Impacts on patient-reported outcomes by treatment with brodalumab for patients suffering from plaque psoriasis in clinical practice
- Conditions
- psoriasis
- Registration Number
- JPRN-jRCTs031180037
- Lead Sponsor
- Imafuku Shinichi
- Brief Summary
Real-life psoriasis patients treated with brodalumab showed improvement in both the physician's objective assessment of lesional severity and the patient's subjective assessment of HRQoL impairment and satisfaction. In the self-assessment, about 90% of the patients judged that the treatment was effective. Brodalumab improved itching, skin pain, anxiety and depressive symptoms, but not sleep problems. Work productivity and activity impairment of the employees were also improved by brodalumab treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 73
1)Patients with plaque psoriasis who aged 18 years or older at the time of informed consent.
2)Patients who have given written informed consent to participate.
3)Patients who are judged to be able to inject oneself with brodalumab by the investigator or subinvestigator at the time of informed consent.
4)Patients who responded inadequately to phototherapies or other existing systemic therapies (except biologics) and who have skin eruptions over 10% or more of the body surface area at enrollment.
5)Patients who were carefully deemed by the investigator or subinvestigator not to continue the treatment protocol with prior biologic(s).
1)Patients with psoriatic erythroderma, pustular psoriasis and guttate psoriasis at the time of informed consent.
2)Patients with a severe infection or active tuberculosis at the time of informed consent.
3)Patients who are judged by the investigator or subinvestigator to be unsuitable for participation in this study.
4)Patients with joint symptoms at enrollment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI) and in Percent Body Surface Area (%BSA) [Time Frame: Week 12, 48] <br>Proportion of Participants Achieving PASI 75, 90 and PASI 100 [Time Frame: Week 12, 48] <br>Mean Change From Baseline on EuroQol - 5 Dimension - 5 Level, Dermatology Life Quality Index, Patient Health Questionnaire - 8, Generalized Anxiety Disorder - 7, Itch Numerical Rating Scale, Skin Pain Numerical Rating Scale, Medical Outcomes Study Sleep Scale, Work Productivity and Activity Impairment-Psoriasis and Treatment Satisfaction Questionnaire for Medication-9 [Time Frame: Week 12, 48] <br>Patient Global Assessment [Time Frame: Week 12, 48]
- Secondary Outcome Measures
Name Time Method