Generalized Pustular Psoriasis
Conditions
Brief summary
The primary and secondary objectives are to respectively monitor the safety and effectiveness of Spesolimab IV in Korean patients with flares with generalized pustular psoriasis (GPP) in a routine medical practice.
Interventions
DRUGSpevigo®
Intravenous
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients starting Spesolimab IV for the first time in accordance with the approved label in Korea (complete enumeration for the first 2 years after product launch) * Patients with generalized pustular psoriasis (GPP) flare * Age \>/=19 years at enrolment * Patients who have signed the data release consent form
Exclusion criteria
* Patients with Severe or life-threatening hypersensitivity to Spesolimab or to any of the excipients * Patients with clinically important active infections (e.g. active tuberculosis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) | Up to 24 weeks |
| Incidence of adverse drug reactions (ADRs) | Up to 24 weeks |
| Incidence of serious adverse events (SAEs) | Up to 24 weeks |
| Incidence of serious adverse drug reactions (SADRs) | Up to 24 weeks |
| Incidence of unexpected adverse drug reactions | Up to 24 weeks |
| Incidence of adverse events of special interest (AESIs) | Up to 24 weeks |
| Incidence of adverse events leading to temporary or permanent discontinuation | Up to 24 weeks |
| Incidence of adverse events leading to death | Up to 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician's Global Assessment for Generalized Pustular Psoriasis (GPPGA) pustulation sub-score of 0 indicating no visible pustules at Week 1 | At Week 1 | The GPPGA is a modified the Physician's Global Assessment (PGA), a physician's assessment of psoriatic lesions, which was adapted to the evaluation of Generalized Pustular Psoriasis (GPP) patients. The investigator scores the erythema, pustules, and scaling of all GPP lesions from 0 to 4. Each component is graded separately, the average is calculated, and the final GPPA is determined from this composite score. A lower score indicates a lesser severity, with 0 being clear and 1 being almost clear. |
| A GPPGA pustulation sub-score of 0 indicating no visible pustules at Week 4 | At Week 4 | The GPPGA is a modified the Physician's Global Assessment (PGA), a physician's assessment of psoriatic lesions, which was adapted to the evaluation of Generalized Pustular Psoriasis (GPP) patients. The investigator scores the erythema, pustules, and scaling of all GPP lesions from 0 to 4. Each component is graded separately, the average is calculated, and the final GPPA is determined from this composite score. A lower score indicates a lesser severity, with 0 being clear and 1 being almost clear. |
| A GPPGA score of 0 or 1 at Week 1 | At Week 1 | The GPPGA is a modified the Physician's Global Assessment (PGA), a physician's assessment of psoriatic lesions, which was adapted to the evaluation of Generalized Pustular Psoriasis (GPP) patients. The investigator scores the erythema, pustules, and scaling of all GPP lesions from 0 to 4. Each component is graded separately, the average is calculated, and the final GPPA is determined from this composite score. A lower score indicates a lesser severity, with 0 being clear and 1 being almost clear. |
| A GPPGA score of 0 or 1 at Week 4 | At Week 4 | The GPPGA is a modified the Physician's Global Assessment (PGA), a physician's assessment of psoriatic lesions, which was adapted to the evaluation of Generalized Pustular Psoriasis (GPP) patients. The investigator scores the erythema, pustules, and scaling of all GPP lesions from 0 to 4. Each component is graded separately, the average is calculated, and the final GPPA is determined from this composite score. A lower score indicates a lesser severity, with 0 being clear and 1 being almost clear. |
Countries
South Korea
Outcome results
None listed