STELARA®
(ustekinumab)
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STELARA® (ustekinumab)
Medical Information
Use of STELARA in the Treatment of Pustular Psoriasis
Last Updated: 01/02/2025
SUMMARY
CLINICAL DATA
- Nine patients with PPP (8 female and 1 male; age range, 26-57 years; mean age, 45.4 years) and 4 males with palmoplantar PsO (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.
- At week 16, in patients with PPP, a 50% improvement in the PPASI (PPASI 50) was achieved in 5 patients, a 75% improvement in the PPASI (PPASI 75) was achieved in 1 patient, and a 90% improvement in the PPASI (PPASI 90) was achieved in 1 patient.
- At week 16, in patients with palmoplantar PsO, PPASI 75 was achieved in 3 patients, and a 100% improvement in the PPASI (PPASI 100) was achieved in 1 patient.
- At week 28, PPASI 50, PPASI 75, and PPASI 90 were achieved in 3, 5, and 1 patients with PPP, respectively.
- All 4 patients with palmoplantar PsO achieved PPASI 100 at week 28.
- One patient reported a serious adverse event (erysipelas).
- Patients diagnosed with nonpustular forms of palmoplantar PsO, history of infection, malignancy, hypersensitivity to STELARA, and other contraindications to treatment with STELARA were not included.
- All patients weighed <100 kg and received STELARA 45 mg at weeks 0, 4, and every 12 weeks thereafter in a hospital setting.
- Patients underwent screening for latent tuberculosis (TB). Blood cell counts, liver and renal function testing was completed at baseline and every 3 months for the duration of the study.
- Clinical outcomes were measured using affected body surface area (BSA), Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA), palmoplantar pustulosis Psoriasis Area and Severity Index (PPP PASI), and the Dermatology Life Quality Index (DLQI) at baseline and every 1-3 months after.
- Clinical records of 5 adult patients (2 male; age range, 34-51 years) with PPPP who had been treated with STELARA were included in this study.
- All patients presented with severe symptoms of PPPP and a history of incomplete or no response to previous treatments.
- Symptoms of PPPP improved in all patients 2-3 weeks after the first dose of STELARA with complete resolution of symptoms by 20 weeks; see Table: Case Descriptions of 5 Patients with PPPP Treated with STELARA.
- No flares or adverse effects were observed with a median duration of follow-up of 15.2 months (range, 11-23).
| 1 | 34-year-old male with a history of plaque PsO, DM, and nonalcoholic fatty liver disease Previous treatments: topical corticosteroids, MTX, CYC, efalizumab, etanercept (50 mg twice weekly), adalimumab (80 mg initially, 40 mg 1 week later, then 40 mg every 2 weeks thereafter) | Patient previously responded to efalizumab for 2 years prior to market withdrawal. He then failed treatment with etanercept and topical corticosteroids. Treatment with adalimumab improved symptoms of plaque PsO initially, then patient developed moderate plaque PsO flare and severe PPPP 1 year later (PPP PASI, 12; PASI, 14.8; BSA, 18%; PGA, 4; DLQI, 15). STELARA 45 mg was initiated. Patient experienced marked improvement in plaque PsO symptoms and complete clearance of PPPP lesions 5 months after starting STELARA 45 mg (PPP PASI, 0; PASI, 5; BSA, 6%; PGA, 1; DLQI, 3). |
| 2 | 51-year-old male with history of plaque PsO, PPPP, and chronic hepatitis C Previous treatments: topical corticosteroids, efalizumab, CYC, etanercept (50 mg weekly) | The patient was being treated with etanercept with minor symptom improvement. He presented with pustules, severe hyperkeratosis and fissures on palms and soles (PPP PASI, 14; PASI, 8.5; BSA, 11%; PGA, 4; DLQI, 13). Treatment was transitioned to STELARA 45 mg. Full recovery was observed after 5 months (PPP PASI, 0; PASI, 0; BSA, 0%; DLQI, 0). |
