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This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.

STELARA® (ustekinumab)

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STELARA - Treatment of Pyoderma Gangrenosum

Last Updated: 03/21/2025

Summary

The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
In the UNITI-1, UNITI-2, and IM-UNITI randomized, double-blind, placebo-controlled phase 3 clinical trials evaluating adult patients with moderately to severely active Crohn's disease (CD), there were a few patients in each trial (UNITI-1, n=2; UNITI-2, n=4; IM-UNITI, n=2 from the primary analysis population) who also had pyoderma gangrenosum (PG). The resolution of their PG lesions was assessed.¹^-³
Published retrospective studies, case series, and case reports have also described the use of STELARA for the treatment of PG.⁴^-²⁴

CLINICAL DATA

Crohn's Disease Phase 3 Clinical Trials

STELARA was evaluated in 3 randomized, double-blind, placebo-controlled clinical trials of adult patients with moderately to severely active CD (Crohn’s Disease Activity Index [CDAI] score of 220 to 450). There were two 8-week intravenous (IV) induction studies (UNITI-1 and UNITI-2) followed by a 44-week subcutaneous (SC) randomized withdrawal maintenance study (IM-UNITI) representing 52 weeks of therapy.²⁵
In both induction studies, patients were randomized to receive a single IV administration of STELARA using a weight-based dosage regimen, or 130 mg, or placebo.²⁵
The IM-UNITI study evaluated patients who achieved clinical response at week 8 of induction with STELARA in UNITI-1 or UNITI-2. Patients were randomized to receive a SC maintenance regimen of either STELARA 90 mg every 8 weeks, STELARA 90 mg every 12 weeks, or placebo for 44 weeks.²⁵
In all 3 studies (UNITI-1, UNITI-2, and IM-UNITI), patients were assessed for PG. For patients with PG, the total number of lesions, size of primary lesion, and resolution were assessed.¹^-³
In the UNITI-1 trial, 2 patients in the 130 mg STELARA group had PG. Both experienced resolution of the primary lesion and reduction in the number of lesions, although 1 patient with 2 lesions at baseline was reported as having 2 lesions at week 8 that were smaller in size than the primary lesions.¹
In the UNITI-2 trial, a total of 4 patients (1 in the STELARA 130 mg group and 3 in the STELARA ~6 mg/kg group) had PG. Resolution of the primary lesion occurred in 1 patient who was in the STELARA ~6 mg/kg group.²
In the IM-UNITI trial, 2 patients in the primary analysis population had PG. One patient was in the placebo group and one patient in the STELARA 90 mg every 12-week group. Both experienced resolution of the primary lesion and reduction in the number of lesions.³

Retrospective Studies

de Risi-Pugliese et al (2019)⁴ describe a multicenter retrospective study conducted between January 2013 and July 2017 to assess the efficacy of STELARA in CD-associated neutrophilic dermatoses (ND), with PG being the most frequent identified.

The efficacy of STELARA was assessed at week 16 after initiation of treatment.
Efficacy results in relation to ND were either complete, partial (>50% reduction in symptoms), or no response. Separately in this analysis, efficacy results in relation to CD were evaluated.
A total of 7 patients with CD who received STELARA were included, and of these, 4 had PG, 2 had amicrobial pustulosis of the folds (APF) and 1 patient had chronic recurring Sweet syndrome.
Of the 7 patients included, 6 had previously received tumor necrosis factor (TNF)-alpha antagonists that were withdrawn due to inefficacy or adverse effects.
Patients were treated with STELARA 90 mg SC every 8 weeks with slightly different induction protocols for both CD and ND treatment. Some of the patients with PG had concomitant immunosuppressant treatment.
Three of the 4 patients with PG experienced a complete response and 1 patient experienced a partial response.
No serious adverse events were reported.

Herberger et al (2019)⁵ described a dual-center, retrospective cohort study evaluating the safety, effectiveness and tolerability of biologics and intravenous immunoglobulins (IVIG) in the treatment of PG.

Fifty-two patients with 75 wound episodes (mean wound size: 53.2 cm²) were included in the study.
Overall, 275 systemic treatments were documented in the 52 patients, with a mean of 5.3 treatments per patient. Prior to the initiation of biologic or IVIG therapy, patients had received a mean of 2.6 and 4.4 previous treatments, respectively.
The dosing regimen for biologics was the same as that for psoriasis.
The majority of systemic agents were initially combined with corticosteroids. Concomitant corticosteroid therapy was used in 85% (57/98) of successful treatment attempts.
Outcomes related to wound healing were: complete remission, which was defined as 100% wound closure, and improvement without complete remission, which was defined as 50-99% wound closure or clinical response based on the physician's assessment.
Improvement or complete remission was seen in 66.6% (6/9) of STELARA-treated patients, with complete remission in 4 patients. STELARA was ineffective in 3 patients.
Mean reduction in wound size with STELARA was 110.4 cm²(standard deviation, 151.6 cm²).
One adverse event (pain) was reported in a patient who received STELARA.

