Consistent ACR20 Response Rates Through Week 100
ACR20 RESPONSE IN BIOLOGIC-NAÏVE PATIENTS THROUGH WEEK 1001-4*†
Open-Label Extension (PSUMMIT I)
- The percentage of biologic-naïve STELARA® patients who achieved significant improvement in joint symptoms peaked at Week 28 and reached a plateau at Week 283,4
- Patients were randomized to receive STELARA® 45 mg, STELARA® 90 mg, or placebo as subcutaneous injection at Weeks 0 and 4 and every 12 weeks thereafter. At Week 24, all remaining patients in the placebo group received STELARA® 45 mg, which they continued at Week 28 and every 12 weeks thereafter2
- ACR20 data were collected once every 4 weeks through Week 24, and once every 12 weeks from Week 28 through Week 1003
PSUMMIT I was considered an open-label trial after Week 24. At Week 24, all patients in the placebo group who were not eligible for early escape crossed over to STELARA® 45 mg. These patients continued at Week 28 and every 12 weeks thereafter. In this ITT analysis, early escape rules were not applied. At Week 24, the data were unmasked to the sponsor for analysis. Study sites and patients remained masked to treatment assignment until study completion. Patients were considered nonresponders if they discontinued treatment due to an unsatisfactory therapeutic effect, initiated protocol-prohibited medications/therapies, or increased the dose of MTX or oral corticosteroids over baseline prior to Week 52. All placebo patients either entered early escape or crossed over to receive STELARA® 45 mg by Week 24 (n=189).2,3