observational study (PMOS) was to assess rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn's disease (CD) and ulcerative colitis (UC) patients' adherence attitudes (beliefs) to maintenance therapy with adalimumab monotherapy or combination therapy with methotrexate (in participants with RA) and to investigate whether there were correlations between such beliefs and adherence to maintenance treatment.

Detailed description

Adalimumab was prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. The assignment of a participant to an adalimumab-containing regimen was decided in advance and was to be current practice. The prescribing of adalimumab was clearly separated from the decision to include the participant in the study. Participants were observed for a maximum of 12 months, with a total of 5 study visits (Screening = Visit 1).

Interventions

DRUGAdalimumab

Adalimumab administered by subcutaneous injection, via pre-filled syringe or autoinjector pen

Sponsors

Raffeiner GmbH
CollaboratorINDUSTRY
AbbVie
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Participants ≥18 years of age with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) * Participants must fulfill international and national guidelines for the use of a biologic disease-modifying antirheumatic drug (bDMARD) in RA, PsA, AS, PS, CD, or UC (chest X-ray and interferon gamma release assay (IGRA) or purified protein derivative (PPD) skin test negative for tuberculosis) * In addition one of the following criteria must be fulfilled: 1. unsatisfactory DMARD response defined as treatment failure with at least two DMARDs including methotrexate in participants with RA or PsA 2. unsatisfactory nonsteroidal anti-inflammatory drug (NSAID) response in participants with AS 3. unsatisfactory response to prior bDMARDs in participants with RA, PsA, or AS 4. unsatisfactory response to, contraindication to, or intolerance to other systemic therapy including cyclosporine, methotrexate, or psoralen with ultraviolet A light (PUVA) in participants with PS 5. unsatisfactory response despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or intolerance or medical contraindications for such therapies in CD 6. unsatisfactory response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or intolerance to or medical contraindications for such therapies in UC

Exclusion criteria

* Participants who are not covered in the latest version of the adalimumab Summary of Product Characteristics (SPC) for the syringe and pen * Participants currently enrolled in another study program or clinical trial * Participants who have been treated with adalimumab before

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in the Beliefs About Medicines Questionnaire (BMQ) Specific Score at 12 MonthsBaseline and 12 monthsThe BMQ-Specific Scale comprises two 5-item factors assessing beliefs about the necessity of prescribed medication (Specific-Necessity) and concerns about prescribed medication based on beliefs about the danger of dependence, long-term toxicity, and the disruptive effects of medication (Specific-Concerns). Individual items are scored on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 (lowest score) to 50 (highest score). Higher scores indicate stronger beliefs.
Correlation Between Beliefs About Medicines Questionnaire (BMQ) Specific Score and Adherence to Treatment as Measured by the Morisky Medication Adherence Scale (MMAS) at 12 MonthsBaseline and 12 monthsThe BMQ-Specific Scale comprises two 5-item factors assessing beliefs about the necessity of prescribed medication (Specific-Necessity) and concerns about prescribed medication based on beliefs about the danger of dependence, long-term toxicity, and the disruptive effects of medication (Specific-Concerns). Individual items are scored on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 (lowest score) to 50 (highest score). Higher scores indicate stronger beliefs. The MMAS is a 4-item self-reported measure of medication-taking behavior. It measures intentional and non-intentional non-adherence (based on forgetting, carelessness, stopping medication when feeling better, or stopping medication when feeling worse). The MMAS consists of 4 questions which can be answered with yes (0) and no (1). The MMAS score is the sum of all four questions and ranges from 0 (non-adherent) to 4 (adherent).

