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 (PBO)-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.^4-24,26

CLINICAL DATA

Crohn's Disease Phase 3 Clinical Trials

• STELARA was evaluated in 3 randomized, double-blind, PBO-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 PBO.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 PBO 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 PBO group and 1 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

Yang et al (2025)²⁶ described a single-center, retrospective cohort study conducted between August 26, 2011, and April 4, 2024, to evaluate the effectiveness of STELARA in managing PG compared with tumor necrosis factor-alpha (TNF-α) inhibitors. The primary outcome was achievement of prednisolone reduction to <5 mg/day following biologic treatment. Infections were the only adverse events observed and were limited to microbiologically confirmed cases requiring antibiotic treatment.

• Among 37 biologic treatments for PG, 19 patients received STELARA and 18 received TNF‑α inhibitors (infliximab, n=10; adalimumab, n=8), with no significant baseline differences between groups.
• Disease severity was reflected by duration of PG (95.22 vs 87.68 months), time to biologic initiation (40.56 vs 28 months), duration of biologic exposure (11.39 vs 20.32 months), initial prednisolone doses (31.25 vs 24.87 mg), and area of ulcer (59.61 vs 40.55 cm²) in the TNF‑α inhibitor vs STELARA groups, respectively.
• Pretreatment disease severity (measured by average ulcer size) did not differ significantly between the TNF-α inhibitors and STELARA groups (P=0.852).
• Overall, 12 of 37 patients achieved prednisolone tapering to <5 mg/day.
• Among 19 patients treated with STELARA, 9 (47.37%) met the primary outcome; among 18 patients treated with TNF‑α inhibitors, only 3 (16.67%) met the primary outcome. This difference was statistically significant (χ²[1]=3.98; P=0.046), representing a small to medium effect size (φ=0.33).
• The infection incidence rate was 6 per 100 patient‑years in the STELARA group vs 29 per 100 patient‑years in the TNF‑α inhibitor group.
• The difference in the infection rates was not statistically significant (P=0.988).
• Treatment outcomes are described in Table: Treatment Outcomes: Prednisolone Weaning and Clinical Response.

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 (NDs), 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 NDs 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 TNF‑α 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.

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 sixth 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.

LITERATURE SEARCH

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 05 January 2026.