scholarly journals Normalization of the epidermal barrier as a method of pathogenetic therapy of Atopic Dermatitis in children

2021 ◽  
Vol 97 (5) ◽  
pp. 52-65
Author(s):  
D. V. Zaslavsky ◽  
A. V. Sobolev ◽  
S. V. Skrek ◽  
A. A. Yunovidova ◽  
M. I. Zelyanina ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Adverse Events ◽  
Skin Diseases ◽  
Palliative Therapy ◽  
Study Drug ◽  
Severity Index ◽  
Efficacy And Safety ◽  
Cosmetic Product ◽  
Average Value ◽  
Days Of Therapy

Background. A key link in the pathogenesis of atopic dermatitis is a violation of the barrier function of the skin. Artificial skin moisturizing with emollients is the basis of palliative therapy for the disease. Aims. The purpose of the study was to assess the effectiveness and tolerability of the cosmetic product Admera. Materials and methods. The article presents the results of an open non-comparative prospective observational study of the efficacy and safety of Admera cream in pediatric patients with mild to moderate atopic dermatitis, conducted at the Pierre Wolkenstein Clinic for Skin Diseases in June-August 2020. Results. The study included 35 patients aged 4 to 17 years. The study included 35 patients aged 4 to 17 years inclusive. The clinical study demonstrated a statistically significant decrease in the Severity scoring of atopic dermatitis (SCORAD) index total score. The average value of this indicator decreased by 33% from the value 36.2 12.3 at the screening visit to 24.2 11.4 at the visit 3 (p 0.001). Assessment of the dynamics of the Eczema area and severity index (EASI) index showed a significant decrease in the total score of the indicator after 14 and 28 days of therapy relative to the baseline (p 0.001). The cosmetic product studied was well tolerated by patients. During the present study, 3 adverse events were reported in 2 patients. According to expert opinion, the recorded undesirable phenomena were not associated with the application of the studied cosmetic product. Reported adverse events were gastrointestinal disorders and included cases of diarrhea, abdominal pain and at the end of the study completely Conclusions. Evaluation of the results of the study showed high efficacy and safety of the study drug as a moisturizing agent: four-week therapy leads to a decrease in the severity of Atopic dermatitis manifestations, a decrease in the intensity of pruritus, an increase in the level of skin hydration in the T-zone and on the patient's body.

scholarly journals A Prospective Randomized Trial of Imipenem-Cilastatin Versus Clindamycin/Tobramycin in the Treatmentof Intra-Abdominal and Pelvic Infections

1993 ◽  
Vol 4 (5) ◽  
pp. 279-287 ◽  
Author(s):  
Lionel A Mandell ◽  
Pierre L Turgeon ◽  
Allan R Ronalds ◽  
The Canadian Clinical Trials Group
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Study Drug ◽  
Efficacy And Safety ◽  
Bacteriological Response ◽  
Intention To Treat ◽  
Days Of Therapy ◽  
Dichotomous Outcomes ◽  
Bacterial Superinfection ◽  
Treat Analysis

Objective: A Canadian multicentre clinical trial in the treatment of intra-abdominal and pelvic infections to compare the efficacy and safety of monotherapy using imipenem-cilastatin (imipenem) (500 mg intravenously every 6 h) versus combination therapy with clindamycin/tobramycin (clindamycin 600 mg intravenously every 6 h and tobramycin 1.7 mg/kg intravenously every 8 h).Methods: Two hundred and fifty patients were entered (88 definite and 162 possible infections) and all were evaluable for analysis of adverse events and intention to treat analysis of efficacy. Dichotomous outcomes used were: cured versus noncured (improved, failed, relapsed).Results: No statistically significant differences were found with the intention to treat analysis (P=0.88) or with definite infections (P=0.81). For overall bacteriological response, no significant differences were noted (P=0.1). Eleven and 15 patients on imipenem and clindamycin/tobramycin, respectively, were colonized with bacteria. Enterococci colonized four of 11 imipenem cases and five of 15 clindamycin/tobramycin cases while fungi colonized six patients on imipenem and four on clindamycin/tobramycin. Five patients on imipenem and seven on clindamycin/tobramycin developed superinfection. In the imipenem group, one case had a bacterial superinfection while four cases were due toCandida albicans.Seven of seven superinfections on clindamycin/tobramycin were bacterial. Three bacteria initially sensitive to the assigned study drug developed resistance. In two patients on imipenem,Enterococcus faecalisandPseudomonas aeruginosabecame resistant after 14 and 10 days of therapy, respectively. On clindamycin/tobramycin, one instance ofBacteroides fragilisresistance after eight days of therapy was seen. Eighty-three adverse events occurred; 47 in the imipenem group and 36 in the clindamycin/tobramycin group. This resulted in discontinuation of antibacterial therapy in 13 patients, seven of whom were on imipenem and six on clindamycin/tobramycin. Comparison of adverse effects showed statistically significant differences for nausea (P=0.02) and hepatotoxicity (P=0.05) occurring with greater frequency in the imipenem and clindamycin/tobramycin groups, respectively.Conclusions: These data support the conclusion that monotherapy with imipenem (500 mg intravenously every 6 h) is as efficacious as clindamycin/tobramycin for treatment of intra-abdominal and pelvic infections. Both regimens are well tolerated.

