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Durability of Treatment Effects in Double-Blind Study: Active Treatment vs. Placebo

This study presents findings on the durability of treatment effects in a double-blind trial where 25% of patients achieved lasting treatment response (LTR) by day 34, with significant results observed by day 7 (p < 0.0001). By the end of the study, 32% of patients on active treatment reported effects opposed to 61% of the placebo group (p < 0.0001). Additionally, worsening fatigue and overall sleep problems were measured, showing statistically significant changes on the MAF and MOS sleep scales over various days (p < 0.0001). Findings were presented at EULAR 2007.

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Durability of Treatment Effects in Double-Blind Study: Active Treatment vs. Placebo

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  1. Durability of Effect in Double-blind Phase Item Active treatment Placebo value P 25% of patients had LTR By day 34 By day 7 <0.0001 LTR by end of study 32% of patients 61% of patients <0.0001 Worsening fatigue (MAF By day 119 By day 27 <0.0001 scale) Worsening in Overall Sleep Problems Index By day 42 By day 14 <0.0001 (MOS - sleep scale) Presented at EULAR 2007.

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