Adverse reactions with SPEVIGO SC for treatment of GPP when not experiencing a flare¹

Adverse reaction (Rate per 100 patient-years)	SPEVIGO SC^a	Placebo
Injection site reaction^b	31.6	12.7
Urinary tract infection	18	0
Pruritus	8.8	0
Arthralgia	13.3	6

There were 3 subjects who discontinued subcutaneous SPEVIGO in the subcutaneous SPEVIGO cohort due to treatment emergent adverse events of psoriasis compared to no subjects in the placebo cohort who discontinued placebo for any treatment emergent adverse event.¹

GPP, generalized pustular psoriasis; SC, subcutaneous.

The safety analysis included all patients who were randomly assigned and received at least one treatment dose.²

^aSPEVIGO SC was administered with a 600 mg subcutaneous loading dose followed by 300 mg subcutaneously every 4 weeks.¹

^bInjection site reactions included erythema, pain, swelling, induration, urticaria, and warmth at the injection site.¹

Adverse reactions shown are for the recommended SPEVIGO SC dose only. For a full list of adverse drug reactions, please refer to the Prescribing Information.

Specific adverse reactions

Infections: The most frequent adverse reactions that occurred in subjects treated with intravenous SPEVIGO were infections. During the 1-week placebo-controlled period in Study Effisayil-1, infections were reported in 14% of subjects treated with SPEVIGO compared with 6% of subjects treated with placebo. Serious infection (urinary tract infection) was reported in 1 subject (3%) treated with SPEVIGO and no subjects treated with placebo. Infections observed through Week 1 in Study Effisayil-1 in subjects treated with SPEVIGO were mild (29%) to moderate (71%).¹

Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS): Two cases of DRESS were reported in Study Effisayil-1 in subjects with GPP who were treated with intravenous SPEVIGO. RegiSCAR DRESS validation scoring (with the following categories: “no,” “possible,” “probable,” or “definite” DRESS) was applied to the reported cases. Reported cases were assessed as “no DRESS” and “possible DRESS”.¹

Clinical development

Guillain-Barre syndrome (GBS): Among approximately 835 subjects exposed to spesolimab-sbzo during clinical development, Guillain-Barre syndrome (GBS) was reported in 3 subjects who received various doses of spesolimab-sbzo via various methods of administration in clinical trials for unapproved indications.¹

Contraindications

SPEVIGO is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab-sbzo or to any of the excipients in SPEVIGO. Reported hypersensitivity reactions have included drug reaction with eosinophilia and systemic symptoms (DRESS).¹

Safety through Week 12

In Study Effisayil-1, additional adverse reactions that occurred through Week 12 in subjects treated with 1 single intravenous dose of randomized SPEVIGO were mild to moderate infections: device-related infection (3%), subcutaneous abscess (3%), furuncle (3%), and influenza (3%).¹

Warnings and precautions

Infections

SPEVIGO may increase the risk of infections. During the one-week placebo-controlled period in the Effisayil-1 trial, infections were reported in 14% of subjects treated with SPEVIGO compared with 6% of subjects treated with placebo.¹

In patients with a chronic infection or a history of recurrent infection, consider the potential risks and expected clinical benefits of treatment prior to prescribing SPEVIGO. Treatment with SPEVIGO is not recommended in patients with any clinically important active infection until the infection resolves or is adequately treated. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur during or after treatment with SPEVIGO. If a patient develops a clinically important active infection, discontinue SPEVIGO therapy until the infection resolves or is adequately treated.¹

Risk of Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SPEVIGO. Avoid use of SPEVIGO in patients with active TB infection.¹

Consider initiating anti-TB therapy prior to initiating SPEVIGO in patients with latent TB or a history of TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SPEVIGO treatment.¹

Vaccinations

Prior to initiating SPEVIGO for treatment of GPP, complete all age-appropriate vaccinations according to current immunization guidelines.¹

Avoid use of live vaccines in patients during and for at least 16 weeks after treatment with SPEVIGO. No specific studies have been conducted in SPEVIGO-treated patients who have recently received live viral or live bacterial vaccines.¹

Use in specific populations

Pregnancy

The limited data on the use of SPEVIGO in pregnant women are insufficient to inform a drug-associated risk of adverse pregnancy-related outcomes. Human IgG is known to cross the placental barrier; therefore, SPEVIGO may be transmitted from the mother to the developing fetus. In an animal reproduction study, intravenous administration of a surrogate antibody against IL36R in mice during the period of organogenesis did not elicit any reproductive toxicity.¹

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.¹

Lactation

There are no data on the presence of spesolimab-sbzo in human milk, the effects on the breastfed infant, or the effects on milk production. Spesolimab-sbzo is a monoclonal antibody and is expected to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SPEVIGO and any potential adverse effects on the breastfed infant from SPEVIGO or from the underlying maternal condition.¹

GPP, generalized pustular psoriasis; IgG, immunoglobulin; IL36R, interleukin-36 receptor; RegiSCAR, Registry of Severe Cutaneous Adverse Reactions.

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Adverse reactions with SPEVIGO SC for treatment of GPP when not experiencing a flare¹

Specific adverse reactions

Clinical development

Contraindications

Safety through Week 12

Warnings and precautions

Infections

Risk of Tuberculosis

Vaccinations

Use in specific populations

Pregnancy

Lactation

Access support and resources for your patients

Indication

Important Safety Information

Contraindications

Warnings and Precautions