scholarly journals Paliperidone ER in the Treatment of Borderline Personality Disorder: A Pilot Study of Efficacy and Tolerability

2011 ◽  
Vol 2011 ◽  
pp. 1-7 ◽  
Author(s):  
Silvio Bellino ◽  
Paola Bozzatello ◽  
Camilla Rinaldi ◽  
Filippo Bogetto
Keyword(s):  
Borderline Personality Disorder ◽  
Pilot Study ◽  
Personality Disorder ◽  
Adverse Events ◽  
Mechanism Of Action ◽  
Severity Index ◽  
Borderline Personality ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Dsm Iv

Antipsychotics are recommended for the treatment of impulsive dyscontrol and cognitive perceptual symptoms of borderline personality disorder (BPD). Three reports supported the efficacy of oral risperidone on BPD psychopathology. Paliperidone ER is the metabolite of risperidone with a similar mechanism of action, and its osmotic release reduces plasmatic fluctuations and antidopaminergic effects. The aim of this study is to evaluate efficacy and safety of paliperidone ER in BPD patients. 18 outpatients with a DSM-IV-TR diagnosis of BPD were treated for 12 weeks with paliperidone ER (3–6 mg/day). They were assessed at baseline, week 4, and week 12, using the CGI-Severity item, the BPRS, the HDRS, the HARS, the SOFAS, the BPD Severity Index (BPDSI), and the Barratt Impulsiveness Scale (BIS-11). Adverse events were evaluated with the DOTES. Paliperidone ER was shown to be effective and well tolerated in reducing severity of global symptomatology and specific BPD symptoms, such as impulsive dyscontrol, anger, and cognitive-perceptual disturbances. Results need to be replicated in controlled trials.

scholarly journals Fexofenadine Treatment of Atopic Dogs: Preliminary Clinical Results

2006 ◽  
Vol 75 (4) ◽  
pp. 549-555 ◽  
Author(s):  
A. Plevnik ◽  
T. Kotnik ◽  
S. Kobal
Keyword(s):  
Atopic Dermatitis ◽  
Severity Index ◽  
Clinical Results ◽  
Efficacy And Safety ◽  
Time Points ◽  
The Third ◽  
Study Results ◽  
Significant Difference ◽  
Severity Index Score ◽  
The Mean

The purpose of our study was to investigate the efficacy and safety of the antihistamine fexofenadine versus methylprednisolone in dogs with atopic dermatitis. Eight dogs were included in the study and randomly allocated to two groups of four animals. The first group (F) received oral fexofenadine and the second group (M) received methylprednisolone. Over a period of 6 weeks, we evaluated the CADESI (Canine Atopic Dermatitis Extent Severity Index) score and the pruritus score and made measurements of biochemical blood indicators (AP, ALT, AST, urea, creatinine) on three occasions. The study results did not reveal any statistically significant differences compared to baseline in AST, ALT, AP, urea and creatinine values in any of the treated groups and at any of the time points during the treatment (p > 0.112). The mean CADESI values and the severity of pruritus were reduced by more than 50% in both groups during the treatment course. There were no statistically significant differences between group M and group F. A statistically significant difference compared to the baseline was found in the reduction of the CADESI score in group F in the sixth week of treatment (p = 0.011). There was also a significant reduction compared to the baseline in the severity of pruritus ingroup M in the third (p = 0.004) and sixth week of treatment (p = 0.022). Our results indicate the possible use of fexofenadine in the treatment of atopic dermatitis in dogs, as it was demonstrated safe and effective in comparison with methylprednisolone.

