RESUMEN
OBJECTIVE: This pooled analysis assessed the safety of omalizumab in children with allergic (immunoglobulin E-mediated) asthma. STUDY DESIGN: Two double-blind, placebo-controlled studies in children (6 to < 12 years) with moderate-to-severe allergic asthma investigated the efficacy/safety of omalizumab. Children on optimized asthma care (inhaled corticosteroids ± other controller medications) were randomized (2:1) to omalizumab (75-375 mg sc, q2 or q4 wk) or placebo. Pooled safety findings from these trials are presented in this publication. RESULTS: The safety population included 926 children (omalizumab, n = 624; placebo, n = 302). Adverse events (AEs) were more frequently reported in the placebo (91.7%) than omalizumab (89.7%) group. The most common AEs were nasopharyngitis, upper respiratory tract infection and headache. Suspected treatment-related AEs included headache, erythema and urticaria; none of which were reported by ≥ 2% of patients receiving omalizumab. Serious AEs (SAEs) were reported by 3.4% and 6.6% of patients receiving omalizumab and placebo, respectively; the most common were appendicitis, pneumonia and bronchitis; no deaths were reported. CONCLUSIONS: Omalizumab has an acceptable safety profile, with a risk of AEs similar to placebo. This, combined with its efficacy profile, suggests that omalizumab may provide an additional asthma management option for children (6 to < 12 years) uncontrolled with current therapy that follows established guidelines.
Asunto(s)
Anticuerpos Monoclonales/efectos adversos , Anticuerpos Monoclonales/uso terapéutico , Asma/tratamiento farmacológico , Inmunoglobulina E/efectos adversos , Algoritmos , Antiasmáticos/efectos adversos , Antiasmáticos/uso terapéutico , Anticuerpos Antiidiotipos , Anticuerpos Monoclonales Humanizados , Asma/etiología , Asma/inmunología , Niño , Método Doble Ciego , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Femenino , Humanos , Masculino , Omalizumab , Placebos , Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos , Índice de Severidad de la EnfermedadRESUMEN
OBJECTIVES: Overview of three dose-response studies demonstrating the efficacy of lumiracoxib, a novel COX-2 selective inhibitor, for chronic pain associated with osteoarthritis (0A), or rheumatoid arthritis (RA) and acute pain following dental extraction. METHODS: OA and RA: 4-week, randomized, placebo- and active-controlled studies of similar design. Patients (OA, n = 583; RA, n = 571) received lumiracoxib 50 mg, 100 mg or 200 mg twice daily (bid), lumiracoxib 400 mg once daily (od), diclofenac 75 mg bid or placebo. Dental: 12-h, single-center, randomized, placebo- and active-controlled study. Patients (n = 202) received single oral doses of lumiracoxib 100 mg or 400 mg, ibuprofen 400 mg or placebo. MAIN OUTCOME MEASURES: OA: pain intensity (PI) in the target joint (visual analogue scale [VAS]) and WOMAC score at Week 4; RA: overall PI (VAS) and ACR20 response at Week 4; Dental: difference (PID, categorical and VAS) score over 12h post dose, time to onset of analgesia. RESULTS: Throughout the OA study, all lumiracoxib doses provided superior reductions in PI versus placebo and at Week 4, all lumiracoxib doses provided efficacy similar to each other and to diclofenac. In the RA study, lumiracoxib 100 mg bid, 200 mg bid and 400mg od were significantly better than placebo in PI at Weeks 1 and 2 (all p < 0.05) but demonstrated borderline significance at Week 4 (lumiracoxib 400 mg od, p = 0.06). In pain following dental surgery, PID scores for both lumiracoxib doses were superior to placebo from 1.5 h onwards and always comparable, or superior, to ibuprofen. Lumiracoxib 400 mg had the fastest onset of analgesia, measured as median time to confirmed first perceptible pain relief using the two-stopwatch method (37.4 min, superiority versus placebo, p < 0.001). Lumiracoxib was well tolerated in all studies. CONCLUSIONS: These studies provide initial evidence that lumiracoxib is an effective, well-tolerated agent for the treatment of chronic and acute pain.