Provide ongoing GPP control with SPEVIGO SC (subcutaneous)

In the Effisayil^® 2 clinical trial, SPEVIGO SC significantly reduced the relative risk of GPP flares by 84% vs placebo over 48 weeks¹

Results from Effisayil® 2 Clinical Trial

While a 600 mg LD of SPEVIGO followed by 300 mg every 12 weeks dosage and a 300 mg LD of SPEVIGO followed by 150 mg every 12 weeks dosage were studied in Study Effisayil^® 2, these dosages are not approved.²

The recommended dosage of SPEVIGO for treatment of GPP when not experiencing a flare is a subcutaneous LD of 600 mg followed by 300 mg subcutaneously, administered every 4 weeks.²

No flares occurred in patients treated with SPEVIGO SC
300 mg after Week 4 through Week 48¹

3 patients experienced a GPP flare in the first 4 weeks after one dose of SPEVIGO SC.^1,a

CI, confidence interval; GPP, generalized pustular psoriasis; GPPPGA, Generalized Pustular Psoriasis Physician Global Assessment; HR, hazard ratio; LD, loading dose; SC, subcutaneous.

GPP flare was defined as an increase of ≥2 in GPPPGA total score from baseline and a GPPPGA pustulation subscore ≥2 or any use of intravenous spesolimab or other investigator-prescribed medication to treat GPP worsening.²

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

Effisayil® 2: SPEVIGO SC for the continuous treatment of GPP when not experiencing a flare^1,3

Watch this video to learn about the key highlights from the pivotal EFFISAYIL 2 clinical study.

Transcript

Generalized pustular psoriasis (GPP) is a serious, neutrophilic, chronic and persistent autoinflammatory condition.

The clinical course of GPP is unpredictable and highly heterogeneous. GPP symptoms may vary over the course of the disease, and may include itching, burning, pain, erythema, pustules and skin scaling. The unpredictability of GPP and its symptoms can have a substantial impact on patients’ quality of life and their ability to perform everyday activities.

In a survey of dermatologists from the CorEvitas psoriasis registry, 83% indicated that patients had chronic symptoms after a GPP flare, which included skin scaling and erythema.

Even when patients are not experiencing a flare, GPP can still have a very large impact on their quality of life.

Patients need a treatment that addresses the acute and chronic phases of GPP.

So, what is SPEVIGO? SPEVIGO is the only FDA-approved treatment for GPP.

GPP is caused by dysregulated IL-36 receptor signaling, leading to a neutrophilic inflammatory response.

SPEVIGO is the only treatment that inhibits signaling in the IL-36 pathway, the key inflammatory pathway in GPP.

The binding of SPEVIGO to the IL-36 receptor prevents the subsequent activation of IL-36 receptor and as a result, downstream activation of pro-inflammatory and profibrotic pathways does not occur. The precise mechanism linking reduced IL-36 receptor activity and the treatment of GPP flares is unclear.

Let’s take a look at the EFFISAYIL 2 trial with SPEVIGO SC, which was the first placebo-controlled study in patients with GPP that focused on treatment when not experiencing a GPP flare. In EFFISAYIL 2, patients were aged between 12 and 75 years old, had to have been diagnosed with GPP, including a history of at least two GPP flares, but were not currently experiencing a flare. To be included, patients were either patients who were receiving treatment for GPP at randomization but had a flare during or after dose reduction or treatment discontinuation or patients who were not receiving treatment for GPP at randomization but had at least two flares in the previous year.

Overall, 123 patients with GPP were randomly divided into four groups to receive either one of three subcutaneous doses of SPEVIGO or placebo, and were assessed every 4 weeks until the end of the study at Week 48.

In case of a flare, participants could receive an open-label dose of SPEVIGO IV.

At the end of the study eligible participants entered a long-term study to receive subcutaneous SPEVIGO for up to 5 years.

In EFFISAYIL 2, the approved SPEVIGO SC dose a, 600 mg loading dose followed by 300 mg every 4 weeks, significantly reduced the relative risk of GPP flares by 84% vs placebo, over 48 weeks of observation.