A Comparison of Proposed Biosimilar and Originator Filgrastim for the Prevention of Neutropenia in Patients with Breast Cancer Receiving Myelosuppressive Adjuvant or Neoadjuvant Chemotherapy: Phase III, Randomized, Double-Blind Trial (The PIONEER study)

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 5133-5133 ◽  
Author(s):  
Kimberly Blackwell ◽  
Vladimir Semiglazov ◽  
Pedro Gascon ◽  
Roumen Nakov ◽  
Stefan Kramer ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Treatment Group ◽  
Adverse Events ◽  
Lower Limit ◽  
Study Drug ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Pioneer Study ◽  
The Mean

Abstract Introduction: Biosimilars are biologics which have demonstrated highly similar safety, potency and purity to an originator product. Several biosimilars of recombinant human filgrastim, based on the originator Neupogen®, have become available in Europe since 2008 and are now in clinical use for the prevention of chemotherapy-induced neutropenia and hematopoietic stem cell mobilization. Filgrastim biosimilars are presently being developed for the U.S. market. Study design: A randomized, double-blind, four-group, multi-center phase III non-inferiority trial was performed with breast cancer patients treated with myleosuppressive chemotherapy. The two filgrastim products – proposed biosimilar, EP2006 (“biosimilar”) vs. originator (U.S.-licensed Neupogen®) - were compared regarding efficacy and safety. Patients included: women ≥18 years with histologically-proven breast cancer eligible for neoadjuvant or adjuvant treatment with docetaxel 75 mg/m2, doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC regimen) given for 6 cycles. Other key inclusion criteria included: Eastern Cooperative Oncology Group performance status ≤2 and adequate bone marrow function. Eligible patients were randomized to 4 groups with 2 of these groups alternating between the biosimilar and the originator filgrastim at the end of each cycle: 1) EP: treatment with EP2006 in all cycles; 2) EPNEU: EP2006 in Cycle 1, alternating between Neupogen and EP2006 in the following cycles; 3) NEUEP: Neupogen in Cycle 1, alternating between EP2006 and Neupogen in the following cycles; 4) NEU: treatment with Neupogen in all cycles. Patients received either biosimilar or originator filgrastim subcutaneously (daily dose of 5 µg/kg body weight) starting on Day 2 of each chemotherapy cycle until the absolute neutrophil count (ANC) recovered to 10×109/L after nadir or up to 14 days. Total duration of the study was 25 weeks: 3 weeks screening, 18 weeks treatment (total 6 cycles, 3 weeks each) and a follow-up visit 4 weeks after the last study drug administration. Primary objective was to assess the efficacy of the biosimilar compared to the originator with respect to mean duration of severe neutropenia (DSN) following Cycle 1 chemotherapy. A one-sided 97.5% confidence interval (CI) for the difference in the mean DSN calculated using ANCOVA model with factors “treatment” and “kind of therapy” and covariates “baseline ANC” was to be considered non-inferior if lower limit of this CI lies entirely above non-inferiority margin of -1 day. All secondary efficacy endpoints and safety endpoints were analyzed descriptively by treatment group. The study was conducted between December 2011 and June 2013. Results: Enrolled were 258 patients in 27 centers, of which 218 patients were randomized to treatment. The baseline characteristics were balanced between different groups. The per-protocol set included 204 patients out of 218 randomized patients. The safety set included 214 patients who received at least one dose of study drug. On average each patient received treatment for 8-9 days per cycle. The mean DSN in Cycle 1 was 1.17±1.11 days (biosimilar) and 1.20±1.02 days (originator); the mean difference in DSN was 0.04 days (97.5% CI, lower limit -0.26 days). The pre-defined non-inferiority criteria were met and the biosimilar was considered non-inferior to the originator filgrastim. The incidence of febrile neutropenia over all 6 cycles chemotherapy was comparably low in all treatment groups (EP: 2/40, 5.0%, EPNEU: 5/45, 11.1%, NEUEP: 1/44, 2.3%, NEU: 0/46, 0.0%). There was no obvious difference in incidences of treatment emergent adverse events between the treatment arms. Twelve patients experienced serious adverse events (EP: 5/53, 9.4% patients; EPNEU: 4/54, 7.4%; NEUEP: 1/55, 1.8%; NEU: 2/52, 3.8%). None of them were study drug related, including one death (in the EP treatment group due to pulmonary embolism). No subjects developed anti-drug antibodies. Conclusion: This large clinical study showed that efficacy and safety of the biosimilar was comparable to the originator filgrastim in prevention of neutropenia in patients with breast cancer. Repeated switching between the biosimilar and the originator filgrastim did not impact efficacy, safety or immunogenicity. Acknowledgment: The authors acknowledge the other investigators of the PIONEER study and acknowledge Gabor Stiegler, Sandoz Biopharmaceuticals for the medical writing. Disclosures Blackwell: Sandoz Biopharmaceuticals: Consultancy. Semiglazov:Sandoz Biopharmaceuticals: Consultancy. Gascon:Sandoz Biopharmaceuticals: Consultancy. Nakov:Sandoz Biopharmaceuticals: Employment. Kramer:Sandoz Biopharmaceuticals: Employment. Schwebig:Sandoz Biopharmaceuticals: Employment. Harbeck:Sandoz Biopharmaceuticals: Consultancy.

