Efficacy of Calcipotriol-Betamethasone Ointment in Patients with Mild to Moderate Plaque Psoriasis: Subgroup Analyses

Dermatology ◽  
2019 ◽  
Vol 235 (6) ◽  
pp. 501-508 ◽  
Author(s):  
Nina Habjanič ◽  
Vesna Lužar-Stiffler ◽  
Mojca Kerec-Kos ◽  
Darja Grabnar Peklar

Background: Several factors have been shown to affect psoriasis pathogenesis, clinical presentation and treatment response. Objectives: The aim of this study was to investigate the potential relationship between patients’ baseline characteristics and the efficacy of calcipotriol-betamethasone ointment in patients with mild to moderate plaque psoriasis and to evaluate whether the efficacy is consistent across subgroups. Method: Using data from the therapeutic equivalence study on patients with plaque psoriasis, post hoc analyses were performed to evaluate the impact of baseline demographic and disease characteristics, habits and comorbidities on the response to treatment with calcipotriol-betamethasone ointment. Results: Body mass index (BMI) and obesity were each independently associated (univariate analysis, p < 0.05) with reduction in modified Psoriasis Area and Severity Index (mPASI) and PASI75 (≥75% improvement in mPASI from baseline). Increased body weight is more common in patients with late-onset psoriasis. There was a significant trend for lower response rates with increasing BMI (p = 0.007) and obesity (p = 0.003). The odds of achieving PASI75 is 2.3 times lower for obese compared to normal-weight subjects.If patients with obesity or hypertension were treated with calcipotriol-betamethasone, they were still more likely to achieve PASI75 after 4-week treatment compared to vehicle (p < 0.001). Conclusion: Increased BMI and obesity present risk factors for reduced treatment effectiveness. Importantly, the efficacy of calcipotriol-betamethasone ointment was consistent in all subgroups.

2020 ◽  
Author(s):  
Maria Quero ◽  
Jordi Comas ◽  
Emma Arcos ◽  
Miguel Hueso ◽  
Diego Sandoval ◽  
...  

Abstract Background Some studies reveal that obesity is associated with a decrease in mortality in haemodialysis (HD) patients. However, few studies have addressed the association between body mass index (BMI) and peritoneal dialysis (PD) patients. Methods We performed this longitudinal, retrospective study to evaluate the impact of obesity on PD patients, using data from the Catalan Registry of Renal Patients from 2002 to 2015 (n = 1573). Obesity was defined as BMI ≥30; low weight: BMI &lt;18.5; normal range: BMI = 18.5–24.99; and pre-obesity: BMI = 25–29.99 kg/m2. Variations in BMI were calculated during follow-up. The main outcomes evaluated were the technique and patient survival. Results Obesity was observed in 20% of patients starting PD. We did not find differences in sex or PD modality, with the obesity group being older (65.9% are ≥55 years versus 59% non-obese, P = 0.003) and presenting more diabetes mellitus and cardiovascular disease (CVD) (47.9% obese versus 25.1% non-obese and 41.7% versus 31.5%, respectively). We did not observe differences in haemoglobin, albumin and Kt/V in obese patients. Regarding peritonitis rate, we did not find any difference between groups, presenting more peritonitis patients on continuous ambulatory peritoneal dialysis and aged ≥65 years [sub-hazard ratio (SHR) = 1.75, P = 0.000 and SHR = 1.56, P = 0.009]. In relation to technique survival, we found higher transfer to HD in the obese group of patients in the univariate analysis, which was not confirmed in the multivariate analysis (SHR = 1.12, P = 0.4), and we did not find differences in mortality rate. In relation to being transplanted, the underweight group, elderly and patients with CVD or diabetic nephropathy presented less probability to undergo kidney transplantation (SHR = 0.65, 0.24, 0.5 and 0.54, P &lt; 0.05). Obese patients did not present differences in survival with weight changes but in normal-weight patients, a gain of 7% of the basal weight during the first year had a protective effect on death risk (hazard ratio 0.6, P = 0.034). Conclusions Obese and non-obese patients starting on PD had similar outcomes.