Overall, 3 patients experienced a GPP flare in the first 4 weeks after 1 dose of SPEVIGO 300mg SC every 4 weeks and no flares occurred after Week 4.

Furthermore, 87% of patients treated with SPEVIGO 300mg SC every 4 weeks remained flare free over 48 weeks.

In the EFFISAYIL 2 trial, patient-reported outcomes included assessment of patients’ health-related quality of life. The clinical trial was not statistically powered to these endpoints. Statistical significance cannot be claimed for the DLQI evaluation.

During EFFISAYIL 2, injection site reaction, urinary tract infection, pruritus and arthralgia were the most commonly observed adverse drug reactions with SPEVIGO SC. Please see additional important safety information on this website and the full prescribing information for SPEVIGO.

In conclusion, SPEVIGO SC significantly reduced the relative risk of GPP flares by 84% vs placebo, over 48 weeks of observation. Overall, no flares occurred with SPEVIGO SC after Week 4 through to the end of the trial at Week 48. 3 patients experienced a GPP flare in the first 4 weeks after one dose of SPEVIGO SC. SPEVIGO SC has been associated with an increased incidence of injection site reaction, urinary tract infection, arthralgia, and pruritus. SPEVIGO is the only FDA-approved treatment for GPP. Please see additional Important Safety Information on this website and the full Prescribing Information for SPEVIGO.

Indication

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 (88 lb).

Important Safety Information

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) and anaphylaxis.

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:

Serious hypersensitivity reactions, including anaphylaxis and delayed reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during and following administration of SPEVIGO. These reactions can occur with the first dose or subsequent doses.
SPEVIGO is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab-sbzo or to any of the excipients in SPEVIGO. 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, headache, nausea, 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.

Please see SPEVIGO Prescribing Information, including Medication Guide.

87% of patients remained flare free over 48 weeks with SPEVIGO SC^1,a,b

Spevigo® SC Efficacy Key Secondary Endpoint for GPP Treatment up to Week 48

Using a 1-sided α of 0.0063 (adjusted for multiplicity), SPEVIGO SC showed statistically significant improvement over placebo.¹

CI, confidence interval; GPP, generalized pustular psoriasis; GPPPGA, Generalized Pustular Psoriasis Physician Global Assessment; SC, subcutaneous.

^aSPEVIGO SC was administered with a 600 mg subcutaneous loading dose followed by 300 mg subcutaneously every 4 weeks.²

^bMeasured as a binary outcome (flare or no flare) and defined as a GPPPGA pustulation subscore of ≥2 and an increase in the GPPPGA score of ≥2.^1,2

Mean pain VAS score in patients treated with SPEVIGO SC⁴

Mean pain VAS in patients treated with SPEVIGO SC graph

61^%

REDUCTION

in mean pain VAS score at Week 48⁴

Mean PSS total scores also improved with SPEVIGO SC treatment.⁴

This analysis reflects the SPEVIGO 300 mg SC q4w arm, and results are based on observed data without imputation (with patient numbers declining over time). Pain VAS and PSS are subjective, scheduled assessments.

PSS, Psoriasis Symptoms Scale; SC, subcutaneous; SD, standard deviation; VAS, visual analog scale; q4w, every 4 weeks.

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

^bOne patient baseline score was missing.⁴

Study Design & Baseline Characteristics

EFFISAYIL 2 was the first and largest randomized, placebo-controlled trial of SPEVIGO SC in patients who were not experiencing a GPP flare^1,3

Effisayil® 2 Clinical Trial of Spevigo® SC Study Design

While a 600 mg LD of SPEVIGO followed by 300 mg q12w dosage and 300 mg LD of SPEVIGO followed by 150 mg q12w dosage were studied in Study EFFISAYIL 2, these dosages are not approved.²

The recommended dosage of SPEVIGO for treatment of GPP when not experiencing a flare is a subcutaneous LD of 600 mg followed by 300 mg subcutaneously, administered q4w.²

GPP, generalized pustular psoriasis; GPPPGA, Generalized Pustular Psoriasis Physician Global Assessment; IV, intravenous; LD, loading dose; OL, open label; OLE, open-label extension; q4w, every 4 weeks; q12w, every 12 weeks; R, randomization; SC, subcutaneous; SD, single dose.

