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.
Study Type
OBSERVATIONAL
Enrollment
21
Intravenous
Pusan National University Yangsan Hospital
Busan, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Incidence of adverse events (AEs)
Time frame: Up to 24 weeks
Incidence of adverse drug reactions (ADRs)
Time frame: Up to 24 weeks
Incidence of serious adverse events (SAEs)
Time frame: Up to 24 weeks
Incidence of serious adverse drug reactions (SADRs)
Time frame: Up to 24 weeks
Incidence of unexpected adverse drug reactions
Time frame: Up to 24 weeks
Incidence of adverse events of special interest (AESIs)
Time frame: Up to 24 weeks
Incidence of adverse events leading to temporary or permanent discontinuation
Time frame: Up to 24 weeks
Incidence of adverse events leading to death
Time frame: Up to 24 weeks
Physician's Global Assessment for Generalized Pustular Psoriasis (GPPGA) pustulation sub-score of 0 indicating no visible pustules 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.
Time frame: At Week 1
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A GPPGA pustulation sub-score of 0 indicating no visible pustules 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.
Time frame: At Week 4
A GPPGA score of 0 or 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.
Time frame: At Week 1
A GPPGA score of 0 or 1 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.
Time frame: At Week 4