scholarly journals Systemic Treatments in Pediatric Psoriasis: A Retrospective Single-Center Study

2021 ◽  
Vol 24 (12) ◽  
pp. 903-909
Author(s):  
Gokhan Sahin ◽  
Fatma Aydin ◽  
Esra Pancar Yuksel
Keyword(s):  
Adverse Events ◽  
Systemic Therapy ◽  
Pediatric Patients ◽  
Age Of Onset ◽  
Demographic Data ◽  
Similar Efficacy ◽  
Efficacy And Safety ◽  
Routine Monitoring ◽  
Systemic Treatments ◽  
Single Center Study

Background: Systemic therapies commonly used in adult psoriasis are mostly used only off-label in children and little is known about the efficacy and tolerability of these drugs in this population. In this study, we aimed to evaluate the efficacy and safety of systemic treatments in pediatric patients with psoriasis. Methods: Data were obtained retrospectively from the Department of Dermatology, Ondokuz Mayis University, School of Medicine between 2010–2019. Our study consisted of 742 pediatric patients (age ≤18 years) with psoriasis. Demographic data, adverse events of systemic treatments and healing periods were considered. Results: A total of 195 patients received systemic treatment. The mean age of onset of disease and the initiation of systemic therapy were 9.68±4.62 and 11.33±4.38 years, respectively. Patients received methotrexate (n=52, 26.67%), cyclosporine (n=18, 9.24%), acitretin (n=106, 54.35%) and others (biologics and/or one of conventional treatments) (n=19, 9.74%) as systemic therapy. Adverse events occurred in 12 patients (incidence of 6.15%, and its related 95% confidence interval of 2.75%, 9.56%) and nine of them had to discontinue the medication due to those adverse events. Healing periods calculated in the remaining 186 patients were 13.25±5.87, 10.85±5.67, 11.05±7.00, and 9.41±4.16 (mean±SD) weeks for acitretin, methotrexate, cyclosporine, and others, respectively. No statistically significant differences were noted between the treatments regarding the healing periods. Conclusion: All treatments were effective and none of them was superior in terms of the healing period. Systemic treatments used in adults can also be used in pediatric patients with psoriasis with similar efficacy and safety rates as long as routine monitoring is provided.

scholarly journals A meta-analysis comparing regorafenib with TAS-102 for treating refractory metastatic colorectal cancer

2020 ◽  
Vol 48 (7) ◽  
pp. 030006052092640
Author(s):  
Guan-Li Su ◽  
Yuan-Yuan Wang ◽  
Jin-Cheng Wang ◽  
Hao Liu
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Metastatic Colorectal Cancer ◽  
Odds Ratio ◽  
Meta Analysis ◽  
Progression Free Survival ◽  
Similar Efficacy ◽  
Efficacy And Safety ◽  
Free Survival ◽  
Hand Foot Syndrome

Objective We performed this meta-analysis to compare the efficacy and toxicity of regorafenib and TAS-102. Methods Electronic databases were searched to identify studies comparing the efficacy and safety of regorafenib and TAS-102 in patients with chemotherapy-refractory metastatic colorectal cancer using pooled analyses. Results Three clinical trials were included in this analysis. Regarding the reasons for treatment discontinuation, regorafenib was significantly associated with disease progression (odds ratio [OR] = 0.33, 95% confidence interval [CI] = 0.21–0.50) and adverse events (OR = 4.38, 95% CI = 2.69–7.13). However, overall (OR = 0.97, 95% CI = 0.81–1.17) and progression-free survival (OR = 1.01, 95% CI = 0.86–1.18) did not significantly differ between the groups. The most common treatment-related adverse events in the regorafenib group were neutropenia (OR = 0.06, 95% CI = 0.03–0.11), hand–foot syndrome (OR = 50.34, 95% CI = 10.44–242.84), and liver dysfunction (OR = 34.51, 95% CI = 8.30–143.43). Conversely, the incidence of thrombocytopenia did not differ between the two groups. Conclusions Regorafenib and TAS-102 have similar efficacy but different adverse event profiles. Differences in the toxicity profiles of the two drugs will help guide treatment selection.

scholarly journals Efficacy and Safety of a Permethrin-Fipronil Spot-On Solution (Effitix®) in Dogs Naturally Infested by Ticks in Europe

