Summary

• The company cannot recommend any practices, procedures, or usage that deviates from the approved labeling.
• Please refer to local labeling for relevant information on STELARA.
• Twelve-week data from ACCEPT, a phase 3, multicenter study, compared the efficacy of STELARA and etanercept in 903 adult patients with moderate to severe plaque psoriasis (PsO). The efficacy and safety of a crossover from etanercept to STELARA were evaluated after week 12.¹

CLINICAL DATA

Placebo-Controlled Trials

The safety and efficacy of STELARA in adult patients diagnosed with plaque PsO were evaluated in 3 (1 phase 2 and 2 phase 3) randomized, double-blind, placebo-controlled studies.

The following includes a list of select criteria utilized to exclude patients from the phase 2 clinical trial:²

• Had received biologic or investigational agents within the previous month or 5 drug half-lives.
• Had received conventional systemic PsO therapy or phototherapy within the previous 4 weeks or have received topical PsO treatment within the previous 2 weeks

The following includes a list of select criteria utilized to exclude patients from the phase 3 placebo-controlled clinical trials:^3,4

• Had used any biologic or investigational agents within the previous 3 months or 5 times the half-life of the biologic, whichever is longer.
• Had received conventional systemic PsO treatment or phototherapy within the previous 4 weeks or have received topical PsO treatment within 2 weeks of administration of study agent.

Active Comparator Trial: ACCEPT

Griffiths et al (2010)¹ described the ACCEPT (Active Comparator [CNTO 1275/Enbrel] Psoriasis Trial) trial in 903 adult patients with moderate to severe plaque PsO.

Study Design/Methods

• Adult patients with a diagnosis of plaque PsO for ≥6 months who were candidates for phototherapy or systemic therapy and had a Psoriasis Area and Severity Index (PASI) score ≥12, a Physician's Global Assessment (PGA) score ≥3, and ≥10% of their body surface area (BSA) involved were eligible for the study.
• Patients also had an inadequate response, intolerance, or contraindication to at least 1 conventional systemic PsO treatment (ie, methotrexate, cyclosporine, or psoralen plus ultraviolet A), and no prior treatment with STELARA or etanercept.
• Patients were ineligible if they had nonplaque or drug-induced forms of PsO, a recent serious infection, a history of chronic or recurrent infectious disease, or a known malignant condition.
• Patients were randomized in a 3:5:5 ratio to receive either STELARA 45 mg (n=209) or 90 mg (n=347) at weeks 0 and 4, or etanercept 50 mg twice weekly (n=347) through week 12.
• At week 12, etanercept-treated patients who did not respond (ie, patients who had moderate, marked, or severe PsO based on PGA score) received STELARA 90 mg at weeks 16 and 20.
• Patients who did not have a response to STELARA received 1 additional dose of STELARA at week 16.

Results

Efficacy

• Of the etanercept-treated patients not achieving a PGA score of cleared or minimal (n=177), 28.2% (n=50) of patients were refractory to high-dose etanercept and continued to have moderate to severe PsO symptoms. Subsequently, these patients crossed over to STELARA 90 mg at weeks 16 and 20.
• Compared with patients who were responders to etanercept, patients who were refractory to etanercept had higher weight and a higher proportion of the following: male patients; patients with PGA scores of marked or severe; patients on prior biologic therapy; and patients who had inadequately responded to, had been intolerant to, or had a contraindication to at least 2 and 3 conventional systemic agents.
• Among patients who did not have a response to etanercept, 48.9% and 23.4% achieved at least 75% improvement in the Psoriasis Area and Severity Index (PASI 75) and at least 90% improvement in the Psoriasis Area and Severity Index (PASI 90) responses, respectively, 12 weeks after crossing over to STELARA 90 mg; 40.4% achieved a PGA of cleared or minimal during this period.

Safety

• At least 1 adverse event (AE) was observed in 79.3% of etanercept-treated patients before crossover to STELARA 90 mg, 64.7% of patients after crossover from etanercept to STELARA 90 mg, and 87.1% and 89.0% of patients who received episodic treatment with STELARA 45 mg and STELARA 90 mg, respectively.
• At least 1 serious AE was experienced by 3.5% and 3.4% of patients before and after crossover from etanercept to STELARA, respectively, and by 8.1% and 7.2% of patients who received episodic treatment with STELARA 45 mg and STELARA 90 mg, respectively.
• There were 3 deaths; 1 patient each in the etanercept group (from a motor vehicle accident), in the STELARA 45 mg group (from a gunshot wound), and in the STELARA 90 mg group (from multisystem organ failure and sepsis in a patient who was retrospectively shown to be positive for human immunodeficiency virus at study entry and who had methicillin-resistant Staphylococcus epidermidis bacteremia).
• Serious infections of a common bacterial or viral origin occurred in 2 patients who received STELARA 45 mg (1.0%), 10 patients who received STELARA 90 mg (2.9%), and 4 etanercept-treated patients (1.2%; 3 before crossover to STELARA and 1 after crossover to STELARA) (P=0.23 for the comparison between the group who received STELARA 45 mg and the group who received STELARA 90 mg).
• Nonmelanoma skin cancer occurred in 9 patients, and malignant conditions other than nonmelanoma skin cancer were reported in 5 STELARA-treated patients. The latter included 1 patient with breast cancer and 1 patient with oral neoplasm in the group of patients who received STELARA 45 mg, chronic lymphocytic leukemia in 1 patient and mycosis fungoides in 1 patient who received STELARA 90 mg (the investigator retrospectively concluded that the case of mycosis fungoides was present prior to randomization, but had been incorrectly diagnosed as PsO), and prostate cancer in 1 patient who received etanercept followed by crossover to STELARA 90 mg.
• Three patients had a myocardial infarction (1 patient each in the etanercept group after crossover to STELARA, in the STELARA 45 mg group, and in the STELARA 90 mg group).

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and DERWENT^®(and/or other resources, including internal/external databases) was conducted on 11 January 2025.

Summarized in this response are relevant data from an active comparator trial.