SPESOLIMAB-SBZO INJ,SOLN
Clinical Criteria Summary
Indication & Patient Population
- Treatment of generalized pustular psoriasis (GPP) flares in adults.
- Supported for first-line use in patients with acute, non–life-threatening, moderate to severe GPP flare based on phase 2 trial evidence.
Disease Severity & Clinical Characteristics
- Moderate to severe intensity GPP flare: GPP-PGA total score of ≥ 3 (Moderate), new or worsening pustules, GPP-PGA-P subscore of ≥ 2 (Mild), and ≥ 5% of body surface area (BSA) with erythema and pustules.
- Acute presentation characterized by rapid onset of erythematous, inflamed skin with generalized, extremely painful, small or coalesced, noninfectious, neutrophilic, pustular, nonacral skin lesions.
- Systemic manifestations may include fever, malaise, and fatigue; mucosal, eye (keratoconjunctivitis, uveitis, iritis), and arthritic manifestations may occur.
Pretreatment Tests & Evaluations
- Tuberculosis (TB) screening required prior to initiation.
Dosage Regimen & Administration
- Recommended dose: 900 mg IV infusion over 90 minutes as a single dose.
- A second single dose (900 mg IV infusion over 90 minutes) may be administered 1 week after the initial dose if flare symptoms persist.
- Dosage form: Injection of 450 mg/7.5 mL (60 mg/mL) solution in a single-dose vial.
Contraindications & Safety Precautions
- Contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab or excipients, including drug reaction with eosinophilia and systemic symptoms (DRESS).
- Avoid live vaccines due to infection risk.
- Monitor for infections, TB reactivation, hypersensitivity, and infusion-related reactions.
Exclusion Criteria & Clinical Considerations
- Not indicated for immediate life-threatening flares warranting intensive care treatment (e.g., cardiovascular/cytokine-driven shock, pulmonary distress syndrome, renal failure).
- Excluded in patients with severe, progressive, or uncontrolled hepatic disease (AST, ALT, or alkaline phosphatase > 3 times upper limit of normal [ULN] or total bilirubin > 2 times ULN).
- Avoid initiation within 2 weeks of dose escalation or initiation of cyclosporine, methotrexate, or retinoids.
- Avoid concurrent use of corticosteroids, methotrexate, cyclosporine, retinoids, IL-17A/RA inhibitors, IL-23 inhibitors, IL-12/23 inhibitor, TNF-alpha inhibitors, JAK inhibitors, PDE4 inhibitors, fumarates, photochemotherapy, natalizumab, alemtuzumab, rituximab, anakinra, topical psoriasis/skin medications, or granulocytes and monocytes adsorptive apheresis (GMA). (Note: Certolizumab may be used concurrently).
- Not recommended for use in women who are pregnant, nursing, or plan to become pregnant during treatment.