Tazarotene/Betamethasone Dipropionate Cream in Patients with Plaque Psoriasis: Results of a Prospective, Multicenter, Observational Study

Dermatology ◽  
2020 ◽  
pp. 1-8
Author(s):  
Chunxia He ◽  
Hongzhong Jin ◽  
Xiguang Liu ◽  
Fengming Hu ◽  
Litao Zhang ◽  
...  
Keyword(s):  
Observational Study ◽  
Real World ◽  
Plaque Psoriasis ◽  
Adverse Reactions ◽  
Response Rates ◽  
The Body ◽  
Betamethasone Dipropionate ◽  
Efficacy And Safety ◽  
Local Skin ◽  
The Mean

<b><i>Background:</i></b> Topical agents are still the mainstay for the treatment of mild-to-moderate plaque psoriasis, in which fixed combinations play an important role. Tazarotene/betamethasone dipropionate (Taz/BD) cream is a novel fixed combination approved for treating plaque psoriasis in China, but its efficacy and safety have not been verified in a real-world environment. <b><i>Objectives:</i></b> The primary objective was to investigate the efficacy and safety of Taz/BD cream in treating plaque psoriasis. The secondary objectives were to assess its relapse after discontinuation and the efficacy and safety profiles during retreatment. <b><i>Methods:</i></b> A prospective, multicenter, large-scale observational study was conducted. Adult patients with chronic plaque psoriasis involving &#x3c;20% of the body surface area were enrolled. Taz/BD cream was applied once daily for 4 weeks. Patients who achieved ≥90% improvement in the Psoriasis Area and Severity Index (PASI) from baseline to week 4 were followed up to investigate relapse after drug withdrawal. Relapsed patients underwent another 4-week treatment. <b><i>Results:</i></b> In total, 2,299 eligible patients were enrolled, and 2,095 patients (91.1%) completed the 4-week study. The mean PASI improvement at week 4 was 53.7%, and the PASI 50/75 response rates were 62.5 and 26.8%, respectively. The mean PASI reduction in plaque induration, desquamation and erythema were 58.3, 61.0 and 40.0%, respectively (<i>p</i> &#x3c; 0.001). Adverse reactions occurred in 445 patients (20.8%) at week 4. The most frequently reported adverse reactions were local skin irritation, including pruritus (10%), pain (6.7%), erythema (6.1%) and desquamation (1.8%). During the post-treatment period, 47 patients (24.0%) relapsed within 8 weeks after drug discontinuation. Forty-five patients were retreated for another 4 weeks, and the PASI 50/75 response rates were 72.7 and 40.9%, respectively. There were no unexpected safety signals during retreatment. <b><i>Conclusion:</i></b> Taz/BD cream is effective and well tolerated in treating mild-to-moderate plaque psoriasis under near real-world conditions and demonstrates efficacy and safety during retreatment.

scholarly journals Effective and Safe Treatment of Psoriatic Disease with the Anti-IL-23p19 Biologic Tildrakizumab: Results of a Real-World Prospective Cohort Study in Nonselected Patients

Dermatology ◽  
2021 ◽  
pp. 1-5
Author(s):  
Katharina A. Drerup ◽  
Claudia Seemann ◽  
Sascha Gerdes ◽  
Ulrich Mrowietz
Keyword(s):  
Cohort Study ◽  
Real World ◽  
Plaque Psoriasis ◽  
Prospective Cohort ◽  
Registry Data ◽  
Comparable Efficacy ◽  
Routine Practice ◽  
Efficacy And Safety ◽  
Phase 3 ◽  
Severe Plaque Psoriasis

<b><i>Background:</i></b> After registration of drugs, evidence about efficacy and safety is solely based on data of phase 2/3 clinical trial programs. A major drawback is the selection of patients following inclusion/exclusion criteria. There is a considerable time and knowledge gap between study and registry data that evaluate real-world evidence (RWE). To close this gap, prospective cohort data are helpful. <b><i>Objectives:</i></b> Soon after tildrakizumab, an interleukin 23p19-inhibitor, was registered for moderate-to-severe plaque psoriasis, a prospective single-center cohort study was established to evaluate efficacy and safety of tildrakizumab in daily practice. <b><i>Methods:</i></b> Following approval of tildrakizumab, patients with moderate-to-severe plaque psoriasis eligible for systemic treatment were included into the Kiel Tildra Cohort (KTC) and followed using routine assessments of efficacy, psoriasis area and severity index (PASI), body surface area (BSA), dermatology life quality index (DLQI), itch (visual analog scale), and safety. Data of the KTC were compared to the respective phase 3 clinical trials. <b><i>Results:</i></b> The KTC included 150 patients differing substantially from those in the trial program. There was a high rate of previous systemic (87.3%) and biologic (31.8%) therapy and of comorbidity in the KTC as compared to the phase 3 studies. Due to the best practice approach, baseline PASI was lower in the KTC, but DLQI was similar in both groups. At the time of this analysis, 126 patients completed week 28, 92 patients week 52, and 58 patients week 76, respectively. There was a constant improvement in PASI, BSA, DLQI, and itch from baseline until week 76. There was no clinically meaningful laboratory abnormality. <b><i>Conclusions:</i></b> Patients treated in routine practice with tildrakizumab differed substantially from the phase 3 studies. Despite systemic pre-treatment and increased comorbidity, tildrakizumab showed comparable efficacy and safety in the KTC. Prospective cohort studies are a suitable tool to generate RWE before registry data become available.