The Efficacy and Safety of Narrowband Ultraviolet B Phototherapy in Geriatric Patients: A Retrospective Study

2019 ◽  
Vol 15 (2) ◽  
pp. 59-65
Author(s):  
Yusharyahya SN ◽  
Legiawati L ◽  
Astriningrum R ◽  
Chandrakesuma V
Keyword(s):  
Retrospective Study ◽  
Cumulative Dose ◽  
Geriatric Patients ◽  
Skin Diseases ◽  
Severity Index ◽  
Ultraviolet B ◽  
Efficacy And Safety ◽  
Psoriasis Area Severity Index ◽  
Geriatric Population ◽  
Uvb Phototherapy

Background: Skin diseases can be one of the factors affecting the quality of life of the growing elderly population. In treating various dermatoses in the elderly, structural and physiological changes of the skin due to ageing need to be considered. Phototherapy has been proven to be a valuable modality for many skin diseases in adults. However, there is currently no study evaluating the use of phototherapy to treat skin diseases in geriatric population in Indonesia. Objective: To learn the efficacy and safety of narrowband ultraviolet B (NB-UVB) phototherapy in geriatric patients. Methods: A retrospective study using data from medical records of patients aged 60 years and above that received NB-UVB phototherapy in Dermatovenereology Clinic at the Dr Cipto Mangunkusumo National General Hospital in 2014–2018. Results: From 34 included patients, 21 (61.7%) patients had psoriasis, 9 (26.5%) had vitiligo, and 5 (14.7%) patients had other dermatoses. Psoriasis Area Severity Index (PASI) 75% was achieved by 52.4% psoriasis patients with a median of 22 sessions and cumulative dose of 26.6 J/cm2. Initial repigmentation was seen in 100% of vitiligo patients starting from a median of 6 sessions and a cumulative dose of 1.5 J/cm2. The side effect of erythema presented in 10 (47.6%) patients, with an event rate of 1.48% per session. Severe erythema was experienced by one vitiligo patient requiring a delay in phototherapy session. Conclusion: Phototherapy is a safe and effective modality for the geriatric population with various skin diseases, using doses and frequency similar to those of adult patients.

scholarly journals SAT0411 EFFICACY AND SAFETY OF IXEKIZUMAB IN PATIENTS WITH PSORIATIC ARTHRITIS AND INADEQUATE RESPONSE TO TNF INHIBITORS: THREE YEAR RESULTS FROM A PHASE 3 STUDY (SPIRIT-P2)

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1158.1-1158
Author(s):  
J. Gratacos-Masmitja ◽  
A. Turkiewicz ◽  
E. Dokoupilova ◽  
A. M. Gellett ◽  
A. T. Sprabery ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Adverse Events ◽  
Disease Activity ◽  
Outcome Measures ◽  
Signs And Symptoms ◽  
Severity Index ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Research Support ◽  
Intent To Treat

