Summary

• The company cannot recommend any practices, procedures or usage that deviate from the approved labeling.
• Clinical studies including phase 2 studies, a retrospective study, and case series that described the use of STELARA in patients with atopic dermatitis (AD) are summarized below.^1-5

CLINICAL DATA

Phase 2 Studies

Saeki et al (2017)¹ conducted a randomized, double-blind, placebo-controlled, phase 2 study to evaluate the efficacy and safety of STELARA in Japanese patients with severe AD.

Study Design/Methods

• Patients entered a 12-week double-blind treatment period with follow-up until week 24.
• Patients (aged 20-65 years) with a diagnosis of severe or very severe active AD (Rajka and Langeland index score of 8-9, Eczema Area and Severity Index (EASI) ≥12 and Investigator’s Global Assessment [IGA] score of 4 or 5) were eligible.
• Patients with an inadequate response to, or who were unwilling to use, phototherapy, topical corticosteroids and/or topical calcineurin inhibitors were also included.
• Exclusion criteria included other skin conditions that could interfere with the assessment of AD, serious infections or herpes within 2 months of screening, a history of malignancy (except basal and squamous cell carcinoma), prior treatment with biologics that targeted IL-12 or IL-23, any other marketed biologic within 3 months or an experimental biologic therapy within 6 months of randomization.
• Patients were randomized 1:1:1 to receive STELARA 45 mg, 90 mg, or placebo at weeks 0 and 4.
• Stable doses of topical corticosteroids (except for those with the highest potency) and topical calcineurin inhibitors, emollients, antileukotriene therapies, or topical or oral herbal products were allowed during the study.
• Percentage change from baseline in EASI score at week 12 was the primary efficacy endpoint.
• Major secondary efficacy endpoints included the proportions of patients achieving a ≥50% and ≥75% improvement from baseline in EASI (EASI 50 and EASI 75), an IGA score of 0 (clear) or 1(almost clear), ≥2-point decrease in IGA, and the change from baseline of Dermatology Life Quality Index (DLQI) and Atopic Dermatitis Itch Scale (ADIS) at week 12.

Results

Patient Characteristics

• A total of 79 patients were randomized to receive STELARA 45 mg (n=24), 90 mg (n=28) or placebo (n=27).
• Baseline characteristics and demographics were generally comparable between the treatment groups with the exception of IgE levels, which were higher at baseline in both STELARA-treated groups.

Efficacy

• The percentage change from baseline in EASI score at week 12 was numerically greater, but not statistically significant, in the STELARA 45 mg and 90 mg groups vs placebo as described in Table: Primary and Major Secondary Efficacy Assessments at Week 12.
• Major secondary endpoints showed non-significant improvement in both STELARA groups vs. placebo as described in the table below.

Safety

• The proportion of patients with treatment-emergent adverse events (TEAEs) was 75% (18/24), 57% (16/28), 74% (20/27), in the STELARA 45 mg, STELARA 90 mg, and placebo groups, respectively.
• Three patients discontinued the study due to TEAEs (n=1, STELARA 90 mg) and withdrawal of consent (n= 1 each, placebo and STELARA 90 mg).
• The most common TEAEs were nasopharyngitis, which was similar across the 3 treatment groups, and worsened AD, which was greater in the placebo group vs STELARA groups.

Khattri et al (2017)² conducted a double-blind, placebo-controlled, phase 2 crossover study that evaluated the safety and efficacy of STELARA in patients with moderate to severe chronic AD over a 40 week period.

Study Design/Methods

• Patients between the age of 18-75 years with a diagnosis of chronic moderate to severe AD (Scoring Atopic Dermatitis [SCORAD] ≥15), which could not be managed with conventional therapy, were eligible.
• Patients underwent a 1:1 randomization and received either STELARA or placebo at weeks 0, 4, and 16 with a crossover to the other agent at weeks 16, 20 and 32.
• Each patient received 3 doses of STELARA. On week 16, each patient received 2 injections (both STELARA and placebo) to reflect the crossover design.
• Dosing of STELARA followed the recommended weight based dosing for plaque psoriasis.
• Triamcinolone 0.025% cream was given twice a day starting at week 0.
• The primary endpoint was a ≥50% decrease from baseline objective SCORAD (SCORAD50) at week 16.
• Secondary endpoint included SCORAD50 response at week 32.

