The ISIS 104838 protocol for this patient population needs to be refined. Realizing Isis’s belief that “longer dosing or higher doses of ISIS 104838 may significantly enhance [biological and clinical] activity” is likely a requirement for real-world viability. Isis plans to initiate additional phase II trials designed to optimize the subcutaneous protocol. Meanwhile, Isis is also optimizing its oral formulations of ISIS 104838.

ISIS 104838 generated a statistically significant response for RA patients in the 157-evaluable patient, 85-day trial. Enrollees received subcutaneous placebo or one of three dose regimens of ISIS 104838 200 mg: every other week, once weekly, or twice weekly. 41% of evaluable once- and twice-weekly recipients achieved ACR20 response versus 23% of evaluable placebo recipients (p=0.04). Other reassuring aspects of this trial were in terms of dropout rates, highly comparable efficacy between the once- and twice weekly study arms, preliminary gauges of swollen and tender joint response, safety profile, and adverse effect profile.

TNF-alpha is a cytokine (small hormone-like protein that transmits signals between cells) important in immune responses and inflammation.

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