Baseline characteristics according to previous exposure to systemic treatment in patients with moderate to severe psoriasis: Results from the PROSE study

2019 ◽  
Vol 81 (4) ◽  
pp. AB175
2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 1012-1012
Author(s):  
Philippe Caillet ◽  
Marina Pulido ◽  
Etienne Brain ◽  
Claire Falandry ◽  
Isabelle Desmoulins ◽  
...  

1012 Background: Advanced breast cancer (ABC) is common in older patients, resulting from the high incidence of breast cancer beyond age 70. This population is often limited in clinical trials. Endocrine therapy (ET) combined with a CDK4/6 inhibitor is the standard of care in ABC overexpressing hormonal receptors (HR+). Data specific to older patients are scarce in the literature, deserving further research. Methods: PALOMAGE is an ongoing French prospective study evaluating palbociclib (PAL) + ET in real life setting in women aged ≥70 with HR+ HER2- ABC, split in 2 cohorts: ET sensitive patients with no prior systemic treatment for ABC (cohort A), and ET resistant patients and/or with prior systemic treatment for ABC (cohort B). Data collected include clinical characteristics, quality of life (EORTC QLQ-C30 and ELD14) and geriatric description [G8 and Geriatric-COre DatasEt (G-CODE)]. This analysis reports on baseline characteristics and safety data for the whole population. Results: From 10/2018 to 10/2020, 400 and 407 patients were included in cohort A and B, respectively. The median age was 79 years (69-98), 15.1% with an age > 85. ECOG performance status (PS) was ≥2 in 17.9% patients, 68.3% had a G8 score ≤14 suggesting frailty, 32.1% had bone only metastasis, and 44% had visceral disease. 35.8% of patients in cohort B had no prior treatment for ABC. Safety data were available for 787 patients. The median follow-up was 6.7 months (IC95% = 6.1-7.6). At start of treatment, full dose of PAL (125 mg) was used in 76% of the patients: 62.6%, 68.7% and 71.6% of patients aged ≥ 80, those with ECOG PS ≥2 and those with a G8 score ≤14, respectively. In the safety population, 70% had ≥1 adverse event (AE), including 43.1% grade 3/4 AE, and 22.9% ≥ 1 serious AE. Most frequent AE reported were neutropenia (43.2%), anemia (17.5%), asthenia (16.3%) and thrombocytopenia (13.6%). Grade 3/4 neutropenia was observed in 32.3% of patients, with febrile neutropenia in 1.1%. Grade 3/4 AE PAL-related were reported in 40.1%, 31.4% of patients aged < 80, ≥80, respectively. Regarding PAL, 23.4% of patients had a dose reduction and 41.8% had a temporary or permanent discontinuation due to AE. Safety data were similar in both cohorts. Geriatric data and impact on safety will be presented. Conclusions: PALOMAGE is a unique large real-world cohort focusing on older patients treated with PAL in France. These preliminary data do not suggest any new safety signal, matching data derived from PALOMA trials. The occurrence of less grade3/4 AE related to PAL in patients aged 80 and beyond might reflect the 30% decrease of PAL dose upfront. Effectiveness analyses are eagerly awaited. Clinical trial information: EUPAS23012 .


2022 ◽  
Vol 23 (1) ◽  
pp. 555
Author(s):  
Xing Wang ◽  
Hannah Kaiser ◽  
Amanda Kvist-Hansen ◽  
Benjamin D. McCauley ◽  
Lone Skov ◽  
...  

Psoriasis is a chronic inflammatory condition associated with atherosclerotic cardiovascular disease (CVD). Systemic anti-psoriatic treatments mainly include methotrexate and biological therapies targeting TNF, IL-12/23 and IL-17A. We profiled plasma proteins from patients with moderate-to-severe psoriasis to explore potential biomarkers of effective systemic treatment and their relationship to CVD. We found that systemically well-treated patients (PASI < 3.0, n = 36) had lower circulating levels of IL-17 pathway proteins compared to untreated patients (PASI > 10, n = 23). Notably, IL-17C and PI3 were decreased with all four examined systemic treatment types. Furthermore, in patients without CVD, we observed strong correlations among IL-17C/PI3/PASI (r ≥ 0.82, p ≤ 1.5 × 10−12) pairs or between IL-17A/PASI (r = 0.72, p = 9.3 × 10−8). In patients with CVD, the IL-17A/PASI correlation was abolished (r = 0.2, p = 0.24) and the other correlations were decreased, e.g., IL-17C/PI3 (r = 0.61, p = 4.5 × 10−5). Patients with moderate-to-severe psoriasis and CVD had lower levels of IL-17A compared to those without CVD (normalized protein expression [NPX] 2.02 vs. 2.55, p = 0.013), and lower IL-17A levels (NPX < 2.3) were associated with higher incidence of CVD (OR = 24.5, p = 0.0028, 95% CI 2.1–1425.1). As a result, in patients with moderate-to-severe psoriasis, we propose circulating IL-17C and PI3 as potential biomarkers of effective systemic anti-psoriatic treatment, and IL-17A as potential marker of CVD.


