記述言語：英語   掲載種別：研究論文（学術雑誌）  

The tyrosine kinase 2 inhibitor deucravacitinib is effective for psoriasis. However, it is unclear whether early responses to deucravacitinib in real-world practice are maintained for 2 years and whether patients without early responses can achieve delayed responses. This study is aimed to evaluate the sustainability of week 16 responses to deucravacitinib treatment for psoriasis and to evaluate delayed responses in week 16 poor responders. This prospective study included 117 Japanese patients with moderate-to-severe psoriasis treated with deucravacitinib. Patients who achieved psoriasis area and severity index (PASI) 75, PASI 90, PASI 100, absolute PASI ≤ 2, absolute PASI ≤ 1, static physician's global assessment (sPGA) 0/1, or dermatology life quality index (DLQI) 0/1 at week 16 were evaluated for maintenance of each outcome. Patients who did not achieve these outcomes at week 16 were evaluated for delayed achievement of each outcome through week 104. In week 16 achievers, week 104 maintenance rates of PASI 75, PASI 90, PASI 100, absolute PASI ≤ 2, and absolute PASI ≤ 1 were 95.2%, 87.5%, 66.7%, 100%, and 91.7%, respectively, while those of sPGA 0/1 and DLQI 0/1 were 100% and 88.9%, respectively. In week 16 non-achievers, week 104 achievement rates for PASI 75, PASI 90, PASI 100, absolute PASI ≤ 2, and absolute PASI ≤ 1 were 25.0%, 15.4%, 7.7%, 50.0%, and 23.5%, respectively, and those for sPGA 0/1 and DLQI 0/1 were 60.0% and 50.0%, respectively. Improvements of rash and quality of life achieved at week 16 of deucravacitinib treatment were mostly sustained through week 104. Some patients without week 16 responses could achieve delayed responses at later time points.

DOI： 10.1111/1346-8138.70139

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Real-world data are limited on 2 year effectiveness of tyrosine kinase 2 inhibitor deucravacitinib for psoriasis, especially that stratified by body mass index (BMI) or age. This study is aimed to evaluate 104 week effectiveness of deucravacitinib in patients with psoriasis, stratified by BMI (< 25 versus ≥ 25 kg/m2) or age (< 65 versus ≥ 65 years). We included 127 patients with moderate-to-severe psoriasis who received deucravacitinib 6 mg once daily. Psoriasis area and severity index (PASI) decreased throughout 104 weeks in whole patients. In between-group comparisons, mean percent reduction of PASI did not significantly differ at any time point in either BMI or age stratification. The amount of decreasing PASI and achievement rates of PASI 75, 90, and absolute PASI ≤ 2 through week 16 to 68 were slightly higher in BMI < 25 than in BMI ≥ 25, thereafter inverted order. The achievement rates of PASI 100 or absolute PASI ≤ 1 were higher in BMI < 25 throughout 104 weeks; week 104 PASI 100 or absolute PASI ≤ 1 rates were 16.7% or 54.2% in BMI < 25 while 0% or 40% in BMI ≥ 25, respectively. Percent reduction of PASI and achievement rates of PASI 75 and 90 were slightly higher in age ≥ 65 years than in age < 65 years by week 52, thereafter inverted order. Week 104 achievement rates of PASI 100 or absolute PASI ≤ 1 were 28.6% or 57.1% in age < 65 years while 0% or 46.7% in age ≥ 65 years, respectively. Deucravacitinib reduced PASI throughout 104 weeks in whole patients. Patients with BMI < 25 or age ≥ 65 years might show slightly higher response to deucravacitinib at early time points around 1 year compared to slightly higher response at later time points in those with BMI ≥ 25 or age < 65 years. Patients with BMI ≥ 25 or age ≥ 65 years might have difficulty in keeping PASI 100 through week 104.