Case Series

Westerdahl et al (2022)⁶ reported results from a case series of 8 patients with PG treated with STELARA.

All 8 patients reported concomitant therapies with STELARA. Patient characteristics and outcomes are described in Table: Characteristics of Patients with Pyoderma Gangrenosum Treated with STELARA.

Characteristics of Patients with Pyoderma Gangrenosum Treated with STELARA⁶

	Patient 1	Patient 2	Patient 3	Patient 4	Patient 5	Patient 6	Patient 7	Patient 8
Age/Sex	69/M	44/F	24/F	36/M	64/F	88/M	50/F	61/M
Type	Pustular	Classic (single ulcer)	Classic (multiple ulcer)	Classic (multiple ulcer)	Classic (multiple ulcer)	Vegetative	Peristomal	Classic (multiple ulcer)
Comorbidities	MGDS	CD	IgA vasculitis, PsO, seronegative arthritis	CD, HS, likely PASH	None	MGUS	CD	None
Location	Trunk	LE	LE	Head, LE	LE	UE	Trunk	LE, Trunk
Previous Tx	Calcipotriene cream, Metronidazole cream, ADM, IFX	Topical steroids, ILS, Mupirocin, ADM, INX, Systemic steroids	ILS, Colchicine, IXE, Systemic steroids	Topical steroids, ILS, ADM, AZA, Doxycycline, Rifampin/clindamycin, IFX	TAC, ADM, Doxycycline, HBO, Systemic steroids	Topical steroids, HBO, IFX, Systemic steroids	Topical steroids, Systemic steroids	Topical steroids, TAC, Colchicine, Doxycycline
Age of ulcers when STELARA was initiated	48 months	20 months	3 months	Not available	7 months	11 months	9 months	2 months
Length of STELARA therapy	24 months	Ongoing	Ongoing	14 months	6 months	6 months	6 months	2 months
Max STELARA dose	90 mg/ 2 months	90 mg/ 2 months	45 mg/ 3 months	90 mg/ 2 months	45 mg/ 3 months	90 mg/ 3 months	45 mg/ 2 months	180 mg/ 2 months
Concomitant treatments with STELARA	Topical steroids, DDS, MMF, Systemic steroids	BMZ	Topical steroids, CYA	BPO, CHX, DDS, Systemic steroids	Topical steroids, SSD, Topical timolol	Topical steroids, TAC	Systemic steroids, TAC	Systemic steroids
Outcomes	Improved	Healed	Healed	Healed	Improved	Healed	Healed	Healed
Abbreviations: ADM, adalimumab; AZA, azathioprine; BPO, benzoyl peroxide; BMZ, betamethasone; CHX, chlorhexidine; CD, Crohn’s Disease; CYA, cyclosporine; DDS, dapsone; F, female; HBO, Hyperbaric Oxygen Therapy; HS, hidradenitis suppurativa; IFX, infliximab; ILS, intralesional steroids; IXE, ixekizumab; LE, lower extremities; M, male; MGDS, monoclonal gammopathy of dermatologic significance; MGUS, monoclonal gammopathy of undetermined significance; MMF, mycophenolate mofetil; PsO, psoriasis; PsA, psoriatic arthritis; PASH, pyoderma gangrenosum-acne-hidradenitis suppurativa syndrome; SSD, silver sulfadiazine cream; TAC, tacrolimus; Tx, treatment; UC, ulcerative colitis; UE, upper extremities.

Low et al (2018)⁷ described 3 cases of recalcitrant PG with differing disease activity that improved with STELARA treatment.