2016 ◽  
Vol 2016 ◽  
pp. 1-7 ◽  
Author(s):  
Christelle Navarro ◽  
Nadège Reymond ◽  
Nolwenn Crastes ◽  
Stéphane Bonneau
Keyword(s):  
Adverse Events ◽  
Broad Spectrum ◽  
Similar Efficacy ◽  
Field Conditions ◽  
Efficacy And Safety ◽  
Safety And Efficacy ◽  
Randomised Study ◽  
Tick Counts ◽  
And Control ◽  
Privately Owned

Effitix is a new broad spectrum product based on the combination of fipronil 6.1% and permethrin 54.5% in a solution for spot-on application. It has been shown to be safe and efficacious in dogs in controlling tick, flea, sandfly, and mosquito infestations in laboratory conditions. The aim of this controlled, randomised study was to assess its safety and efficacy against natural tick infestations in field conditions. One hundred eighty-two privately owned dogs were included in France and Germany: 123 dogs were treated on day 0 with the permethrin-fipronil combination (Effitix) and 59 with a permethrin-imidacloprid combination (Advantix®). Tick counts were conducted on days 0 (before treatment), 7, 14, 21, and 28. The percentages of efficacy on days 7, 14, 21, and 28 were, respectively, 91.2%, 97%, 98.3%, and 96.7% with Effitix and were 94.8%, 96.9%, 95.7%, and 94.6% with Advantix. Very few adverse events were reported. Most were not serious and/or not related to the treatment with pruritus being the most common. One administration of Effitix was highly effective and safe to treat and control tick infestations for four weeks in field conditions and had a similar efficacy as the permethrin-imidacloprid combination for all visits.

scholarly journals Pediatric Ventricular Assist Device Support in the Netherlands

2020 ◽  
Vol 11 (3) ◽  
pp. 275-283
Author(s):  
Sofie Rohde ◽  
Christiaan F. J. Antonides ◽  
Rahatullah Muslem ◽  
Pieter C. van de Woestijne ◽  
Marijke H. van der Meulen ◽  
...  
Keyword(s):  
Heart Failure ◽  
The Netherlands ◽  
Adverse Events ◽  
Ventricular Assist Device ◽  
Pediatric Patients ◽  
Assist Device ◽  
Ventricular Assist ◽  
Single Center Study ◽  
End Stage Heart Failure ◽  
End Stage

Background: This study aimed to evaluate the changes in heart transplantation (HTx) waiting list mortality following the introduction of the Berlin Heart EXCOR (BH EXCOR) in the Netherlands, as well as the occurrence of adverse events in these children. Methods: A retrospective, single-center study was conducted including all pediatric patients (≤18 years) awaiting HTx. Patients were grouped in two eras based on availability of the BH EXCOR in our center, era I (1998-2006; not available) and era II (2007 to July 31, 2018; available). Results: In total, 87 patients were included, 15 in era I and 72 in era II. Extracorporeal membrane oxygenator support was required in 1 (7%) patient in era I and in 13 (18%) patients in era II. Overall mortality (7/15 in era I vs 16/72 in era II; 47% vs 22%, P = .06) and transplantation rates (8/15 in era I vs 47/72 in era II; 53% vs 65%, P = .39) did not differ significantly. Eleven (39%) patients of the pediatric ventricular assist device (VAD) population died, with the predominant cause being cerebrovascular accidents (CVAs) in eight (29%) patients. Furthermore, 14 (50%) of the pediatric VAD patients survived to transplantation. Adverse events most frequently occurring in VAD patients included CVA in 14 (50%), mostly (68%) within 30 days after VAD implantation, and bleeding requiring rethoracotomy in 14 (50%), all within 30 days after VAD implantation. Conclusions: The introduction of the BH EXCOR has positively impacted the survival of pediatric patients with end-stage heart failure in our center. The predominant cause of death changed from end-stage heart failure in era I to CVA in era II. We emphasize the need for large prospective registry–based studies.

scholarly journals Efficacy and Safety of Rituximab in Chinese Children With Refractory Anti-NMDAR Encephalitis

2020 ◽  
Vol 11 ◽  
Author(s):  
Xiangjun Dou ◽  
Dongjing Li ◽  
Yan Wu ◽  
Zhijing Wang ◽  
Le Yang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Pediatric Patients ◽  
Clinical Symptoms ◽  
Complete Recovery ◽  
Chinese Children ◽  
Second Line ◽  
Efficacy And Safety ◽  
Treatment Protocols ◽  
Nmdar Encephalitis

