RESUMO
BACKGROUND: Adalimumab biosimilar MSB11022 (Idacio ®) has been approved for the same indications as its originator (Humira ®), based on findings from clinical trials in plaque psoriasis. Data on its efficacy and safety in inflammatory bowel disease, however, are scarce. METHODS: Retrospective, observational study of 44 patients with inflammatory bowel disease: 30 were treated with originator adalimumab, 5 were directly started on MSB11022, and 9 switched from originator to biosimilar adalimumab. To evaluate the effectiveness of the use of adalimumab in inflammatory bowel disease, both laboratory markers (fecal calprotectin and C-reactive protein) and scales that measure the activity of inflammatory bowel disease using specific scales (Harvey-Bradshaw Index (HBI) have been usEd.) for Crohn's disease and Mayo Score for Ulcerative Colitis. Efficacy was evaluated by recording the adverse effects that could occur with the administration of adalimumab (original or biosimilar). The success of the switch was determined by analyzing meaningful differences in effectiveness and safety criteria. Concomitant therapy and the need for dose intensification were also analyzed. Objective of this study was to assess the effectiveness and safety of biosimilar adalimumab in adalimumab-naïve patients and patients switched from originator adalimumab. RESULTS: No significant differences were observed in clinical disease activity (P=.317) or biochemical parameters [fecal calprotectin (P=.445) and C-reactive protein P=.661)] after the switch from the originator adalimumab to MSB11022. There was not a significant reduction in the concomitant use of corticosteroids and thiopurines (P=.157). No emergency room visits or hospitalizations were observed during the study period and none of the patients experienced serious adverse effects. CONCLUSIONS: Between originator adalimumab and biosimilar-start cohorts, no differences were observed, between originator adalimumab and switch cohorts, no significant differences were found either, and with the pre- and post-switch to biosimilar comparison, 2 of the 9 patients experienced AEs after the switch. The biosimilar showed a favorable safety profile (one patient with a serious adverse effect (rash) with biosimilar discontinued treatment) and no significant changes to clinical or biochemical parameters were observed after the switch.
RESUMO
Introducción: Las reacciones de hipersensibilidad a fármacos (RHF) son eventos potencialmente mortales que se producen durante la administración de diversos agentes quimioterápicos. Pueden cursar con un dolor intenso, considerado en algunos casos como dolor irruptivo oncológico (DIO). Actualmente no existen guías para el tratamiento de este tipo específico de dolor. Objetivos: Evaluar, en pacientes oncológicos, la eficacia del citrato de fentanilo sublingual 100 mcg en el tratamiento del DIO asociado a RHF durante la infusión de quimioterapia. Material y métodos: Estudio retrospectivo con pacientes que recibieron quimioterapia en el servicio de Oncología Médica del Hospital de Denia entre 2013 y 2016 y que fueron tratados con fentanilo por DIO asociado a RHF (EVA > 7). Se estableció la gravedad del DIO mediante una escala EVA antes y después de administrar fentanilo. Se utilizó la t de Student para comparar las puntuaciones EVA antes y después del tratamiento. Resultados: En total, se incluyeron 34 pacientes (73,53 % mujeres, edad media 59,68 años). Los tratamientos quimioterápicos asociados a una mayor frecuencia a la aparición de DIO por RHF fueron docetaxel y oxaliplatino (ambos 35,29 %), seguidos de paclitaxel (20,59 %). En promedio, los pacientes tuvieron un valor basal de EVA de 8,55 (DE 0,79) antes de ser tratados con fentanilo. Tras el tratamiento, la intensidad media del dolor fue de 1,48 (DE 1,50), siendo la diferencia significativa (p < 0,001). La duración media del episodio de DIO fue de 5,29 minutos (DE 2,25), y el tiempo medio hasta el inicio del alivio del dolor de 1,52 minutos (DE 0,71). Conclusiones: Fentanilo sublingual es un fármaco efectivo en el manejo del DIO asociado a RHF durante la infusión de taxanos y oxaliplatino, donde permite un alivio rápido y signifi cativo del dolor. Se debe seguir investigando su papel en este contexto mediante ensayos clínicos controlados
Introduction: Drug hypersensitivity reactions (DHR) are events that can occur during the administration of several chemotherapeutic agents and which could potentially be life-threatening. These events may present with intense pain, in some cases known as breakthrough cancer pain (BTCP). There are no currently available treatment guidelines for this specifi c type of pain. Objectives: To assess the effi cacy of sublingual fentanyl citrate 100 mcg in cancer patients in the treatment of DHR-related BTCP during chemotherapy infusion. Material and methods: A retrospective study with patients receiving chemotherapy in the Medical Oncology Department of Hospital de Denia between 2013 and 2016 who were treated with fentanyl due to DHR-related BTCP (VAS [Visual Analogue Scale] > 7). BTCP severity was determined via a VAS before and after fentanyl administration. Student's t-test was used to compare VAS scores before and after the treatment. Results: A total of 34 patients were included (73.53 % women; mean age: 59.68 y/o). The chemotherapy treatments that were most frequently associated with the occurrence of DHR-related BTCP were docetaxel and oxaliplatin (both 35.29 %), followed by paclitaxel (20.59 %). On average, patients had a baseline VAS score of 8.55 (SD 0.79) before being treated with fentanyl. After treatment, the mean pain intensity was 1.48 (SD 1.50), which represented a signifi cant difference (p < 0.001). The mean duration of the BTCP episode was of 5.29 minutes (SD 2.25), and the mean time to achieve pain relief was 1.52 minutes (SD 0.71). Conclusions: Sublingual fentanyl is an effective drug in the management of DHR-related BTCP during the infusion of taxanes and oxaliplatin, as it provides for a rapid and significant pain relief. Its role in this context should be further investigated by means of controlled clinical trials
