June 22, 2015
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Improvement in health-related quality of life seen when sarilumab was added to treatment for RA

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Many patients who received sarilumab in addition to methotrexate reported a better health-related quality of life compared with patients who received placebo and methotrexate, especially for bodily pain, vitality and fatigue, according to research presented at the European League Against Rheumatism Annual European Congress of Rheumatology.

In a controlled, phase 3 trial, researchers randomly assigned 1,197 American College of Rheumatology 20 (ACR20) responders to receive treatment with either placebo plus methotrexate, sarilumab 150 mg every 2 weeks plus methotrexate, or 200 mg sarilumab plus methotrexate.

Vibeke Strand

Using the SF-36 v2, the researchers measured patients’ health-related quality of life (HRQoL), and fatigue was measured using the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale. At 24 weeks, the researchers calculated the percentage of ACR20 responders who met or exceeded the patient acceptable system state (PASS), those who considered well-being as satisfactory in six SF-36 domains and those who had general population normative values for both and FACIT-fatigue scores. Additionally, the Chi-square test was used to test for statistically differences between placebo and other treatments.

According to the researchers, at 24 weeks, the percentage of responders in the 150 mg and 200 mg groups with scores above PASS exceeded the placebo group in all six SF-36 domains. Both sarilumab groups were statistically significant for physical functioning, vitality, social functioning and mental health.

At 24 weeks, 46.3% (150 mg) and 54% (200 mg) of responders exceeded placebo in all SF-36 domains and FACIT-fatigue with scores with above normative values. The researchers observed similar results at 52 weeks. – by Monica Jaramillo

Reference:

Stand V, et al. Paper #FRI0058. Presented at: European League Against Rheumatism Annual European Congress of Rheumatology; June 10-13, 2015; Rome.

Disclosures: Strand reports she is a consultant for AbbVie, Afferent, Amgen, Giogen, Idec, Bioventus, BMS, Carbylan, Celgene, Celltrion, Consortium of Rheumatology, Researchers of North America, Crescendo, Genetech/Roche, GSK, Hospira, Iroko, Janssen, Lily, Merck, Novartis, Pfizer, Regeneron, Sanofi, SKK, Takeda, UCB and Vertex. Please see the full study for a list of all other authors’ relevant financial disclosures.