2020 ◽  
Vol 2 (1) ◽  
Author(s):  
Francesca Pasqualin ◽  
Silvia V. Guidoni ◽  
Mario Ermani ◽  
Elena Pegoraro ◽  
Domenico M. Bonifati

Abstract Background Recently different subtypes of myasthenia gravis (MG) have been described. They differ for clinical features and pathogenesis but the prognosis and response to treatment is less clear. The aim of the study was to evaluate outcome and treatment effectiveness including side effects in late onset MG (LOMG) compared with early onset MG (EOMG). Methods We analysed retrospectively 208 MG patients. Clinical features were recorded as well as treatment and side effects. Outcome at the last follow-up was evaluated with MGSTI and MGPIS scales. Results The 208 patients included were classified as follow: 36 ocular MG, 40 EOMG, 72 LOMG, 25 thymoma-associated, 14 anti-MuSK and 21 double seronegative. Similar positive outcome was achieved in either early and late onset subgroup. We found pharmacological remission and minimal manifestations at the MGFA-PIS in the 95% and 94,4% of EOMG and LOMG respectively but in LOMG a lower dose of immunosuppressors (MGSTI< 2) was required compared to EOMG (p = 0,048). Severe side effects were present in a small percentage of patients in both group but diabetes was more frequent in LOMG vs EOMG (2,2% vs 5%, p = 0.017). Conclusions Despite LOMG has more comorbidities that might interfere with treatment and outcome, therapeutic management does not seem to differ between EOMG and LOMG. A similar positive outcome was seen in both subgroups but LOMG group seems to require lower doses of medication to control symptoms.


2014 ◽  
Vol 41 (6) ◽  
pp. 1230-1232 ◽  
Author(s):  
Mital Patel ◽  
Stephanie W. Liu ◽  
Abrar Qureshi ◽  
Joseph F. Merola

Psoriasis is a chronic inflammatory disease that encompasses a large spectrum of clinically distinct subtypes. Although chronic plaque psoriasis is reported as the most common form of psoriatic skin disease, there is growing evidence that other variants including scalp, nail, inverse, and palmoplantar psoriasis are prevalent, undertreated, and associated with significant impairment in quality of life. Currently, the Psoriasis Area and Severity Index (PASI) is the standard to assess psoriasis severity as well as response to treatment; however, the PASI has several limitations. In response to this need and as a complementary objective measure to the PASI, we created the Brigham Scalp Nail Inverse Palmoplantar Psoriasis Composite Index (B-SNIPI), based on patient-surveyed, patient-reported outcomes equally weighted with physician assessment of disease activity. Herein we summarize the B-SNIPI as presented at the 2013 Annual Meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).


2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 591-591
Author(s):  
Umang Shah ◽  
Ashish Abhay Khot ◽  
Dharmendra Goyal ◽  
Shuang Guo ◽  
Andreas Kaubisch ◽  
...  

591 Background: The role of biologic agents in the treatment of mCRC has been studied in clinical trials. These studies included ≥ 90% patients (pts) of white race. Hispanics and blacks were largely underrepresented. CER allows exploration of the impact of biologic agents in a cohort composed largely of pts from minorities. We present the results of a cohort of pts served by Montefiore Einstein Cancer Center (MECC) in Bronx, NY. Methods: Pts diagnosed and treated for mCRC from January 2000 to December 2011 were identified using data from the MECC Cancer Registry. Pts demographic and clinical characteristics were extracted from pts medical records. A Cox proportional–hazard model was used to assess survival differences between pts treated with chemotherapy alone vs. pts treated with chemotherapy plus biologics. Results: A total of 293 pts where identified; 45% were black, 27% were Hispanic, and 28% were white. Of the pts receiving biologics, 90% received bevacizumab and 50% received cetuximab or panitumumab. The median overall survival was 15.2 months in the chemotherapy alone group and 25.6 months chemotherapy + biologics group (p=0.003). Univariate analysis showed that 1 metastatic site vs. ≥ 2, CEA <40 ng/mL, receiving ≥ 2 lines of chemotherapy and exposure to biologics were independently associated with longer survival. Multivariate analysis of the whole cohort (n=290), which included all ethnic groups, showed that exposure to biologics offered a survival benefit (HR of 0.70, 95%CI 0.52–0.93, p=0.02), after adjusting for gender, age, CEA, number of metastatic sites and lines of chemotherapy received. Subgroup analysis based on ethnicity showed survival benefit for Whites (HR of 0.38, 95%CI 0.22–0.66, P=0.001) but not for Hispanics (HR of 0.65, 95%CI 0.35–01.23, p=0.18) nor Blacks (HR of 1.04, 95%CI 0.63–1.70, p=0.87). Conclusions: In this cohort weighted heavily towards ethnic minorities, the addition of biologics to chemotherapy was associated with longer survival, an effect mainly driven by whites. Hispanics and blacks did not seem to benefit from exposure to biologics. An effort should be made to include minority pts in ongoing clinical trials.


2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Jia Zhang ◽  
Shaoping Wan ◽  
Fen Dong ◽  
Li Pan ◽  
Wuli Yihuo ◽  
...  