^aAn optional second dose of SPEVIGO 900 mg IV could be administered to patients with persistent flare symptoms at Day 8.¹

^bPatients receiving OL SPEVIGO 300 mg SC q12w have the option to escalate to 300 mg SC q4w.¹

^cPatients will be given the opportunity to enter an OLE trial (EFFISAYIL ON, 1368-0025) if they have completed the treatment period in this study up to Week 48 (i.e., no premature discontinuation of trial treatment), agree to participate in the OLE trial, and meet the trial eligibility criteria.¹

Endpoint summary^1,2

Time to GPP flare, up to Week 48

Occurrence of ≥1 GPP flare, up to Week 48

Time to worsening of PSS score up to Week 48
(≥4-point increase in total PSS score from baseline)

Time to worsening of DLQI
(≥4-point increase in total DLQI score from baseline)

Sustained flare prevention (GPPPGA score of 0 or 1) at all visits up to Week 48

DLQI, Dermatology Quality of Life Index; GPP, generalized pustular psoriasis; GPPPGA, Generalized Pustular Psoriasis Physician Global Assessment; PSS, Psoriasis Symptoms Scale.

Baseline characteristics¹

Characteristics	SPEVIGO 300 mg SC q4w after a 600 mg loading dose (N=30)	Placebo (N=31)
Female, n (%)	18 (60)	18 (58.1)
Race Asian, n (%) White, n (%)	21 (70) 9 (30)	17 (54.8) 14 (45.2)
Mean age (SD), years	40.2 (16.4)	39.5 (14.0)
Mean BMI (SD), kg/m²	25.6 (7.3)	26.9 (8.3)
Systemic GPP medication at randomization, n (%)	22 (73.3)	22 (71)
GPPPGA total score, n (%)
0	3 (10)	4 (12.9)
1	27 (90)	27 (87.1)
Mean GPPASI total score (SD)	3.92 (4.42)	3.11 (2.81)
Mean PSS total score (SD)	5.3 (3.8)	3.6 (2.9)
Mean DLQI total score (SD)	11.1 (6.9)	7.2 (5.6)
*IL36RN* mutations (genotyping), n (%) Yes No Unknown^d	7 (23.3) 19 (63.3) 4 (13.3)	4 (12.9) 22 (71) 5 (16.1)
Mean historical number of flares per year (SD)	2.4 (1.9)	2.4 (1.2)
Concurrent plaque psoriasis,^e n (%)	7 (23.3)	10 (32.3)

Baseline characteristics shown are for the approved SPEVIGO dose only. Please refer to the referenced publication for full study information.

BMI, body mass index; DLQI, Dermatology Life Quality Index; GPP, generalized pustular psoriasis; GPPASI, Psoriasis Area and Severity Index for Generalized Pustular Psoriasis; GPPPGA, Generalized Pustular Psoriasis Physician Global Assessment; IL36RN, interleukin-36 receptor antagonist gene; PSS, Psoriasis Symptoms Scale; q4w, every 4 weeks; SC, subcutaneous; SD, standard deviation.

^dIL36RN mutation status was unknown for some patients where no blood sample was obtained.¹

^eThe presence of concurrent plaque psoriasis was based on the investigator’s clinical investigation at enrollment.¹

Select study inclusion criteria¹

Adolescents and adults aged 12–75 years (weighing ≥40 kg) with a documented diagnosis of Generalized Pustular Psoriasis (GPP), as defined by ERASPEN^1,2,f:

History of GPP with ≥2 past GPP flares with fresh pustulation (new appearance or worsening)^1,2,g
GPPPGA total score of 0 or 1 at screening and randomization¹
Patients not on concurrent GPP treatment at randomization¹:
- Must have had ≥2 flares in the previous year, ≥1 of which must have been with systemic symptoms (fever, elevated CRP or WBC count, asthenia, and/or myalgia)
Patients on concurrent GPP treatment within 12 weeks prior to randomization¹:
- Must have a history of flaring during or after dose reduction or discontinuation of concurrent treatment
- Patients on concurrent treatment with retinoids, methotrexate, and/or cyclosporin must stop this treatment on the day of randomization

CRP, C-reactive protein; ERASPEN, European Rare and Severe Psoriasis Expert Network; GPP, generalized pustular psoriasis; GPPPGA, Generalized Pustular Psoriasis Physician Global Assessment; ULN, upper limit of normal; WBC, white blood cell.

