8:02AM NPS Pharm reports new data from STEPS 2 support the long term use of gattex; patients on gattex treatment beyond one year continue to achieve clinically meaningful reductions in parenteral support requirements, with some achieving complete independence (NPSP) 29.74 : STEPS 2 is a two-year open-label extension study of 88 adult patients with SBS. Investigators reported that the long-term use of Gattex in patients with SBS resulted in additional, clinically meaningful reductions in the volume and days per week of parenteral support requirements in this extension study.
In addition, 10 of the 13 patients who achieved complete independence from parenteral support were those who received 30 months of Gattex in the 6-month STEPS pivotal study and the 24-month STEPS 2 study. Two patients who received placebo in STEPS and 24 months of Gattex in STEPS 2 and one patient who bypassed STEPS and was enrolled directly into STEPS 2 also achieved independence from parenteral support. No new unexpected safety concerns were observed with long-term Gattex treatment and the product's safety profile remains consistent with the product's label.
The primary objective of STEPS 2 was to study long-term safety and durability of effect in patients who completed, participated in, or qualified for participation in STEPS, a 24-week, placebo-controlled, multi-center, international Phase 3 study of Gattex in adult subjects with SBS. The majority of patients in STEPS 2 achieved and maintained clinically meaningful responses after Gattex treatment. A responder was defined as a subject who achieved a 20 to 100 percent reduction in the volume of parenteral support from baseline.
A higher percentage of patients who received Gattex for 30 months (the Gattex/Gattex group) responded and achieved greater reductions in parenteral support volume and days per week compared with those who received Gattex for 24 months (Placebo/Gattex group and Not-treated/Gattex group). In addition, 33 percent of patients (10/30) who received 30 months of Gattex achieved complete independence from parenteral support. The rates of adverse events of special interest as described in the U.S. Prescribing Information remain consistent.
The most common adverse events were abdominal pain, catheter sepsis, and episodes of decreased weight, nausea, gastrointestinal stoma complications, and abdominal distension.
