VITALITY: impact of adalimumab on health and disability outcomes in patients with Crohn’s disease, rheumatoid arthritis, or psoriasis treated in clinical practice in New Zealand

Abstract

Objective: VITALITY, a 6-month, multicenter, prospective, observational study, assessed the effects of originator adalimumab (HUMIRA) on health and disability outcomes in patients with Crohn’s disease (CD), rheumatoid arthritis (RA), or psoriasis treated in routine clinical practice in New Zealand (NZ).

Methods: Biologic-naïve adults initiating adalimumab in accordance with NZ funding requirements were recruited. The primary endpoint was 6-month change from baseline in World Health Organization Disability Assessment Schedule (WHODAS) 2.0 score in all participants completing the study (full analysis set). Secondary endpoints included 6-month change in other patient-reported outcomes (PROs) of work activity and wellbeing (Work Productivity and Activity Impairment Questionnaire: General Health, Kessler Psychological Distress Scale, Flourishing Scale, and Subject Vitality Scale) and in disease-specific PRO measures.

Results: In total, 164 participants with severe disease initiating adalimumab completed the WHODAS 2.0 at baseline, of whom 114 (69.5%) completed the study at 6 months. Mean WHODAS 2.0 score halved from 15.2 points (SD = ±9.1) at baseline to 7.3 points (SD = ±7.2) after 6 months’ adalimumab treatment (mean difference = 7.9 points; 95% CI = 6.4–9.4; p < .001), with statistically significant improvements seen as early as 2 months after adalimumab initiation (p < .001). The proportion of participants with a WHODAS 2.0 score ≥ 10 more than halved, from 68.3% to 28.9%, between baseline and 6 months. Other PROs also improved significantly at 6 months, as did disease-specific measures. No new adalimumab safety signals were observed.

Conclusions: Health and disability outcomes improved significantly after 6 months of adalimumab use in NZ patients with severe CD, RA, or psoriasis.

Clinicaltrials.gov: NCT02451839.

Keywords:

• Adalimumab
• arthritis
• rheumatoid
• Crohn’s disease
• disability evaluation
• psoriasis
• surveys and questionnaires

Transparency

Declaration of funding

The study conduct and financial support for the study were provided by AbbVie. AbbVie participated in study design, the interpretation of data, review, and approval of the publication.

Declaration of financial/other relationships

R. Gearry, S. Inns, and R. Suppiah have served as consultants to AbbVie, and have received research funding and speaker fees from AbbVie. D. Poppelwell is an employee of AbbVie and owns AbbVie stock. M. Rademaker has received an unrestricted educational grant from AbbVie. C. Frampton has no disclosures. Peer reviewers on this manuscript have received an honorarium from CMRO for their review work but have no other relevant financial relationships to disclose.

Acknowledgements

Juliette Allport, of Syntax Scientific Writing Ltd, Auckland, NZ, provided medical writing and editing services in the development of this manuscript. AbbVie provided funding to Syntax Scientific Writing Ltd for this work. The authors would like to thank the investigators who participated in this trial: Greenlane Clinical Centre, Auckland District Health Board, Auckland, New Zealand: Steven Lamb; Waikato Hospital, Waikato District Health Board, Waikato, New Zealand: Doug White, Frank Weilert; Hawke’s Bay Hospital, Mid Central District Health Board, Hawke’s Bay, New Zealand: Stephen Sawyers, Malcom Arnold; Wellington Hospital, Capital and Coast District Health Board, Wellington, New Zealand: Rees Cameron, Andrew Harrison, Scott Barker; Dunedin Hospital, Southern District Health Board, Otago, New Zealand: Michael Schultz, Simon Stebbings; Tauranga Hospital, Bay of Plenty District Health Board, Tauranga, New Zealand: Tracey Kain, Adrian Claydon; Timaru Rheumatology Studies, Timaru, New Zealand: Daniel Ching; Porter Rheumatology, Nelson, New Zealand: David Porter; Waitemata District Health Board, Auckland, New Zealand: Kristine Ng, Russell Walmsley; Memorial Avenue Consultancy, Christchurch, New Zealand: Marina Sew Hoy; Christchurch Hospital, Canterbury District Health Board, Christchurch, New Zealand: Victoria Scott-Lang; Middlemore Hospital, Counties Manukau District Health Board, Auckland, New Zealand: Ravinder Ogra.

Previous presentation

Results from the VITALITY study were presented as posters at the Annual Scientific Meeting of the New Zealand Society of Gastroenterology, November 21–23, 2018 in Dunedin, New Zealand; the Asia Pacific Leagues of Associations for Rheumatology Congress, April 8–11, 2019 in Brisbane, Australia; and the Annual Scientific Meeting of the Australian College of Dermatologists, May 16–17, 2019 in Melbourne, Australia.

Data availability

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