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These may be signs of new or worsening heart failure. Clinical studies of weight gain with Humira Clinical trials published after the FDA approved Humira have investigated weight gain with this drug and other Tumor Necrosis Factor (TNF) alpha inhibitors. One observational study looked at the effect of TNF blocker therapy on the weight of patients with rheumatoid arthritis (RA). Patients in the study were using adalimumab (Humira, 44 patients), etanercept (Enbrel, 27 patients), or methotrexate (40 patients) as a single treatment for at least 24 months and had no previous use of other biologic therapy. At the start of the study (baseline), and at 12 and 24 months, each patient completed a questionnaire about physical activity, smoking, alcohol, and food habits. After 24 months of therapy, there was an increase of weight only in patients treated with the TNF blockers. Patients on etanercept and adalimumab therapy showed a risk of weight gain that was 6 times greater compared to those on methotrexate therapy.
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