^fThe European Rare And Severe Psoriasis Expert Network (ERASPEN) characterizes GPP as primary, sterile, macroscopic pustules with accumulations of neutrophils on non-acral skin, excluding cases in which pustulation is restricted to psoriatic plaques.⁵

^gAt screening, the confirmation of diagnosis of GPP as defined by ERASPEN and the patients must have had previous evidence of systemic symptoms for past GPP flares, such as fever, asthenia, myalgia, elevated CRP, leukocytosis with peripheral blood neutrophilia (above ULN).^6,7

Select study exclusion criteria⁶

Patients were excluded if they presented with:

SAPHO syndrome
Primary erythrodermic plaque psoriasis
Severe, progressive, or uncontrolled hepatic disease
Treatment with any defined restricted medication, any drug considered by the investigator to interfere with the safe conduct of the study, or prior exposure to SPEVIGO or another IL-36R inhibitor biologic
Biologic treatments must not be taken for 12 weeks, or 5 half-lives (whichever is shorter), prior to randomization. Systemic immunomodulatory treatments (e.g., corticosteroids) are not permitted 4 weeks prior to randomization

IL-36R, interleukin-36 receptor; SAPHO, synovitis-acne-pustulosis hyperostosis-osteitis.

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Indication

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 (88 lb).

Please see SPEVIGO Prescribing Information, including Medication Guide.

Important Safety Information

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) and anaphylaxis.

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:

Serious hypersensitivity reactions, including anaphylaxis and delayed reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during and following administration of SPEVIGO. These reactions can occur with the first dose or subsequent doses.
SPEVIGO is contraindicated in patients with severe or life-threatening hypersensitivity to spesolimab-sbzo or to any of the excipients in SPEVIGO. 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, headache, nausea, 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.

Please see SPEVIGO Prescribing Information, including Medication Guide.

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References

Morita A, Strober B, Burden AD, et al. Efficacy and safety of subcutaneous spesolimab for the prevention of generalised pustular psoriasis flares (Effisayil 2): an international, multicentre, randomised, placebo-controlled trial. Lancet. 2023;402(10412):1541–1551. doi:10.1016/S0140-6736(23)01378-8
SPEVIGO. Prescribing Information. LEO Pharma Inc.
Strober B, Mostaghimi A, Anadkat MJ, et al. Measuring GPPGA, pain, symptom, and quality of life index scores in untreated generalized pustular psoriasis: results from the placebo group of the Effisayil 2 trial. Poster presented at: Winter Clinical Dermatology Conference; January 12–17, 2024; Honolulu, HI.
Bhutani T, Ferris L, DiRuggiero D, et al. Spesolimab improves quality of life as measured by Psoriasis Symptom Scale (PSS) and Pain Visual Analog Scale (VAS) in generalized pustular psoriasis (GPP) over time: Results from the EFFISAYIL® 2 trial. Poster presented at: American Academy of Dermatology Annual Meeting; March 7–11, 2025; Orlando, FL. Poster 61643.
Navarini AA, Burden AD, Capon F, et al; for the ERASPEN Network. European consensus statement on phenotypes of pustular psoriasis. J Eur Acad Dermatol Venereol. 2017;31(11):1792–1799. doi:10.1111/jdv.14386
Morita A, Choon SE, Bachelez H, et al. Design of Effisayil™ 2: a randomized, double-blind, placebo-controlled study of spesolimab in preventing flares in patients with generalized pustular psoriasis. Dermatol Ther (Heidelb). 2023;13(1):347–359. doi:10.1007/s13555-022-00835-6
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