2014 ◽  
Vol 24 (6) ◽  
pp. 662-669 ◽  
Author(s):  
Francisco Vanaclocha ◽  
Isabel Belinchón ◽  
José L. Sánchez-Carazo ◽  
Raquel Rivera ◽  
José M. Carrascosa ◽  
...  

2020 ◽  
Vol 6 (3) ◽  
pp. 224
Author(s):  
Mary Kathryn Abel ◽  
Raagini Suresh ◽  
Jodie Raffi ◽  
Kristin Razzeca ◽  
Jenny E. Murase

2014 ◽  
Vol 33 (2) ◽  
pp. 163-177 ◽  
Author(s):  
Laura M. Sawyer ◽  
David Wonderling ◽  
Karina Jackson ◽  
Ruth Murphy ◽  
Eleanor J. Samarasekera ◽  
...  

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 344-344 ◽  
Author(s):  
Richard S. Finn ◽  
Philippe Merle ◽  
Alessandro Granito ◽  
Yi-Hsiang Huang ◽  
Gyorgy Bodoky ◽  
...  

344 Background: SOR is standard first-line systemic treatment for HCC unsuitable for locoregional therapy. RESORCE showed that REG improves overall survival (OS) in patients who progressed during SOR treatment (HR 0.63, 95% CI 0.50, 0.79; P < 0.001). This exploratory analysis describes outcomes for the sequence of SOR followed by REG. Methods: 573 patients were randomized 2:1 to receive REG 160 mg/day (d), 3 wks on/1 wk off or PBO. Data on prior SOR treatment and radiologic progression were prospectively collected. Efficacy and safety were evaluated by the last SOR dose. Time from the start of SOR to death was assessed. Results: Baseline characteristics were balanced. Times from the start of SOR to progression on SOR and times from progression on SOR to start of study drug were similar (Table). When analyzed based on last SOR dose 800 mg/d vs < 800 mg/d, rates of all grade treatment-emergent adverse events (TEAEs) on study were similar (REG: 100% vs 100%; PBO: 92% vs 93%). TEAE grades 3/4/5 by last SOR dose 800 mg/d vs < 800 mg/d were 52/11/15% vs 61/10/12%, respectively, with REG and 30/8/24% vs 32/7/14% with PBO. HRs (95% CI) REG/PBO for OS by last SOR dose were similar: 0.67 (0.51, 0.87) for 800 mg/d and 0.68 (0.48, 0.97) for < 800 mg/d. Median OS (95% CI) from the start of SOR was 26.0 months (22.6, 28.1) for REG and 19.2 months (16.3, 22.8) for PBO. Clinical trial information: NCT01774344. Conclusions: This exploratory subgroup analysis by prior SOR dose demonstrates a consistent survival benefit for REG. In addition, the safety profile of REG was not remarkably different when analyzed by the last SOR dose.[Table: see text]


Author(s):  
Neda Shahriari ◽  
Sarah Mattessich ◽  
Tin-Chi Lin ◽  
Heather J Litman ◽  
Robert R McLean ◽  
...  

Aim: To evaluate whether the presence of a history of depression hinders psoriasis response to systemic therapies and to delineate baseline characteristics of patients whose depressive symptoms improved on systemic treatment. Methods: We studied patients within the Corrona® Psoriasis Registry, a prospective, multicenter observational disease-based registry, that were enrolled through September 2018, comparing changes from enrollment to 12-month visit. Results: There was a statistically significant improvement in all disease characteristics and most patient-reported outcomes in patients reporting a history of depression and in those that did not while there was no statistically significant difference in the degree of change comparing these two cohorts. Patients who noted improvement in depressive symptoms had more severe baseline disease characteristics and reported overall worse baseline patient-reported outcomes. Conclusions: History of depression does not portend a differential response to systemic treatment. Patients with improvement in depressive symptoms had worse baseline characteristics.


Sign in / Sign up

Export Citation Format

Share Document