| 3 | 38-year-old female with a history of PPPP and bipolar disorder Previous treatments: MTX (10 mg/week), CYC (200 mg/day), acitretin (25 mg/day) and PUVA, leflunomide (20 mg/day) | The patient discontinued treatment with acitretin 25 mg daily + PUVA due to lack of efficacy. Patient experienced a flare of PPP (PPP PASI, 6; BSA, <1%; PGA, 3; DLQI, 15). Treatment with STELARA 45 mg was initiated. The patient responded 1 month after the first injection, resolution of symptoms occurred 5 months later, and improvement was maintained for 20 months (PPP PASI, 0; PASI, 0; PGA, 0; DLQI, 0). |
| 4 | 50-year-old female with PPPP, isolated PsO vulgaris lesions, and arterial hypertension Previous treatments: acitretin (25 mg/day) | Treatment with acitretin was discontinued after patient developed extensive palmoplantar involvement with pustules and erythematous desquamative plaques (PPP PASI, 11.7; PGA, 4; DLQI, 18). Treatment with STELARA 45 mg was initiated, and complete resolution of PPP and PsO vulgaris symptoms was observed (PPP PASI, 0; DLQI, 0). Patient was asymptomatic 11 months after starting treatment with STELARA. |
| 5 | 48-year-old female with history of PsO and PsA Previous treatments: adalimumab, etanercept (50 mg twice weekly) with MTX (15 mg/week), CYC | Treatment with adalimumab was discontinued after PPPP and flare of PsO occurred. Subsequent treatment with etanercept + MTX resulted in no response after 1 month. Patient presented with severe PsO flare, palmoplantar pustules, and local pustules on PsO lesions (PASI, 14.8; PPP PASI, 17.6; BSA, 23%; PGA, 5; DLQI, 19). Treatment with STELARA 45 mg was initiated 1 week after etanercept + MTX was discontinued. Complete resolution of PPPP lesions, and improvement in arthritis symptoms occurred after 3 months (PASI, 3; DLQI, 5). After 21 months of STELARA treatment, PPPP lesions were resolved (PPP PASI, 0; PASI, 0; DLQI, 0). (Patient described separately by Puig [2012]3 |
| Abbreviations: BSA, body surface area; CYC, cyclosporine; DLQI, Dermatology Life Quality Index; DM, diabetes mellitus; MTX, methotrexate; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; PPP, palmoplantar pustulosis; PPP PASI, palmoplantar pustulosis Psoriasis Area and Severity Index; PPPP, palmoplantar pustular psoriasis; PsA, psoriatic arthritis; PsO, psoriasis; PUVA, psoralen and ultraviolet A. | ||
- Patients with PPPP (n=20) and PPP (n=13) were included in this study along with 7 healthy subjects.
- Skin biopsies from palms and soles were collected and were analyzed via reverse transcription polymerase chain reaction (RT-PCR) and immunohistochemistry to gain additional insight into the pathophysiology and the potential role of interleukin (IL)-23 signaling in PPPP and PPP.
- Patients with PPPP or PPP were randomized to receive STELARA 45 mg or 90 mg (for patients ≥100 kg) or placebo at weeks 0 and 4. Patients receiving placebo crossed over to receive STELARA at week 16.
- The primary endpoint at week 16 was the proportion of patients achieving a 50% improvement in the Palmoplantar Pustulosis Area and Severity Index (PPPASI 50).
- All patients randomized to STELARA weighed <100 kg and therefore received the 45 mg dose.
- An 89-fold increase in IL-17 expression was observed in samples from palms and soles of patients with PPPP compared with healthy subjects (P=0.006). A trend towards a significant increase of IL-17 expression was observed in patients with PPP (190-fold; P=0.051).
- No increase in IL-12/IL-23 expression was observed in patients with either PPPP or PPP (P=1.0 for both comparisons). A 22-fold and 72-fold increase has been reported in IL-23 and IL-17, respectively, in previous studies in patients with plaque PsO.
