Generalized Pustular Psoriasis (GPP) (U.S.), March 2023
The MarketVue®: Generalized Pustular Psoriasis market landscape report combines primary (KOL interviews and survey data) and secondary market research to empower strategic decision-making and provide a complete view of the market.
Every MarketVue® includes a disease overview, epidemiology (US and EU5), current treatment, unmet needs, pipeline and access and reimbursement chapter.
Topics covered in this report:
- Disease overview: Review the disease pathophysiology and potential druggable targets
- Epidemiology: Understand prevalence, diagnosed and drug-treated prevalence of the population and key market segments
- Current treatment: Understand the treatment decision tree and strengths and weaknesses of current on-label and off-label treatment
- Unmet needs: Identify opportunities to address treatment or disease management gaps
- Pipeline analysis: Compare current and emerging therapy clinical development strategy; their performance on efficacy, safety, and delivery metrics; and their potential to address unmet needs
- Value and access: Gain insights into the drug pricing landscape and payer controls within the disease market or analogous markets
Methodology:
Research for the MarketVue®: Generalized Pustular Psoriasis report is supported by 4 qualitative interviews with key opinion leaders, a quantitative survey with 27 physicians and secondary research.
Geographies covered:
United States plus epidemiology for EU5 (France, Germany, Italy, Spain, United Kingdom)
Key companies mentioned:
- Boehringer Ingelheim
- AnaptysBio
- Shanghai Huaota Biopharmaceutical
Key drugs mentioned:
- Calcipotriene
- Tacrolimus
- Acitretin
- Methotrexate
- Cyclosporine
- Apremilast (Otezla)
- Infliximab (Remicade)
- Adalimumab (Humira)
- Secukinumab (Cosentyx)
- Ixekizumab (Taltz)
- Brodalumab (Siliq)
- Guselkumab (Tremfya)
- Risankizumab (Skyrizi)
- Ustekinumab (Stelara)
- Spesolimab (Spevigo)
- Canakinumab (Ilaris)
- Gevokizumab
- Anakinra (Kineret)
- Etanercept (Enbrel)
- Imsidolimab
- HB0034
Key takeaways from the report:
Before the approval of Spevigo, the treatment landscape for GPP consisted solely of off-label therapies approved for psoriasis, including:
- Topical therapies
- Cyclosporine
- Methotrexate
- Biologics used to treat psoriasis (e.g., anti-TNF-α, IL-1, IL-17, etc.)
The approval of Spevigo for active GPP flares marks a major shift in the treatment of GPP, but unmet needs remain for long-term maintenance therapies for flare prevention. These unmet needs could be short-lived, however, as Boehringer-Ingelheim (BI) recently announced that their subcutaneous formulation of spesolimab met its primary and secondary endpoints in a Phase 2 clinical trial (Effisayil-2) exploring efficacy for GPP flare prevention. Subcutaneous spesolimab could receive approval and enter the market as soon as 2024. Nearly 80% of surveyed dermatologist indicated that they would be very likely to prescribe a subcutaneous spesolimab if it was approved as a maintenance therapy, according to REACH’s MarketVue® assessment.
Spesolimab potential approval as an acute and maintenance therapy would avoid many of the challenges associated with prescribing off-label therapies to treat GPP and could offer dermatologists the opportunity to establish a continuity of care of both flare control and subsequent long-term flare prevention utilizing the same therapy.
Dermatologist, U.S.: “An ideal drug would be something that’s safe, gets acute flare under control quickly, and something that gives a sustained response that we can administer outpatient to hopefully keep their disease under control on a day-to-day basis, so minimal to little skin involvement and also prevention of the acute flares.”
Beyond spesolimab, there remains little in the pipeline for GPP. Like BI, AnaptysBio has an IL-36 inhibitor, imsidolimab, in clinical trials for both flare control and prevention, but will seek to outlicense the drug before approval. This development could potentially delay imsidolimab’s entry to market, but even with approvals for both spesolimab and imsidolimab, some unmet needs may be left unaddressed for those that do not respond well to IL-36 inhibitors.
