Reveal the Level of Anxiety in Patients With Crohn's Disease Receiving Adalimumab

Conditions

Anxiety, Severe Crohn's Disease

Keywords

monoclonal, anxiety, antibodies, adalimumab, severe crohn's disease, quality of life, biological products

Brief summary

It has been shown that emotional health issues, such as state anxiety, are more prevalent in patients suffering from inflammatory bowel disease (IBD) compared to physically healthy subjects. Such findings have to be taken into consideration when making an educated guess that psychological factors such as depression and anxiety in particular interact with the course of Crohns disease. Therefore the treatment of the underlying disease may have a significant influence on the level of psychological disorders. Several studies have shown that treatment with tumor necrosis factor alpha (TNF-α) antibodies ameliorates the emotional/psychological status of patients, however the impact of adalimumab therapy on anxiety correlated with the status of inflammatory bowel disease (IBD) remains unclear. The primary objective of this study was to describe and evaluate changes in levels of anxiety assessed by validated patient questionnaires after 6 months of treatment with adalimumab.

Related papers

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Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

No

Inclusion criteria

* Patients for whom Adalimumab (Humira) therapy is indicated and has been prescribed according to the product label and who meet the following criteria: * Male and female patients aged 18 to 65 years suffering from severe active Crohns Disease, attending a routine medical visit. * Able to complete questionnaires. * Patients with status active severe Crohns disease which required immunosuppressive treatment * Patients must fulfil international and national guidelines for the use of a biologic therapies in Crohns Disease (Chest X-ray and interferon gamma release assay (IGRA) or PPD (purified protein derivative)-skin test negative for tuberculosis). * Patients have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. * Patients who have been prescribed in line with the European Summary of Product Characteristics (SMPC)

Exclusion criteria

* The following patients will not be included in this observational study: * Previous therapy with TNF-α blocker within the last 8 weeks * Active Central Nervous System opportunistic infections or Central Nervous System malignancies. * History of Cerebrovascular Accident * Abuse of illicit substances (such as psychoactive drugs) within the previous 3 months * Change of medication-based treatment of generalized anxiety and panic disorder, psychiatric disorder * No informed consent * Contraindication to adalimumab (Humira) therapy according to the SMPC * Current or planned pregnancy * Lactation according to SMPC * Planned change of site within the next 24 weeks.

Design outcomes

Primary

Measure	Time frame	Description
Change in State Trait Anxiety Index (STAI) State Scores From Baseline to After 6 Months of Treatment With Adalimumab	Baseline and Visit 3 [Month 6]	The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.
Change in State Trait Anxiety Index (STAI) Trait Scores From Baseline to After 6 Months of Treatment With Adalimumab	Baseline and Visit 3 [Month 6]	The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.
Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab	Baseline and Visit 3 [Month 6]	HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.
Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab	Baseline and Visit 3 [Month 6]	HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.

Secondary

Measure	Time frame	Description
Hospital Anxiety and Depression Score (HADS) - Anxiety Scores by Visit	Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]	HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.
Short Inflammatory Bowel Disease Questionnaire (sIBDQ) Scores by Visit	Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]	The sIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL). A higher score indicates a better HRQoL.
Hospital Anxiety and Depression Score (HADS) - Depression Scores by Visit	Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]	HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.
Harvey-Bradshaw Index (HBI) Scores by Visit	Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]	Harvey-Bradshaw Index (HBI) is for use in the assessment and quantification of symptoms and the present level of disease activity of patients with Crohn's disease. It is a validated clinical index for Crohn's disease, including the 5 categories of: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25 with higher scores indicating higher disease activity. The scores were classified as follows: less than 5 is remission, 5 to 7 is mild, 8 to 16 is moderate, and greater than 16 is severe.
State Trait Anxiety Index (STAI) State Scores by Visit	Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]	The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.
State Trait Anxiety Index (STAI) Trait Scores by Visit	Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]	The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.

Countries

Austria

Participant flow

Participants by arm

Arm	Count
Adalimumab Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)	83
Total	83

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lack of Efficacy	3
Overall Study	Lost to Follow-up	10
Overall Study	Pregnancy	1
Overall Study	Protocol Violation	3
Overall Study	Withdrawal by Subject	4

Baseline characteristics

Characteristic	Adalimumab
Age, Continuous	37.6 years STANDARD_DEVIATION 11.7
Participants with Comorbidities No	65 participants
Participants with Comorbidities Yes	18 participants
Sex: Female, Male Female	43 Participants
Sex: Female, Male Male	40 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	9 / 83

Outcome results

Primary

Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab

HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.

Time frame: Baseline and Visit 3 [Month 6]

Population: All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.

Arm	Measure	Group	Value (NUMBER)
Adalimumab	Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab	Normal to Normal	33 participants
Adalimumab	Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab	Normal to Suggestive	5 participants
Adalimumab	Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab	Normal to Case	2 participants
Adalimumab	Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab	Suggestive to Normal	5 participants
Adalimumab	Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab	Suggestive to Suggestive	7 participants
Adalimumab	Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab	Suggestive to Case	0 participants
Adalimumab	Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab	Case to Normal	1 participants
Adalimumab	Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab	Case to Suggestive	2 participants
Adalimumab	Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab	Case to Case	4 participants

Primary

Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab

HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.

Time frame: Baseline and Visit 3 [Month 6]

Population: All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.

Arm	Measure	Group	Value (NUMBER)
Adalimumab	Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab	Normal to Normal	47 participants
Adalimumab	Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab	Normal to Suggestive	8 participants
Adalimumab	Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab	Normal to Case	0 participants
Adalimumab	Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab	Suggestive to Normal	0 participants
Adalimumab	Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab	Suggestive to Suggestive	2 participants
Adalimumab	Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab	Suggestive to Case	0 participants
Adalimumab	Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab	Case to Normal	1 participants
Adalimumab	Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab	Case to Suggestive	1 participants
Adalimumab	Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab	Case to Case	0 participants

Primary

Change in State Trait Anxiety Index (STAI) State Scores From Baseline to After 6 Months of Treatment With Adalimumab

The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.

Time frame: Baseline and Visit 3 [Month 6]

Population: All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.

Arm	Measure	Value (MEAN)	Dispersion
Adalimumab	Change in State Trait Anxiety Index (STAI) State Scores From Baseline to After 6 Months of Treatment With Adalimumab	-1.7 scores on a scale	Standard Deviation 9.8

Primary

Change in State Trait Anxiety Index (STAI) Trait Scores From Baseline to After 6 Months of Treatment With Adalimumab

The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.

Time frame: Baseline and Visit 3 [Month 6]

Population: All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.

Arm	Measure	Value (MEAN)	Dispersion
Adalimumab	Change in State Trait Anxiety Index (STAI) Trait Scores From Baseline to After 6 Months of Treatment With Adalimumab	-9.0 scores on a scale	Standard Deviation 9.2

Secondary

Harvey-Bradshaw Index (HBI) Scores by Visit

Harvey-Bradshaw Index (HBI) is for use in the assessment and quantification of symptoms and the present level of disease activity of patients with Crohn's disease. It is a validated clinical index for Crohn's disease, including the 5 categories of: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25 with higher scores indicating higher disease activity. The scores were classified as follows: less than 5 is remission, 5 to 7 is mild, 8 to 16 is moderate, and greater than 16 is severe.