- At week 16, no statistically significant difference was observed in PPPASI 50 scores in patients treated with STELARA vs those treated with placebo.
| Chu et al (2011)5 | 37-year-old female with a history of Crohn’s disease | The patient developed vesiculopustules on palms and soles during treatment with adalimumab. Adalimumab was discontinued and topical corticosteroids were initiated. CYC 5 mg/kg per day was initiated after no improvement in symptoms was observed. Attempts to transition therapy to other agents (MTX, PUVA, efalizumab, MMF, and alefacept) were ineffective. Patient began treatment with STELARA 90 mg with a brief overlap with CYC. Mild, transient worsening of PPP occurred when CYC was discontinued. Patient remained in near complete remission after 4 doses of STELARA 90 mg. |
| 45-year-old female with a history of rheumatoid arthritis | The patient developed vesiculopustules on palms and soles during treatment with etanercept. Etanercept was discontinued and treatment with oral and topical corticosteroids was initiated. After minimal symptom improvement, CYC 5 mg/kg per day was initiated. Symptoms markedly improved after 2 weeks. Attempts to transition to treatment with isotretinoin, MMF, MTX, or topical PUVA were not successful. STELARA 45 mg was initiated and gradual improvement in symptoms occurred after 3 doses. Dose of CYC was titrated down to 25 mg twice daily with additional CYC doses required during flares that occurred with vigorous activity/sweating. | |
| Gerdes et al (2010)6 | 61-year-old female with a history of obesity, PPP, smoking, and arterial hypertension Weight: 105 kg Previous treatments: multiple topical agents, PUVA, acitretin, CYC, fumarates, efalizumab, adalimumab, MTX, etanercept | Patient was responding to treatment with CYC for 4 years but another long-term therapy was needed due to concomitant arterial hypertension. STELARA 90 mg was initiated after patient presented with fresh multiple pustules on hands and feet. One month after first STELARA injection, symptoms worsened and the patient received superpotent topical steroids concomitantly. One month after second STELARA injection, symptoms worsened again. STELARA was discontinued and low dose CYC was reinitiated resulting in symptom control. |
| 52-year-old female with a history of PPP and smoking Weight: 60 kg Previous treatments: multiple topical agents, PUVA, systemic corticosteroids, fumarates, acitretin, MTX | Patient presented with multiple fresh pustules/crusts on soles of both feet and a DLQI score of 20. Slight reduction in hyperkeratotic scales was noted 1 month after first STELARA 45 mg injection. Three months after second STELARA injection, the patient presented with fresh pustules and crusts in previously affected areas (DLQI, 10). STELARA was discontinued due to unsatisfactory symptom control. | |
| 49-year-old female with a history of PPP (anti-TNF agent-induced), plaque PsO, PsA, and smoking Weight: 69 kg Previous treatments: multiple topical agents, systemic corticosteroids, MTX, adalimumab, PUVA, infliximab | The patient presented with anti-TNF agent-induced PPP on palms and soles (DLQI, 25). Treatment with STELARA 45 mg was initiated. Fewer pustular lesions were observed 4 weeks after first STELARA injection. Three months after second STELARA dose, symptoms of plaque PsO improved and joint symptoms were resolved. No fresh pustules developed, but hyperkeratotic lesions were still present on the soles. DLQI improved to 7. Treatment with STELARA was continued. | |
| 70-year-old female with a history of PPP Weight: 70 kg Previous treatments: multiple topical agents, systemic corticosteroids, fumarates, acitretin, MTX, efalizumab | The patient was responding to treatment with efalizumab but discontinued therapy when it was withdrawn from the market. New pustular lesions and crusts developed on both soles and STELARA 45 mg was initiated. Four weeks later, additional fresh pustules and crusts were observed. After 3 months, symptoms had improved with a few crusts remaining on right sole and decreased fresh and old pustules on the left sole. Treatment with STELARA was continued. | |
| Abbreviations: CYC, cyclosporine; DLQI, Dermatology Life Quality Index; MMF, mycophenolate mofetil; MTX, methotrexate; PPP, palmoplantar pustulosis; PsA, psoriatic arthritis; PsO, psoriasis; PUVA, psoralen and ultraviolet A; TNF, tumor necrosis factor. | ||
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References
| 1 | Weger W, Aigner B, Wolf P, et al. Treatment of palmoplantar pustulosis and psoriasis with ustekinumab [abstract]. J Invest Dermatol. 2015;135(Suppl. 3):S20. Abstract P071. |
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