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"SLE is a chronic disease, and patients need new therapies that providedurable efficacy with a favorable safety profile," said Michelle A. Petri,M.D., M.P.H., Professor, Division of Rheumatology, Department of Medicine,Johns Hopkins University. "The Phase 2 results presented at ACR showed thatthe significant clinical benefit observed for LymphoStat-B in serologicallyactive SLE patients at 52 weeks appears to be sustained through 2.5 years. Welook forward to further evaluation of LymphoStat-B in larger Phase 3 studies,which are ongoing."
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A separate poster presentation of the safety profile of LymphoStat-Bshowed that LymphoStat-B was well tolerated in combination with SLE standard-of-care therapy during long-term exposure, with incidence rates of adverseevents, serious adverse events, malignancies, infections and laboratoryabnormalities remaining comparable to placebo or decreasing through 2.5 yearsof treatment (Merrill et al).
"The results through 2.5 years confirm and extend the results reported atWeeks 52 and 76," said David C. Stump, M.D., Executive Vice President,Research and Development, HGS. "At Week 52 in LymphoStat-B patients withactive SLE, we saw significant reductions in SLE disease activity versusplacebo as measured by the SELENA SLEDAI and BILAG indices, the Physician'sGlobal Assessment, and, most importantly, by the response rate chosen as theprimary efficacy endpoint of the Phase 3 trials. We are encouraged by thecontinued improvement in these patients, and by the improvement over time inpatients crossing over from placebo to LymphoStat-B after 52 weeks. If thePhase 2 results are confirmed in our ongoing Phase 3 trials, we believe thatLymphoStat-B could represent a breakthrough in the treatment of SLE."
The primary objectives of the Phase 2 study were to evaluate the efficacyand safety of LymphoStat-B (belimumab) plus standard of care, versus placeboplus standard of care. A total of 449 patients with active SLE wererandomized to receive one of three different doses of LymphoStat-B or placebo(1, 4 or 10 mg/kg) administered intravenously over a 52-week treatment period,in addition to standard-of-care therapy. At the end of 52 weeks, 345 patientschose to participate in an optional 24-week extension phase of the study,during which all patients received LymphoStat-B. At Week 76, 296 patientschose to remain on LymphoStat-B treatment in an open-label long-termcontinuation phase of the Phase 2 trial, in which all patients are receiving10 mg/kg LymphoStat-B. As of October 1, 2007, 244 patients remained onLymphoStat-B treatment in the continuation study.
Key Findings to Date from the Phase 2 Study
In June 2006, HGS reported the 52-week results of the Phase 2 trial ofLymphoStat-B in patients with SLE. The 52-week results demonstrated thatLymphoStat-B significantly reduced disease activity versus placebo in patientswith serologically active SLE across multiple clinical measures, exhibitedclinically relevant biological activity, and appeared generally safe and welltolerated. Frequency and severity of adverse events were similar to placebo,with no increase at higher doses. Among the findings at Week 52 was asignificantly improved response