Patient 1 was a 42-year-old female who developed skin ulceration and necrosis following minor trauma to the dorsal right hand and forearm.
- Over a period of 3.5 years, more than 20 new lesions developed on her arms, legs, lower face and lower abdomen, initially as inflammatory plaques that rapidly developed into painful necrotic ulcers.
- Previous treatments included: prednisolone, IV methylprednisolone, cyclosporine, azathioprine, mycophenolate mofetil (MMF), IVIG, dapsone, cyclophosphamide, infliximab, topical tacrolimus, intralesional steroids, hyperbaric oxygen, ultrasonic and surgical debridement. Due to long-term immunosuppression, she developed significant complications and her severe pain required regular narcotic analgesia.
- STELARA 90 mg was administered at weeks 0 and 4, then every 6 weeks; later changed to 45 mg every 3 weeks.
- Significant improvement was seen at 3 months with a reduction in ulcer size and pain, and fewer new lesions.
- At 24 months, PG remained well controlled on STELARA, prednisolone, MMF, IVIG, and dapsone with all previous lesions healed and occasional new ulcers that were small and healed rapidly.
Patient 2 was a 57-year-old female diagnosed with PG after a 6-month history of a painful nonhealing ulcer on the left shin following superficial trauma.
- The ulcer enlarged over 4 years and a second adjacent lesion developed, resulting in a deep wound over most of the left anterior lower leg.
- Combinations of immunosuppressants included: prednisolone, IV methylprednisolone, cyclosporine, azathioprine, MMF, IVIG, dapsone, pentoxifylline, adalimumab, infliximab, hyperbaric oxygen, ultrasonic and surgical debridement. Complications secondary to long-term immunosuppression occurred and regular narcotic analgesia was required for pain relief.
- STELARA 90 mg was administered at weeks 0 and 4, then every 8 weeks; later changed to 45 mg every 4 weeks.
- A distinct improvement was seen at 6 months, with a reduction in ulcer size and a decrease in pain and analgesic requirements.
- Healing was ongoing and fewer episodes of secondary cellulitis were observed at 13 months on maintenance treatment with STELARA, prednisolone, MMF, and dapsone.
Patient 3 was a 36-year-old female who presented with a 12-month history of painful ulcers of the lower legs and breast.
- Treatment with high-dose oral prednisolone led to multiple complications. Other medications (prednisolone, cyclosporine, MMF, methotrexate [MTX], IVIG, infliximab, and hyperbaric oxygen) either failed to heal the ulcers or caused unacceptable toxicity.
- She was treated with STELARA 90 mg at weeks 0 and 4, then every 8 weeks; later changed to 45 mg every 4 weeks.
- Ulcer size and pain significantly improved within 5 months and the dose of prednisolone was weaned to 5 mg daily.
- At 14 months of ongoing treatment with STELARA, prednisolone, MMF, and IVIG, the ulcers were almost completely healed.

Allnutt et al (2017)⁸ reported the outcomes of STELARA treatment in 6 patients from a single institution with varying presentations of refractory PG.

Concomitant therapy included the continued use of combinations of prednisolone, MMF, dapsone, MTX, cyclosporine, and IVIG; however, no new therapies were initiated.
Improvement in pain and lesion size was reported in 5 cases while treatment with analgesics and immunosuppressive agents was reduced.
Time to improvement ranged from 2 weeks to 6 months after initiation of STELARA treatment.
In the 6^th case, STELARA was used to prevent relapse of recalcitrant disease and results were promising after 4 months of treatment.
Steroid-related complications and the frequency of secondary cellulitis were reduced in these patients.
No adverse events were reported.

Case Reports

Case reports are described in Table: Case Reports of Patients Receiving STELARA for the Treatment of Pyoderma Gangrenosum.

Case Reports of Patients Receiving STELARA for the Treatment of Pyoderma Gangrenosum

