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Fatigue, disease activity may predict rescue medication need in patients with RA receiving sarilumab
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Disease activity and energy levels were predictive of the need for rescue medications in patients with rheumatoid arthritis who were treated with sarilumab compared with those treated with placebo, according to research presented at the European League Against Rheumatism Annual European Congress of Rheumatology.
The 1,197 patients with rheumatoid arthritis (RA) comprising the intent-to-treat cohort of the MOBILITY trial were randomly assigned at a 1:1:1 ratio to receive placebo plus methotrexate, 150 mg sarilumab every 2 weeks plus methotrexate or 200 mg sarilumab every 2 weeks plus methotrexate. Patients were assessed at baseline, every 4 weeks between week 2 and week 28, and every 8 weeks through week 52. Early rescue was defined as rescue medication used within the first 16 weeks of study entry, and late rescue was defined as rescue medication administered between week 20 and week 52.
Vibeke Strand
The impact of treatment compared with the use of rescue medication was evaluated using multinomial logistic modelling, and baseline variables were studied to identify variables that could predict the use of rescue medication independently from treatment.
Rescue medication was not used by 940 of the 1,197 patients, 153 had early rescue intervention and 104 had late rescue treatment. Among patients assigned to placebo, 61% received no rescue intervention, 15% received early intervention and 24% received late rescue compared with 86% of patients treated with 150 mg sarilumab who had no rescue, 6% who had early rescue and 8% who had late rescue. No rescue was received by 89% of patients taking 200 mg of sarilumab, whereas 4% received early rescue medication and 7% received late rescue.
Baseline patient characteristics, such as disease activity score (DAS28), other disease indices, swollen and tender joint counts, Functional Assessment of Chronic Illness Therapy - Fatigue results and SF-36 vitality domain were most predictive of the risk for use of rescue medication, according to the researchers.
The estimated odds ratio (OR) for patients who received placebo was 4.6 for early rescue and 5.2 for no rescue compared with 150 mg or 200 mg of sarilumab treatment. Baseline scores of two-point-higher DAS28 scores were associated with a 78% increase in OR, whereas four-point-higher baseline DAS28 scores correlated with a 218% increased OR for early rescue. A five-point-lower SF-36 vitality score was associated with 7% increased OR for early rescue, and a 10-point-lower SF-36 score correlated with a 13% increase in OR.
The researchers concluded that DAS28 scores and patient-reported outcomes of pep, energy and fatigue were the greatest predictors of the need for rescue intervention among patients in the trial. – by Shirley Pulawski
Reference:
Strand V, et al. Paper #AB0321. Presented at: European League Against Rheumatism Annual European Congress of Rheumatology; June 10-13, 2015; Rome.
Disclosure s : Strand reports she is a consultant for AbbVie, Afferent, Amgen, Biogen Idec, Bioventus, BMS, Carbylan, Celgene, Celltrion, Consortium of Rheumatology Researchers of North America (CORRONA), Crescendo, Genentech/Roche, GSK, Hospira, Iroko, Janssen, Lilly, 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.