RESUMEN
In this original research, we present the results in terms of effectiveness and safety of bimekizumab for hidradenitis suppurativa in real clinical practice. Results indicated significant improvement in all activity scores and patient-reported outcomes at week 16, including a notable decrease in mean IHS4 from 27.1 to 15.6 (p < 0.001), HS-PGA from 5.1 to 3.2 (p < 0.001), VAS pain from 8.3 to 4.7 (p < 0.001) and DLQI from 21.6 to 12.6 (p < 0.001). Bimekizumab, administered every 2 or 4 weeks, was well-tolerated with no discontinuations and no new safety concerns identified. These findings corroborate the drug's effectiveness and favourable safety profile observed in phase 3 clinical trials, supporting its use in real-world clinical practice for treating HS.
RESUMEN
BACKGROUND: Acne-induced hyperpigmentation (AIH) may accompany acne vulgaris (AV) inflammation in all skin phototypes. Trifarotene has shown depigmenting properties in vivo. This study evaluated trifarotene plus skincare because it is increasingly recognized that holistic AV management should include skincare and treatments. METHODS: This is a phase IV double-blind, parallel-group study of patients (13-35 years) with moderate AV and AIH treated with trifarotene (N = 60) or vehicle (N = 63) plus skincare regimen (moisturizer, cleanser, and sunscreen) for 24 weeks. Assessments included the AIH overall disease severity (ODS) score, post-AV hyperpigmentation index (PAHPI), exit interviews, photography, and acne assessments. Standard safety assessments were included. RESULTS: Trifarotene 50 µg/g cream improved significantly from baseline in ODS score versus vehicle (-1.6 vs. -1.1, P = 0.03) at Week 12, but scores were comparable between groups at Week 24 (primary endpoint). Trifarotene had a better reduction in PAHPI score at Week 24 (-18.9% vs. -11.3% vehicle, P < 0.01). Lesion count reductions were higher with trifarotene at Week 12 versus vehicle (P < 0.001) and at Week 24 (P < 0.05), as were IGA success rates versus vehicle at Weeks 12 (P < 0.05) and 24 (P < 0.05). Patients agreed that the skincare regimen contributed to less irritation, making treatment adherence easier. Photography showed improvements in pigmentation and erythema across all skin types. AEs were more common in the vehicle group versus trifarotene (30.2 vs. 16.7%, respectively). CONCLUSIONS: In all skin phototypes, there was more rapid improvement in the ODS and PAHPI scores with trifarotene by Weeks 12 and 24, respectively. The combination of trifarotene and skincare correlated with high patient satisfaction and adherence to the treatment protocol.
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Acné Vulgar , Hiperpigmentación , Índice de Severidad de la Enfermedad , Cuidados de la Piel , Protectores Solares , Adolescente , Adulto , Femenino , Humanos , Masculino , Adulto Joven , Acné Vulgar/complicaciones , Acné Vulgar/tratamiento farmacológico , Fármacos Dermatológicos/administración & dosificación , Fármacos Dermatológicos/efectos adversos , Método Doble Ciego , Hiperpigmentación/etiología , Hiperpigmentación/tratamiento farmacológico , Hiperpigmentación/prevención & control , Retinoides , Cuidados de la Piel/métodos , Crema para la Piel/administración & dosificación , Pigmentación de la Piel/efectos de los fármacos , Pigmentación de la Piel/efectos de la radiación , Protectores Solares/administración & dosificación , Minorías Étnicas y RacialesRESUMEN
BACKGROUND: Biological therapy dose modification is a common practice in the long-term treatment of plaque psoriasis. OBJECTIVE: The objective of the study was to determine prevalence, characteristics of patients, effectiveness, treatment survival of secukinumab dose reduction (SEC-DR) strategy and assess its safety and cost implications. METHODS: A retrospective, observational, multicenter cohort study was conducted in patients with plaque psoriasis treated with secukinumab and up to 2 years of follow-up. RESULTS: In 63/347 patients with an initial standard dose regimen, SEC-DR was tried at any moment in 18.2% of them after sustained response. In 51 patients, the interval between administrations was increased while in 12 patients, monthly dose was reduced to 150 mg. Successful SEC-DR was achieved in 77.8% of the patients, with sustained PASI response to the end of the study. Survival of secukinumab treatment and safety profile were not compromised by DR. The use of DR saved 33% of the cost, including failures in which standard treatment was resumed. LIMITATIONS: The proper of the study designed and the arbitrary definition of "DR success." CONCLUSION: Off-label SEC-DR strategy was used in patients with sustained response to standard dose regimen; this strategy showed long-term efficacy without compromising treatment survival or worsening the safety profile while also being cost saving.