Patient Information	STELARA Treatment Regimen	Response
Carpineti et al (2023)⁹ A 73-year-old woman with steroid-dependent, longstanding pancolonic UC, previously biologic-naive and treated with azathioprine, presented with sepsis (fever, 39 °C; white blood cell count, 18000; C-reactive protein, >200 mg/dL; procalcitonin, 0.75 ng/mL) and moderate UC relapse (partial Mayo score 10, Mayo endoscopic subscore 1) with multiple painful, ulcerated, vegetative and purulent lesions in the oral cavity and skin (leg and sacral regions). Sepsis resolved 3 days after starting IV piperacillin-tazobactam treatment. The patient was diagnosed with multiple PG and oral pyostomatitis vegetans based on dermatological assessment. Following IV methylprednisolone 60 mg/day, improvement in orocutaneous lesions and remission of intestinal symptoms was seen. However, after steroid tapering, orocutaneous lesions worsened. Due to the patient’s age and the recent septic event, anti-TNF treatment was not considered, and STELARA was initiated.	390 mg IV followed by a maintenance therapy of 90 mg every 8 weeks	Complete healing of orocutaneous lesions, along with clinical and biochemical remission (partial Mayo score 0, normalized C-reactive protein, fecal calprotectin <150 μg/g), was achieved by the end of STELARA induction and maintained steroid-free for the next 10 months.
Smith et al (2023)¹⁰ A 2-year-old boy with recurrent skin infections presented with violaceous, edematous plaques, and denuded bullae on the trunk, inguinal folds, buttocks, and extremities. The rash, initially "red patches and bumps," progressed and ulcerated following PICC line placement. Skin biopsy revealed neutrophilic dermatosis consistent with Sweet syndrome. The disease progressed despite initiating IV methylprednisolone. Central ulcerations and hemorrhage were present for 75% of the patient’s lesions; laboratory investigations showed elevated white blood cell count (67,700/µL, reference: 6000-17,500 µL) with 80% neutrophils. Punch biopsies demonstrated marked papillary dermal edema and a nodular neutrophil-predominant infiltrate. The patient was diagnosed with PG based on clinical morphology, pathergy, and ulcerative lesion evolution, treated with IV methylprednisolone, infliximab, IV cyclosporine, IVIG, and STELARA, resulting in significant improvement.	30 mg SC every 12 weeks	The patient remains stable on IVIG 10 g infusions every 4 weeks and STELARA while awaiting a bone marrow transplant. Significant improvement in skin disease was noted over months, with prior lesions healed and displaying cribriform scarring typical of resolved PG. No new lesions have developed since treatment initiation.
Zhang et al (2022)¹¹ A 29-year-old man presented to the clinic with skin lesions, including erythema, vesicle, plaques, and ulcers. The patient was diagnosed with PG based on physical examination and skin biopsies. STELARA was initiated after inadequate response to infliximab.	360 mg single IV infusion	At 1 month, lesions gradually subsided after STELARA therapy was initiated.
Groudan et al (2021)¹² A 65-year-old man with a history of recurrent deep vein thromboses and on treatment with apixaban, who had a longstanding, severe colonic CD and had undergone colectomy and ileostomy, presented with ulcerating PG around his ostomy. Due to a history of PG-related bleeding, apixaban was intermittently discontinued. The patient was switched from adalimumab to vedolizumab; however, PG persisted, and bleeding was reported at follow-up appointments.	90 mg SC every 2 months	At the 4-month follow-up after the initiation of STELARA, the patient reported an improvement in PG. The patient also reported a flare in PG 1-2 weeks before receiving the last injection of STELARA. Tacrolimus ointment was prescribed and at the 8-month follow-up, the patient reported further improvement in PG. At the 2-year follow-up after starting STELARA, the patient did not report any recurrence of PG.
López González et al (2021)¹³ A 29-year-old woman with complex fistulizing CD, with total colectomy and terminal ileostomy performed 8 years earlier, had a history of PG, and was on treatment with adalimumab (80 mg/2 weeks) presented with a 2-month history of very painful pretibial skin lesions on both legs along with fever. A biopsy confirmed the diagnosis of PG and the patient was started with targeted antibiotic therapy, corticosteroid therapy, and local measures, and was discharged with partial improvement. However, the skin lesions worsened after 1 month.	First dose, 260 mg IV; maintenance therapy, 90 mg every 8 weeks	The patient’s dermatological symptoms improved after receiving the initial IV dose of STELARA, with no observed recurrence of gastrointestinal symptoms. The patient was free of dermatological and gastrointestinal symptoms while on maintenance therapy with STELARA.
Petty et al (2020)¹⁴ A woman in her 50s with a 10month history of plaque psoriasis and palmoplantar pustulosis treated with acitretin, adalimumab, and secukinumab developed PG on the bilateral aspect of her lower legs. Patient was treated with cyclosporine and infliximab was added after 4 months of treatment. Leukocytoclastic vasculitis was seen after 2 infliximab doses and treatment was discontinued. Prednisone was added to cyclosporine.	90 mg on weeks 0 and 4 and then every 8 weeks	Improvement in PG with largest lesion on right posterior aspect of lower leg mostly re-epithelialized after 2 doses of STELARA. Cyclosporine and prednisone were tapered 2 months after initiation of STELARA.
