Summary

• The company cannot recommend any practices, procedure, or usage that deviate from the approved labeling.
• An open-label study and case reports have reported the use of STELARA in patients with palmoplantar psoriasis (PP).^1-5

CLINICAL STUDIES

Open-Label Studies

Weger et al (2015)¹ evaluated the use of STELARA in patients with PP (n=4) and palmoplantar pustulosis (n=9). Details regarding patients with PP are summarized below.

Study Design/Methods

• Four males with PP (age range, 32-51 years; mean age, 44.3 years) received treatment with STELARA.
• Patients weighing <100 kg received STELARA 45 mg and patients weighing >100 kg received STELARA 90 mg.
• The Palmoplantar Psoriasis Area and Severity Index (PPASI) was used to evaluate patients at baseline, week 16, and week 28.

Results

• At week 16, in patients with PP, a 75% improvement in the PPASI (PPASI 75) was achieved in 3 patients and a 100% improvement in the PPASI (PPASI 100) was achieved in 1 patient.
• All 4 patients with PP achieved PPASI 100 at week 28.
• In the overall study population (PP, n=4; palmoplantar pustulosis, n=9), 1 patient reported a serious adverse event (erysipelas).

Au et al (2013)² reported the use of STELARA in patients with PP (presence of both, an extra-palmoplantar psoriatic lesion and any palm or sole involvement [pustular, nonpustular, or both] revealed on physical examination) in a small, single-center, open-label study.

Study Design/Methods

• Twenty patients, ages 18-85 years, with moderate to severe PP (defined as a Palm-Sole Physician's Global Assessment [PGA] ≥3) who previously failed a topical psoriasis treatment were included.
  • To confirm the diagnosis of PP, all patients had to have both well-defined psoriatic plaques on the palms and/or soles and evidence of psoriasis in another area with a minimum of 1 plaque or psoriatic nail changes.
  • Patients were excluded if they had received antitumor necrosis factor (TNF) agents or other biologic therapies within 3 months of baseline; any investigational drug, psoralen and ultraviolet A (PUVA), or oral systemic treatments (including corticosteroids, methotrexate [MTX], cyclosporine, or retinoids) within 4 weeks of baseline; or ultraviolet B (UVB) therapy or topical treatments including corticosteroids, retinoids, vitamin D derivatives, or anthralin within 2 weeks of baseline.
  • Application of low or moderate potency topical corticosteroids was permitted as needed on the scalp, axillae, and groin, but dose and formulation were required to remain constant throughout the trial.
• The study was composed of 3 phases: a pretreatment screening phase for up to 28 days; a 16-week open-label treatment phase (no other systemic psoriasis therapies were permitted); and an 8-week observational phase.
• Patients weighing <100 kg received 45 mg and those >100 kg received 90 mg of STELARA at weeks 0, 4, and 16.
• The primary endpoint was measured as the percentage of patients achieving clinical clearance (Palm-Sole PGA of 0 or 1) at week 16; Palm-Sole PGA was scored on a 5-point scale and measured the overall degree of erythema, induration, and scale of palm and/or sole lesions, with 5 as the most severe disease and 0 as clear.
• Secondary endpoints included Dermatology Life Quality Index (DLQI), pain Visual Analogue Scale (VAS), and pruritus VAS.

Results

Patient Characteristics

• Nine of 20 patients (45%) were male and all but 2 were Caucasian. Average age was 53.6 years and average weight was 93.4 kg. Mean Palm-Sole PGA at baseline was 3.4 (median was 3), average DLQI was 13.8, and average pain VAS was 49.1 mm.
• Ten of 20 patients (50%) had pustules at baseline.
• Thirty-five percent of patients had failed light therapy and 30% had failed a systemic medication. Twenty-five percent of patients were previously treated with an anti-TNF agent, but no patients reported a history of anti-TNF-flared PP.

Efficacy

• After 16 weeks of treatment with STELARA, 7 of 20 patients (35%) achieved clinical clearance.
• Six of 9 patients (67%) who received 90 mg compared to 1 of 11 patients (9%) who received 45 mg achieved clinical clearance (P=0.02).
• Among 5 patients who were previously treated with anti-TNF agents, 2 achieved clinical clearance compared to 5 of 15 anti-TNF-naïve patients (P=nonsignificant).
• Twelve of 20 patients (60%) had an improvement of at least 2 points on the Palm-Sole PGA scale at 16 weeks; median PGA decreased from a baseline value of 3 to 2 at the end of 16 weeks. At week 16, 12 of 20 patients (60%) had an improvement of ≥50% in PGA, and 78% of patients who received STELARA 90 mg achieved a ≥50% improvement in PGA from baseline compared to only 36% of patients who received STELARA 45 mg (P=0.039).
• Mean DLQI decreased by 47% (13.9 to 6.65, P=0.003) and mean pain VAS scores decreased by 33% (49 to 29, P=0.04); both measures correlated with the PGA response (correlation coefficient 0.97, P<0.005). Correlations between PGA and DLQI or PGA and pain VAS were also present after stratification by dose, both at STELARA 45 mg (correlation coefficient 0.97 and 0.93 respectively, P<0.05) and STELARA 90 mg (correlation coefficient 0.95 and 0.80 respectively, P<0.05).
• Mean change in pruritus VAS from baseline was statistically significant. The lowest mean scores for Palm-Sole PGA, pain VAS, and pruritus VAS were 2, 25.7, and 24.3, respectively, which occurred at week 12. During the remainder of the study, these efficacy parameters did not increase more than 10% above the lowest mean values.
• No statistically significant differences were observed when the results were stratified by gender, race, presence of pustules, prior TNF usage, or age.
• At 24 weeks, mean values showed 56% improvement in DLQI, and 34% improvement in pain VAS score (P<0.05 for both comparisons).

