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.
• Griffiths et al (2011)¹ evaluated the results from the PHOENIX 1² and ACCEPT³ phase 3 clinical trials in order to assess response to retreatment with STELARA after withdrawal from therapy in adult patients with moderate to severe plaque psoriasis (PsO).

CLINICAL STUDIES

Study Designs

PHOENIX 1 was a phase 3, double-blind, placebo-controlled, multicenter trial evaluating the efficacy and safety of STELARA in 766 adult patients with moderate to severe plaque PsO. Patients initially randomized to STELARA who achieved at least 75% improvement in Psoriasis Area and Severity Index 75 (PASI 75) at weeks 28 and 40 were rerandomized at week 40 to either continue STELARA maintenance treatment or to placebo (withdrawal from therapy). Patients withdrawn from therapy at week 40 were retreated with their original dose of STELARA (with induction doses at weeks 0 and 4) when they lost at least 50% of Psoriasis Area and Severity Index (PASI) improvement. Retreatment response was evaluated 12 weeks after resuming treatment.^2,4

ACCEPT was a phase 3, multicenter study that compared the efficacy of STELARA and etanercept in 903 adult patients with moderate to severe plaque PsO. Patients who were responders to STELARA (Physician's Global Assessment [PGA] score ≤2) at week 12 (n=494) were withdrawn from therapy. Regression of the PGA score to a score of >2 allowed patients to be eligible for retreatment with their original dose of STELARA reinitiated at weeks 0 and 4.³

Griffiths et al (2011)¹ evaluated the results from the PHOENIX 1² and ACCEPT³ phase 3 clinical trials in order to assess response to retreatment with STELARA after withdrawal from therapy.

PHOENIX 1

• At week 40, 320 patients with at least a PASI 75 at weeks 28 and 40 were withdrawn from STELARA therapy.¹
• The median time to loss of PASI 75 in patients withdrawn from treatment was about 15 weeks. There were no reports of rebound psoriasis in patients withdrawn from treatement.²
• Among PASI 75 responders, 95% (134/141) of patients in the STELARA 45-mg group and 91% (163/179) of patients in the STELARA 90-mg group were retreated.¹
• Twelve weeks after retreatment, PASI 75 response was achieved in 83% (102/123) of patients in the STELARA 45-mg group and 87% (117/134) of patients in the STELARA 90-mg group.
• Among patients who were retreated, 44% experienced at least 1 adverse event (AE), 1% experienced a serious AE, and 23% experienced an infection within the 12 weeks of starting therapy with STELARA during the initial treatment phase. Within the 12-week period after retreatment, 39%, 1%, and 19%, experienced an AE, serious AE, and infection, respectively.

ACCEPT

• Baseline characteristics of patients who entered the retreatment phase were comparable to those of the overall trial population.¹
• The median time to recurrence (classified as moderate, marked, or severe disease) was 14.4 weeks among patients who received STELARA 45 mg, and 18.1 weeks among those who received STELARA 90 mg.³
• Among the 494 responders withdrawn from therapy, 83% (149/179) of patients in the STELARA 45-mg group and 75% (237/315) of patients in the STELARA 90-mg group were retreated.¹
• Twelve weeks after the initial retreatment dose, 80% (121/152) of patients in the STELARA 45-mg group and 86% (207/240) of patients in the STELARA 90-mg group regained a PGA score of 0, 1, or 2.
• Among patients who were retreated, 69% experienced at least 1 AE, 1% experienced a serious AE, and 28% experienced an infection within the 12 weeks after initially starting therapy with STELARA. Within the 12-week period after retreatment, 47%, 2%, and 24%, reported an AE, serious AE, and infection, respectively.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 25 December 2024.