New analyses on the potential impact of SPEVIGO® in generalized pustular psoriasis patient-reported outcomes presented at AAD 2025

• Improvements in Psoriasis Symptom Scale (PSS), Pain Visual Analog Scale (VAS) and Dermatology Life Quality Index (DLQI) scores were observed in post-hoc exploratory analyses of the EFFISAYIL^® 2 trial
• Findings suggest the potential benefit of continuously treating generalized pustular psoriasis (GPP) with subcutaneous spesolimab

RIDGEFIELD, Conn., March 7, 2025 /PRNewswire/ -- Today, Boehringer Ingelheim announced new analyses to be presented at the American Academy of Dermatology (AAD) annual meeting in Orlando that explore the effect that SPEVIGO^® (spesolimab-sbzo) may have on the physical symptoms and mental health burden associated with generalized pustular psoriasis (GPP). These post-hoc exploratory analyses from the EFFISAYIL^® 2 clinical trial assessed the efficacy and safety of subcutaneous SPEVIGO in patients suffering from GPP.^1,2

Distinct from plaque psoriasis, GPP is a serious and rare, chronic, heterogenous, inflammatory neutrophilic disease associated with painful skin manifestations and systemic symptoms, such as fever, pain, and fatigue.^3-6 GPP's unpredictable nature can potentially have significant long-term impacts on quality of life for people living with it and may cause fear and anxiety over the disease course.^5,7

"Generalized pustular psoriasis profoundly affects patients' physical and mental well-being, often disrupting their education, careers, and personal relationships. We are encouraged by the improvements observed in patient-reported outcomes with spesolimab. These studies strengthen our commitment to delivering innovative treatments for those living with severe dermatological conditions like GPP," says Vicky Brown, Senior Vice President and Head of Immunology, Oncology, and Eye Health, Boehringer Ingelheim Pharmaceuticals, Inc.

In the EFFISAYIL 2 clinical trial, patients with a history of GPP were randomized to receive one of three active treatment regimens or a placebo. Participants were asked to rate their GPP symptoms – including pain, redness, itching, and burning – using the Psoriasis Symptom Scale (PSS), the Pain Visual Analog Scale (VAS), and the Dermatology Life Quality Index (DLQI). The PSS ranges from 0 to 16, while the Pain VAS ranges from 0 to 100, with higher scores indicating more severe symptoms. Of the 30 patients randomized to receive subcutaneous spesolimab, 300 mg every four weeks after a 600mg loading dose, participants reported a reduction in mean Pain VAS scores over the course of the trial, with more than half (56.5%) of patients reporting a Pain VAS score of 0 at Week 48 and the mean PSS score decreasing from 5.34 to 2.96 by Week 48.

Patients were also asked to rate the impact of GPP through a 10-item questionnaire to assess changes in quality of life using the DLQI. The results found that mean DLQI scores improved from a "very large effect on patient's life" score (11.14) at baseline to a "small effect on patient's life" score (4.57) at week 48 following treatment with SPEVIGO.

Measurable improvements in mean PSS, Pain VAS and DLQI scores were observed by the first assessment at Week 4.

"The results from EFFISAYIL 2 provide valuable insights into the chronicity of generalized pustular psoriasis," said Dr. Tina Bhutani, study author. "The data are a pivotal step in advancing patient-centered care in GPP."

These findings may provide healthcare professionals with data that can help inform their choice of treatment regimens for people living with GPP.

About SPEVIGO^®
SPEVIGO^® is a novel, humanized, selective antibody that specifically blocks the activation of the IL-36R, a signaling pathway within the immune system shown to be involved in the pathogenesis of several autoinflammatory diseases, including GPP. It is the first targeted therapy for the treatment of GPP and has been evaluated in the largest clinical program specifically for the treatment of patients with GPP.

What is SPEVIGO^®?
SPEVIGO^® is a prescription medicine used to treat generalized pustular psoriasis (GPP) in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg). It is not known if SPEVIGO^® is safe and effective in children under 12 years of age or who weigh less than 88 pounds (40kg).

Important Safety Information

Do not receive SPEVIGO^® if you or your child have had a severe or life-threatening allergic reaction to spesolimab-sbzo or any of the ingredients in SPEVIGO^®.

What is the most important information I should know about SPEVIGO^®? SPEVIGO^® may cause serious side effects, including:

• Infections. SPEVIGO^® may lower the ability of your or your child's immune system to fight infections and may increase your or your child's risk of infections. Your healthcare provider should check you or your child for infections and tuberculosis (TB) before starting treatment with SPEVIGO^® and may treat you or your child for TB before you begin treatment with SPEVIGO^® if you have a history of TB or have active TB. Your healthcare provider should watch you or your child closely for signs and symptoms of TB during or after treatment with SPEVIGO^®. Tell your healthcare provider right away if you or your child have an infection or have symptoms of an infection during or after treatment with SPEVIGO^®, including:
  • fevers, chills, or sweats
  • muscle aches
  • cough
  • shortness of breath
  • blood in your phlegm (mucus)
  • burning when you urinate
  • urinating more often than normal
• Allergic reactions and infusion-related reactions. Serious allergic reactions may happen during or after your or your child's SPEVIGO^® injection. If you or your child have a serious allergic reaction, your healthcare provider will stop treatment with SPEVIGO^®. If you or your child are given SPEVIGO^® in a vein (intravenously) and have an infusion- related reaction, your healthcare provider will stop your or your child's SPEVIGO^® infusion and treat your or your child's symptoms and may restart SPEVIGO^® at a slower infusion rate. Tell your healthcare provider or get emergency medical help right away if you or your child get any of the following symptoms during or after your or your child's SPEVIGO^® injection:
  • feeling faint, dizzy, or lightheaded
  • swelling of your face, eyelids, lips, mouth, tongue, or throat
  • trouble breathing or throat tightness
  • fever
  • mouth sores
  • chest tightness
  • hives or skin rash that is different than the rash from generalized pustular psoriasis (GPP)
  • itching
  • swollen lymph nodes

