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Original Investigation |

Biological vs Conventional Combination Treatment and Work Loss in Early Rheumatoid Arthritis:  A Randomized Trial

Jonas K. Eriksson, MSc1; Martin Neovius, PhD1; Johan Bratt, MD, PhD2; Ingemar F. Petersson, MD, PhD3,4; Ronald F. van Vollenhoven, MD, PhD5; Pierre Geborek, MD, PhD4; Sofia Ernestam, MD, PhD6
[+] Author Affiliations
1Unit of Clinical Epidemiology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden
2Unit of Rheumatology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden
3Section of Orthopedics, Department of Clinical Sciences, Lund University, Lund, Sweden
4Section of Rheumatology, Department of Clinical Sciences, Lund University, Lund, Sweden
5Unit of Clinical Therapy Research, Inflammatory Diseases, Department of Medicine, Karolinska Institutet, Stockholm, Sweden
6Department of Learning, Informatics and Medical Education, Karolinska Institutet, Stockholm, Sweden
JAMA Intern Med. 2013;173(15):1407-1414. doi:10.1001/jamainternmed.2013.7801.
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Importance  The introduction of biological tumor necrosis factor inhibitors has improved the treatment of rheumatoid arthritis (RA) but at a substantial cost. These drugs have been shown to lead to superior radiological outcomes compared with a combination of conventional disease-modifying antirheumatic drugs over 2 years.

Objective  To investigate whether radiological superiority translates into better work loss outcomes.

Design, Setting, and Participants  Multicenter, 2-arm, parallel, randomized, active-controlled, open-label trial. Patients with early RA (symptom duration <1 year) were recruited from 15 rheumatology clinics in Sweden from October 1, 2002, through December 31, 2005. The study population was restricted to working-age patients (aged <63 years).

Interventions  Patients who did not achieve low disease activity after 3 to 4 months of methotrexate therapy were randomized to receive additional biological treatment with infliximab or conventional combination treatment with sulfasalazine plus hydroxychloroquine.

Main Outcomes and Measures  Monthly sick leave and disability pension days 21 months after randomization retrieved from the nationwide Swedish Social Insurance Office register. Main analyses were by intention to treat, including all patients, and adjusted for baseline sick leave and disability pension.

Results  Of 204 eligible patients, 105 were randomized to biological and 99 to conventional treatment. Seven patients in the biological and 4 in the conventional treatment group never received the study drug, and 72 and 52 patients, respectively, followed the study per protocol for 21 months. The baseline mean (SD) work loss was 17 (13) d/mo (median, 16 d/mo) in both groups (mean difference, 0.6 d/mo; 95% CI, −3.0 to 3.9). The mean changes in work loss at 21 months were −4.9 d/mo in the biological and −6.2 d/mo in the conventional treatment group (adjusted mean difference, 1.6 d/mo; 95% CI, −1.2 to 4.4). Including only patients receiving at least 1 dose of assigned treatment, the adjusted mean difference was 1.5 d/mo (95% CI, −1.5 to 4.4), and in per-protocol analysis the adjusted mean difference was 0.3 d/mo (95% CI, −2.8 to 3.8).

Conclusions and Relevance  The radiological superiority of biological compared with conventional combination therapy did not translate into better work loss outcomes in patients with early RA who had experienced an insufficient response to methotrexate.

Trial Registration  clinicaltrials.gov Identifier: NCT00764725

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Figures

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Figure 1.
Monthly Days on Sick Leave and Disability Pension at Randomization

Mean monthly days on sick leave and disability pension by subgroup at randomization (maximum, 30 days; no missing data). The “overall” category represents all randomized patients (both treatment arms combined); controls, general population comparators matched 5:1 by age, sex, educational level, and place of residence; error bars, SEs. We used t tests to compare sex and smoking status categories and 1-way analysis of variance to compare age, educational level, and health assessment questionnaire (HAQ) categories (<1.0, 1.0-1.49, and ≥1.5).

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Figure 2.
Monthly Days on Sick Leave and Disability Pension by Day of Randomization

Mean monthly days on sick leave and disability pension by day of randomization (maximum, 30 days; no missing data). Run-in represents treatment with methotrexate; controls, general population comparators matched 5:1 by age, sex, educational level, and place of residence; error bars, SEs. Biological treatment included infliximab plus methotrexate; conventional treatment, sulfasalazine and hydroxychloroquine plus methotrexate.

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Figure 3.
Monthly Work Loss and Percentage of Patients by Category of Work Loss

Median monthly work loss (solid line) and percentage of patients by category of monthly work loss (maximum, 30 days; no missing data). Biological treatment included infliximab plus methotrexate; conventional treatment, sulfasalazine and hydroxychloroquine plus methotrexate.

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