Secondary

MeasureTime frameDescription
Change in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores Over TimeBaseline, Month 3, Month 6, Month 9, Month 12The RADAI is a questionnaire for participants used for measuring disease activity. The index consists of 6 questions. The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness, and (6) tender joints rated on a joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The first 4 items are rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity. The scores on the last 2 items range from 0 to 6 and 0 to 48, respectively, but are transformed on the same scale of 0 to 10. The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Over TimeBaseline, Month 3, Month 6, Month 9, Month 12The 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. Lower scores indicate less disease activity.
Change in Morisky Medication Adherence Scale (MMAS) Scores From Month 3 to Month 12At Month 3 and Month 12The MMAS is a 4-item self-reported measure of medication-taking behavior. It measures intentional and non-intentional non-adherence (based on forgetting, carelessness, stopping medication when feeling better, or stopping medication when feeling worse). The MMAS consists of 4 questions which can be answered with yes (0) and no (1). The MMAS score is the sum of all four questions and ranges from 0 (non-adherent) to 4 (adherent).
Changes in Erythrocyte Sedimentation Rate (ESR) Over TimeBaseline, Month 3, Month 6, Month 9, Month 12Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body, and is based on the sedimentation and aggregation of erythrocytes (red blood cells). A higher ESR is indicative of increased inflammation. The normal range in healthy individuals is 0 - 10 mm/h for men and 0-15 mm/h for women.
Change in Psoriasis Area and Severity Index (PASI) Score Over TimeBaseline, Month 3, Month 6, Month 9, Month 12The Psoriasis Area and Severity Index (PASI) is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Change in C-reactive Protein (CRP) Concentration Over TimeBaseline, Month 3, Month 6, Month 9, Month 12C-reactive protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy individuals is usually lower than 1 mg/dL, slightly increasing with age, and increased in a variety of disorders such as rheumatic diseases.
Change in the Treatment Satisfaction Questionnaire for Medication (TSQM) Scores From Month 3 to Month 12At Month 3 and Month 12The 11-item Treatment Satisfaction Questionnaire for Medication (TSQM) Version II is an instrument to assess participants' satisfaction with medication, providing scores on four scales (side effects, effectiveness, convenience, and global satisfaction). The 11 questions can be answered either with yes/no or by means of a five or seven stage scale (ranging from very unsatisfied to satisfied). TSQM Scale scores range from 0 to 100 and higher scores represent higher satisfaction.

Participant flow

Pre-assignment details

All enrolled participants

Participants by arm

ArmCount
Participants Receiving Adalimumab
Adults with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), plaque psoriasis (PS), Crohn´s disease (CD), or ulcerative colitis (UC) received 40 mg adalimumab every two weeks.
96
Total96

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAggravation of NY Heart Assoc 3 status1
Overall StudyExanthema1
Overall StudyLack of Efficacy8
Overall StudyLost to Follow-up9
Overall StudyParticipant moved to Germany1
Overall StudySerious Adverse Event1
Overall StudyWithdrawal by Subject1

Baseline characteristics

CharacteristicParticipants Receiving Adalimumab
Age, Continuous47.99 years
STANDARD_DEVIATION 14.6
Number of participants per disease subgroup
Ankylosing spondylitis (AS)
29 Participants
Number of participants per disease subgroup
Plaque psoriasis (PS)
13 Participants
Number of participants per disease subgroup
Psoriatic arthritis (PsA)
12 Participants
Number of participants per disease subgroup
Rheumatoid arthritis (RA)
42 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
96 Participants
Sex: Female, Male
Female
60 Participants
Sex: Female, Male
Male
36 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 96
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
1 / 96

Outcome results

Primary

Change From Baseline in the Beliefs About Medicines Questionnaire (BMQ) Specific Score at 12 Months

The BMQ-Specific Scale comprises two 5-item factors assessing beliefs about the necessity of prescribed medication (Specific-Necessity) and concerns about prescribed medication based on beliefs about the danger of dependence, long-term toxicity, and the disruptive effects of medication (Specific-Concerns). Individual items are scored on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 (lowest score) to 50 (highest score). Higher scores indicate stronger beliefs.

Time frame: Baseline and 12 months

Population: Participants with available data

ArmMeasureValue (MEAN)Dispersion
Participants Receiving AdalimumabChange From Baseline in the Beliefs About Medicines Questionnaire (BMQ) Specific Score at 12 Months-1.4 units on a scaleStandard Deviation 5
Primary

Correlation Between Beliefs About Medicines Questionnaire (BMQ) Specific Score and Adherence to Treatment as Measured by the Morisky Medication Adherence Scale (MMAS) at 12 Months

The BMQ-Specific Scale comprises two 5-item factors assessing beliefs about the necessity of prescribed medication (Specific-Necessity) and concerns about prescribed medication based on beliefs about the danger of dependence, long-term toxicity, and the disruptive effects of medication (Specific-Concerns). Individual items are scored on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 10 (lowest score) to 50 (highest score). Higher scores indicate stronger beliefs. The MMAS is a 4-item self-reported measure of medication-taking behavior. It measures intentional and non-intentional non-adherence (based on forgetting, carelessness, stopping medication when feeling better, or stopping medication when feeling worse). The MMAS consists of 4 questions which can be answered with yes (0) and no (1). The MMAS score is the sum of all four questions and ranges from 0 (non-adherent) to 4 (adherent).

