ated patients also demonstratedgreater improvement in the SF-36 physical and mental component summary scores thanplacebo-treated patients. The responses were maintained for up to 2 years in an open-labelextension study.
14.7 Plaque Psoriasis
The safety and efficacy of infliximab were assessed in 3 randomized, double-blind, placebocontrolledstudies in patients 18 years of age and older with chronic, stable plaque psoriasisinvolving ≥10% BSA, a minimum PASI score of 12, and who were candidates for systemictherapy or phototherapy. Patients with guttate, pustular, or erythrodermic psoriasis wereexcluded from these studies. No concomitant anti-psoriatic therapies were allowed during the study, with the exception of low-potency topical corticosteroids on the face and groin afterWeek 10 of study initiation.
Study I (EXPRESS) eva luated 378 patients who received placebo or infliximab at a dose of5 mg/kg at Weeks 0, 2, and 6 (induction therapy), followed by maintenance therapy every 8
weeks. At Week 24, the placebo group crossed over to infliximab induction therapy (5 mg/kg),followed by maintenance therapy every 8 weeks. Patients originally randomized to infliximabcontinued to receive infliximab 5 mg/kg every 8 weeks through Week 46. Across alltreatment groups, the median baseline PASI score was 21 and the baseline Static PhysicianGlobal Assessment (sPGA) score ranged from moderate (52% of patients) to marked (36%)to severe (2%). In addition, 75% of patients had a BSA > 20%. Seventy-one percent ofpatients previously received systemic therapy, and 82% received phototherapy.
Study II (EXPRESS II) eva luated 835 patients who received placebo or infliximab at doses of3 mg/kg or 5 mg/kg at Weeks 0, 2, and 6 (induction therapy). At Week 14, within eachinfliximab dose group, patients were randomized to either scheduled (every 8 weeks) or asneeded (PRN) maintenance treatment through Week 46. At Week 16, the placebo groupcrossed over to infliximab induction therapy (5 mg/kg), followed by maintenance therapyevery 8 weeks. Across all treatment groups, the median baseline PASI score was 18, and 63%of patients had a BSA > 20%. Fifty-five percent of patients previously received systemictherapy, and 64% received a phototherapy.
Study III (SPIRIT) eva luated 249 patients who had previously received either psoralen plusultraviolet A treatment (PUVA) or other systemic therapy for their psoriasis. These patientswere randomized to receive either placebo or infliximab at doses of 3 mg/kg or 5 mg/kg atWeeks 0, 2, and 6. At Week 26, patients with a sPGA score of moderate or worse (greaterthan or equal to 3 on a scale of 0 to 5) received an additional dose of the randomizedtreatment. Across all treatment groups, the median baseline PASI score was 19, and thebaseline sPGA score ranged from moderate (62% of patients) to marked (22%) to severe(3%). In addition, 75% of patients had a BSA >20%. Of the enrolled patients, 114 (46%)received the Week 26 additional dose.
In Studies I, II and III, the primary endpoint was the proportion of patients who achieved areduction in score of at least 75% from baseline at Week 10 by the PASI (PASI 75). In Study Iand Study III, another eva luated outcome included the proportion of patients who achieved ascore of “cleared” or “minimal” by the sPGA. The sPGA is a 6-category scale ranging from“5 = severe” to “0 = cleared” indicating the physician’s overall assessment of the psoriasis
severity fo |
