Health-Related Quality-of-Life Evaluation of Crohn Disease Patients After Receiving Natalizumab Therapy

Abstract

Crohn disease (CD) is a chronic inflammatory condition without a permanent medical cure and commonly requiring a lifetime of care. This article discusses the impact of natalizumab induction and maintenance therapy on the health-related quality of life (HRQoL) of CD patients. Two natalizumab phase III studies were evaluated: the Efficacy of Natalizumab in Crohn's Disease Response and Remission (ENCORE) study evaluated the HRQoL of CD patients during 12 weeks of natalizumab induction therapy, and the Evaluation of Natalizumab As Continuous Therapy (ENACT-2) trial evaluated the effect of natalizumab maintenance therapy on HRQoL for a period of 48 weeks past a 12-week induction period (ENACT-1). HRQoL assessments were made with the Inflammatory Bowel Disease Questionnaire (IBDQ) and the Short Form-36 (SF-36). In the ENCORE study, induction therapy with natalizumab was demonstrated to significantly increase HRQoL scores at 12 weeks when compared with patients on placebo. During the ENACT-2 trial, IBDQ and SF-36 scale scores of patients who responded to natalizumab induction remained stable whereas those on placebo worsened. At week 60, the mean change from baseline on all scales of the IBDQ and the SF-36 were significantly higher for those who continued to receive natalizumab as compared to those who received placebo (p </= .016 for all scales). Natalizumab significantly improved the patient's clinical status and HRQoL shortly after treatment was initiated, and the effect was maintained for 60 weeks.

Sustained prolonged topical delivery of bioactive human insulin for potential treatment of cutaneous wounds

“…Recombinant peptides are an increasingly important therapeutic intervention against a variety of medical conditions including diabetic, oncologic, cardiovascular, immunosuppressive and gastroenterological diseases (Liu et al, 2009;Stevenson, 2009;Thomas et al, 2009;Parker et al, 2004;Dudley-Brown et al, 2009). Therapeutic peptides are part of a larger class of biopharmaceuticals that also encompasses monoclonal antibodies and nucleic acid-based medicinal products (Walsh, 2005;Aberra and Lichtenstein, 2006;Golzio et al, 2005).…”

Disease-Specific Knowledge, Coping, and Adherence in Patients with Inflammatory Bowel Disease

“…Both UC and CD can have a negative impact on health and quality of life (QOL) for several reasons: uncertainty regarding etiopathogenesis, the unpredictable and lifelong course of disease, and challenges managing disease symptoms and complications [1]. Earlier studies have shown that patients with CD have lower QOL than patients with UC, which may in part be due to the fact that patients with CD require more surgeries, experience more complications such as perianal disease, and may have more disease-associated pain [3][4][5][6][7].…”

Experiencia local con natalizumab en pacientes con enfermedad de Crohn refractaria a anti-TNF: Casos clínicos

“…Además, este fármaco ha demostrado ser eficaz en población pediátrica con EC con tasas de remisión clínica de 50% 18 . Otros han señalado que su uso puede disminuir el riesgo de cirugía 21 y mejorar la calidad de vida de los pacientes con EC 22 . Nuestra experiencia demuestra que natalizumab tuvo una respuesta efectiva alcanzando la remisión clínica en los tres pacientes.…”