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. Author manuscript; available in PMC: 2018 Dec 1.
Published in final edited form as: Otolaryngol Clin North Am. 2017 Sep 28;50(6):1135–1151. doi: 10.1016/j.otc.2017.08.009

Table 1.

Studies of biologics studied in CRS patients

Study Year Drug name & Mechanism Study population End points Adverse events Interesting points or problem with study
Randomized Clinical Trials
Gevaert P, Calus L et al. 75 2013 Omalizumab - Anti-IgE 24 patients - CRSwNP with comorbid asthma

  1. Endoscopic Nasal polyp scores

  2. CT scores

  3. Nasal and asthma

 URI symptoms Small sample size. Was effective independent of allergy status or symptom/QoL questionnaires elevated serum IgE.
Pinto JM et al.74 2010 Omalizumab - Anti-IgE 14 patients - 12 with CRSwNP

  1. Lund Mackay Score

  2. SNOT-20

  3. UPSIT

  4. NPIF

  5. Eosinophil levels

 concern for anaphylaxis, 1 patient with malignancy Showed minor improvements in radiographic severity Patients resumed previous therapy and were allowed to have “rescue” medications
Gevaert P, Lang- Loidolt D et al.62 2006 Reslizumab - Anti IL-5 24 pts CRSwNP (grade 3–4 or surgical salvage)

  1. Endoscopic Nasal polyp scores (qualitative)

  2. NPIF

  3. Serum eosinophila

  4. IL-5 levels

  5. ECP levels

 URI symptoms

  1. Increased baseline IL-5 predicted responsiveness

  2. Rebound Eosinophilia
Gevaert P, Van Bruaene N et al.63 2011 Mepolizumab - Anti-IL-5 30 pts CRSwNP (grade 3–4 or surgical salvage)

  1. Endoscopic Nasal polyp scores

  2. CT scores

  3. NPIF

  4. Symptoms

  5. Serum eosinophila

  6. IL-5R levels

  7. ECP levels

 URI symptoms

  1. Significantly improved symptoms and reduced nasal polyps.

  2. Followup to 48 weeks
Bachert C, Mannent L, et al.84 2016 Dupilumab - mAb to IL-4R- αsubunit 60 CRSwNP with and without Asthma

  1. Endoscopic Nasal polyp scores

  2. CT scores

  3. UPSIT

  4. NPIF

  5. SNOT22

  6. Serum IgE

  7. IL-5 levels

  8. Eotaxin-3 levels

 Nasopharyngitis, HA, injection site reactions

  1. Dramatic improvements in symptoms and biomarkers of type 2 inflammation.
Retrospective studies
Vennera Mdel C, Picado C et al.73 2011 Omalizumab - Anti-IgE 18 severe asthmatic patients with nasal polyps

  1. Endoscopic Nasal polyp scores

  2. Intranasal steroid use
Chandra RK, Clavenna M et al.76 2016 Omalizumab - Anti-IgE 25 patients with asthma and CRS

  1. Antibiotic use - 60% reduction

  2. Systemic steroid use - 42% reduction