Before you or your child receive SPEVIGO^®, tell your healthcare provider about all of your medical conditions, including if you or your child:

• have an infection that does not go away or that keeps coming back.
• have TB or have been in close contact with someone with TB.
• have recently received or are scheduled to receive an immunization (vaccine). You or your child should not receive live vaccines during and for at least 16 weeks after treatment with SPEVIGO^®. You or your child should be brought up to date with all vaccines before starting SPEVIGO^®.
• are pregnant or plan to become pregnant. It is not known if SPEVIGO^® can harm your or your child's unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if SPEVIGO^® passes into your breast milk. Talk to your healthcare provider about the best way to feed your or your child's baby during treatment with SPEVIGO^®.

Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of SPEVIGO^®?

The most common side effects of SPEVIGO^® given in a vein (intravenously) for GPP flare treatment include:

• feeling tired or weak
• nausea and vomiting
• headache
• itching or itchy bumps
• a collection of blood under the skin at the infusion site or bruising
• urinary tract infection

The most common side effects of SPEVIGO^® when given under the skin (subcutaneously) for treatment of GPP when not experiencing a flare include:

• redness, pain, swelling, hardening, hives, or warmth at the injection site
• joint pain
• urinary tract infection
• itching

These are not all of the possible side effects of SPEVIGO®. Call your doctor for medical advice about side effects.     

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‐800‐FDA‐1088.

Please see full Prescribing Information, Medication Guide, and Instructions for Use.

About the EFFISAYIL^® clinical trial program
The EFFISAYIL^® clinical trial program evaluated the largest and broadest population of GPP patients in trials of a therapy specifically targeting the IL-36 pathway for GPP:

• EFFISAYIL^® 1: A Phase II study that demonstrated treatment with a single intravenous dose of spesolimab significantly improved signs and symptoms of GPP in patients experiencing a flare, including rapid pustular and skin clearance. These results supported the approval of spesolimab as the first specific treatment for GPP flares in adults in major markets
• EFFISAYIL^® 2: A Phase IIb study that showed spesolimab significantly reduced the risk of GPP flares by 84% over 48 weeks compared to placebo. In the trial with 123 patients, no flares were observed after week 4 of spesolimab SC treatment in the high-dose group (n=30)
• EFFISAYIL^® ON: An open-label extension study to evaluate the long-term safety and efficacy of spesolimab in patients with GPP who have completed previous spesolimab trials

About generalized pustular psoriasis
GPP is a chronic, heterogenous, neutrophilic inflammatory disease associated with skin and systemic symptoms that is distinct from plaque psoriasis. GPP is recognized as a separate clinical entity from other forms of psoriasis, with the IL-36 pathway being a key driver of GPP and triggering response to treatment. Prevalence of GPP is low and varies considerably across geographical regions, ranging from 1.76 to 124 patients per million persons in reports from key countries, including France, Japan, Sweden, and South Korea. GPP can become life-threatening (mortality rates ranging from 2% to 16%) due to severe complications, such as multisystem organ failure and sepsis requiring urgent hospital care; many GPP patients also suffer from various comorbidities, which contribute to the ongoing burden for the patient and healthcare systems. GPP symptoms appear unpredictable and present on a continuum, which greatly impacts a patient's quality of life, and may cause fear and anxiety over the disease course, as well as long-term impacts on quality of life related to work/school, emotional health, social activities, and finances.

About Boehringer Ingelheim
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in Research and Development, the company focuses on developing innovative therapies in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow. Learn more at https://www.boehringer-ingelheim.com/us.

¹Bhutani T, 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 2025 AAD Annual Meeting; March 2025; Orlando.
²Gordon K, et al. Spesolimab improves quality of life as measured by Dermatology Life Quality Index (DLQI) in generalized pustular psoriasis (GPP) over time: Results from the EFFISAYIL® 2 trial. Poster presented at 2025 AAD Annual Meeting; March 2025; Orlando.
³Marrakchi S, Puig L. Pathophysiology of generalized pustular psoriasis. Am J Clin Dermatol. 2022;23:13–19.
⁴Strober B, et al. Dermatol Ther. (Heidelb) 2021;11:529–41.
⁵Prinz JC, Choon SE, Griffiths CEM, et al. Prevalence, comorbidities and mortality of generalized pustular psoriasis: A literature review. J Eur Acad Dermatol Venereol. 2023;37:256–273.
⁶Reisner DV, Johnsson FD, Kotowsky N, et al. Impact of generalized pustular psoriasis from the perspective of people living with the condition: Results of an online survey. Am J Clin Dermatol. 2022;23:65–71.
⁷Gooderham MJ, Van Voorhees AS, Lebwohl MG. An update on generalized pustular psoriasis. Expert Rev Clin Immunol. 2019;15:907–919.

Media Contact
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Boehringer Ingelheim Pharmaceuticals, Inc.
Phone: +1 203-448-1263
Email: [email protected] 

SOURCE Boehringer Ingelheim