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Randomized Controlled Trial
. 2013 Oct 31;15(5):R173.
doi: 10.1186/ar4361.

Health-related quality of life and functional ability in patients with early arthritis during remission steered treatment: results of the IMPROVED study

Lotte Heimans, Kirsten V C Wevers-de Boer, K K Michel Koudijs, Karen Visser, Yvonne P Goekoop-Ruiterman, Joop B Harbers, Gerda M Steup-Beekman, Leroy R Lard, Bernard A M Grillet, Tom W J Huizinga, Cornelia F Allaart
Randomized Controlled Trial

Health-related quality of life and functional ability in patients with early arthritis during remission steered treatment: results of the IMPROVED study

Lotte Heimans et al. Arthritis Res Ther. .

Abstract

Introduction: The aim of this study was to investigate patient reported outcomes (PROs) of functional ability and health related quality of life (HRQoL) in patients with early (rheumatoid) arthritis during one year of remission steered treatment.

Methods: In this study, 610 patients with early rheumatoid arthritis (RA) or undifferentiated arthritis (UA) were treated with methotrexate (MTX) and tapered high dose of prednisone. Patients in early remission (Disease Activity Score (DAS) <1.6 after 4 months) tapered prednisone to zero and when in persistent remission, also tapered MTX. Patients not in early remission were randomized to either MTX + hydroxychloroquine + sulphasalazine + prednisone (arm 1) or to MTX + adalimumab (arm 2). Every 4 months, patients filled out the Health Assessment Questionnaire (HAQ) and the McMaster Toronto Arthritis Patient Preference Questionnaire (MACTAR), the Short Form 36 (SF-36) and visual analogue scales (VAS). Change scores were compared between treatment groups. The association with achieving remission was analyzed using linear mixed models.

Results: During year 1, patients who achieved early remission had the most improvement in PROs with scores comparable to the general population. Patients in the randomization arms showed less improvement. Scores were comparable between the arms. There was a significant association between achieving remission and scores of HAQ, MACTAR and physical HRQoL.

Conclusions: In early arthritis, PROs of functional ability and HRQoL after one year of remission steered treatment reach normal values in patients who achieved early remission. In patients not in early remission, who were randomized to two strategy arms, PROs improved less, with similar scores in both treatment arms.

Trial registrations: ISRCTN11916566 and EudraCT2006-006186-16.

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Figures

Figure 1
Figure 1
Functional ability as measured by the Health Assessment Questionnaire and the McMaster Toronto Arthritis Patient Preference Questionnaire. Scores in the first year in the general population (only for Health Assessment Questionnaire (HAQ)), the early remission group, arm 1, arm 2 and the outside protocol subgroup. MACTAR: McMaster Toronto Arthritis Patient Preference Questionnaire.
Figure 2
Figure 2
Summary components scores of health as measured by the 36-Item Short Form Health Survey. The 36-Item Short Form Health Survey (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS) can be calculated from the eight SF-36 domains (physical functioning, role limitations due to physical functioning, bodily pain, general health, vitality, social functioning, role limitations due to emotional functioning and mental health) [12,13]. OP: outside protocol subgroup.
Figure 3
Figure 3
The eight domains of health measured by the 36-Item Short Form Health Survey. For the eight domains measured by the 36-Item Short Form Health Survey (physical functioning, role limitations due to physical functioning, bodily pain, general health, vitality, social functioning, role limitations due to emotional functioning and mental health), the total score ranges from 0 (worst) to 100 (best). OP: outside protocol subgroup.
See this image and copyright information in PMC

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