Práctica clínica en prevención de migraña con anticuerpos monoclonales del péptido relacionado con el gen calcitonina: evidencias de casos reales / Clinical practice in prevention of migraine with calcitonin-gene related peptide monoclonal antibodies: real-world evidence

Introducción: Los anticuerpos monoclonales (mAbs) del péptido relacionado con el gen de la calcitonina (CGRP) son un novedoso tratamiento para prevenir la migraña crónica y la episódica de alta frecuencia. Método: Se realizó un estudio observacional, retrospectivo, multicéntrico para analizar la efectividad y seguridad de los mAbs anti-CGRP (erenumab, galcanezumab, fremanezumab). La variable de efectividad fue la reducción en los días de migraña al mes (MMDs). La seguridad se midió con los efectos adversos descritos. Resultados: Los resultados de 127 pacientes muestran efectividad similar entre erenumab y galcanezumab en la reducción de los MMDs. Una proporción importante de pacientes cambió de mAb por pérdida de respuesta o fallo primario tras una media de 7 meses: 15,11% erenumab; 24% galcanezumab. Algunos pacientes se trataron con-comitantemente con toxina botulínica A: 8,13% erenumab; 12% galcanezumab; 6,25% fremanezumab. Más del 60% de pacientes habían sido tratados previamente con toxina botulínica A con falta de respuesta tras varias dosis. Se describieron efectos adversos cardiovasculares (dolor en el pecho, taquicardia) exclusivamente en pacientes con erenumab. Conclusiones: La práctica clínica actual se basa en el intercambio de mABs anti-CGRP en casos de falta de respuesta o migraña refractaria, aunque su evidencia es limitada y se ha demostrado que la efectividad entre los tres fármacos es equivalente. Las Agencias Reguladoras recomiendan un período de 12 semanas para evaluar la efectividad del mAb. La mitad de los pacientes refirieron falta de seguimiento por Neurología. Los farmacéuticos clínicos son nece-sarios en la atención integrada de la migraña. (AU)

Introduction: Calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) are novel therapeutic option for prevention of chronic migraine (CM) and high-frequency episodic migraine (HFEM). Method: An observational, retrospective, multicentre, real-world evidence study was developed to analyse the ef-fectiveness and safety of anti-CGRP mAbs (erenumab, galcanezumab, fremanezumab). Effectiveness was measured by monthly migraine days (MMDs) reduction. Adverse events were recorded for safety outcome. Results: Results from 127 patients showed similar effectiveness between erenumab and galcanezumab in MMDs reduction. A notable proportion of patients switched of mAb because of loss of response or primary no-response after seven months: 15.11% erenumab; 24% galcanezumab. Some patients were concomitant treated with Onabot-ulinumtoxin A (Onabot A): 8.13% erenumab; 12% galcanezumab; 6.25% fremanezumab. More than 60% of the total were previously treated with Onabot A with loss of response. Cardiovascular adverse events are exclusively reported by erenumab group (chest pain, tachycardia). Conclusions: Current clinical practice is based on switching of CGRP mAbs after loss of response or refractory mi-graine, even though evidence for this practice is limited and effectiveness between the drugs has been demonstrat-ed to be equivalent. The period of 12 weeks since the first dose of the CGRP mAb, recommended by Regulatory Agencies, should be respected to determine if the mAb selected is being ineffective. At least, half of the patients complained about lack of follow-up by reference neurologist. Clinical pharmacists are important to help these pa-tients manage the burden of migraine. (AU)

Cutaneous leishmaniasis associated with TNF-α blockers: a case report.

Leishmaniasis is a chronic protozoan disease that is found in diverse geographical areas of the world. Leishmania spp. are endemic in the Mediterranean coasts of southern Europe. Tumour necrosis factor alpha (TNF-α) plays an important role in the defence of the host against infection by Leishmania spp. In this case report we describe Leishmania infection caused by a monoclonal antibody against TNF-α: infliximab. A 51-year-old patient with psoriatic arthritis treated with infliximab, 5 mg/kg every 6 weeks as immunomodulatory treatment and methotrexate 10 mg weekly as a conventional disease-modifying antirheumatic drug, visited his otorhinolaryngologist owing to a lesion in his left nostril. The lesion was diagnosed as cutaneous leishmaniasis so treatment with infliximab was suspended. The patient was then treated with liposomal amphotericin B and showed a total recovery of the lesion; liposomal amphotericin B was maintained at 5 mg/kg monthly.