García Cámara et al (2019)¹⁵ A 46-year-old male with peristomal PG, CD, and ankylosing spondylitis.	One 520 mg IV dose, and 90 mg SC every 8 weeks thereafter.	Marked improvement in skin lesion and gastrointestinal symptoms after 8 weeks. On week 12 and after 4 months of treatment, complete closure of PG, disappearance of joint symptoms, and partial response of luminal symptoms, with no need for steroids. Twelve months after initiating treatment, the patient was completely cured of PG and clinical response of CD.
Nunes et al (2019)¹⁶ A 45-year-old male with CD who was treated with azathioprine, infliximab, corticosteroids, and cyclosporine and developed PG on his left leg.	One 520 mg IV dose, followed by 90 mg SC every 8 weeks.	Complete healing of skin lesions after IV dose. Patient remained in clinical remission.
Piqueras-García et al (2019)¹⁷ A 33-year-old female with UC with difficult to manage PG refractory to other treatments on the lower limbs.	90 mg SC on week 0, 4, 10, and every 8 weeks thereafter.	PG completely resolved in 12 weeks. Patient was able to reduce dosage of concomitant prednisone from 50 mg/day to 5 mg/day. After 10 months, patient was able to withhold concomitant cyclosporine 3 mg/kg/day and reduce prednisone dose to 2.5 mg every 2 days.
Vallerand et al (2019)¹⁸ A 47-year-old male with myasthenia gravis on long-term systemic corticosteroids, diabetes mellitus, hypertension, dyslipidemia, chronic kidney disease, gout, obstructive sleep apnea, monoclonal gammopathy of unknown significance, and hepatic steatosis who developed PG on the same right leg that was traumatized after bumping into a metal rod 1 year prior. Workup revealed no evidence of inflammatory bowel disease, no features or serology consistent with autoimmune arthritis, and no other association with PG.	One 520 mg IV dose, followed by 90 mg SC every 8 weeks.	After 6 months, the patient experienced a dramatic improvement in the size of the ulcer (ulcer decreased by approximately half).
Benzaquen et al (2017)¹⁹ A 56-year-old female with psoriatic arthritis who was treated with adalimumab and developed paradoxical PG on her right leg.	Three doses of 45 mg SC.	PG healed, and psoriasis cleared.
Cosgarea et al (2016)²⁰ A 71-year-old male with PG on the left hip and left shoulder.	Not specified.	Patient did not show response to STELARA therapy and developed new lesions under the breast and clavicle. Patient had a renal carcinoma on the left kidney. Treatment was stopped, and the patient had a radical nephrectomy. After recovery from surgery, the patient still had PG lesions. STELARA was restarted. Patient showed a response a few days after the first STELARA dosing. Complete healing of ulcerations took up to 3 months.
Greb et al (2016)²¹ A 50-year-old male with severely recalcitrant PG (same patient presented in Goldminz et al [2012]²³).	90 mg SC every 6 weeks (with a daily oral regimen of 40 mg of prednisone and 100 mg of dapsone) for 2 years, on which the patient was stable. Due to significant disease flares, the dose of STELARA was raised to 135 mg every 6 weeks and oral treatments were continued.	After 4 months on the higher STELARA dose, less active vegetative ulcers and scar replaced the larger ulcers on the buttocks and lower legs. At 8 months, the affected areas were composed of granulation tissue and well-healed scars. Clinical clearance and pain control were maintained with STELARA and dapsone. Prednisone was tapered off over a 9month course. Patient had complete disease clearance 15 months after increasing the STELARA dose without flare.
Fahmy et al (2012)²² A 34-year-old female with CD and chronic peristomal PG.	90 mg SC at weeks 0 and 2, and then every 8 weeks beginning at week 10.	Improvement of her PG starting at week 4 with complete healing by week 10.
Goldminz et al (2012)²³ A 47-year-old male with severely recalcitrant PG (same patient presented in Greb et al [2016]²¹).	One 90 mg SC dose (added to a daily oral regimen of 50 mg of prednisone and 100 mg of dapsone in which the patient had experienced significant disease flares). A second 90 mg dose was given 4 weeks later and then every 8 weeks subsequently.	After 4 weeks since receiving one dose of STELARA, lesions became less active. After 22 weeks, the initial lesions were healing well with residual postinflammatory hyperpigmentation, and minimal crust and scarring.
Guenova et al (2011)²⁴ A 37-year-old female with recalcitrant PG on the right leg. Her tissue sample analysis displayed highly elevated expression of IL-23 on both transcriptional and protein level in a recalcitrant PG lesion.	45 mg administered twice on week 0 and week 4 (topical application of tacrolimus was continued).	Cleaning of the bluish margins and constant scaling down of the size of the PG lesion was observed 8 weeks after the start of STELARA. Significant decrease of IL-23 expression in PG and complete healing after 14 weeks of treatment. No relapse occurred in a 6-month follow-up period while not receiving STELARA. Treatment was tolerated well with no reported adverse effects.
Abbreviations: CD, Crohn’s disease; IL-23, interleukin-23; IV, intravenously; IVIG, intravenous immunoglobulins; PG, pyoderma gangrenosum, PICC, peripherally inserted central catheter; SC, subcutaneously; TNF, tumor necrosis factor; UC, ulcerative colitis.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 03 February 2025.

References

Show

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