1. DISEASE OVERVIEW
A recurrent inflammatory disorder causing pustules across the skin’s surface
Figure 1.1. Common triggers of GPP flares
Figure 1.2. Complications related to GPP
Figure 1.3. Frequency and management of GPP symptom flares/exacerbations
2. EPIDEMIOLOGY & PATIENT POPULATIONS
Disease definition
Figure 2.1. G6 prevalent cases of GPP by region
Table 2.1. Prevalent and drug-treated populations of GPP in the U.S. and EU5
3. CURRENT TREATMENT
Overview
Figure 3.1. Treatment goals for GPP
Figure 3.2. Current treatment patient share
TNF-alpha inhibitors and IL-17 inhibitors are the most commonly used biologics in GPP
Figure 3.3. Dermatologist-reported biologic use in GPP patients by drug class
Figure 3.4. Preferred second-line biologic classes among surveyed dermatologists
Figure 3.5. Percentage of GPP patients who fail first-line biologic therapy
Dermatologists choose biologics that are effective in psoriasis
Treatment decisions for GPP
Figure 3.6 Treatment algorithm for GPP
Dermatologists tend to view GPP as a form of psoriasis
GPP treatment options are moderately effective
Table 3.1. Upside and downsides of currently GPP treatments
Off-label GPP treatment options have their limitations
An IL-36 biologic is the first approved therapy for GPP
Figure 3.7. Results of Ph 2 Trial of a Single IV dose of Spesolimab in Patients with an Acute GPP Flare
Figure 3.8. Prior use of IV spesolimab (Spevigo) for the treatment of GPP flare
Figure 3.9. Dermatologists’ reported efficacy of IV spesolimab in treating GPP flare
Interviewed dermatologists who have prescribed Spevigo report patients have responded well
Figure 3.10. Dermatologists’ likelihood of prescribing spesolimab as a SC maintenance therapy if approved
Dermatologists consider efficacy and fast onset of action as top attributes for GPP treatment agents
Figure 3.11. Percentage of dermatologists selecting attribute among their top three most important for treatment selection in GPP
GPP has a severe impact on psycho-social aspects and the quality of life of patients
Figure 3.12. Dermatologists’ rating of the impact of GPP on patients
Key treatment dynamics that shape disease management and drug use in GPP
Table 3.2. Must-know GPP treatment dynamics for now and the future
Figure 3.13. Percentage of patients with unsatisfactory outcomes with current GPP treatments
The GPP pipeline is limited to IL-36R inhibitors
Figure 3.14. Important dynamics of GPP market evolution
4. UNMET NEED
Overview
Figure 4.1. Top unmet needs in GPP
Figure 4.2. Dermatologist-reported unmet needs in GPP
Physician perspectives on unmet needs in GPP
5. PIPELINE ANALYSIS
Overview
Figure 5.1. Percent of U.S. dermatologists rating GPP therapy target as “promising”
The ongoing IL-36 trial designs indicate intended treatment goals
Table 5.1. Comparison of ongoing trials of anti-IL-36R antibodies in GPP
Critical spesolimab data will arrive in Q4 of 2022
Figure 5.3. Key dates for the IL-36 therapies
Figure 5.4. Selected results from phase 2 GALLOP trial of imsidolimab in adult patients with active GPP
Figure 5.5. Trial design of imsidolimab’s Phase 3 GEMINI program in GPP
Spesolimab may secure another critical corner of the market if approved for maintenance therapy
6. VALUE & ACCESS
Overview
Table 6.1. Current therapy pricing, U.S. 2023
Patient access considerations based on the recent approval of Spevigo
Figure 6.1. Resources offered by BI to help facilitate Spevigo patient access
7. METHODOLOGY
Primary market research approach
Epidemiology methodology
Value and access methodology
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