Effectiveness of brodalumab in achieving treatment satisfaction for patients with plaque psoriasis: The ProLOGUE study

Imafuku, Shinichi; Ohata, Chika; Okubo, Yukari; Tobita, Rie; Saeki, Hidehisa; Mabuchi, Tomotaka; Hashimoto, Yuki; Murotani, Kenta; Kitabayashi, Hiroki; Kanai, Yasumasa

doi:10.1016/j.jdermsci.2022.02.007

Cited by 12 publications

(32 citation statements)

References 33 publications

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“…At baseline and at weeks 12 and 48, a total of 73, 73, and 69 patients had evaluable PASI data and 73, 72, and 65 patients had complete PRO data, respectively. 18 …”

Section: Resultsmentioning

confidence: 99%

“…At baseline and at weeks 12 and 48, a total of 73, 73, and 69 patients had evaluable PASI data and 73, 72, and 65 patients had complete PRO data, respectively. 18 Thirty-four patients (46.6%) had comorbidities at baseline, with the major (incidence $ 5%) ones being hypertension (27.4%), hyperuricemia or gout (17.8%), diabetes mellitus (13.7%), dyslipidemia (13.7%), and hepatic steatosis or abnormal hepatic function (9.6%). 15 Analyses of the DLQI scores between patients with major comorbidities and those without major comorbidities at baseline revealed no significant difference at baseline and at weeks 12 and 48 (Wilcoxon's rank-sum test; data not shown).…”

Section: Patient Characteristicsmentioning

confidence: 99%

“… 12 , 13 Approximately 30% to 40% of patients with psoriasis have an absolute PASI score of ≤10 and do not meet the eligibility criteria for RCTs in patients with moderate-to-severe plaque psoriasis, 14 , 15 indicating the need for patient assessment using absolute PASI in real-life settings. An absolute PASI score of ≤2 or a PASI score of 90 is used as a suitable treatment target for psoriasis 16 , 17 , 18 ; however, there is only limited research that suggests strategies for the improvement of HRQoL in patients who achieve the absolute PASI-based treatment target without complete HRQoL improvement.…”

Section: Introductionmentioning

confidence: 99%

“… 19 , 20 To assess its effectiveness in Japanese patients with plaque psoriasis, we conducted impacts on patient-reported outcomes by brodalumab for patients suffering from plaque psoriasis in clinical practice (ProLOGUE), a single-arm, open-label, multicenter, prospective study (Japan Registry of Clinical Trials identifier: jRCTs031180037). 15 , 18 In the current analysis of the ProLOGUE study, we assessed the real-life effectiveness of brodalumab in the improvement of HRQoL (DLQI score and European Quality of Life 5-Dimension 5-Level [EQ-5D-5L] 21 Utility Index [UI] score). We then investigated the factors associated with incomplete HRQoL improvement despite the achievement of clear or almost-clear skin in patients with psoriasis in terms of patient-reported outcomes (PROs).…”

Section: Introductionmentioning

confidence: 99%

“…and 2, and once every 2 weeks thereafter) until week 48. No criteria were set for concomitant or prohibited therapies 18. …”

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confidence: 99%

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Itch as a critical factor in impaired health-related quality of life in patients with plaque psoriasis achieving clear or almost-clear skin: Analysis of the single-arm, open-label, multicenter, prospective ProLOGUE study

Miyagi¹,

Kanai²,

Murotani³

et al. 2022

JAAD International

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“…At baseline and at weeks 12 and 48, a total of 73, 73, and 69 patients had evaluable PASI data and 73, 72, and 65 patients had complete PRO data, respectively. 18 …”

Section: Resultsmentioning

confidence: 99%

Section: Patient Characteristicsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“…and 2, and once every 2 weeks thereafter) until week 48. No criteria were set for concomitant or prohibited therapies 18. …”

mentioning

confidence: 99%

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Itch as a critical factor in impaired health-related quality of life in patients with plaque psoriasis achieving clear or almost-clear skin: Analysis of the single-arm, open-label, multicenter, prospective ProLOGUE study