DOI： 10.1111/1346-8138.70137

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, has been reported to be effective and tolerable for moderate-to-severe palmoplantar pustulosis (PPP) in clinical trials, but real-world data are limited. To evaluate the 28-week real-world effectiveness of apremilast in patients with PPP. We conducted a single-center, retrospective study of 15 adult patients (≥ 18 years) with moderate-to-severe PPP (baseline physician's global assessment score ≥ 3) who required systemic treatment because topical therapy alone was insufficient or unsuitable. Patients received apremilast 30 mg twice daily. Palmoplantar Pustulosis Area and Severity Index (PPPASI) and Dermatology Life Quality Index (DLQI) were assessed at weeks 0, 4, 16, and 28 of treatment. Mean PPPASI and DLQI scores decreased continuously through Week 28. At Week 28, mean percent reductions of PPPASI and DLQI from baseline were 76.9% and 63.4%, respectively. Week 28 rates achieving PPPASI 50, PPPASI 75, PPPASI 90, and DLQI 0/1 were 90.0%, 60.0%, 30.0%, and 42.9%, respectively. Treatment-emergent adverse events were diarrhea in six patients, leading to discontinuation of apremilast in one patient. No serious adverse events occurred. These findings suggest that apremilast treatment is effective and tolerable for PPP patients requiring systemic treatment in routine practice. Further studies with larger cohorts and longer observation are required to confirm the sustainability of its clinical benefits.

DOI： 10.1111/1346-8138.70184

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Two-year effectiveness of tyrosine kinase 2 inhibitor deucravacitinib is unknown for psoriasis in real-world, especially in patients with different histories of systemic therapy. To evaluate the 104-week effectiveness of deucravacitinib in patients with psoriasis, stratified by prior use of apremilast or biologics. We studied 131 patients with moderate-to-severe psoriasis who received deucravacitinib 6 mg/day. Psoriasis area and severity index (PASI) and dermatology life quality index (DLQI) were analyzed in subgroups stratified by prior apremilast or biologic therapy. Deucravacitinib decreased PASI and DLQI through 104 weeks regardless of prior apremilast or biologic therapy. Week 104 achieving PASI 100 and absolute PASI ≤ 1 were higher in apremilast-naïve patients (15.4% and 53.8%) than in apremilast-experienced patients (0% and 25%, respectively). Week 104 achieving PASI 75, PASI 90, PASI 100, and absolute PASI ≤ 1 were higher in biologic-naïve patients (84.6%, 57.7%, 15.4%, and 53.8%) than in biologic-experienced patients (25%, 25%, 0%, and 25%, respectively). Deucravacitinib reduced PASI and DLQI through 104 weeks in patients with psoriasis regardless of prior apremilast or biologic therapy, with lower sustainability of PASI 100 or absolute PASI ≤ 1 achievements in patients with prior apremilast or biologic treatment.

DOI： 10.1111/1346-8138.70175

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記述言語：英語   掲載種別：研究論文（学術雑誌）  

Background: A monoclonal anti-interleukin-13 antibody, lebrikizumab, has demonstrated favorable efficacy for atopic dermatitis (AD). However, it is unclear whether early responses to lebrikizumab may be maintained for a longer term or whether patients without early responses may achieve delayed responses in real-world clinical practice.Objectives:To evaluate the sustainability of clinical outcomes achieved at week 16 of lebrikizumab plus topical corticosteroids (TCS) treatment for AD through week 48 and the achievement of delayed responses in patients without early clinical outcomes.Methods:This prospective study included 134 Japanese patients with moderate-to-severe AD treated with lebrikizumab plus TCS. Patients who achieved Eczema Area and Severity Index (EASI) 50, EASI 75, EASI 90, EASI 100, Investigator's Global Assessment (IGA) 0/1, or Peak Pruritus Numerical Rating Scale (PP-NRS) 4 at week 16 were evaluated for maintenance rates of respective outcomes, while week 16 nonachievers were evaluated for delayed achievement rates of respective outcomes at weeks 24, 36, and 48.Results:In week 16 achievers, week 48 maintenance rates of EASI 50, EASI 75, EASI 90, and EASI 100 were 100%, 94.9%, 100%, and 87.5%, respectively, while those of IGA 0/1 and PP-NRS 4 were 86.7% and 97.1%, respectively. In week 16 nonachievers, week 48 achievement rates for EASI 50, EASI 75, EASI 90, and EASI 100 were 50.0%, 50.0%, 36.5%, and 3.4%, respectively, and those for IGA 0/1 and PP-NRS 4 were 26.5% and 23.1%, respectively.Conclusion:Improvements of rash and pruritus achieved at week 16 of lebrikizumab plus TCS treatment were mostly sustained through week 48. Some patients without week 16 responses could achieve delayed responses at later time points.

DOI： 10.1177/17103568251409806

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