SUMMARY

• The company cannot recommend any practices, procedures, usage, or dosing that deviate from the approved labeling.
• Data from an observational study and several case reports that describe the use of STELARA in patients with comorbid multiple sclerosis (MS) are summarized below.^1-5
• A phase II, multicenter, randomized, double-blind, placebo-controlled study evaluated the efficacy, safety, and pharmacokinetics of repeated subcutaneous (SC) injections of STELARA in adult patients with relapsing-remitting multiple sclerosis (RRMS). This trial reported no statistically significant difference in the primary endpoint. Due to the lack of demonstrated efficacy in all dosage groups, long-term safety follow-up of this trial was discontinued after week 37.⁶

CLINICAL DATA

Single-Center Observational Study

Ossorio-Garcia et al (2018)¹ reported the use of STELARA in patients with psoriasis through a single-center observational study to evaluate long term efficacy and safety.

• Over an 8-year period, 64 patients with moderate-to-severe psoriasis treated with STELARA were included in the study.
• In addition to psoriasis, other comorbidities included a history of hepatitis, cardiovascular events, psoriatic arthritis (PsA), Crohn’s disease (CD), hidradenitis suppurativa (HS), and MS.
• Patients were treated with STELARA for an average of 35.5 months.
• Efficacy analyses included mean percent improvement in Psoriasis Area and Severity Index (PASI) and overall survival.
• Discontinuation of STELARA occurred in 29% (7) patients from the treatment withdrawal group (38% [24 patients]) due to a total improvement of their disorder.
• No joint inflammation impairment was reported in patients with PsA. Furthermore, no patient discontinued treatment due to severe adverse events and there were no severe adverse reactions during follow-up.

Case Reports

Assefa et al (2019)² described the use of STELARA for PsA and psoriasis in a 42-year-old man with MS.

• The 42-year-old patient presented to the hospital with difficulty speaking and a past medical history of PsA and psoriasis. After a diagnosis of MS was made, steroid pulse induction was initiated which also improved his psoriatic skin lesions and PASI score.
• Reoccurrence of psoriatic skin lesions were seen along with the development of joint pain when a β-interferon was started for MS maintenance. During his second year of admission, he was switched to STELARA from tacrolimus due to a lack of improvement.
• With STELARA, his skin eruptions cleared but joint pain in the hands/feet worsened, and radiological deterioration was noted.
• The patient was later switched to secukinumab at 47 years due to an increase in Expanded Disability Status Scale (EDSS) score to 7.5 (baseline EDSS score of 2 at his initial evaluation).

Kapizioni et al (2019)³ reported the case of a young patient with MS and a new diagnosis of CD.

• STELARA was initiated in this patient due to the development of acute pancreatitis on azathioprine therapy.
• Within the first two months of STELARA treatment, the patient had clinical and biochemical response. Mucosal healing was achieved at 12 months according to the Simple Endoscopic Score for Crohn’s Disease (SES-CD).
• After 17 months of treatment with STELARA, there were no reports of new lesions or clinical episodes of MS.

Ettler et al (2016)⁴ presented a case of a 30-year-old male with severe treatment-resistant erythrodermic psoriasis and comorbid MS treated with STELARA.

• The 30-year-old male failed previous therapies for his psoriasis including methotrexate, cyclosporine A and adalimumab.
• The patient achieved almost complete remission with etanercept after one year but discontinued due to development of optic neuritis in his right eye. After treatment for optic neuritis, he was switched to STELARA.
• Optic neuritis developed in the left eye after two years of efficacious treatment with STELARA.
• STELARA was discontinued and he was treated for neuritis with high-bolus corticosteroids.
• MS was diagnosed by the attending neurologist and was treated with low-dose intravenous immunoglobulin (IVIG) every month. Two weeks following his first infusion of IVIG, he presented with an exacerbation of his psoriasis most likely due to rebound phenomenon after STELARA/corticosteroid discontinuation.
• After unsuccessful treatment for his psoriasis with corticosteroids and methotrexate, STELARA was reinitiated with concomitant low-dose prednisone to prevent a relapse of MS.
  • His psoriasis significantly improved without worsening his MS after 1.5 years of treatment.

Chang et al (2015)⁵ described two cases of patients with plaque psoriasis, PsA, and MS.

• Case 1:
  • A 48-year-old man with a past medical history of severe plaque psoriasis, PsA, and MS was previously treated with methotrexate and efalizumab for psoriasis/PsA.
  • Due to discontinuation of efalizumab, the patient was switched to acitretin in combination with topicals for psoriasis. Due to worsening of cutaneous lesions, this treatment was switched to STELARA.
  • With STELARA, there was 90% clearance of cutaneous lesions 6 months after initiation.
  • His MS has remained stable without progression/improvement for 3.5 years since starting STELARA and is in close monitoring with his neurologist as he is not on any immunotherapy for the condition.
• Case 2:
  • A 66-year-old female with a past medical history of MS, moderate to severe plaque psoriasis, and PsA was previously treated with methotrexate for 4 years but discontinued therapy due to liver toxicity.
  • IVIG was initiated but later discontinued due to aseptic meningitis and the patient could not tolerate phototherapy.
  • STELARA was initiated and more than 80% improvement in her cutaneous lesions was reported 4 months after starting treatment. Scalp lesion flare-ups were controlled with topical medications as needed.
  • During the 4 years of therapy with STELARA, her MS remained stable without progression.

LITERATURE SEARCH

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 04 April 2024.