Review Article

Anti-IL-5 and IL-5Ra: Efficacy and Safety of New Therapeutic Strategies in Severe Uncontrolled Asthma

Table 1

Exacerbations, OCS sparing, QoL, and safety of main clinical trials about anti-IL-5 and anti-IL-5Ra.

EXACERBATIONOCS sparingQoLSAFETY

MEPOLIZUMABPavord et al. [7]exacerbation (48%with 75mg dose/39% with 250mg dose/52% with 750mg dose)not performedno improvement of QoL (tests using AQLQ )common: headache, nasopharyngitis, infusion related reaction
Serious: 3 death (1 septic shock after acute pancreatitis, fatal asthma attack, suicide)
FloodPage et al. [8]no significant difference between groups (16% placebo, 18 % 250 mg, 10% 750 mg)not performedimprovement in treated patients, with all doseserious: placebo (bladder carcinoma, unintended pregnancy, and asthma exacerbation); 250 mg of mepolizumab (hydrocephalus/cerebrovascular disorder, constipation, and gastrointestinal disturbance); 750 mg of mepolizumab (asthma exacerbation)
Bet et al. [9]32% exacerbation lessreducing daily dosage ( 2,65 times more than patient receiving placebo)small change in ACQcommon: headache, nasopharyngitis, infusion related reaction
Serious: asthma exacerbation, pneumonia (both in placebo group)
Ortega et al. [10]exacerbation (with intravenous medication, 47%; with subcutaneous administration, 53%)not performedimprovement in QoLcommon: headache, nasopharyngitis, upper respiratory tract infection
Nair et al. [11]reduction of exacerbations in treated patientsreducing daily dosagenot performedcommon: 1 patient with shortness of breath, 1 with aches and tiredness
serious: 1 death in placebo group
Chupp et al. [12]reduction of exacerbations of 58%not performedimprovement of QoL (tests using SGRQ)common: headache, nasopharyngitis, urticaria, arthralgia, arrhythmias, injection-site reaction Serious: 8 arrhythmias (2 in mepolizumab and 6 in placebo), 1 deep venous thrombosis in mepolizumab group

RESLIZUMABCastro et al. [13]exacerbation (people without exacerbation: 44%with placebo, 61% with reslizumab)no improvement in OCS sparingimprovement of QoL (test using ACQ)common: nasopharyngitis, upper respiratory tract infection
serious: 2 anaphylactic reaction
Castro et al. [14]exacerbation (people without exacerbation:52% with placebo,73% with reslizumab)no improvement in OCS sparingimprovement of QoL (test using AQLQ and ACQ-7)common: nasopharyngitis
serious: pneumonia, worsening of asthma
Corren et al. [15]not performed due to the short observation period (16 weeks)not performedimprovement of QoL (test using ACQ-7)serious: 2 anaphylactic reactions, 1 colon cancer (all in reslizumab group)
Bjemer et al. [16]not performed due to the short observation period (16 weeks)not performedimprovement of QoL (test using ACQ and AQLQ)serious: placebo (1 acute myocardial infarction), 3 asthma exacerbations, 1 sinusitis, 1 pneumonia, 1 road traffic accident and 1 rib fracture

BENRALIZUMABCastro et al. [17]no difference in noneosinophilic patients between benralizumab and placebo. Reduction in eosinophilic patients.not performedimprovement in AQLQ in people with at least 300 eosinophils/mmcserious: 100 mg dosage acute cholecystitis, herpes zoster, polyarteritis nodosa, and uterine leiomyoma 20 mg dosage: erythema nodosum
Nowak et al. [18]exacerbation (49%) and exacerbation requiring hospitalization (60%)not performedno significant improve in ACQ and AQLQcommon: headache, asthma, dizziness, cough, pyrexia, bronchitis, anxiety, muscle spasm
serious: tachycardia and anxiety
Bleecker et al. [19]exacerbation in Q4W and Q8Wnot performedimprovement in patients with baselinecommon: nasopharyngitis, worsening of asthma
serious: allergic granulomatous angiitis, panic attack, paraesthesia
Fitzgerald et al. [20]exacerbation in Q4W and Q8Wnot performedblood eosinophils ≥300 cells per μLcommon: nasopharyngitis, worsening of asthma
serious: urticaria, asthma, herpes zoster, chest pain
Nair et al. [21]exacerbation (55% with 30 mg dose every 4 weeks; 70% with 30 mg dose every 8 weeks)interruption of OCS (56% of who received drug every 4 weeks and 52% of 8 weeks administration, as compared with 19% treated with placebo)improvement in patients with baselineserious: worsening of asthma, pneumonia, hearth failure, pericarditis (placebo). Two case of death in Q8W due to pneumonia and acute cardiac failure.