Background: The efficacy and safety of omalizumab in adult patients with refractory chronic urticaria (CU) is well established, but there is little information on the treatment of children. Here, we assessed the efficacy, time to onset of effects, improvement of quality of life, and safety of omalizumab in children and adolescents with CU. Methods: Patients aged < 18 years with antihistamine-resistant CU were treated with 150 or 300 mg of omalizumab every four weeks. We used the recently validated Chinese version of urticaria control test (UCT) to assess disease control status, children’s dermatology life quality index (CDLQI) to evaluate quality of life impairment, and monitored adverse events to assess the safety. Results: We treated 12 CU patients (7 female, mean age 10.2 ± 4.4 years, range 3–16) with omalizumab. Two thirds (67%) of the patients achieved well-controlled CU (defined as a UCT score ≥ 12) after the first administration. The UCT score significantly increased from 2.5 (0.0-5.8) at baseline to 12.0 (1.3-13.8) after four weeks (Z=-3.063, P=0.002) and 15.0 (13.5-16.0) after 16 weeks (Z=-3.065, P=0.002). The CDLQI score decreased from 17.5 (14.5-20.5) at baseline to 9.0 (3.0-13.8) after four weeks (Z=-2.984, P=0.003) and 2.0 (0.0-6.8) after 16 weeks (Z=-3.063, P=0.002). No adverse events were observed. Conclusion: Omalizumab is effective, fast acting and safe for children and adolescents with antihistamine-resistant chronic urticaria.
This systematic review evaluates the efficacy, safety and economic impact of dupilumabcompared to standard of care for uncontrolled moderate-to-severe atopic dermatitis (AD). Pubmed, EMBASE and Cochrane Library were searched for RCTs and health economic evaluations. Critical and important AD-related outcomes were considered. The risk of bias and the certainty of the evidence were assessed using GRADE. Seven RCTs including 1845 subjects > 12 years treated with dupilumab16 to 52 weeks were evaluated. For adultsthere is high certainty that dupilumabdecreasesSCORAD (MD -30,72; 95%CI -34,65% to -26,79%) and EASI-75 (RR 3.09; 95%CI 2.45 to 3.89), pruritus (RR 2.96; 95%CI 2.37 to 3.70), rescue medication (RR 3.46; 95%CI 2.79 to 4.30), sleep disturbance (MD -7.29; 95%CI -8.23 to -6.35), anxiety/depression (MD -3.08; 95% CI -4.41 to -1.75) and improves quality of life (MD -4.80; 95% CI -5.55 to -4.06). The efficacy for adolescents is similar. Dupilumab-related adverse events (AEs) slightly increase (low certainty). The evidence for dupilumab-related serious AE is uncertain. The incremental cost-effectiveness ratio ranged from 28,500 £ (low certainty) to 124,541 US$ (moderate certainty).More data on long term safety are needed both for children and adults, together with more efficacy data in the paediatric population.
This systematic review evaluates the efficacyand safety of omalizumab for chronic spontaneous urticaria (CSU). Pubmed, EMBASE and Cochrane Library were searched for RCTs. Critical and important CSU-related outcomes were considered. The risk of bias and the certainty of the evidence were assessed using GRADE. Ten RCTs including 1620 subjects aged 12 to 75 years old treated with omalizumab for 16 to 40 weeks were evaluated. Omalizumab 150 mg: does not result in clinically meaningful improvement(high certainty) of the urticaria activity score (UAS)7 (mean difference (MD) -5; 95%CI -7.75 to -2.25) and the itch severity score(ISS)7 (MD -2.15; 95% CI -3.2 to -1.1); does not increase (moderate certainty) quality of life (QoL) (Dermatology Life Quality Index (DLQI); MD -2.01; 95%CI -3.22 to -0.81); decreases (moderate certainty) rescue medication use (MD -1.68; 95%CI -2.95 to -0.4). Omalizumab 300 mg:results in clinically meaningful improvements(moderate certainty)of the UAS7 (MD -11.05; 95%CI -12.87 to -9.24), theISS7 (MD -4.45; 95%CI -5.39 to -3.51), and QoL (high certainty)(DLQI; MD -4.03; 95% CI -5.56 to -2.5); decreases (moderate certainty) rescue medication use (MD -2.04; 95%CI -3.19 to -0.88) and drug-related serious AEs (RR 0.77; 95%CI 0.20 to 2.91).