Time frame: Baseline and 12 months

Population: Participants with available data

ArmMeasureValue (NUMBER)
Participants Receiving AdalimumabCorrelation Between Beliefs About Medicines Questionnaire (BMQ) Specific Score and Adherence to Treatment as Measured by the Morisky Medication Adherence Scale (MMAS) at 12 Months-.173 Spearman correlation coefficient
Secondary

Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Over Time

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. Lower scores indicate less disease activity.

Time frame: Baseline, Month 3, Month 6, Month 9, Month 12

Population: Participants with ankylosing spondylitis with available data

ArmMeasureGroupValue (MEAN)Dispersion
Participants Receiving AdalimumabChange in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Over TimeBaseline5.39 units on a scaleStandard Deviation 1.52
Participants Receiving AdalimumabChange in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Over TimeMonth 33.61 units on a scaleStandard Deviation 2.05
Participants Receiving AdalimumabChange in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Over TimeMonth 62.98 units on a scaleStandard Deviation 1.96
Participants Receiving AdalimumabChange in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Over TimeMonth 91.72 units on a scaleStandard Deviation 1.44
Participants Receiving AdalimumabChange in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score Over TimeMonth 122.34 units on a scaleStandard Deviation 2.3
Secondary

Change in C-reactive Protein (CRP) Concentration Over Time

C-reactive protein (CRP) was measured from blood samples as a marker for inflammation. Higher levels are indicative of more inflammation. Normal concentration in healthy individuals is usually lower than 1 mg/dL, slightly increasing with age, and increased in a variety of disorders such as rheumatic diseases.

Time frame: Baseline, Month 3, Month 6, Month 9, Month 12

Population: Participants with available data

ArmMeasureGroupValue (MEAN)Dispersion
Participants Receiving AdalimumabChange in C-reactive Protein (CRP) Concentration Over TimeBaseline1.60 mg/dLStandard Deviation 2.75
Participants Receiving AdalimumabChange in C-reactive Protein (CRP) Concentration Over TimeMonth 30.87 mg/dLStandard Deviation 1.66
Participants Receiving AdalimumabChange in C-reactive Protein (CRP) Concentration Over TimeMonth 61.54 mg/dLStandard Deviation 8.68
Participants Receiving AdalimumabChange in C-reactive Protein (CRP) Concentration Over TimeMonth 90.47 mg/dLStandard Deviation 0.74
Participants Receiving AdalimumabChange in C-reactive Protein (CRP) Concentration Over TimeMonth 120.65 mg/dLStandard Deviation 1.25
Secondary

Change in Morisky Medication Adherence Scale (MMAS) Scores From Month 3 to Month 12

The MMAS is a 4-item self-reported measure of medication-taking behavior. It measures intentional and non-intentional non-adherence (based on forgetting, carelessness, stopping medication when feeling better, or stopping medication when feeling worse). The MMAS consists of 4 questions which can be answered with yes (0) and no (1). The MMAS score is the sum of all four questions and ranges from 0 (non-adherent) to 4 (adherent).

Time frame: At Month 3 and Month 12

Population: Participants with available data

ArmMeasureValue (MEAN)Dispersion
Participants Receiving AdalimumabChange in Morisky Medication Adherence Scale (MMAS) Scores From Month 3 to Month 120.2 units on a scaleStandard Deviation 0.9
Secondary

Change in Psoriasis Area and Severity Index (PASI) Score Over Time

The Psoriasis Area and Severity Index (PASI) is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.

Time frame: Baseline, Month 3, Month 6, Month 9, Month 12

Population: Participants with psoriasis with available data

ArmMeasureGroupValue (MEAN)Dispersion
Participants Receiving AdalimumabChange in Psoriasis Area and Severity Index (PASI) Score Over TimeBaseline18.0 units on a scaleStandard Deviation 11.5
Participants Receiving AdalimumabChange in Psoriasis Area and Severity Index (PASI) Score Over TimeMonth 35.1 units on a scaleStandard Deviation 6.6
Participants Receiving AdalimumabChange in Psoriasis Area and Severity Index (PASI) Score Over TimeMonth 61.5 units on a scaleStandard Deviation 1.9
Participants Receiving AdalimumabChange in Psoriasis Area and Severity Index (PASI) Score Over TimeMonth 91.8 units on a scaleStandard Deviation 2.5
Participants Receiving AdalimumabChange in Psoriasis Area and Severity Index (PASI) Score Over TimeMonth 125.9 units on a scaleStandard Deviation 6.8
Secondary

Change in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores Over Time

The RADAI is a questionnaire for participants used for measuring disease activity. The index consists of 6 questions. The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness, and (6) tender joints rated on a joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The first 4 items are rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity. The scores on the last 2 items range from 0 to 6 and 0 to 48, respectively, but are transformed on the same scale of 0 to 10. The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.

