RESUMEN
OBJECTIVES: The aim of this research was to describe the cases of TNF-α antagonist-related alopecia reported in the French Pharmacovigilance Database (FPVD) and to investigate the association between exposure to TNF-α antagonists and occurrence of alopecia. METHODS: All spontaneous reports of TNF-α antagonist-related alopecia recorded in the FPVD between January 2000 and April 2012 were colligated and described. We conducted disproportionality analyses (case/non-case method) to assess the link between the occurrence of alopecia and exposure to TNF-α antagonists. Cases were all reports of alopecia and non-cases were all other reports recorded during the study period. Exposure to TNF-α antagonists was sought in cases and in non-cases. Reporting odds ratios (RORs) were calculated to assess the association. Docetaxel was used as positive control and acetaminophen as negative control. We performed sensitivity analyses excluding cases of androgenic alopecia and those occurring in psoriatic patients. RESULTS: Among 282 590 spontaneous reports of adverse drug reactions (ADRs) collated in the FPVD, 1068 cases (alopecia reports) were identified. Of these cases, 52 (4.9%) occurred during exposure to TNF-α antagonists (18 involved infliximab, 17 adalimumab, 15 etanercept and 2 certolizumab). Exposure to TNF-α antagonists was more frequent among alopecia reports than among other ADR reports for all TNF-α antagonists pooled (ROR 3.0, 95% CI 2.3, 4.0) as well as for each antagonist separately, with similar values. Sensitivity analyses yielded similar results. The RORs were 29.9 (95% CI 25.3, 35.5) with docetaxel and 0.3 (95% CI 0.2, 0.4) with acetaminophen. CONCLUSION: The present study confirms a strong link between TNF-α antagonist exposure (class effect) and the occurrence of alopecia.
Asunto(s)
Alopecia/inducido químicamente , Antirreumáticos/efectos adversos , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Adalimumab , Adulto , Sistemas de Registro de Reacción Adversa a Medicamentos , Anticuerpos Monoclonales/efectos adversos , Anticuerpos Monoclonales/uso terapéutico , Anticuerpos Monoclonales Humanizados/efectos adversos , Anticuerpos Monoclonales Humanizados/uso terapéutico , Antirreumáticos/uso terapéutico , Certolizumab Pegol , Bases de Datos Factuales , Etanercept , Femenino , Francia , Humanos , Fragmentos Fab de Inmunoglobulinas/efectos adversos , Fragmentos Fab de Inmunoglobulinas/uso terapéutico , Inmunoglobulina G/efectos adversos , Inmunoglobulina G/uso terapéutico , Infliximab , Masculino , Farmacovigilancia , Polietilenglicoles/efectos adversos , Polietilenglicoles/uso terapéutico , Receptores del Factor de Necrosis Tumoral/uso terapéuticoAsunto(s)
Artritis Psoriásica/tratamiento farmacológico , Hipo/inducido químicamente , Metotrexato/efectos adversos , Metotrexato/uso terapéutico , Administración Oral , Adulto , Antirreumáticos/administración & dosificación , Antirreumáticos/efectos adversos , Antirreumáticos/uso terapéutico , Femenino , Hipo/diagnóstico , Humanos , Infusiones Parenterales , Metotrexato/administración & dosificación , Resultado del TratamientoRESUMEN
Among the many clinical manifestations of light-chain (AL) amyloidosis, musculoskeletal involvement is rarely reported. We describe the case of a 72-year-old woman who was referred to our rheumatology department for fixed flexion contractures of the fingers that developed concomitantly with a decline in general health. Macroglossia and recent-onset dyspnea were noted. Investigations, which included a tongue biopsy, established the diagnosis of kappa light-chain amyloidosis with soft tissue, bone, and cardiac deposits. Melphalan and dexamethasone therapy was successful in stabilizing the clinical and laboratory abnormalities within 6 months. This case is remarkable in that the musculoskeletal manifestations were at the forefront of the clinical picture and led to the diagnosis.
Asunto(s)
Amiloidosis/diagnóstico , Amiloidosis/inmunología , Contractura/etiología , Articulaciones de los Dedos , Cadenas kappa de Inmunoglobulina/metabolismo , Anciano , Amiloidosis/tratamiento farmacológico , Contractura/diagnóstico , Dexametasona/uso terapéutico , Femenino , Humanos , Melfalán/uso terapéutico , Resultado del TratamientoRESUMEN
Among the many clinical manifestations of light-chain (AL) amyloidosis, musculoskeletal involvement is rarely reported. We describe the case of a 72-year-old woman who was referred to our rheumatology department for fixed flexion contractures of the fingers that developed concomitantly with a decline in general health. Macroglossia and recent-onset dyspnea were noted. Investigations, which included a tongue biopsy, established the diagnosis of kappa light-chain amyloidosis with soft-tissue, bone and cardiac deposits. Melphalan and dexamethasone therapy was successful in stabilizing the clinical and laboratory abnormalities within 6 months. This case is remarkable in that the musculoskeletal manifestations were at the forefront of the clinical picture and led to the diagnosis.