Rapid and complete GPP pustular
clearance* at
Week 11-3
With SPEVIGO IV (intravenous), 54% of patients achieved rapid and complete pustular clearance* at Week 11-3
 |
11.4% (n=4) of patients had onset of pustular clearance as early as Day 23,4
-
*
Pustular clearance was defined as GPPPGA pustulation subscore of 0 (no visible pustules).1
-
†
SPEVIGO IV was administered as a single 900 mg dose by intravenous infusion.1
-
‡
Missing values or any use of other medication for GPP within the first week of the trial was regarded as nonresponse for the analysis of the endpoint.3
-
§
54% of patients achieved the primary endpoint, pustular clearance at Week 1.3
-
CI=confidence interval; GPP=generalized pustular psoriasis; GPPPGA=Generalized Pustular Psoriasis Physician Global Assessment; IV=intravenous.
With SPEVIGO IV treatment, 43% of patients achieved a 0 or 1 total GPPPGA score at Week 13
 |
The GPPPGA total score is the calculated average of the composite
score of pustules, erythema, and scaling5
-
*
Missing values or any use of other medication for GPP within the first week of the trial was regarded as nonresponse for the analysis of the endpoint.3
-
†
SPEVIGO IV was administered as a single 900 mg dose by intravenous infusion.1
SPEVIGO IV treatment delivered rapid and complete pustular clearance* in 54% of patients at Week 11,2
-
*
Pustular clearance was defined as GPPPGA pustulation subscore of 0 (no visible pustules).1
In an exploratory endpoint of the EFFISAYIL 1 trial, the efficacy of SPEVIGO IV treatment was sustained during
the 12-week study period3
 |
-
*
In EFFISAYIL 1, flare persistence was defined as GPPPGA total score ≥2 and GPPPGA pustulation subscore ≥2.3
-
†
Pustular clearance was defined as GPPPGA pustulation subscore of 0 (no visible pustules).1
 |
In an exploratory endpoint of the EFFISAYIL 1 trial, the efficacy of SPEVIGO IV treatment was sustained during
the 12-week study period3
 |
In the EFFISAYIL 1 trial, patient-reported outcomes included assessment of pain, redness, itching, burning sensations, and fatigue3
 |
- The clinical trial was not statistically powered to these endpoints3
- Analysis included patients who received up to 2 doses of SPEVIGO IV3
- Patients with missing values, any use of other GPP medication, or use of SPEVIGO IV for a new GPP
flare were excluded from analysis3
FACIT=Functional Assessment of Chronic Illness Therapy; IQR=interquartile range; PSS=Psoriasis Symptom Scale; VAS=Visual Analogue Scale.
References
-
SPEVIGO® [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; March 2024.
-
Strober B, Kotowsky N, Medeiros R, et al. Unmet medical needs in the treatment and management of generalized pustular psoriasis flares: evidence from a survey of Corrona registry dermatologists. Dermatol Ther (Heidelb). 2021;11(2):529-541. doi:10.1007/s13555-021-00493-0
-
Bachelez H, Choon SE, Marrakchi S, et al; for the Effisayil 1 Trial Investigators. Trial of spesolimab for generalized pustular psoriasis. N Engl J Med. 2021;385(26):2431-2440. doi:10.1056/NEJMoa2111563
-
Data on File. Clinical Trial Report. 2021. Boehringer Ingelheim Pharmaceuticals, Inc.
-
Choon SE, Lebwohl MG, Marrakchi S, et al. Study protocol of the global Effisayil 1 phase II, multicentre, randomised, double-blind, placebo-controlled trial of spesolimab in patients with generalized pustular psoriasis presenting with an acute flare. BMJ Open. 2021;11(3):e043666. doi:10.1136/bmjopen-2020-043666
-
Data on File. Boehringer Ingelheim Pharmaceuticals, Inc.
-
Rentz AM, Skalicky AM, Esser D, et al. Reliability, validity, and the ability to detect change of the Psoriasis Symptom Scale (PSS) in patients with plaque psoriasis. J Dermatolog Treat. 2020;31(5):460-469. doi:10.1080/09546634.2019.1709612
-
Gould D, Kelly D, Goldstone L, Gammon J. Examining the validity of pressure ulcer risk assessment scales: developing and using illustrated patient simulations to collect the data. J Clin Nurs. 2001;10(5):697-706. doi:10.1046/j.1365-2702.2001.00525.x
SPEVIGO is indicated for the treatment of generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg.
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).