scholarly journals Efficacy and safety of eltrombopag in the treatment of severe chronic immune thrombocytopenia in children of China: A single-center observational study

2019 ◽  
Vol 33 ◽  
pp. 205873841987212 ◽  
Author(s):  
Xiaoling Cheng ◽  
Kuo Yan ◽  
Jingyao Ma ◽  
Zhenping Chen ◽  
Libo Zhao ◽  
...  
Keyword(s):  
Adverse Events ◽  
Observational Study ◽  
Immune Thrombocytopenia ◽  
Response Rates ◽  
Drug Dosage ◽  
Efficacy And Safety ◽  
Bleeding Events ◽  
Serious Adverse Events ◽  
Durable Response ◽  
Chronic Immune Thrombocytopenia

The treatment of severe chronic immune thrombocytopenia (SCITP) in pediatric patients is challenging. We evaluated the clinical efficacy and safety of eltrombopag in children with SCITP in China. This observational study was carried out at the Hematology Oncology Center, Beijing Children’s Hospital between April 2017 and July 2018. Patients with SCITP who had at least 12 weeks of eltrombopag treatment and follow-up data were included. Baseline data, such as age, drug dosage, pre-study platelet count, concomitant medications, and bleeding severity, were collected. Treatment response rates, durable response rates, bleeding events, and adverse events were assessed during eltrombopag therapy for at least 12 weeks. The median duration of eltrombopag therapy was 16 (12–48) weeks. The overall, complete, and partial response rates were 75% (15/20), 35% (7/20), and 40% (8/20), respectively. The durable response rate was 70% (14/20). No serious bleeding events or serious adverse events occurred during the study period. Eltrombopag appears to be effective and safe in children with SCITP, although additional research is needed to confirm this.

Efficacy and Safety of Apremilast Monotherapy for Moderate to Severe Psoriasis: Retrospective Study

2018 ◽  
Vol 22 (3) ◽  
pp. 290-296 ◽  
Author(s):  
Arvin Ighani ◽  
Jorge R. Georgakopoulos ◽  
Linda L. Zhou ◽  
Scott Walsh ◽  
Neil Shear ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Real World ◽  
Plaque Psoriasis ◽  
Safety Data ◽  
Retrospective Chart Review ◽  
Oral Drug ◽  
Efficacy And Safety ◽  
Full Spectrum ◽  
Severe Plaque Psoriasis

Background: Apremilast is a new oral drug for the treatment of moderate to severe plaque psoriasis that reduces inflammation by inhibiting phosphodiesterase 4. Its efficacy and safety data are limited; hence, real-world outcomes are important for elucidating the full spectrum of its adverse events (AEs) and expanding generalizability of clinical trial findings. Objective: Assess the efficacy and safety of apremilast monotherapy in real-world practice. Methods: A retrospective chart review was conducted in 2 academic dermatology practices. Efficacy was measured as the proportion of patients achieving a ≥75% reduction from baseline Psoriasis Area and Severity Index score (PASI-75) or a Psoriasis Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) at 16 weeks. Safety was measured as the proportion of patients reporting ≥1 AE at 16 weeks. Results: Thirty-four patients were included. Efficacy: 19 patients (55.9%) achieved PASI-75 or PGA 0/1. Safety: 23 patients (67.6%) experienced ≥1 AEs. Five patients (14.7%) withdrew treatment prior to week 16 due to AEs. One patient withdrew treatment due to mood lability and depression. Common AEs included headache (32.4%), nausea (20.6%), diarrhoea (14.7%), weight loss (8.8%), and loose stool (8.8%). Conclusion: Apremilast monotherapy had higher efficacy with similar safety outcomes in the real world compared to clinical trials. There were higher proportions of reported headaches compared to clinical trials. This study supports the apremilast monotherapy clinical trial findings, suggesting that it has an acceptable safety profile and significantly reduces the severity of moderate to severe plaque psoriasis. Limitations include the retrospective nature of the study.

