The findings from a new phase III study comparing the efficacy and safety of Stelara (ustekinumab) with etanercept, in the treatment of moderate to severe plaque psoriasis, showed a higher clinical response with Stelara over a 12-week period compared to high-dose etanercept. The results of the study, published in the New England Journal of Medicine, also demonstrated clinical benefit of Stelara among patients who failed to respond to etanercept.
In the comparator study of 903 patients, 68% and 74% of patients receiving subcutaneous injections of Stelara (45mg or 90mg) at weeks zero and four, achieved at least a 75% improvement in their psoriasis symptoms as measured by the psoriasis area and Severity Index (PASI 75) at week 12, the primary endpoint. This was higher compared to the 57% of patients who achieved PASI 75 receiving the maximum recommended dose for etanercept; subcutaneous injections of 50mg twice per week for 12 weeks (P = 0.01 for Stelara 45mg; P < 0.001 for Stelara 90mg, each compared with etanercept).
Onset of clinical response occurred more rapidly among Stelara-treated patients, with higher numbers of patients achieving PASI 75 by week eight, as compared to patients receiving etanercept.
Investigators also reported that a greater proportion of patients receiving Stelara achieved a marked improvement in psoriasis as assessed by PASI 90 response, or nearly complete clearance of psoriasis. At week 12, 36% of patients receiving Stelara 45mg and 45% of patients receiving Stelara 90mg achieved PASI 90, compared to 23% of patients receiving etanercept (P < 0.001 for each comparison versus etanercept).
Moreover, a greater proportion of patients in the Stelara 45mg and 90mg treatment groups achieved a Physician Global Assessment (PGA) score of ‘cleared’ or ‘minimal’ (65% and 71% of patients, respectively), compared to patients in the etanercept treatment group (49%; p < 0.001 for each comparison versus etanercept).
Patients who had an inadequate response to etanercept, as measured by PGA score (classified as moderate, marked or severe psoriasis at week 12), received an injection of Stelara 90mg at weeks 16 and 20. At week 28, investigators reported that nearly half of patients (49%) who failed to respond to etanercept and who crossed over to Stelara, achieved PASI 75.
Through week 12 of the study, the percentage of study participants experiencing at least one adverse event (AE) was comparable between the Stelara 45mg group (66%), the Stelara 90mg group (69%) and the etanercept 50mg group (70%). The proportion of patients experiencing at least one serious AE through week 12 were as follows: 1.9% and 1.2% of patients receiving Stelara 45mg or 90mg, respectively, compared with 1.2% of patients receiving etanercept. Rates of specific AEs were generally comparable between treatment groups with the exception of injection site reactions, which were reported in 25% of patients treated with etanercept versus 4.3% and 3.7% with Stelara 45mg and 90mg, respectively. This disparity, however, may have been influenced by the greater number of etanercept injections administered, compared to two Stelara injections.
Through week 64, the rates and types of AEs were generally comparable between patients in the 45mg (87%) and 90mg (89%) Stelara groups, and also before and after crossover from etanercept to Stelara (79% vs 65%). This was also the case for serious adverse events (3.5% vs 3.4%).