cusing on induration, erythema, and scaling. Treatment success, defined as“cleared” or “minimal,” consisted of none or minimal elevation in plaque, up to faint redcoloration in erythema, and none or minimal fine scale over < 5% of the plaque.
Study II also eva luated the proportion of patients who achieved a score of “clear” or“excellent” by the relative Physician’s Global Assessment (rPGA). The rPGA is a 6-category scale ranging from “6 = worse” to “1 = clear” that was assessed relative to baseline. Overall
lesions were graded with consideration to the percent of body involvement as well as overall
induration, scaling, and erythema. Treatment success, defined as “clear” or “excellent,”
consisted of some residual pinkness or pigmentation to marked improvement (nearly normal
skin texture; some erythema may be present). The results of these studies are presented in
Table 12.
Table 12 Psoriasis studies I, II, and III, Week 10 percentage of patients who achieved
PASI 75 and percentage who achieved treatment “success” with Physician’s
Global Assessment
Placebo Infliximab
3 mg/kg 5 mg/kg
Psoriasis Study I -patients randomizeda 77 - 301
PASI 75 2 (3%) - 242 (80%)*
sPGA 3 (4%) - 242 (80%)*
Psoriasis Study II -patients randomizeda 208 313 314
PASI 75 4 (2%) 220 (70%)* 237 (75%)*
rPGA 2 (1%) 217 (69%)* 234 (75%)*
Psoriasis Study III -patients randomizedb 51 99 99
PASI 75 3 (6%) 71 (72%)* 87 (88%)*
sPGA 5 (10%) 71 (72%)* 89 (90%)*
* P < 0.001 compared with placebo a Patients with missing data at Week 10 were considered as nonresponders.
b Patients with missing data at Week 10 were imputed by last observation.In Study I, in the subgroup of patients with more extensive psoriasis who had previously
received phototherapy, 85% of patients on 5 mg/kg infliximab achieved a PASI 75 at Week10 compared with 4% of patients on placebo.
In Study II, in the subgroup of patients with more extensive psoriasis who had previouslyreceived phototherapy, 72% and 77% of patients on 3 mg/kg and 5 mg/kg infliximabachieved a PASI 75 at Week 10 respectively compared with 1% on placebo. In Study II,among patients with more extensive psoriasis who had failed or were intolerant tophototherapy, 70% and 78% of patients on 3 mg/kg and 5 mg/kg infliximab achieved a PASI75 at Week 10 respectively, compared with 2% on placebo.
Maintenance of response was studied in a subset of 292 and 297 infliximab-treated patients inthe 3 mg/kg and 5 mg/kg groups; respectively, in Study II. Stratified by PASI response atWeek 10 and investigational site, patients in the active treatment groups were re-randomizedto either a scheduled or as needed maintenance (PRN) therapy, beginning on Week 14.The groups that received a maintenance dose every 8 weeks appear to have a greaterpercentage of patients maintaining a PASI 75 through week 50 as compared to patients whoreceived the as-needed or PRN doses, and the best response was maintained with the 5 mg/kg every 8-week dose. These results are shown in Figure 4. At Week 46, when infliximab serumconcentrations were at trough level, in the every 8-week dose group, 54% of patients in the 5mg/kg group compared to 36% in the 3 mg/kg group achieved PASI 75. The lower percentage
of PASI 75 responders in the 3 mg/kg every 8-week dose group compared to the 5 mg/kggroup was associated with a lower percentage of patients with detectable trough serum |