Ipilimumab in real-world clinical practice: efficacy and safety data from a multicenter observational study

2017 ◽  
Vol 29 (4) ◽  
pp. 245-251 ◽  
Author(s):  
Alberto Russi ◽  
Vera Damuzzo ◽  
Marco Chiumente ◽  
Jacopo Pigozzo ◽  
Marco Cesca ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Observational Study ◽  
Real World ◽  
Safety Data ◽  
Efficacy And Safety ◽  
Multicenter Observational Study

scholarly journals Validity of the Use of Wrist and Forehead Temperatures in Screening the General Population for COVID-19: A Prospective Real-World Study

2020 ◽  
Author(s):  
Ge CHEN ◽  
Jiarong XIE ◽  
Guangli DAI ◽  
Peijun ZHENG ◽  
Xiaqing HU ◽  
...  
Keyword(s):  
General Population ◽  
Observational Study ◽  
Electric Vehicle ◽  
Real World ◽  
Prospective Observational Study ◽  
Real Life ◽  
High Fever ◽  
Tympanic Temperature ◽  
Infrared Thermometer ◽  
The Mean

Background: We aimed to compare the accuracy of individuals’ wrist and forehead temperatures with their tympanic temperature under different circumstances. Methods: We performed a prospective observational study in a real-life population in Ningbo First Hospital in China. We consecutively recorded individuals’ wrist and forehead temperatures in Celsius (°C) using a noncontact infrared thermometer (NCIT). We also measured individuals’ tympanic temperature using a tympanic thermometer (IRTT) and defined fever as a tympanic temperature of ≥37.3 °C. Results: We enrolled 528 participants, including 261 indoor and 267 outdoor participants. We grouped the outdoor participants into four groups according to their means of transportation to the hospital: by foot, by bicycle/electric vehicle, by car, or as a passenger in a car. Under different circumstances, the mean difference in the forehead measurement ranged from -1.72 to -0.56 °C across groups, and that in the wrist measurement ranged from -0.96 to -0.61°C. Both measurements had high fever screening abilities in indoor patients. (Wrist: AUC 0.790; 95% CI: 0.725-0.854, P<0.001; forehead: AUC 0.816; 95% CI: 0.757-0.876, P <0.001). The cut-off value of the wrist measurement for detecting a tympanic temperature of ≥37.3 °C was 36.2 °C, with 86.4% sensitivity and 67.0% specificity, and the best threshold for the forehead measurement was 36.2 °C, with 93.2% sensitivity and 60.0% specificity. Conclusion: Wrist measurements are more stable than forehead measurements under different circumstances. Both measurements have favorable fever screening abilities in indoor patients. The cut-off values were both 36.2 °C.

scholarly journals Prevalence of sleep disturbance and the association between poor disease control in people with ankylosing spondylitis within the Australian clinical setting (ASLEEP study): a real-world observational study using the OPAL dataset

2021 ◽  
Author(s):  
Kathleen Tymms ◽  
Belinda E. Butcher ◽  
Tracey L. Sletten ◽  
Tegan Smith ◽  
Catherine O’Sullivan ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Observational Study ◽  
Disease Control ◽  
Sleep Disturbance ◽  
Real World ◽  
Symptom Duration ◽  
Fatigue Score ◽  
Obstructive Sleep ◽  
Good Disease Control ◽  
The Mean

Abstract Introduction Sleep disturbance and fatigue are commonly reported in ankylosing spondylitis (AS) but specific prevalence and the relationship to disease control are unknown. Method This retrospective non-interventional observational study of data from the OPAL dataset included patients with AS (ICD code M45, M45.0 or M08.1), aged 18 to 95 years and had completed ≥ 1 sleep questionnaire between 1 January 2019 and 30 September 2020. The prevalence of insomnia and obstructive sleep apnoea were assessed using the Insomnia Severity Index (ISI) and Multivariate Apnoea Prediction Index (MAPI), respectively. Propensity score (PS) matching based on sex, age and symptom duration increased comparability between patients administered tumour necrosis factor inhibitors (TNFi) and interleukin 17A inhibitors (IL-17Ai). Results Four hundred ninety-five patients were included. The mean ISI total score in the overall population was 8.6 ± 6.2. Self-reported moderate or severe clinical insomnia was present in 16% and 3.2% of patients, respectively. The mean MAPI score was 0.4 ± 0.3, self-reported apnoea was identified in 31.5% of patients and the mean FACIT-Fatigue score was 36.1 ± 10.7. In the PS matched population, the only treatment-related difference was the mean MAPI score (IL-17Ai 0.4 ± 0.3 and TNFi 0.3 ± 0.2, p = 0.046). Those with poor disease control (BASDAI ≥ 4) were more likely (odds ratio [OR] 7.29, 95% CI 2.37 to 22.46, p = 0.001) to have a greater severity of insomnia symptoms than those with good disease control. Conclusion In this real-world AS cohort, poor disease control was associated with sleep disturbance. Little difference in sleep disturbance was observed between biologic TNFi and IL-17Ai treatment. Key Points • Sleep disturbance and fatigue are common in patients with ankylosing spondylitis.• In our real-world cohort, self-reported apnoea was reported in one-third of patients; and one in five patients reported moderate to severe insomnia.• Those with poor disease control were more likely to experience greater sleep disturbance than those with good disease control.