Time frame: Baseline, Month 3, Month 6, Month 9, Month 12

Population: Participants with rheumatoid arthritis with available data

ArmMeasureGroupValue (MEAN)Dispersion
Participants Receiving AdalimumabChange in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores Over TimeBaseline5.52 units on a scaleStandard Deviation 1.66
Participants Receiving AdalimumabChange in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores Over TimeMonth 33.99 units on a scaleStandard Deviation 1.64
Participants Receiving AdalimumabChange in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores Over TimeMonth 62.75 units on a scaleStandard Deviation 1.58
Participants Receiving AdalimumabChange in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores Over TimeMonth 91.83 units on a scaleStandard Deviation 1.64
Participants Receiving AdalimumabChange in Rheumatoid Arthritis Disease Activity Index (RADAI) Scores Over TimeMonth 121.86 units on a scaleStandard Deviation 1.79
Secondary

Change in the Treatment Satisfaction Questionnaire for Medication (TSQM) Scores From Month 3 to Month 12

The 11-item Treatment Satisfaction Questionnaire for Medication (TSQM) Version II is an instrument to assess participants' satisfaction with medication, providing scores on four scales (side effects, effectiveness, convenience, and global satisfaction). The 11 questions can be answered either with yes/no or by means of a five or seven stage scale (ranging from very unsatisfied to satisfied). TSQM Scale scores range from 0 to 100 and higher scores represent higher satisfaction.

Time frame: At Month 3 and Month 12

Population: Participants with available data

ArmMeasureGroupValue (MEAN)Dispersion
Participants Receiving AdalimumabChange in the Treatment Satisfaction Questionnaire for Medication (TSQM) Scores From Month 3 to Month 12Efficacy6.80 units on a scaleStandard Deviation 23.52
Participants Receiving AdalimumabChange in the Treatment Satisfaction Questionnaire for Medication (TSQM) Scores From Month 3 to Month 12Side Effects1.95 units on a scaleStandard Deviation 17.72
Participants Receiving AdalimumabChange in the Treatment Satisfaction Questionnaire for Medication (TSQM) Scores From Month 3 to Month 12Convenience3.46 units on a scaleStandard Deviation 16.5
Participants Receiving AdalimumabChange in the Treatment Satisfaction Questionnaire for Medication (TSQM) Scores From Month 3 to Month 12Global Satisfaction3.28 units on a scaleStandard Deviation 24.45
Secondary

Changes in Erythrocyte Sedimentation Rate (ESR) Over Time

Erythrocyte sedimentation rate (ESR) indirectly measures how much inflammation is in the body, and is based on the sedimentation and aggregation of erythrocytes (red blood cells). A higher ESR is indicative of increased inflammation. The normal range in healthy individuals is 0 - 10 mm/h for men and 0-15 mm/h for women.

Time frame: Baseline, Month 3, Month 6, Month 9, Month 12

Population: Participants with available data

ArmMeasureGroupValue (MEAN)Dispersion
Participants Receiving AdalimumabChanges in Erythrocyte Sedimentation Rate (ESR) Over TimeBaseline29.3 mm/hrStandard Deviation 23.7
Participants Receiving AdalimumabChanges in Erythrocyte Sedimentation Rate (ESR) Over TimeMonth 324.1 mm/hrStandard Deviation 20.5
Participants Receiving AdalimumabChanges in Erythrocyte Sedimentation Rate (ESR) Over TimeMonth 617.4 mm/hrStandard Deviation 15.8
Participants Receiving AdalimumabChanges in Erythrocyte Sedimentation Rate (ESR) Over TimeMonth 917.8 mm/hrStandard Deviation 18.9
Participants Receiving AdalimumabChanges in Erythrocyte Sedimentation Rate (ESR) Over TimeMonth 1216.0 mm/hrStandard Deviation 16.7

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026