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INTRODUCTION: Real-world data on the needs of patients with psoriasis and patient-perceived benefits of apremilast are limited. We report such data from France. METHODS: The multicenter, observational REALIZE study was conducted in real-life clinical practice in France and enrolled patients with moderate-to-severe plaque psoriasis who had initiated apremilast per French reimbursement criteria in the 4 weeks preceding enrollment (September 2018-June 2020). Physician assessments and patient-reported outcomes (PROs) were collected at enrollment, 6 months, and 12 months. PROs included the Patient Benefit Index for skin diseases (PBI-S), Dermatology Life Quality Index (DLQI), and 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9). The primary outcome was PBI-S ≥ 1 (minimum clinically relevant benefit) at month 6. RESULTS: Of 379 enrolled patients who received ≥ 1 dose of apremilast, most [n = 270 (71.2%)] remained on apremilast at 6 months and over half [n = 200 (52.8%)] persisted at 12 months. Patients reported the following treatment goals as most important (≥ 70% reported goal as "very important" in the Patient Needs Questionnaire): get better skin quickly, regain disease control, be healed of skin alterations, and have confidence in the therapy. Most patients persisting on apremilast achieved a PBI-S ≥ 1 at months 6 and 12 (91.6% and 93.8%, respectively). Mean (SD) DLQI decreased from 11.75 (6.69) at enrollment to 5.17 (5.35) and 4.18 (4.39) at months 6 and 12, respectively. Most patients (72.3%) reported moderate-to-severe pruritus at enrollment and no/mild pruritus at months 6 and 12 (78.8% and 85.9%, respectively). Mean (SD) TSQM-9 Global Satisfaction scores were 68.4 (23.3) and 71.7 (21.5) at months 6 and 12, respectively. Apremilast was well tolerated; no new safety signals were identified. CONCLUSIONS: REALIZE provides insights regarding the needs of patients with psoriasis and the patient-perceived benefits of apremilast. Patients who persisted on apremilast reported improvements in quality of life, high treatment satisfaction, and clinically relevant benefits. TRIAL REGISTRATION: NCT03757013.
Psoriasis is a chronic disease and can have a large impact on patients' quality of life. Patients often discontinue psoriasis treatments for a number of reasons, including side effects, ineffectiveness, and inconvenience. Apremilast (Otezla) is a twice-daily oral tablet for the treatment of moderate-to-severe plaque psoriasis. Data on the needs of patients with psoriasis and the patient-perceived benefits of psoriasis treatments, including apremilast, are limited. The REALIZE (Real Life Data for OTEZLA Evidence) study collected data from 379 patients with moderate-to-severe psoriasis receiving apremilast for up to 12 months in clinical practice across France. Patients completed questionnaires regarding their treatment goals, how well apremilast treatment met these goals, their quality of life, and their satisfaction with apremilast treatment. At the beginning of the study, patients reported getting better skin quickly, regaining control of their psoriasis, being healed of psoriatic lesions on their skin, and having confidence in their psoriasis treatment as their most important treatment goals. Over half of the patients continued apremilast for 12 months, with most reporting that apremilast successfully met their treatment needs. Patients also reported high satisfaction with apremilast and improved quality of life. The adverse events reported in the REALIZE study were similar to the known safety profile of apremilast. Our data show that apremilast is an effective, convenient, and well-tolerated treatment that improves the symptoms of psoriasis and meets patients' needs and expectations.
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BACKGROUND: Several studies have revealed the frequency of antiretroviral (ARV) drug prescription errors. We analyzed highly active antiretroviral therapy (HAART) prescribing practices for human immunodeficiency virus (HIV)-infected patients undergoing hemodialysis in France. METHODS: Prescribed ARV drug doses in our cohort (consisting of all HIV-infected patients who underwent hemodialysis from 1 January 2002 and were prospectively followed up until 1 January 2004) were compared with the recommended doses for patients undergoing hemodialysis. The log-rank test was used to compare the outcomes among different groups of treated patients. RESULTS: One hundred seven of the 129 patients in our cohort received a total of 317 ARV drugs, 59% of which were improperly prescribed. The dosing was too low for 18% of the patients and too high for 39% of the patients. Twenty-eight patients (26%) did not receive any of their ARV drugs at the recommended dose. The lowest prescribed dose (8% of the daily recommended dose) was observed with indinavir and zidovudine, and the highest prescribed dose (1000% of the recommended dose) was observed with stavudine. Among patients who received HAART, those who were prescribed an insufficient dose of a protease inhibitor had more-severe HIV disease and worse 2-year survival than did the other patients (mean rate of survival+/-standard deviation, 79.5%+/-7.5% vs. 95.4%+/-2.6%, respectively; P<.02). For dialyzable ARV drugs, the delay between ARV drug receipt by the patients and dialysis sessions was not respected in 9% of cases, and in 73% of cases, it was not known whether the patients took the ARV drugs before or after dialysis sessions. CONCLUSION: This is, to our knowledge, the first study to show a significant association between ARV drug prescription errors and survival in patients undergoing dialysis.