Patients 62 60 58 randomised 9 (15%) 22 (37%)a 20 (34%)b ACR 20 4 (6%) 9 (15%)c 9 (16%)c ACR 50 1 (2%) 3 (5%)c 3 (5%)c ACR 70 a p<0.01 b p<0.05 c p=NS Enthesitis and Dactylitis For patients with enthesitis and/or dactylitis at baseline, in PSUMMIT I, a significant improvement in enthesitis and dactylitis score was observed in the STELARA 45 mg and 90 mg groups compared to placebo. In PSUMMIT II, a significant improvement in enthesitis score and numerical improvement in dactylitis score were observed in the 90 mg group (p=NS) compared with the placebo group (see Table 10). In both studies, improvement in enthesitis score and dactylitis score were maintained at Week 52. Table 10. Summary of percent change in enthesitis and dactylitis scores at Week 24 PSUMMIT I PSUMMIT II STELARA STELARA 45 mg 90 mg Placebo 45 mg 90 mg Placebo (N=206) (N=205) (N=204) (N= 104) (N= 103) (N= 105) Enthesitis score d Patients randomised with enthesitis at baseline 145 142 154 73 72 76 N 137 140 148 68 70 70 Median 0.00 -42.86 a -50.00 b 0.00 -33.33 c -48.33a Dactylitis score e Patients randomised with dactylitis at baseline 96 101 99 38 48 41 N 92 99 95 33 46 38 Median 0.00 -75.00 b -70.83 b 0.00 0.00 c -64.58 c a p<0.01 b p<0.001
Patients randomised 62 60 58 ACR 20 9 (15%) 22 (37%)a 20 (34%)b ACR 50 4 (6%) 9 (15%)c 9 (16%)c ACR 70 1 (2%) 3 (5%)c 3 (5%)c a p<0.01 b p<0.05 c p=NS Enthesitis and Dactylitis For patients with enthesitis and/or dactylitis at baseline, in PSUMMIT I, a significant improvement in enthesitis and dactylitis score was observed in the STELARA 45 mg and 90 mg groups compared to placebo. In PSUMMIT II, a significant improvement in enthesitis score and numerical improvement in dactylitis score were observed in the 90 mg group (p=NS) compared with the placebo group (see Table 10). In both studies, improvement in enthesitis score and dactylitis score were maintained at Week 52. Table 10. Summary of percent change in enthesitis and dactylitis scores at Week 24 PSUMMIT I PSUMMIT II STELARA STELARA Placebo (N=206) 45 mg (N=205) 90 mg (N=204) Placebo (N= 104) 45 mg (N= 103) 90 mg (N= 105) Enthesitis score d Patients randomised with enthesitis at baseline 145 142 154 73 72 76 N 137 140 148 68 70 70 Median 0.00 -42.86 a -50.00 b 0.00 -33.33 c -48.33a Dactylitis score e Patients randomised with dactylitis at baseline 96 101 99 38 48 41 N 92 99 95 33 46 38 Median 0.00 -75.00 b -70.83 b 0.00 0.00 c -64.58 c a p<0.01 b p<0.001