Results

Patient Characteristics

• A total of 33 patients were enrolled in the 2 treatment arms.
• Baseline characteristics and demographics were not different between the groups.
• Twenty-seven patients completed visits through 16 weeks, while 21 patients completed all required visits through week 40.

Efficacy

• SCORAD50 response was higher in the STELARA vs placebo group at week 16, but the difference was not statistically significant.
• SCORAD50 responses, that were stable in the placebo group until week 16, showed rapid improvement following crossover to STELARA and peaked at week 28.
• SCORAD50 responses in both groups suggested that response was optimal 8 weeks after administration of STELARA.

Safety

• Twenty-four adverse events (AEs), classified as mild or moderate, were self-reported in 14 patients.
• No significant differences were found between treatment arms in AE frequency.
• No serious AEs were reported.

Retrospective Study

Fernández-Antón Martínez et al (2014)³ reported results from a retrospective study of patients with severe AD treated with STELARA.

Study Design/Methods

• Patients who had severe AD refractory to oral corticosteroids, phototherapy (Psoralen-UVA or narrowband UVB), and to at least 2 systemic drugs, including cyclosporine, azathioprine, methotrexate (MTX) and mycophenolate mofetil were included.
• A visual analogue scale (VAS) for pruritus and the SCORAD index were used to quantify results at baseline and during weeks 4 and 16.
• All patients were administered subcutaneous (SC) doses of STELARA 45 mg at weeks 0 and 4 and then every 12 weeks.

Results

• The study included 4 male patients (age range, 23-29 years) with AD who had been treated with STELARA.
• The number of injections of STELARA during the study period varied between 4 and 6.
• Marked improvements in VAS pruritus scores and the SCORAD index were seen after the second injection of STELARA (week 4) in 2 of the patients and after the third injection (week 16) in the other 2 patients, as described in Table: Clinical Results in Atopic Dermatitis in 4 Patients.

• No adverse effects, infections, or other complications were observed during the study period.

Case Series

Weiss et al (2017)⁴ reported the use of STELARA in 3 patients with severe therapy-refractory AD.

• The mean EASI and SCORAD index before treatment were 39.5±7.3 and 68.4±16.1, respectively.
• All patients received STELARA 45 mg SC at weeks 0, 4, and 12 and every 8 weeks thereafter.
• All patients showed an improvement of clinical disease activity with consecutive injections, achieving a 50% reduction in the (EASI) score by week 16 (16.0±6.6, P<0.0005).
• Patients also experienced decreases in the SCORAD index (38.3±0.5; P=0.0186) and reductions of pruritus according to the 5-D itch and VAS (P<0.05).
• Analysis of SCORAD parameters showed patients experienced improvement in erythema, induration/papulation, and xerosis.
• A common cold in 1 patient was the only reported adverse event.

Nic Dhonncha et al (2017)⁵ reported the use of STELARA in 10 patients with severe AD.

• Eight patients were male.
• The age of AD onset ranged between 0 and 27 years; 6 patients had documented AD since childhood.
• Nine patients had been treated with at least 2 previous systemic agents (including cyclosporine [n=8], azathioprine [n=8], and mycophenolate mofetil [n=7]), as well as topical therapies.
• All patients were treated as per a weight-based schedule, either receiving STELARA 45 mg or 90 mg SC at weeks 0, 4, and every 12 weeks thereafter.
• The median duration of treatment was 10 months (mean, 19.1 months; range, 4-71 months).
• Disease control was achieved in 4 of 10 patients, with 1 achieving complete response and 3 achieving almost complete response.
• Six patients failed to respond.
• One patient developed elevated alanine aminotransferase, reaching twice the upper limit of normal.
• STELARA was stopped in 6 patients due to lack of efficacy. One responder defaulted, and another responder stopped due to financial pressure.
• After 2 years, 2 patients had sustained disease control.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 06 November 2024.