Background:Ixekizumab (IXE) is a high affinity monoclonal antibody that selectively targets interleukin-17A. In the SPIRIT-P2 study, IXE every 4 (Q4W) or 2 (Q2W) weeks was superior to placebo (PBO) in improving the signs and symptoms of psoriatic arthritis (PsA) at Week 24 in patients (pts) with prior inadequate response or intolerance to 1 or 2 tumor necrosis factor inhibitors (TNFi).Objectives:To determine efficacy and safety of IXE treatment up to 3 years in pts with PsA.Methods:In SPIRIT-P2 (NCT02349295), 310 pts entered the extension period where pts maintained their original ixekizumab dose, and placebo pts received IXEQ4W or IXEQ2W (1:1). Pts failing to demonstrate ≥20% improvement in both tender and swollen joint counts at Week 32, or any subsequent visit, were discontinued (mandatory discontinuation criteria). Efficacy outcomes were ACR20/50/70 response, Psoriasis Area and Severity Index (PASI) 75/90/100 response, Leeds Enthesitis Index (LEI), Leeds Dactylitis Index-Basic (LDI-B), Minimal Disease Activity (MDA), and Disease Activity in Psoriatic Arthritis (DAPSA). Ad-hoc efficacy data are presented for intent-to-treat (ITT) pts initially randomized to IXE at Week 0. Observed and modified non-responder imputation (mNRI; missing data treated as non-response for pts discontinued due to lack of efficacy or adverse events [AEs]) was applied to categorical measures. Observed and modified baseline observation carried forward (mBOCF) was applied to continuous efficacy measures. Safety was analysed in pts exposed to at least one dose of IXE.Results:Of the 245 pts initially randomized to IXE at Week 0 (ITT), 64 (26.1%) pts discontinued due to lack of efficacy and 22 (9.0%) pts due to mandatory discontinuation criteria. Efficacy results are summarized below (Figure 1). Pts in SPIRIT-P2 who received IXEQ4W and IXEQ2W for 156 weeks reported sustained improvement in ACR responses and manifestations of PsA, including enthesitis, dactylitis, and skin outcomes. Treat-to-target measures such as MDA and DAPSA (Low Disease Activity or Remission) were achieved by 30.8% and 47.7% of pts, respectively on IXEQ4W, and by 29.2% and 40.7% of pts, respectively on IXEQ2W. Incidence rates (IR) of treatment-emergent adverse events (TEAEs) are provided below (Figure 2). Most TEAEs were mild or moderate in severity, and 38 out of 337 (5.9%) pts (safety population) discontinued due to AEs. The most common TEAEs were infections (IR=33.1) and injection site reactions (IR=5.4). Three deaths were reported in the study.Figure 1.Efficacy Outcome Measures at Week 156 (Intent-to-treat Population).ACR=American College of Rheumatology; IXE=ixekizumab; LEI=Leeds Enthesitis Index; LDI-B=Leeds Dactylitis Index-Basic; mNRI=modified non-responder imputation; PASI=Psoriasis Area and Severity Index; Q2W=every two weeks; Q4W=every four weeks.Figure 2.Safety Outcome Measures (Weeks 0-156).Safety was analysed in patients exposed to at least one dose of ixekizumab. During the double-blind treatment period (Weeks 0-24), one patient reported serious adverse events of anal fistula and anal abscess, which were considered by the sponsor to be IBD; however, an independent adjudication committee of external experts reviewed the case and determined the events to be “Not IBD.”Conclusion:In pts treated with IXE who had prior inadequate response or intolerance to 1 or 2 TNFi, improvements in the signs and symptoms of PsA persisted up to 3 years. No unexpected safety signals were observed, and the safety profile was consistent with previous studies of IXE.Disclosure of Interests:Jordi Gratacos-Masmitja Grant/research support from: a grant from Pfizzer to study implementation of multidisciplinary units to manage PSA in SPAIN, Consultant of: Pfizzer, MSD, ABBVIE, Janssen, Amgen, BMS, Novartis, Lilly, Speakers bureau: Pfizzer, MSD, ABBVIE, Janssen, Amgen, BMS, Novartis, Lilly, Anthony Turkiewicz Grant/research support from: Received research grants from AbbVie, Eli Lilly and Company, Janssen, Novartis, and Pfizer, Consultant of: Received consulting fees from AbbVie, Eli Lilly and Company, Janssen, Novartis, and Pfizer, Speakers bureau: On speaker bureau for Abbvie, Eli Lilly and Company, Janssen, Novartis, Pfizer, Eva Dokoupilova Grant/research support from: Eli Lilly, AbbVie, Novartis, Amanda M. Gellett Shareholder of: Eli Lilly and company, Employee of: Eli Lilly and company, Aubrey Trevelin Sprabery Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Vladimir J. Geneus Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Arnaud Constantin Grant/research support from: Study was sponsored by Sanofi Genzyme, Consultant of: Consulting fees from Abbvie, BMS, Celgene, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, UCB

