EDITORIAL - Longterm treatment benefits are best reflected by patient reported outcomes

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Journal of Rheumatology

Dec 2007

Editorial

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Longterm Treatment Benefits Are Best Reflected by Patient Reported Outcomes

C. VIBEKE STRAND, MD,

Clinical Professor, Adjunct,

Division of Immunology/Rheumatology,

Stanford University,

Palo Alto, California;

BRUCE CRAWFORD, MA, MPH,

Mapi Values,

Boston, Massachusetts, USA

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Since 1998, the American College of Rheumatology (ACR) criteria (ACR

20/50/70% responses) and improvements in the Disease Activity Score

(DAS) have been utilized to demonstrate efficacy of 7 new disease

modifying antirheumatic drugs (DMARD). " Improvement in physical

function and health related quality of life [hrQOL] " are established

labeling claims, in response to US Food and Drug Administration

requirements for " durability of response " over 24 months of treatment.

The Health Assessment Questionnaire (HAQ) has become the primary

measure of physical function in RA, accompanied by use of generic

measures such as the Medical Outcomes Study Short-Form 36 (SF-36),

EuroQOL (EQ-5D), and Health Utilities Index-3 (HUI3) to assess HRQOL

in RA1. Patient reported outcomes have been shown to best

differentiate active from placebo therapy2-4.

In this issue of The Journal, Mittendorf and colleagues report

treatment associated improvements in HRQOL and fatigue in 505 patients

with RA who successfully completed several randomized dose-finding

protocols and received longterm treatment with adalimumab for a mean

of 1.6 years5. Mean disease duration in this population was 12.4

years, and patients had failed a mean of 3.7 prior DMARD; 47% were

retired and only 30% were employed. The largest cohort in this

open-label continuation study had completed the placebo controlled 6

month monotherapy DE011 trial. Those receiving 40 mg adalimumab (n =

96–99) or placebo (n = 91–93) every other week provide a comparison of

initial responses to active therapy.

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