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The NZRA Biologics Register: baseline characteristics and outcome from the first year of enrolment

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Authors:
Summary:

This report analysed data from the first 12 months of registrations on the NZRA Biologics Register, which was initiated at the same time as the launch of public funding of Humira for the treatment of adult rheumatoid arthritis (RA) on 1 January 2006. Data concerned 244 patients, representing 84.4% of Pharmac approvals; 80% of the patients were female, the mean age was 56 years and mean disease duration was 13 years. Europeans were overrepresented and Mäori significantly under-represented (3.8%). Upon commencing Humira, 70% were taking prednisone at a mean daily dose of 10mg. At first reapplication, compliance with the registry was 82%, and the following disease activity measures had decreased from baseline; ESR 42 to 23, CRP 37 to 11 , tender swollen joint count 20 to 2.7, physician global VAS 75 to 20 mm, patient global VAS 74 to 25 mm, pain VAS 71 to 23 mm, HAQ 1.78 to 0.96, and prednisone use 70% to 34%. Responses were sustained at 12 and 18 months. “These data confirm the efficacy of Humira in a New Zealand cohort of RA patients with relatively severe and longstanding RA, but raise concerns about equality of access and risk of severe infection”, conclude the researchers.

Comment:
Ethical dilemmas arise for Mäori when a new treatment is offered as part of a research trial. Questions include: am I a guinea pig? Do I want to hear all this new information when I’m already feeling vulnerable with ill health or in the hospital? Can I continue to get the new treatment at the end of the study? And from the other side – this treatment looks better than standard care and because this is a common disease for Mäori, every effort should be made to ensure Mäori participants are recruited. As the researcher suggests here, a new treatment for RA appears to be very effective, RA is more common in Mäori than non-Mäori yet the percentage of Mäori receiving the new drug was low, raising concerns about quality of health care and information.
Reference: N Z Med J. 2007;120(1266):U2858
Independent commentary by Dr. Matire Hardwood

Dr Matire Harwood (Ngapuhi) has worked in Hauora Māori, primary health and rehabilitation settings as clinician and researcher since graduating from Auckland Medical School in 1994. She also holds positions on a number of boards, committees and advisory groups including the Health Research Council. Matire lives in Auckland with her whānau including partner Haunui and two young children Te Rangiura and Waimarie.

Research Review publications are intended for New Zealand health professionals.

Disclaimer: This publication is not intended as a replacement for regular medical education but to assist in the process. The reviews are a summarised interpretation of the published study and reflect the opinion of the writer rather than those of the research group or scientific journal. It is suggested readers review the full trial data before forming a final conclusion on its merits.

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