Allogeneic adipose-derived mesenchymal stem cell therapy in dogs with refractory atopic dermatitis: clinical efficacy and safety

2018 ◽  
Vol 183 (21) ◽  
pp. 654-654 ◽  
Author(s):  
Antonio José Villatoro ◽  
Manuel Hermida-Prieto ◽  
Viviana Fernández ◽  
Fernando Fariñas ◽  
Cristina Alcoholado ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Global Assessment ◽  
Clinical Signs ◽  
Severity Index ◽  
Positive Outcome ◽  
Efficacy And Safety ◽  
Promising Alternative ◽  
Canine Atopic Dermatitis ◽  
Mesenchymal Stem Cell Therapy ◽  
Common Skin

Canine atopic dermatitis (AD) is a common skin disease with a 10–15 per cent prevalence. Current treatments vary in their efficacy and safety. The immunomodulatory properties of mesenchymal stem cells (MSCs) make them a promising alternative treatment. The aim of this study was to evaluate the therapeutic efficacy and safety of allogeneic canine adipose MSCs (cAd-MSCs) in dogs with refractory AD. Twenty-six dogs, suffering from AD for at least 12 months, not responding to conventional therapy, received an intravenous dose of 1.5×106 cAd-MSCs/kg bodyweight. Clinical signs, haematological and biochemistry profiles, and AD severity were assessed in a six-month follow-up using a validated scoring system (Canine Atopic Dermatitis Extent and Severity Index, version 4 (CADESI-04)). The degree of pruritus was quantified using a validated visual analogue scale, and also owner’s global assessment of treatment efficacy. Twenty-two animals completed the study. Pruritus and CADESI-04 scores decreased significantly after one week or month of treatment, respectively, and remained stable for six months. Owner’s global assessment score was 2.15±1.15 for all the animals in the study. In conclusion, systemic administration of allogeneic cAd-MSCs appeared to be a simple therapy with positive outcome in the remission of clinical signs for AD refractory to conventional medications, for at least six months and with no adverse events.

scholarly journals Application of Janus Kinase Inhibitors in Atopic Dermatitis: An Updated Systematic Review and Meta-Analysis of Clinical Trials

2021 ◽  
Vol 11 (4) ◽  
pp. 279
Author(s):  
Hou-Ren Tsai ◽  
Jing-Wun Lu ◽  
Li-Yu Chen ◽  
Tai-Li Chen
Keyword(s):  
Atopic Dermatitis ◽  
Adverse Events ◽  
Kinase Inhibitors ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Meta Analysis ◽  
Severity Index ◽  
Janus Kinase ◽  
Drug Discontinuation ◽  
Jak Inhibitors

Janus kinase (JAK) inhibitors are promising treatments for atopic dermatitis (AD). The aim of this study was to assess the efficacy and safety of JAK inhibitors for AD treatment via the “Grading of Recommendations Assessment, Development, and Evaluation” approach. We identified 15 randomized controlled trials comparing oral or topical JAK inhibitors against placebo to treat AD. A random-effects meta-analysis was performed, and the numbers-needed-to-treat (NNTs)/numbers-needed-to-harm (NNHs) were calculated. Patients treated with JAK inhibitors were associated with higher rates of achieving eczema area and severity index-75 (rate ratio (RR): 2.84; 95% confidence interval (CI): 2.20–3.67; I2: 38.9%; NNT = 3.97), Investigator’s Global Assessment response (RR: 2.99; 95% CI: 2.26–3.95; I2: 0%; NNT = 5.72), and pruritus numerical rating scale response (RR: 2.52; 95% CI: 1.90–3.35; I2: 39.4%; NNT = 4.91) than those treated with placebo. Moreover, patients treated with JAK inhibitors had a higher risk of treatment-emergent adverse events (RR: 1.14; 95% CI: 1.02–1.28; I2: 52%; NNH = 14.80) but not adverse events leading to drug discontinuation. According to the evidence-based results, JAK inhibitors are potentially effective strategies (certainty of evidence: “moderate”) for treating AD with tolerable side effects (certainty of evidence: “low”). Nevertheless, long-term follow-up is required.

