RESUMEN
BACKGROUND: Over the last few years, novel therapeutic approaches based on the use of monoclonal antibodies against cytokines, or their cognate receptors, involved in psoriasis progression have shown remarkable results, being capable to reduce disease progression and increase patient's quality of life. Among these is etanercept (Enbrel®, Pfizer, Sandwich, UK) and its biosimilar compound SB4 (Benepali®, Samsung Bioepis, Delft, The Netherlands), both approved for the treatment of moderate to severe psoriasis. Aim of the present study was to evaluate in a less controlled environment, such as real-life, the actual bioequivalence between the etanercept (ETN) and the SB4 in term of safety, efficacy and patient's quality of life. METHODS: For this purpose, we analyzed a case study consisting of 65 patients affected by plaque psoriasis, with or without psoriatic arthritis at our dermatological outpatient center of Sant'Andrea Hospital in Rome, all of them under treatment with either ETN or the biosimilar SB4 drug for at least 3 months. The indicators used to evaluate the effectiveness of the therapies were the Psoriasis Area and Severity Index, the Visual Analogue Scale (VAS) for itch, the VAS for pain, and the Dermatology Life Quality Index. RESULTS: The results showed no significant differences among the two drugs in all the analyzed parameters confirming the equivalence between the ETN and its biosimilar SB4. CONCLUSIONS: Overall, we can confirm the overlapping clinical efficacy between ETN and its biosimilar SB4 drug and that even in an uncontrolled environment such as real-life, the biosimilar drugs are an excellent opportunity to reduce health costs allowing to expand the audience of patients who can benefit from these innovative treatments.
Asunto(s)
Artritis Psoriásica , Biosimilares Farmacéuticos , Psoriasis , Artritis Psoriásica/tratamiento farmacológico , Biosimilares Farmacéuticos/uso terapéutico , Etanercept/uso terapéutico , Humanos , Psoriasis/tratamiento farmacológico , Calidad de VidaRESUMEN
Background: Omalizumab is not considered a disease-modifying drug and, accordingly, a large proportion of patients experience a relapse following withdrawal from treatment. Patients & methods: A total of 42 patients who underwent at least one cycle of treatment with omalizumab were enrolled. Two groups of relapsed and not-relapsed subjects were compared. Then, patients were divided into subgroups. Results: Female patients relapse more frequently than male subjects. Patients who relapsed complained a long duration of disease, while patients who did not relapse had short a history of disease. Very early responders are thought to have a high recurrence rate. Basal IgE levels were increased in early responders and cholesterol levels were high in very early responders, who relapse following withdrawal from omalizumab. High D-dimer levels were observed in late responders. Conclusion: The identification of clinical and serological predictors will play a pivotal role in the future management of patients treated with omalizumab.
Asunto(s)
Antialérgicos/uso terapéutico , Urticaria Crónica/tratamiento farmacológico , Omalizumab/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Recurrencia , Factores Sexuales , Resultado del Tratamiento , Adulto JovenAsunto(s)
Dermatitis Irritante/etiología , Juniperus/efectos adversos , Dermatitis Irritante/diagnóstico , Dermatitis Irritante/patología , Diagnóstico Diferencial , Femenino , Hemorragia/etiología , Hemorragia/patología , Humanos , Persona de Mediana Edad , Prurito/etiología , Prurito/patología , Enfermedades Cutáneas Vesiculoampollosas/diagnóstico , Enfermedades Cutáneas Vesiculoampollosas/etiología , Enfermedades Cutáneas Vesiculoampollosas/patología , Luz Solar/efectos adversosRESUMEN
BACKGROUND: Perampanel (PER) is a novel antiepileptic drug approved as an add-on therapy for focal onset seizures with or without generalization and primary generalized tonic-clonic seizures. Aim of this study was to evaluate PER efficacy and tolerability as add-on therapy in patients with drug-resistant focal onset seizures and especially temporal lobe epilepsy (TLE). METHODS: An observational, prospective, multicentre study on adult with drug-resistant focal epilepsy consecutively recruited from six Italian tertiary epilepsy centres. All patients received add-on PER according to indication and clinical judgement. Seizure frequency and adverse events (AEs) were recorded at 6 and 12â¯months after PER introduction. RESULTS: Study sample comprised 246 patients, 77 of which with TLE. Seventy-five (35.9%) out of 209 and 66 (38.8%) out of 170 patients still taking PER resulted to be responders (i.e. ≥50% of seizure frequency or seizure free) after six and 12â¯months, respectively. In the TLE group, 39 (57.3%) out of 68 subjects on PER after 6â¯months and 32 (60.4%) out of 53 subjects taking PER after 12â¯months were responders. Overall reported incidence of AEs was 26.1%. In 28 cases (11.3%) AEs lead/contributed to PER discontinuation. The most frequently reported AE were dizziness (14/84) and somnolence (14/84). Regarding TLE patients, 25.9% of them experienced at least one AE and discontinuation for AEs occurred in eight (10.4%). CONCLUSIONS: This study confirmed the good efficacy and safety of PER for drug-resistant focal epilepsy in real-life conditions and, above all, for the first time provide its effectiveness in patients with TLE.
Asunto(s)
Epilepsia del Lóbulo Temporal , Preparaciones Farmacéuticas , Adulto , Anticonvulsivantes/uso terapéutico , Quimioterapia Combinada , Epilepsia del Lóbulo Temporal/tratamiento farmacológico , Humanos , Italia , Nitrilos , Estudios Prospectivos , Piridonas , Resultado del TratamientoRESUMEN
BACKGROUND: Atopic dermatitis (AD) is a chronic relapsing eczematous dermatitis typically affecting young patients in a percentage from 15 to 20%; although it typically affects young people and adults, recent papers highlighted the emerging of the disease in the elderly population. METHODS: The aim of the study was to identify the clinical criteria and allergic sensitization that may be able to support physicians and dermatologists in making a correct diagnosis of AD in the elderly. The second aim of this study was to investigate the incidence, the main features, the gender prevalence, the immunological profile, and comorbidities characterizing patients older than 65 years affected by AD. RESULTS: Based on clinical and serological patterns, different phenotypes of AD were identified: generalized AD (55%) characterized by eczematous lesions involving typical areas of the body or prurigo nodularis-like AD; chronic eczematous hand dermatitis (23%); face and neck involvement (9%); and nummular eczema (13%). Skin prick tests revealed a positivity for aeroallergens in 49.6% of patients, most of them being polysensitized (55%). Additionally, food skin prick tests were positive in 25% of patients. Most of the patients reported comorbidities, particularly IgE-mediated diseases, such as seasonal rhino-conjunctivitis, asthma, and chronic obstructive pulmonary disease. Gastrointestinal symptoms such as meteorism, dyspepsia, cramps/abdominal pain, and diarrhea/constipation, were observed in 35% of patients consequent to food allergy. CONCLUSION: In our study, we suggest clinical and serological criteria that may be able to guide in the diagnosis of AD in Caucasian elderly, and to design an appropriate treatment according to the current standard protocol.