Summary

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• There are available data on the use of STELARA in patients with hidradenitis suppurativa (HS) from prospective studies, retrospective studies, and case series.^1-6

CLINICAL DATA

Prospective Studies

Sanchez-Martinez et al (2020)¹ reported efficacy and safety results from a prospective analysis of STELARA in 6 patients with refractory HS.

Study Design/Methods

• Patients with HS treated with STELARA from January 2017 to August 2018 were included in the prospective analysis.
• Patients received a weight-based induction dose, followed by a subcutaneous maintenance dose of 90 mg every 8 weeks.
• The primary endpoint was clinical response, assessed by International Hidradenitis Suppurativa Severity Score System (IHS4) and Hidradenitis Suppurativa Clinical Response (HiSCR), prior to treatment and at week 12.
• The secondary endpoint was safety, which included the incidence and severity of side effects based on Common Terminology Criteria for Adverse Events (CTCAE) classification.

Results

• Demographics and clinical baseline characteristics of the 6 patients included in this analysis are summarized in Table: Demographics and Clinical Baseline Characteristics.

• IHS4 and HiSCR results measured at week 12 are summarized in Table: Efficacy Results at Week 12.

• No adverse effects were reported during the 12-week follow-up period.

Blok et al (2016)² conducted an open-label, prospective study to evaluate the efficacy and safety of STELARA in 17 patients with moderate-to-severe HS.

Study Design/Methods

• Patients were eligible if they had moderate-to-severe HS (Hurley stage II-III) with a treatment history of at least 1 systemic anti-inflammatory/immunosuppressive agent or surgery.
• The washout period for systemic immunosuppressive medication was at least 3 months.
• Patients received STELARA 45 mg (if patient was ≤100 kg) or 90 mg (if patient was >100 kg) at weeks 0 and 4 (induction phase) and at weeks 16 and 28 (maintenance phase).
• The intervention period was 40 weeks, which consisted of a treatment phase
  (weeks 0-28), followed by a 12-week posttreatment phase.
• Topical resorcinol 15% cream for incision and drainage of acutely painful lesions were the only escape treatments allowed.
• Assessments were performed at baseline (week 0) and at weeks 4, 10, 16, 22, 28, 34, and 40.
• At every visit, the modified Sartorius scale (mSS) score was assessed. A ≥50% reduction in these scores was considered a marked response; a 25%-49% reduction, a moderate response; a 1%-24% reduction, a mild response; and a ≤0% reduction, a nonresponse.
• A visual analogue scale (VAS) was used to determine the degree of experienced pain. The Dermatology Life Quality Index (DLQI) and Skindex-29 questionnaire were used to investigate patient-reported outcomes.
• The primary endpoint was the proportion of patients with marked improvement (≥50% reduction) in mSS score at week 40. Secondary outcomes included the mean change in patient-reported pain, Skindex-29 score, and the DLQI.

Results

Patient Characteristics

• Seventeen patients (4 men, 13 women) were included in the study.
• Twelve patients completed the protocol. Five patients dropped out of the study due to unresponsiveness to STELARA (n=3), withdrawal of informed consent for psychological reasons (n=1), and an adverse event (AE) of urticaria (n=1).
• The mean age was 35 years (range, 20-53), mean body mass index (BMI) was 28.3 kg/m², and mean disease duration was 18 years.

Efficacy

• At week 40, of the 17 patients, improvement of the mSS was deemed marked in 6 (35%), moderate in 8 (47%), and mild in 1 (6%); there was no change in or worsening of the mSS in 2 patients (12%).
• The mean mSS of the intent-to-treat population significantly reduced from 112.12 at baseline to 60.18 at week 40 (46.33% improvement; P<0.01).
• The mean reported pain on the VAS (0-10) was 5.8 at the start of treatment and 4.6 at week 40.
• At week 40, of the 17 patients, there was a clinically meaningful improvement on the Skindex-29 overall domain (score decrease by at least 1 compared with week 0) in 6 (35%), on the functioning domain in 8 (47%), on the emotions domain in 4 (24%), and on the symptoms domain in 3 (18%).
• At baseline, the DLQI indicated that HS had a very large (score of 11-20) or extremely large (score of 21-30) effect on daily life in 71% of patients; at week 40, this had reduced to 59%. At week 40, clinically meaningful improvement of the DLQI (reduction of ≥5 points) was observed in 7 patients (41%).
• Resorcinol 15% cream was used by 4 patients for troublesome inflammatory lesions and for incision and drainage by 1 patient.
• The protocol was violated for 2 patients: they received intralesional corticosteroids for painful lesions that were not suitable for incision and drainage.

Safety

• The most common AEs were headache, fatigue, and upper respiratory tract infections.
• All AEs were considered mild and temporary.

Retrospective Studies

Hollywood et al (2022)³ conducted a retrospective study to evaluate the response, tolerability, and drug survival of STELARA in patients with HS.

Study Design/Methods

• Patients with HS treated with STELARA who attended 1 follow-up appointment from January 2017 to September 2020 were included in this analysis.
• A consultant dermatologist with a specialist interest in HS reviewed all patients.
• Improvement was defined as reduced flare count (patient-reported based on increased symptoms and formation of new lesions) and improvement in quality of life (QoL), as measured by the DLQI.