Purpose: To assess the efficacy and safety of rituximab treatment as second-line immunotherapy in pediatric cases of anti-NMDA receptor (NMDAR) encephalitis.Methods: We retrospectively recruited 8 patients with anti-NMDAR encephalitis who were treated with rituximab as second-line immunotherapy. We evaluated the clinical features, laboratory examination results and treatment protocols of the Chinese children and defined good outcomes based on the modified Rankin scale (mRS) score (0–2) at the last follow-up.Results: A total of eight pediatric patients (median age 6.7 years; four female) with refractory anti-NMDAR encephalitis were recruited to the study. Rituximab was given after a median duration of disease of 57 days (range 50.5–113.75 days). The use of rituximab led to a significant reduction in the mRS and CD19+ B-cells compared to before rituximab infusion (P < 0.05). Five patients (62.5%) had a good outcome (mRS ≤ 2) including four patients (50%) who showed complete recovery (mRS = 0) at the last follow-up. Transient infusion adverse events were recorded in 2 patients (25%). Two patients (25%) had severe infectious adverse events (AEs) and two patients with grade 5 (death). None of the patients developed progressive multifocal leukoencephalopathy (PML).Conclusion: Our study provides evidence that rituximab can efficiently improve the clinical symptoms of anti-NMDAR encephalitis in children. However, due to the risk of adverse infections, rituximab should be restricted in pediatric patients with high rates of mortality and disability.

scholarly journals A comparative study of efficacy and safety of topical calcitriol and topical calcipotriol in stable chronic plaque type psoriasis

2019 ◽  
Vol 8 (3) ◽  
pp. 402
Author(s):  
Leela Hugar ◽  
Ramesh H.
Keyword(s):  
Adverse Events ◽  
Safety Profile ◽  
Similar Efficacy ◽  
Efficacy And Safety ◽  
Point Scale ◽  
Global Improvement ◽  
Local Tolerance ◽  
Plaque Type ◽  
The Subject ◽  
The Difference

Background: Topical calcitriol and calcipotriol, the two vitamin D derivatives although considered efficient in treating psoriasis, their comparative studies are relatively scanty. The objective of the present study was to evaluate and compare the efficacy and safety of calcitriol and calcipotriol in stable chronic plaque-type psoriasis.Methods: Total 50 patients of chronic stable plaque-type psoriasis were randomly divided into two groups of 25 each. One group received calcitriol 3µg/g ointment and the other group received calcipotriol 50µg/g ointment twice daily for 12 weeks. Efficacy evaluations comprised global improvement (on a 4-point scale from 0: no change, to 3: clear or almost clear) assessed clinically and by the subject. Efficacy further included the ‘dermatological sum score’ (DSS) at each study visit. Safety evaluations (on a 5-point scale from 0: none, to 4: very severe) included clinical assessment of cutaneous safety and assessment of cutaneous discomfort by the subject.Results: Both calcitriol and calcipotriol were significantly effective (p <0.001) in reduction of DSS but the difference between the two groups was not statistically significant. Mean score of global improvement assessed clinically was 2.20 for calcitriol and 2.16 for calcipotriol (p >0.05) and by the subject was 1.92 for calcitriol and 1.84 for calcipotriol (p >0.05). The difference between the two groups was not statistically significant. The mean worst score for cutaneous safety was higher in calcipotriol group compared to calcitriol group (0.28 vs 0.04 and 0.36 vs 0.04 by clinically and by the subject, respectively). Statistically significant better safety profile (p <0.05) was seen for calcitriol, only when assessed by the subject. 24% treatment related adverse events were reported with calcipotriol against only 4% with calcitriol.Conclusions: Topical calcitriol and calcipotriol showed similar efficacy in the treatment of chronic plaque psoriasis while calcitriol showed better safety profile in comparison with calcipotriol, in terms of local tolerance and induced less treatment related adverse events.

scholarly journals Efficacy and Safety of Pediatric Procedural Sedation Outside the Operating Room

2020 ◽  
Vol 10 (4) ◽  
Author(s):  
Thitima Sirimontakan ◽  
Ninuma Artprom ◽  
Nattachai Anantasit
Keyword(s):  
Adverse Events ◽  
Operating Room ◽  
Demographic Data ◽  
Procedural Sedation ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Physical Status Classification ◽  
Sedation And Analgesia ◽  
American Society ◽  
American Society Of Anesthesiologists

