N/A N=168

An ObserVatIonal STudy of the Effectiveness of AdaLimumab on Health and Disability Outcomes in New Zealand Patients With Immune-Mediated InflammaTorY Diseases (VITALITY)

Crohn's Disease · Rheumatoid Arthritis · Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT02451839 ↗

Enrolled (actual)

168

Serious AEs

11.0%

Results posted

Jun 2019

Primary outcome: Primary: Change From Baseline in WHODAS 2.0 Response Score at Month 6 Across All Indications — 7.9 units on a scale — p=< 0.001

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AbbVie
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in WHODAS 2.0 Response Score at Month 6 Across All Indications	7.9	< 0.001 sig
SECONDARY Change From Baseline in WHODAS 2.0 Response Score at Month 2 Across All Indications	5.7	<0.001 sig
SECONDARY Change From Baseline in WHODAS 2.0 Response Score at Month 4 Across All Indications	7.1	<0.001 sig
SECONDARY Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Crohn's Disease	6.3	<0.001 sig
SECONDARY Change From Baseline in WHODAS 2.0 Response Score at Month 6 In Participants With Psoriasis	8.1	<0.001 sig
SECONDARY Change From Baseline in WHODAS 2.0 Response Score at Month 6 in Participants With Rheumatoid Arthritis	9.5	<0.001 sig
SECONDARY Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Absenteeism	10.6	0.015 sig
SECONDARY Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Presenteeism	18.0	<0.001 sig
SECONDARY Change From Baseline in WPAI:GH 2.0 Score at Month 6 Across All Indications: Work Productivity Loss	9.7	0.006 sig
SECONDARY Change From Baseline in WPAI:GH V2.0 Score at Month 6 Across All Indications: Activity Impairment	24.1	<0.001 sig
SECONDARY Change From Baseline in K10 at Month 6 Across All Indications	6.1	<0.001 sig
SECONDARY Change From Baseline in Flourishing Scale at Month 6 Across All Indications	-2.3	0.006 sig
SECONDARY Change From Baseline in Subjective Vitality Scale at Month 6 Across All Indications	-5.4	<0.001 sig
SECONDARY Change From Baseline in HAQ-DI Score at Month 6 in Participants With Rheumatoid Arthritis	0.4	<0.001 sig
SECONDARY Change From Baseline in SIBDQ Score at Month 6 in Participants With Crohn's Disease	-16.3	<0.001 sig
SECONDARY Change From Baseline in DLQI Score at Month 6 in Participants With Psoriasis	11.0	<0.001 sig
SECONDARY Number of Participants Remaining on Treatment at Month 6	108	—

Summary

For public health purposes disability is becoming increasingly important as an outcome measure. Despite this, there are few data on the effectiveness of adalimumab on disability outcomes in patients with immune-mediated inflammatory diseases (IMIDs), particularly in the Phase IV setting. There are even less data available in New Zealand, which did not have the opportunity to participate to a major extent in large, multinational, Phase III pivotal studies of adalimumab in IMIDs. The World Health Organisation Disability Assessment Schedule (WHODAS) 2.0 is a simple, validated, free and easy-to-use generic assessment instrument for health and disability. It is applicable across cultures, in all adult populations. It is a responsive measure that can show what difference a treatment makes. Results from study of effect of adalimumab on WHODAS scores and other patient-reported outcomes (PROs) of work activity and well-being will be of interest to a variety of stakeholders in the healthcare system including patients, healthcare practitioners and payers.

Eligibility Criteria

Inclusion Criteria

Patients with a diagnosis of rheumatoid arthritis, Crohn's disease or psoriasis who have made a decision with their physician to commence treatment with adalimumab in accordance with routine medical practice and with the approved adalimumab New Zealand Datasheet.
Patients who have been evaluated for tuberculosis risk factors/exposure for active/latent tuberculosis infection (per local requirements and according to the approved adalimumab New Zealand Datasheet).
Adult subjects, 18-75 years old, who have voluntarily signed and dated an informed consent form prior to any study-specific procedures.

Exclusion Criteria

Previous treatment with adalimumab.
Previous treatment with any biologic.
Severe infection including sepsis, active tuberculosis or opportunistic infection.
Moderate to severe heart failure (New York Heart Association Class II/III).
Concurrent administration with anakinra.
Hypersensitivity to adalimumab or its excipients.
Any condition that in the opinion of the investigator would compromise the subject's well-being or ability to perform the study requirements.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02451839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.