WARNINGS AND PRECAUTIONS
Infections: SPEVIGO may increase the risk of infections. 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.
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. 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.
Hypersensitivity and Infusion-Related Reactions:
- SPEVIGO-associated hypersensitivity reactions may include immediate reactions, such as anaphylaxis, and delayed reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS).
- Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported in clinical trials with spesolimab-sbzo in subjects with GPP.
- If a patient develops signs of anaphylaxis or other serious hypersensitivity, discontinue SPEVIGO immediately and initiate appropriate treatment.
- If a patient develops mild or moderate hypersensitivity during an intravenous infusion or other infusion-related reactions, stop SPEVIGO infusion and consider appropriate medical therapy (eg, systemic antihistamines and/or corticosteroids). Upon resolution of the reaction, the infusion may be restarted at a slower infusion rate with gradual increase to complete the infusion.
Vaccinations: Prior to initiating SPEVIGO for treatment of GPP, complete all age-appropriate vaccinations according to current immunization guidelines. 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.
ADVERSE REACTIONS
Intravenous SPEVIGO for Treatment of GPP Flare (Study Effisayil-1): Most common adverse reactions reported in ≥5% of patients treated with SPEVIGO in the clinical trial were asthenia and fatigue, nausea and vomiting, headache, pruritus and prurigo, infusion site hematoma and bruising, and urinary tract infection (UTI).
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 (UTI) was reported in 1 subject (3%) in the SPEVIGO group and no subjects in the placebo group. Infections observed through Week 1 in Study Effisayil-1 in subjects treated with SPEVIGO were mild (29%) to moderate (71%).
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.”
Subcutaneous SPEVIGO for Treatment of GPP When Not Experiencing a Flare (Study Effisayil-2): Regarding the exposure-adjusted incidence rates for subjects on randomized treatment prior to receiving rescue treatment for flare or completing trial without a flare, the rate per 100-patient years for injection site reaction (including erythema, pain, swelling, induration, urticaria, and warmth at the injection site) was 31.6 for the subcutaneous SPEVIGO cohort (600 mg loading dose followed by 300 mg every 4 weeks) vs 12.7 for the placebo cohort. The rate per 100-patient years for UTI was 18 for SPEVIGO vs 0 for placebo. The rate per 100-patient years for pruritus was 8.8 for SPEVIGO vs 0 for placebo. The rate per 100-patient years for arthralgia was 13.3 for SPEVIGO vs 6 for the placebo cohort. There were 3 subjects who discontinued subcutaneous SPEVIGO 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.
Safety in Study Effisayil-2 After Flare: In Effisayil-2, subjects who experienced a GPP flare and received at least one dose of an open-label single intravenous 900 mg dose of SPEVIGO were treated with open-label subcutaneous SPEVIGO 300 mg. These subjects (n=19) received subcutaneous dosing at every 12 weeks, which could have been increased to every 4 weeks based on GPPPGA total score or pustulation subscore increased by ≥1 from any previous open-label maintenance visit. The reported safety profile of open-label subcutaneous SPEVIGO use after treatment of GPP flare with open-label intravenous SPEVIGO use was consistent with the safety profiles of use of SPEVIGO from Trial Effisayil-1 and randomized controlled data from Trial Effisayil-2.
Clinical Development of Spesolimab-sbzo
Guillain-Barre Syndrome (GBS): Among approximately 835 subjects exposed to spesolimab-sbzo during clinical development, GBS was reported in 3 subjects who received various doses of spesolimab-sbzo via various methods of administration in clinical trials for unapproved indications.
SPECIFIC POPULATIONS
Pediatric Use: The safety and effectiveness of SPEVIGO for the treatment of GPP have been established in pediatric patients 12 years of age and older and weighing at least 40 kg. Use of SPEVIGO for this indication is supported by data from a randomized, placebo-controlled study, which included 6 pediatric subjects 14 to 17 years of age with a history of GPP treated with subcutaneous SPEVIGO (Study Effisayil-2), and evidence from an adequate and well-controlled study of intravenous SPEVIGO in adults with GPP (Study Effisayil-1), with additional pharmacokinetic analyses showing similar drug exposure levels in adults and pediatric subjects 12 years of age and older and weighing 40 kg or more. The safety and effectiveness of SPEVIGO in pediatric patients younger than 12 years of age or in pediatric patients weighing less than 40 kg have not been established.
CL-SPG-100005 03.19.2024
Please see SPEVIGO Prescribing Information, including Medication Guide.