scholarly journals An observational study «FOLLITROPIN» comparing the efficacy of follitropin alpha biosimilar: the real-world data

2021 ◽  
Vol 15 (1) ◽  
pp. 5-21
Author(s):  
D. P. Kamilova ◽  
M. M. Ovchinnikova ◽  
E. Sh. Ablyaeva ◽  
M. M. Leviashvili ◽  
N. S. Stuleva ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Observational Study ◽  
Clinical Efficacy ◽  
Real World ◽  
Ovarian Stimulation ◽  
Successful Implementation ◽  
Efficacy And Safety ◽  
The Real ◽  
Real Clinical Practice

Introduction. The efficacy and safety of biosimilar follitropin alpha have been demonstrated in randomized blinded prospective clinical trials of phases I and III. Unfortunately, there is a gap between the clinical trials and real clinical practice data. The real-world patient data helps to create an evidence-based background for successful implementation of medicine at everyday practice in a nonselected population.Aim: to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.Materials and Methods. A retrospective observational anonymized cohort study of follitropin alpha biosimilar (Primapur®) as a pre-filled pen injector with a dose adjustment of 5 IU, aimed to investigate its efficacy and safety in a nonselected population with indications to assisted reproductive technologies (ART) was carried out. The ovarian stimulation (OS) protocols included: monotherapy protocols with using only Primapur®; mixed protocols (recombinant and urinary-derived gonadotropins); short protocols with using antagonists of gonadotropin-releasing hormone (GnRH) and long protocols with GnRH agonists. The stimulation protocols were analyzed with Primapur® application for at least 5 days.Results. The overall clinical efficacy of ovarian stimulation cycles (N = 5484) was: oocytes retrieved - 9.5 ± 7.2, mature (MII) - 6.8 ± 6.6, fertilized (2PN) - 6.1 ± 5.8, clinical pregnancy per ET (PR) - 38.4 %. Mixed gonadotropin protocols (N = 2625) vs. monotherapy with Primapur® (N = 2859): oocytes retrieved - 8.6 ± 6.8 vs. 10.3 ± 7.4 (p < 0.001), mature (MII) - 6.7 ± 6.2 vs. 7.7 ± 6.9 (p < 0.001), fertilized (2PN) - 5.8 ± 5.2 vs. 7.2 ± 6.2 (p < 0.001). There were statistically significant differences between oocyte yields in mixed vs. monotherapy protocols due to subgroup differences, including age, body mass index (BMI) and IVF/ICSI attempts. No statistically significant differences were found for PR: 39.3 % vs. 37.6 % (p = 0.314). Monotherapy protocols with GnRH antagonist OS (N = 2183) vs. GnRH agonist (N = 676) revealed: oocytes retrieved - 10.5 ± 7.5 vs. 9.6 ± 7.0 (p = 0.032), mature (MII) - 7.6 ± 6.9 vs. 6.7 ± 5.7 (p < 0.001), fertilized (2PN) - 7.3 ± 6.3 vs. 5.7 ± 5.0 (p < 0.001). There were statistically significant differences between BMI and IVF/ICSI attempts. No statistically significant differences were found for PR: 37.9 % vs. 35.9 % (p = 0.482). All medicines were well tolerated and no serious adverse reactions were reported.Conclusion. This was the largest retrospective observational study conducted in the field of fertility in Russia and involved 5484 ovarian stimulation protocols at 35 IVF clinics. The obtained results demonstrated similar clinical efficacy for follitropin alpha biosimilar Primapur® in different OS protocols in real clinical practice. 

Sign in / Sign up

Export Citation Format

Share Document