Background: The volume of pediatric Procedural Sedation and Analgesia (PSA) outside the operating room has been increasing. This high clinical demand leads non-anesthesiologists, especially pediatric intensivists, pediatricians, and emergency physicians, to take a role in performing procedural sedation. Our department has established the PSA service by pediatric intensivists since 2015. Objectives: We aimed to assess the efficacy and safety of PSA outside the operating room conducted by pediatric intensivists and identify risk factors for severe adverse events. Methods: This was a retrospective descriptive study conducted from January 2015 to July 2019. Children aged less than 20 years who underwent procedural sedation were included. We collected demographic data, sedative and analgesic medications, American Society of Anesthesiologists (ASA) Physical Status Classification, indications for sedation, the success of procedural sedation, and any adverse events. Results: Altogether, 395 patients with 561 procedural sedation cases were included. The median age was 55 months (range: 15 to 119 months), and 58.5% (231/395) were male. The rate of successful procedures under PSA was 99.3%. Serious Adverse Events (SAE) occurred in 2.7%. Patients who received more than three sedative medications had higher SAE than patients who received fewer medications (adjusted for age, location of sedation, type of procedure, and ASA classification) (odds ratio: 8.043; 95% CI: 2.472 - 26.173, P = 0.001). Conclusions: Our data suggest that children who undergo procedural sedation outside the operating room conducted by pediatric intensivists are safe and effectively treated. Receiving more than three sedative medications is the independent risk factor associated with serious adverse events.

scholarly journals AB0971 LONG-TERM EFFICACY AND SAFETY OF CANAKINUMAB IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS: RESULTS FROM A SINGLE-CENTER STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1780.1-1781
Author(s):  
E. Alexeeva ◽  
E. Krekhova ◽  
T. Dvoryakovskaya ◽  
K. Isaeva ◽  
A. Chomakhidze ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Remission ◽  
Efficacy And Safety ◽  
Single Center ◽  
Term Efficacy ◽  
Single Center Study ◽  
One Year ◽  
Center Study

Background:Results from various phase 3 clinical studies have demonstrated the efficacy of canakinumab to treat patients with systemic juvenile idiopathic arthirtis (sJIA). However, limited information is available on the long-term efficacy and safety of this drug to treat children with sJIA.Objectives:To evaluate the long-term efficacy and safety of canakinumab in patients with sJIA treated at the National Medical Research Center of Children`s health, Moscow, Russia.Methods:This was a prospective, single-center study that included canakinumab (CAN)-naive patients diagnosed with sJIA following the International League of Associations for Rheumatology (ILAR) criteria and start receiving CAN treatment from 10/2012 to 03/2016. Patients included in this study also participated, for defined periods of time, in the clinical trialNCT02296424. Patients with active disease started treatment with canakinumab 4 mg/kg. A treat-to-target approach was used, canakinumab was discontinued in patients on clinical remission, either following theNCT02296424protocol or by investigator’s decision, and re-introduced in those patients who experienced a relapse afterwards. Disease characteristics and demographics were recorded at the time of diagnosis and initiation of treatment (study entry). Disease activity was evaluated periodically using the adaptedJIAACR core set measures, and percentages of patients with inactive disease and on clinical remission were calculated using the sJIA ACR criteria. Response to treatment was also evaluated by calculating modified ACR responses and JADAS-71 scores. Safety was assessed by collecting and classifying adverse events (AEs) at each visit.Results:Nineteen patients presenting with sJIA were included in this study, with a median age at treatment initiation of 9.6 (interquartile range, IQR 6.4-11.1) years and a median disease duration of 4.4 (IQR 1.2-7.0) years. Most patients (17/19) had been treated previously with one or more biologic agents for sJIA. As of 23 December of 2019, the median time of follow up was 55.5 (47-71.7) months, with all patients being followed for at least 3.5 years and 5 patients followed for more than 7 years. As it is shown in figure 1, most patients (16/19) were on clinical remission one year after starting therapy, and this effect was sustained at year 3.5 (17/19). ACR 90 responses were observed in 84.2% (16/19) patients at one year and 94.7% (18/19) patients at 3.5 years, whereas JADAS-71 scores decreased from 15 (14: 28.5) at baseline to 0 (0: 0) at one year with 4/19 patients maintained with JADAS-71 >0); at 3.5 years, only one patient had JADAS-71>0 (0.47, due to slight ESR increasing). Concerning the 5 patients with >7 years of follow up, three of them were in clinical remission for more than 3 years, including one who had discontinued therapy more than 2 years. Another patient had a relapse after attempting drug discontinuation, but recovered clinical remission after reintroducing canakinumab, and remained in this state for the last two years. The remaining patient has persistent low levels of disease activity during the last four years of follow up. AEs required hospitalization were reported in 36.8% (7/19) patients.Conclusion:Sustained clinical remission was observed in most patients with sJIA treated with canakinumab for up to 7 years, with no new or unexpected adverse events reported.Disclosure of Interests:Ekaterina Alexeeva Grant/research support from: Roche, Pfizer, Centocor, Novartis, Speakers bureau: Roche, Novartis, Pfizer., Elizaveta Krekhova: None declared, Tatyana Dvoryakovskaya: None declared, Ksenia Isaeva: None declared, Aleksandra Chomakhidze: None declared, Evgeniya Chistyakova: None declared, Olga Lomakina: None declared, Rina Denisova: None declared, Anna Mamutova: None declared, Anna Fetisova: None declared, Marina Gautier: None declared, Dariya Vankova: None declared, Meyri Shingarova: None declared, Ivan Kriulin: None declared, Alina Alshevskaya: None declared, Andrey Moskalev: None declared

