RESUMEN
OBJECTIVE: No studies evaluating the rapidity of response to biological therapies are available for Crohn's disease (CD). The aim of this study was to evaluate rapidity of onset of clinical response and impact on quality of life (QoL) of adalimumab therapy in adult anti-TNF-naïve patients with moderately-to-severely active CD. PATIENTS AND METHODS: RAPIDA was an open-label, single-arm, prospective, multicenter clinical trial. Adult patients with moderately-to-severely active luminal CD, anti-TNF-naïve, and unresponsive to conventional therapy were treated with adalimumab. Clinical disease activity, QoL and inflammatory biomarkers were measured at day 4, and weeks 1, 2, 4, and 12 after treatment initiation. RESULTS: Eighty-six patients were included in the intention-to-treat (ITT) analyses. Clinical disease activity was reduced from a median of 9.0 points to 6.0 points at day 4. Clinical response (≥ 3-point reduction in the Harvey-Bradshaw Index, HBI) was achieved by 61.6% (d4) and 75.6% (w1) of patients in the ITT population (median 2.5 days) and with non-responder imputation (NRI), by 55.8% and 53.4%, respectively. The proportion of patients in clinical remission (HBI<5) at weeks 2 and 4 in the ITT population was 54.7% and 62.8%, respectively (median 7.0 days), and 38.4% and 45.3% in the NRI population. All QoL scores significantly improved and inflammatory biomarkers significantly decreased from day 4 onwards (p<0.0001). CONCLUSION: Rapid clinical response and remission, improvement in QoL and fatigue, and a reduction of inflammatory biomarkers were achieved with adalimumab as early as day 4 in adult anti-TNF-naïve patients with moderately-to-severely active CD.
Asunto(s)
Adalimumab/uso terapéutico , Enfermedad de Crohn/tratamiento farmacológico , Calidad de Vida , Inhibidores del Factor de Necrosis Tumoral/uso terapéutico , Adulto , Anciano , Biomarcadores/sangre , Enfermedad de Crohn/sangre , Fatiga/tratamiento farmacológico , Femenino , Humanos , Análisis de Intención de Tratar , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Inducción de Remisión , Índice de Severidad de la Enfermedad , España , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
A phenyltriazine compound has been used for the first time as a monomer in the construction of a hydrogel. This physically cross-linked soft material showed blue fluorescence when excited under UV-light. Polymer formation and intermolecular H-bonds arising from triazine moieties operate as aggregation-induced emission (AIE) mechanisms. The combination of soft materials and AIE properties expands the applications of these materials. As a proof of concept, two luminescent dyes have been incorporated into the hydrogel to produce a white-light-emitting material.