Results

Patient Characteristics

• The baseline demographics and clinical characteristics of the 16 patients included in this study are summarized in Table: Baseline Demographics and Clinical Characteristics.
• All patients had failed first-line treatments (outlined in the British Association of Dermatology [BAD] HS guidelines).
  • Prior treatments included the following: tetracycline, 100% (n=16); clindamycin and rifampicin, 69% (n=11); metformin, 69% (n=11); dapsone, 50% (n=8); liraglutide, 25% (n=4); anakinra, 25% (n=4); and spironolactone, 12.5% (n=2).
  • All patients (n=16) had failed adalimumab as monotherapy, and 56% (n=9) had failed infliximab.
  • Three patients were started on STELARA therapy for management of coexisting Crohn’s disease.

Efficacy

• Subjective clinical improvement was observed in 56% of patients (9/16), and no clinical improvement, in 25% of patients (4/16). Three of the 16 patients switched from adalimumab to STELARA for the management of Crohn’s disease, and all 3 patients maintained good control of HS symptoms.
  • Of the 9 patients with subjective clinical improvement, 8 had severe disease (Hurley stage III) and 1 had moderate disease (Hurley stage II).
• The mean pretreatment DLQI was 16.6 (range, 1-25), and mean follow-up DLQI was 10.25 (range, 1-27).
• The mean duration of treatment was 16 months.
• Drug survival at 6, 12, 24, and 36 months was 94% (15/16), 61% (8/13), 50% (4/8), and 33% (2/6), respectively.

Safety

• Eight patients discontinued treatment due to primary failure (n=3), secondary failure (n=1), suboptimal clinical improvement (n=2), recurrent infections (n=1), and quiescent Crohn’s disease (n=1).

Montero-Vinchez et al (2022)⁴ evaluated the outcomes of STELARA in a retrospective, multicenter series of patients with HS between November 2017 and December 2019.

Study Design/Methods

• Patients with moderate to severe HS (Hurley stage II-III) who failed previous treatment were included.
• Disease severity was assessed using the Physician’s Global Assessment (HS-PGA), and pain was assessed using the Numerical Pain Rating Scale (NPRS).
• The primary outcome was a ≥1-point reduction in HS-PGA, and the secondary outcome was a decrease of ≥20% in NPRS.
• Safety was evaluated using clinical records.

Results

• Ten patients were included; the median age was 44 years.
• Four patients had concomitant components of the follicular occlusion tetrad, and 2 patients had Crohn’s disease.
• Overall, 90% (9/10) of patients (adalimumab, 8; infliximab, 4) were biologic-experienced and 10% (1/10) of patient was biologic-naïve.
• All patients received STELARA for psoriasis.
• The median treatment duration was 48 weeks.
• A reduction of at least 1 point in HS-PGA was reported in 70% (7/10) of patients, and a reduction of ≥2 points in NPRS was reported in 80% (8/10) of patients.
• Among patients with no improvement, no worsening in HS severity or symptoms was reported.
• No treatment-related AEs were reported.

Case Series

Jiang et al (2022)⁵ reported results of STELARA in the treatment of HS in 6 patients with Hurley stage III disease from January 2017 to June 2021.

• The mean age was 53.5 years, and the mean BMI was 38.1 kg/m².
• All 6 patients were African American, 5 of whom were female.
• All patients had been previously treated with adalimumab, and 4, with infliximab.
• STELARA maintenance dose was 90 mg every 4 weeks for 5 patients and 90 mg every 8 weeks for 1 patient.
• At weeks 8-12, compared with baseline, mean percentage change in IHS4 was -36.1% (95% confidence interval [CI], -70.9% to -1.3%), total abscess and inflammatory nodule (AN) count change was -6.9 (95% CI, -13.6 to -0.2), and mean difference in VAS pain score was -2.5 (95% CI, -5.5 to 0.5).
• Reductions in draining fistulae and AN count were observed with a decrease in IHS4.
• An unadjusted regression analysis showed that IHS4 decreased by 0.43 per week and draining fistulae decreased by 0.09 per week.
• No adverse reactions were reported.

Valenzuela-Ubina et al (2022)⁶ evaluated STELARA for the treatment of HS in a case series of 10 patients.

• The mean age was 42.9 years, and 60% (6/10) were female.
• Eight patients were previously treated with adalimumab.
• Clinical severity was assessed using the Hurley staging system and HS-PGA scale.
• Analytical parameters of systemic inflammation (APSI) included serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and leukocyte levels.
• At baseline, 90% of patients had Hurley stage III disease and 1 patient had stage II disease.
• HS-PGA scale was reported as moderate to severe in 2 patients, severe in 5 patients, and very severe in 1 patient.
• STELARA 90 mg subcutaneously every 2 months was initiated for 9 patients. The remaining 1 patient received STELARA 45 mg subcutaneously every 3 months. The average treatment duration was 17.6 months (range, 4-29).
• Nine patients responded to STELARA treatment and achieved a HiSCR therapeutic outcome.
• Eight patients achieved a reduction of 1 Hurley stage, and 2 patients remained in stage III after finishing treatment.
• All 9 responding patients achieved a reduction of ≥1 point in HS-PGA.
• After STELARA initiation, 80% of patients continued treatment and reported mild
  HS-PGA.
• Statistically significant mean APSI decrease was reported in all patients, with P values of 0.002, 0.015, and 0.0004 for leukocytes, ESR, and CRP, respectively.
• One patient who received a lower STELARA dosage did not respond to treatment.
• No treatment-related AEs 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 03 June 2024.