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Anticuerpos Monoclonales Humanizados , Anticuerpos Monoclonales , Psoriasis , Humanos , Anticuerpos Monoclonales/efectos adversos , Estudios de Cohortes , Reducción Gradual de Medicamentos , Psoriasis/tratamiento farmacológico , Psoriasis/inducido químicamente , Estudios Retrospectivos , Índice de Severidad de la Enfermedad , Resultado del TratamientoRESUMEN
Background: Due to the age when it becomes apparent and the treatment needed, cow's milk proteins (CMP) allergy requires an accurate diagnosis to avoid labelling infants falsely as allergic and subjecting them to unnecessary diets. The objective of this multi-centre study carried out at the Allergy Units of 14 Children's Hospitals was to discover the epidemiological, clinical and evolutionary characteristics of cow's milk protein allergy (CMPA). Methods and results: Infants suspected of CMPA who attended allergy clinics at the hospitals taking part during the study period were studied and a detailed clinical history was collected on all of them. Prick tests were done with cow's milk and its proteins and specific IgE anti-bodies were determined by means of CAP with the same allergens as the Prick test. The challenge test with cow's milk was carried out unless contraindicated by the diagnostic protocol. Two different challenge regimens were used: one of them carried out in 3 days and the other in one day. 409 infants with suspected CMPA were included and the diagnostic challenge test was performed on 286 patients (70 %) and not carried out on 123, as it was not indicated according to the protocol. IgE-mediated allergy was confirmed in 234 infants (58 %) and in 15 (4 %) non-IgE-mediated hypersensitivity was diagnosed. The two challenge regimens were equally secure. The average age when the reaction to cow's milk formula took place was 3.5 months (10 days-10 months). The symptoms appeared in the first week of introduction in 95 % of cases and appeared in 60 % with the first feeding with the formula. The most frequent clinical signs were cutaneous in 94 % of cases and the majority of cases appeared within 30 minutes of the feed. 99 % had been breast fed and 44 % had received some cow's milk supplement during the lactation period. Sensitization to egg not given in the feed was noted in 30 % and to beef in 29 %, being well tolerated in all of these. Conclusions: Carrying out an appropriate diagnostic protocol in infants attending for suspected CMPA allows allergy to be ruled out in a high percentage of cases
Objetivos: La alergia a proteínas de leche de vaca (PLV)por la edad en la que se presenta y el tratamiento que requiere exige un diagnóstico de certeza para evitar etiquetar al lactante de falsamente alérgico sometiéndolo a dietas innecesarias. Se trata de un estudio multicéntrico realizado en las unidades de alergia de 14 Hospitales infantiles para conocer las características epidemiológicas, clínicas y evolutivas de la alergia a proteínas de leche de vaca (APLV). Material y métodos: Se estudiaron a los niños con sospecha de APLV que acudieron a las consultas de alergia de los hospitales participantes, en el periodo del estudio, realizándoles a todos ellos una detallada historia clínica, Prick-test con leche de vaca y sus proteínas y determinación de anticuerpos IgE específicos mediante CAP para los mismos alergenos del Prick. Se llevó a cabo la prueba de provocación con leche de vaca de no estar contraindicada según el protocolo diagnóstico. Se utilizaron dos pautas de provocación distintas una de ellas llevada a cabo en 3 días y la otra en un día. Resultados: Se incluyeron 409 niños con sospecha de APLV realizándose prueba de provocación diagnóstica en 286 pacientes (70%), no llevándose a cabo en 123 por no estar indicada según el protocolo. Se confirmó alergia IgE mediada en 234 lactantes (58%) y en 15 (4%) se diagnosticó de Hipersensibilidad no IgE mediada. Las dos pautas de provocación utilizadas fueron igualmente seguras. La edad media de la reacción con formula de leche de vaca tuvo lugar a los 3.5 meses (10 días-10 meses). Los síntomas aparecieron en la primera semana de su introducción en el 95% y en el 60% aparecieron con la primera toma de fórmula. Las manifestaciones clínicas más frecuentes fueron las cutáneas en el 94% y se presentaron en la mayoría de los casos en los primeros 30 minutos tras la toma del alimento. El 99% había recibido lactancia materna y el 44% había recibido algún suplemento de leche de vaca durante la lactancia. Se observó sensibilización a huevo no introducido en la alimentación en el 30% y sensibilización a carne de ternera en el 29% siendo bien tolerada en todos ellos. Conclusiones: El realizar un protocolo diagnóstico adecuado en los niños que consultan por sospecha de CMPA permite descartar la alergia en un alto porcentaje de casos