scholarly journals Efficacy and safety of oncolytic viruses in advanced or metastatic cancer: a network meta-analysis

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Ruiyang Xie ◽  
Xingang Bi ◽  
Bingqing Shang ◽  
Aiping Zhou ◽  
Hongzhe Shi ◽  
...  
Keyword(s):  
Adverse Events ◽  
Systemic Treatment ◽  
Metastatic Cancer ◽  
Meta Analysis ◽  
Objective Response ◽  
Oncolytic Viruses ◽  
Efficacy And Safety ◽  
Talimogene Laherparepvec ◽  
Systemic Treatments ◽  
Grade 3

Abstract Background Oncolytic viruses (OVs) have shown prospects in advanced and metastatic cancer, and many clinical trials have been carried out. To compare OV therapies comprehensively and provide a categorized profile and ranking of efficacy and safety, a network meta-analysis was conducted. Methods A total of 5948 studies were screened and 13 randomized controlled trials with 1939 patients, of whom 1106 patients received OV therapies, comparing four OVs (NTX-010, pexastimogene devacirepvec (Pexa-Vec), talimogene laherparepvec (T-VEC), and pelareorep) were included in a Bayesian network meta-analysis. Eligible studies reported at least one of the following clinical outcome measures: objective response rate (ORR) and grade ≥ 3 adverse events. Results Compared to systemic treatments alone, talimogene laherparepvec (T-VEC) (OR 7.00, 95% CI 1.90–26.00) and T-VEC plus systemic treatment (2.90, 0.80–11.00) showed better objective response rates (ORRs), whereas Pexa-Vec 1 * 109 pfu plus systemic treatment (0.91, 0.26–3.00) and pelareorep plus systemic treatment (1.10, 0.61–2.00) were found to be comparable. The grade ≥ 3 adverse event ranking of the treatments from worst to best was as follows: T-VEC (ranking probability 24%), Pexa-Vec 1 * 109 pfu plus systemic treatment (21%), Pexa-Vec 1 * 109 pfu (17%), T-VEC plus systemic treatment (13%), pelareorep plus systemic treatment (13%), systemic treatments (18%), Pexa-Vec 1 * 108 pfu (12%), and NTX-010 (20%). Conclusions Compared with other oncolytic virus therapies for patients with advanced or metastatic cancer, T-VEC and T-VEC plus systemic treatment appear to provide the best ORR therapy in terms of monotherapy and combination respectively, but should be given with caution to grade ≥ 3 adverse events. Conversely, combining OVs with chemotherapy or target agents was demonstrated not to improve efficacy compared with chemotherapy or target agents alone. Combining OV therapies with immune-checkpoint inhibitors, instead of chemotherapy or target agents, tended to provide better ORRs without causing severe adverse events. This study will guide treatment choice and optimize future trial designs for investigations of advanced or metastatic cancer.

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