scholarly journals Efficacy of Dupilumab on Different Phenotypes of Atopic Dermatitis: One-Year Experience of 221 Patients

2020 ◽  
Vol 9 (9) ◽  
pp. 2684
Author(s):  
Simona Tavecchio ◽  
Luisa Angileri ◽  
Francesco Pozzo Giuffrida ◽  
Francesca Germiniasi ◽  
Angelo Valerio Marzano ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Atopic Dermatitis ◽  
Rating Scale ◽  
Numerical Rating Scale ◽  
Clinical Manifestations ◽  
Life Quality ◽  
Daily Practice ◽  
Severity Index ◽  
Efficacy And Safety

Background: The clinical features of adult-onset atopic dermatitis (AD) are heterogeneous and the diagnosis can be a challenge. A new biologic drug (dupilumab) has been approved for moderate to severe AD in adult patients. The efficacy and safety have been demonstrated in clinical trials, but these studies do not reflect conditions in daily practice and do not consider the different clinical manifestations of AD. Objectives: Analyzing the dupilumab activity in a real-world setting and comparing its efficacy on different AD phenotypes. Methods: We retrospectively evaluated 221 AD patients treated with dupilumab, stratified into six clinical phenotypes: classic, generalized eczema inflammatory and lichenoid patterns, prurigo, nummular eczema, and erythroderma. At baseline and at weeks 4, 16, and 52, the disease severity was assessed through the Eczema Area and Severity Index (EASI) and the quality of life was assessed through the Dermatology Life Quality Index (DLQI) questionnaire, Peak Pruritus Numerical Rating Scale (itch NRS), and Peak Sleep NRS. Results: We found a significant improvement after 16 weeks of treatment (p < 0.0001) in all six phenotypes for all the assessed scores mentioned above, persisting up to week 52. The best improvement was seen in the more severe phenotypes, particularly the erythrodermic one. Conclusions: The present study confirmed the efficacy and safety of dupilumab in the treatment of severe AD. Its strength was in the stratification of AD patients in six different phenotypes based on their clinical presentation, all of whom markedly improved in terms of both clinically evident and reported symptoms, as well as their quality of life.

Novel Therapeutic Approaches and Targets for the Treatment of Atopic Dermatitis

2020 ◽  
Vol 22 (1) ◽  
pp. 73-84
Author(s):  
Leonardo Pescitelli ◽  
Elia Rosi ◽  
Federica Ricceri ◽  
Nicola Pimpinelli ◽  
Francesca Prignano
Keyword(s):  
Atopic Dermatitis ◽  
Monoclonal Antibodies ◽  
Small Molecules ◽  
Cell Activation ◽  
Skin Diseases ◽  
Severe Atopic Dermatitis ◽  
Efficacy And Safety ◽  
Inflammatory Skin Diseases ◽  
Th2 Cell

Background: Atopic Dermatitis is one of the most common inflammatory skin diseases, with an estimated prevalence of 2.1-4.9% in adults. Recently, advances in Atopic Dermatitis understanding have highlighted the role of inappropriate Th2 cell activation as principally involved in its pathogenesis. Other immune pathways seem to play a key role in the complex Atopic Dermatitis pathophysiology. The anti-IL-4/IL-13 was the first monoclonal antibody approved for the treatment of moderate to severe atopic dermatitis in adult patients whose disease is resistant to other therapies. Following its interesting results in terms of efficacy and safety, new therapies are in development. Methods: Monoclonal antibodies targeting IL-5, IL-13, IL-17, IL-22, IL-23, IL-31 and TSLP are currently under investigation on patients with moderate to severe Atopic Dermatitis patients. Moreover, small molecules like anti-PDE4 and JAK inhibitors may also represent other treatment possibilities. Results: In this section, we present data available on the efficacy and safety of newer molecules for the treatment of Atopic Dermatitis. Conclusion: The extreme clinical heterogeneity and the chronic progression of Atopic Dermatitis need for newer, safer and more effective treatments, able to control the disease and to improve the quality of life of affected patients. Dupilumab, and the other monoclonal antibodies and small molecules currently under investigation aim to improve the clinical management of Atopic Dermatitis.

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