Erratum: A Practical Approach to Severe Asthma in Children

AnnalsATS would like to correct two errors in the publication of an article in the April 2018 issue of the journal (1). In Table 4, the approved ages for Mepolizumab and Benralizumab in rows 2 and 4 should read as “Age ≥ 12 yr” instead of “Age ≥ 2 yr.” Additionally, in the first row, the IgE age ranges were reversed; these should read as “IgE 30–700 (age ≥ 12) yr and IgE 30–1,300 (age 6–11) yr” instead of “IgE 30–700 (age 6–11) yr and IgE 30–1,300 (age ≥ 12) yr.” The corrected table is published in full below.

Table 4.

U.S. Food and Drug Administration–approved biologic drugs for pediatric severe asthma

Drug	Mechanism of Action	Dosing (Route)	Applicable Population	Clinical Outcomes	Potential Serious Side Effects
Omalizumab (Xolair) FDA approved 2002	Anti-IgE mAb	150, 225, 300, or 375 mg Q2W or Q4W (SC); based on weight and IgE	Age ≥ 6 yr	↓Exacerbation frequency	Anaphylaxis (up to 0.2%)
	Binds IgE Fc region		Moderate to severe asthma and perennial aeroallergen sensitization	↓Symptoms	Not associated with malignancy in postmarketing safety study (92)
	Prevents binding to mast cells/basophils			↓ICS dose
			IgE 30–700 (age ≥ 12) yr	↑FEV1
			IgE 30–1,300 (age 6–11) yr	↑QOL
Mepolizumab (Nucala) FDA approved 2015	Anti–IL-5 mAb	100 mg Q4W (SC)	Age ≥ 12 yr	↓Exacerbation frequency	Hypersensitivity reactions
	Inhibits IL-5 binding to α-subunit of IL-5 receptor complex on eosinophils		Severe eosinophilic asthma	↓Symptoms	Herpes zoster
	Inhibits growth, differentiation, recruitment, activation, and survival of eosinophils		Blood eosinophil count ≥ 150 cells/μl within 6 wk or >300 in past 12 mo	↓OCS dose
				±FEV1
				↑QOL
Reslizumab (Cinqair) FDA approved 2016	Anti–IL-5 mAb	3 mg/kg Q4W (IV)	Age ≥ 18 yr	↓Exacerbation frequency	Anaphylaxis (0.3%)
	Inhibits IL-5 binding to α-subunit of IL-5 receptor complex on eosinophils		Severe eosinophilic asthma	↓Symptoms	Transient ↑CPK
	Inhibits growth, differentiation, recruitment, activation, and survival of eosinophils		Blood eosinophil count ≥ 400 cells/μl*	↑FEV1	Note: patients aged 12–18 yr had higher rate of exacerbations than placebo
				↑QOL
Benralizumab (Fasenra) approved 2017	Anti–IL-5 mAb	30 mg Q4W × 3 doses, then Q8W (SC)	Age ≥ 12 yr	↓Exacerbation frequency	Patients with Helminth infections excluded from clinical trials—may interfere with infection clearance
	Simultaneously binds Fc receptor on NK cells depleting eosinophils by antibody-dependent cell-mediated cytotoxicity and apoptosis		Severe eosinophilic asthma	↓Symptoms	Hypersensitivity reactions
			Blood eosinophil count ≥ 300 in past 12 mo and two or more exacerbations*	↓OCS dose
				↑FEV1

Definition of abbreviations: CPK = creatine phophokinase; Fc = fragment crystallizable; FDA = U.S. Food and Drug Administration; FEV₁ = forced expiratory volume in 1 second; ICS = inhaled corticosteroids; IgE = immunoglobulin E; IV = intravenous; mAB = monoclonal antibody; NK cell = natural killer cell; OCS = oral corticosteroids; QOL = quality of life; Q2W = every 2 weeks; Q4W = every 4 weeks; Q8W = every 8 weeks; SC = subcutaneous.

^*Phase III trial entry criteria, not part of labeled indication definition.

Bold text indicates key clinical findings.