Background. Rising hypertension prevalence, coupled with increasing overweight and obesity rates, has been observed in Yi people. Moreover, the growing blood pressure level among Yi people was mostly attributable to the continuous increase of body mass index (BMI). However, little is known about the trend of association between them. Methods. Consequently, we investigated the impact of overweight/obesity on hypertension over three periods (1996, 2007-2008, 2015) using data from Yi Migrant Study (n = 8749). The Yi Migrant Study incorporated three successive cross-sectional studies which were implemented by the same team with consistent protocols. Results. Compared with period 1 (1996), the influence of overweight/obesity on hypertension risk significantly increased in period 2 (2007-2008) and period 3 (2015); relative excess risk due to interaction (RERI) was 1.59 (95% CI: 0.12, 3.05) and 1.41 (95% CI: 0.30, 2.78), respectively. Meanwhile, the overweight/obese population in period 3 did not show hypertension risk higher than that in period 2 (RERI = 0.15; 95% CI: −0.76, 1.07). Additionally, we observed a continuously growing trend of hypertension risk among normal weight Yi people. Conclusions. During the past two decades, there was a significant increase in the association between overweight/obesity and hypertension in Yi people, whereas the increasing trend has leveled off in more recent years. These findings suggest that overweight/obesity and hypertension are becoming more epidemic comorbidity over time. Interventions to prevent hypertension should focus not only on the overweight/obese population, but also on those with normal weight.


2020 ◽  
Vol 97 (1143) ◽  
pp. 16-22
Author(s):  
Manlio Guazzaroni ◽  
Donatella Ferrari ◽  
Feliciana Lamacchia ◽  
Vanessa Marisi ◽  
Doriana Tatulli ◽  
...  

Psoriasis (PsO) is a chronic skin disease. This study aims to evaluate clinical and subclinical response to calcipotriol+betamethasone foam, in patients with PsO, comparing, for the first time, data from microvascular ultrasound (MicroV) and shear wave elastography (SWE) with Psoriasis Area and Severity Index (PASI).MethodsBetween November 2018 and April 2019 in Tor Vergata Hospital (Roma, Italy), we enrolled 26 patients with PsO who were ageds 20–75 years, with PASI score ≥4, candidated for calcipotriol+betamethasone foam treatment. They underwent MicroV and SWE evaluation at baseline (T0) and after 4 weeks of treatment (T4). Clinical follow-up was carried on at T4, T8 and T12. Student’s t-test (p values<0.05 statistically significant) was used to compare SWE and PASI values.ResultsAt T0, SWE stiffness values of target plaques (61.5% on elbows, 23% knees, 7.7% sacrum,7.7% legs) were significantly higher than values under healthy skin. At T4, all patients showed a significant reduction of PASI; MicroV showed reduction in vascularisation of responsive plaques in 85% of cases, only in 15%, the vascularisation degree remained stable; and SWE values of target plaques were significantly lower compared with T0. Only in 7.7%, there was a relapse at T12.ConclusionsCalcipotriol+betamethasone foam is a very effective topical treatment in a short-medium term follow-up in patients with PsO. MicroV and SWE evaluate response to treatment (in term of plaque vascularisation and stiffness), so they could represent promising early indicators of therapeutic response and help the physician to establish a better clinical-therapeutic management of patients with PsO.


2019 ◽  
Vol 4 (4) ◽  
pp. 180-185 ◽  
Author(s):  
Kim Papp ◽  
Andrew Blauvelt ◽  
John Sullivan ◽  
Yayoi Tada ◽  
Paula Polzer ◽  
...  

Background: The impact of treatment with interleukin 17 (IL-17) inhibitors on the efficacy of subsequent IL-17 inhibitor therapy is unknown. Objective: To evaluate the impact of previous treatment with IL-17 inhibitors on the 52-week efficacy of ixekizumab in patients with moderate-to-severe psoriasis. Methods: In a phase 3, randomized, double-blinded trial (IXORA-P; NCT02513550), patients with moderate-to-severe plaque psoriasis were randomized (2:1:1) to ixekizumab 80 mg every 2 weeks (IXE Q2W, n = 611), every 4 weeks (IXE Q4W, n = 310), or IXE Q4W/IXE Q2W dose adjustment (per predefined criteria; n = 306). Psoriasis Area and Severity Index 75%, 90%, and 100% response rates (PASI 75, PASI 90, and PASI 100) were assessed. Results: Overall, 288 (23.5%) of 1227 patients were IL-17 inhibitor experienced (brodalumab, 22.6%; secukinumab, 1.1%). The PASI 75, 90, and 100 at week 52 were similar between IL-17 inhibitor-naive and IL-17 inhibitor-experienced patients. The PASI 75 at week 52 for IL-17 inhibitor-naive and -experienced patients was 85% and 89% (IXE Q2W), 79% and 81% (IXE Q4W), and 83% and 85% (IXE Q4W/IXE Q2W), respectively. The PASI 90 at week 52 for IL-17 inhibitor-naive and -experienced patients was 79% and 82% (IXE Q2W), 65% and 67% (IXE Q4W), and 73% and 75% (IXE Q4W/IXE Q2W), respectively. The PASI 100 at week 52 for IL-17 inhibitor-naive and -experienced patients was 60% and 59% (IXE Q2W), 44% and 42% (IXE Q4W), and 49% and 52% (IXE Q4W/IXE Q2W), respectively. Safety findings were generally similar between IL-17 inhibitor-naive and -experienced patients. Conclusion: Ixekizumab was demonstrated to be an effective and safe therapeutic option for patients previously treated with other IL-17 inhibitors.


SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A200-A200
Author(s):  
M Sforza ◽  
V Castronovo ◽  
A Galbiati ◽  
M Zucconi ◽  
A Oldani ◽  
...  

Abstract Introduction Insomnia disorder (ID) is characterized by high degree of heterogeneity. Aim of our study was to identify ID patients subtypes in terms of sleep and non-sleep clinical baseline (BL) features and CBT-I efficacy. Methods 294 chronic insomnia patients (61.6% female, mean age 40.7 ± 12.3 yrs) underwent 7-sessions group CBT-I. By use of latent class analysis (LCA) we identified ID subtypes according to BL score of Glasgow Sleep Effort Scale (GSES); Epworth Sleepiness Scale (ESS); Dysfunctional Beliefs and Attitudes about Sleep (DBAS -16); Morningness-Eveningness Questionnaire Self-Assessment (MEQ-SA); Perceived Stress Scale (PSS); Profile of Mood States (POMS); Beck Depression Inventory (BDI-II); Stay-Trait Anxiety Inventory (STAI-Y); Treatment effectiveness (Delta score of Insomnia Severity Index ISI between BL and end-of-treatment). Results We chose 3 latent classes as most parsimonious model. According to questionnaires’ cut-off, we labeled three classes: Class 1 (insomnia+anxiety+depression+stress) (n=62), Class 2 (insomnia+anxiety+depression) (n=153), Class 3 (only insomnia) (n=79). The variables that best differentiate the 3 classes were POMS (.772), STAY (.660), PSS (.545), BDI (.406) and ISI (.228) at BL. In particular, for ISI, the best item predicting groups differentiation was item 3 on the impact of insomnia on daytime functioning (.224). Moreover, we found a significant interaction between CBT-I treatment effect and the 3 classes at the ISI score (p=.001), GSES score (p=.002), DBAS score (p&lt;.05), PSS score (p&lt;.001), POMS score (p&lt;.001), BDI score (p&lt;.001) and STAI-Y score (p&lt;.001). Conclusion Our data driven analysis results suggest that the heterogeneity of ID patients can be best represented by non-sleep scores, in particular those regarding depression, anxiety, stress and daytime functioning. These information can be useful in predicting the outcome of CBT-I. Support No


2007 ◽  
Vol 7 ◽  
pp. 1063-1069 ◽  
Author(s):  
Arnon D. Cohen ◽  
Raquel Shalev ◽  
Ron Yaniv ◽  
Avner Shemer

QoolSkin is novel herbal topical medication indicated for the treatment of patients with psoriasis and we endeavored to determine the efficacy of QoolSkin in patients with chronic plaque psoriasis. In an open-label, parallel-group study conducted at four sites in Israel, patients with chronic plaque psoriasis were treated by application of QoolSkin two to three times per day, for a period of 16 weeks. Clinical assessment was performed using the Psoriasis Area and Severity Index (PASI) and the Beer-Sheva Psoriasis Severity Score (BPSS). The study included 100 patients (48 men, 52 women; age 18–65 years). QoolSkin was well tolerated and there were no local or systemic side effects. There was a 19% reduction in PASI, from a mean of 9.8 ± 9.5 before treatment to 8.0 ± 9.6 after treatment (p = 0.09). There was a 20% reduction in BPSS, from a mean of 16.1 ± 9.8 before treatment to 12.8 ± 10.6 after treatment (p = 0.01). The reduction in PASI and BPSS was pronounced in women (32 and 31%, respectively) as compared to men (9 and 11%, respectively). The reduction in PASI and BPSS was parallel to the length of time the patients were treated by QoolSkin. In patients treated by one of the investigators, who applied QoolSkin three times per day and for a long period of time (mean 101.1 days), the reduction in PASI was 32.0% and the reduction in BPSS was 37.8%. In patients with chronic plaque psoriasis, QoolSkin treatment was well tolerated. Application of QoolSkin was associated with a decrease in disease severity, as assessed by the patients and physicians. Application of QoolSkin three times per day for long period is associated with a better response to treatment.


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