Miyagi¹,

Kanai²,

Murotani³

et al. 2022

JAAD International

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Effectiveness of Long-Term Treatment with Brodalumab on Anxiety or Depressive Symptoms in Japanese Patients with Psoriasis: The ProLOGUE Study

Ohata

Kanai

Murotani

et al. 2023

Dermatol Ther (Heidelb)

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Introduction: Evidence on treatment effectiveness in patients with psoriasis having anxiety or depressive symptoms helps shared decisionmaking. This single-arm, open-label, prospective study-ProLOGUE-was conducted to assess the effectiveness of brodalumab on selfassessed anxiety and depressive symptoms in Japanese patients with psoriasis. Methods: Patients aged C 18 years with plaque psoriasis without peripheral arthritis symptoms who had responded inadequately to current therapies were enrolled at 15 Japanese facilities and received brodalumab 210 mg subcutaneously.

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Management of Moderate to Severe Plaque Psoriasis with Brodalumab in Daily Practice: Real-World Evidence from the LIBERO Study in the Czech Republic

Gkalpakiotis,

Kojanová,

Fialová

et al. 2023

Dermatol Ther (Heidelb)

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Introduction Psoriasis is a chronic, immune-mediated inflammatory skin disease. Despite the availability of several therapies, many patients affected by this disease remain untreated, do not have adequate response, or suffer from treatment-related toxic effects. It has been shown that the interleukin (IL)-17 pathway plays a key role in the immunopathogenesis of psoriasis. Brodalumab, the first human monoclonal IgG2 antibody that selectively binds to subunit A of the human IL-17 receptor, blocking interactions with a number of cytokines of the IL-17 family, has confirmed fast onset of action, high complete clearance rates, and sustained efficacy. Nevertheless, there is only a limited amount of published real-world evidence (RWE) data. Methods This was an open-label, multicenter, real-world, prospective, non-interventional, non-controlled (single-arm) observational study (LIBERO-CZ) assessing the management of moderate to severe psoriasis with brodalumab in daily practice for up to 52 weeks of treatment. Results Fifty-four patients (70.4% male, mean age 46.9 ± 13.4 years, weight 95.6 ± 22.7 kg, disease duration 18.6 ± 12.7 years) were enrolled and included in the final analysis. Forty-nine of the patients completed the study and five discontinued prematurely; 51.8% of all the enrolled patients were biologic-naïve. At baseline, 28% patients were classified as severe (psoriasis area severity index (PASI) ≥ 20). Overall, the mean PASI decreased by 15.6 from 16.1 (± 5.0) at baseline to 0.5 (± 1.2) at the last visit. The primary endpoint of an absolute PASI ≤ 3 at week 12 (as observed analysis) was achieved by 95.9% of patients. The static Physician’s Global Assessment (sPGA) success (defined as clear = 0 and almost clear = 1) at week 52 was achieved by 92.1% of patients. PASI 75, PASI 90, and PASI 100 were achieved by 98.0%, 87.8%, and 75.5% of patients, respectively, after approximately 52 weeks of treatment. The study also recorded very positive results concerning patient-reported outcomes. Conclusions LIBERO-CZ confirms the fast onset and high clearance rates of brodalumab in real life in both biologic-naïve and biologic-experienced patients.

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Effectiveness of brodalumab in achieving treatment satisfaction for patients with plaque psoriasis: The ProLOGUE study

Cited by 12 publications

References 33 publications

Itch as a critical factor in impaired health-related quality of life in patients with plaque psoriasis achieving clear or almost-clear skin: Analysis of the single-arm, open-label, multicenter, prospective ProLOGUE study

Itch as a critical factor in impaired health-related quality of life in patients with plaque psoriasis achieving clear or almost-clear skin: Analysis of the single-arm, open-label, multicenter, prospective ProLOGUE study

Effectiveness of Long-Term Treatment with Brodalumab on Anxiety or Depressive Symptoms in Japanese Patients with Psoriasis: The ProLOGUE Study

Management of Moderate to Severe Plaque Psoriasis with Brodalumab in Daily Practice: Real-World Evidence from the LIBERO Study in the Czech Republic

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