Safety

• No serious adverse events related to STELARA were observed.
• Four of 20 patients (20%) developed an upper respiratory tract infection (each resolving in <2 weeks), 2 patients (10%) developed acne or acneiform eruptions, and 1 patient developed acute bronchitis.
• Three patients withdrew from the study due to lack of efficacy, 1 patient withdrew due to hospitalization for bile duct stone removal, and 1 patient was lost to follow-up after week 8.
• The 1 patient who withdrew due to bile stones was hospitalized; the event was not considered related to study participation.

Case Reports

Guevara et al (2015)³ reported 3 cases of PP that were treated with STELARA.

Case 1

• A 58-year-old woman with moderate PP was treated with STELARA 45 mg every 3 months.
• The patient previously received conventional treatments, which resulted in partial remission.
• DLQI was 15.
• The patient developed severe depression due to public rejection and retired from her job. The patient worsened with adalimumab treatment.
• There was a 70% improvement in PP 2 weeks after the second dose of STELARA.

Case 2

• A 54-year-old woman with diabetes, hypertension, and moderate PP was treated with STELARA 45 mg every 3 months.
• DLQI was 20.
• The patient previously achieved partial remission with MTX and worsened with etanercept treatment.
• All of the patient’s lesions were eliminated by the third dose of STELARA.

Case 3

• A 35-year-old woman with severe scalp and PP (alopecia on severely affected scalp patches) was treated with STELARA 45 mg every 3 months.
• DLQI was 14.
• The patient previously received conventional treatments and anti-TNF inhibitors, which she did not respond to.
• A 50% improvement was seen with isotretinoin 1 mg/kg/day.
• The patient developed a urinary tract infection and a relapse to her initial lesions.
• After receiving STELARA treatment, the patient had complete improvement in scalp and palm psoriasis and an 80% improvement in sole psoriasis.

Nuño-González et al (2012)⁴ reported 1 case of hyperkeratotic PP that was treated with STELARA.

• A 56-year-old man (weight: 76 kg), with a 1.5-year history of PP and no other lesions or joint involvement, was treated with 45 mg of STELARA.
• Previous treatments were as follows: high potency topical corticosteroids and calcipotriol (no improvement); topical PUVA therapy 3 times a week for 6 months (poor response); and MTX 15 mg per week associated with elevated transaminase values (5 times baseline) and marked gastrointestinal symptoms that led to withdrawal of treatment after 2 months.
• He had severe hyperkeratosis, fissuring, and 100% involvement of the palms and soles; it was difficult for him to walk and carry out his daily activities. Treatment with acitretin 50 mg/day resulted in some improvement but was poorly tolerated because of dry skin, cheilitis, joint pain, gynecomastia, alopecia, and hypertriglyceridemia (352 mg/dL). Reduction of the dose to 35 mg yielded little improvement in the side effects and worsening of the lesions; treatment was suspended after 9 months.
• STELARA therapy was prescribed as an initial dose followed by another 4 weeks later and one every 3 months thereafter. Complete PP resolution was seen at 16 weeks after receiving 2 injections of STELARA. STELARA therapy continued for the last 12 months with continued response to therapy.
• No side effects were reported.

Bulai Livideanu et al (2010)⁵ reported 2 cases of severe PP or psoriasis of the hands and feet that were treated with STELARA.

Case 1

• A 42-year-old nonsmoking man (weight: 95 kg) with isolated PP since age 18 years and a history of concomitant axial and/or peripheral psoriatic arthritis was treated with 45 mg of STELARA.
• Previous treatments included topicals (corticosteroids and vitamin D derivatives), acitretin, phototherapy, MTX, etanercept, infliximab, and adalimumab without significant improvement.
• He had multiple painful fissures on his hands and feet, which greatly impeded his walking. Localized PPASI was 54.
• Improvement in PP was seen after 7 months and 3 injections of STELARA, with an 85% improvement in localized PPASI observed. Slight improvement in psoriatic arthritis was observed. STELARA therapy was continued, combined with a low dose of MTX.
• No side effects were reported.

Case 2

• A 29-year-old obese woman (weight: 100 kg), with a history of smoking and an 8-year history of severe PP, was treated with 90 mg of STELARA.
• Previous treatments included cyclosporine, adalimumab, etanercept, and MTX, which were not effective or tolerated.
• Localized PPASI was 40.
• Her palms cleared 1 month after a single injection of STELARA, while her soles still had hyperkeratotic skin lesions and inflammation. Localized PPASI was 24. There was significant improvement in concomitant plaque psoriasis on other parts of her body.
• A good clinical improvement in PP was observed 4 months after the first STELARA injection; localized PPASI was 14. STELARA therapy was continued.
• No side effects were reported.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 26 December 2024.

Summarized in this response are data specific for patients receiving STELARA with PP only. Definition of PP may vary across studies.