Biological therapy effective option for treating chronic rhinosinusitis
'Biologics' are medicinal products produced by a biological process. Monoclonal antibodies are one type, which can treat inflammatory conditions
UK: Researchers have found that biologics especially dupilumab improves rhinosinusitis symptoms and quality of life after 24 weeks of treatment.
Chronic rhinosinusitis is characterized by inflammation of the nasal and sinus linings, nasal blockage, rhinorrhoea, facial pressure/pain and loss of sense of smell. It occurs with or without nasal polyps. It is a very common condition. It may significantly decrease the quality of life. Treatment is directed at enhancing mucociliary clearance, improving sinus drainage/outflow, eradicating local infection and inflammation, and improving access for topical medications.
Researchers at the UK Cochrane center conducted a randomized control trial with about three months of follow up. They compared biologics (currently, monoclonal antibodies) against placebo/no treatment in patients with chronic rhinosinusitis.
The researchers used standard Cochrane methodological procedures for the study. The primary outcome was disease‐specific health‐related quality of life (HRQL), disease severity and serious adverse events (SAEs). The secondary outcome was the avoidance of surgery, the extent of disease (measured by endoscopic or computerized tomography (CT) score), generic HRQL and adverse events (nasopharyngitis, including sore throat). GRADE to assess the certainty of the evidence for each outcome was also used in the study.
Eight RCTs were included. Of 986 adult participants, 984 had severe chronic rhinosinusitis with nasal polyps; 43% to 100% of participants also had asthma. Three biologics, with different targets, were evaluated: dupilumab, mepolizumab, and omalizumab.
Anti‐IL‐4Rα mAb (dupilumab) versus placebo/no treatment (all receiving intranasal steroids)
Three studies (784 participants) evaluated dupilumab.
Disease‐specific HRQL was measured with the SNOT‐22. At 24 weeks, the SNOT‐22 score was 19.61 points lower (better) in participants receiving dupilumab
Symptom severity measured on a 0‐ to 10‐point visual analogue scale (VAS) was 3.00 lower in those receiving dupilumab
The risk of serious adverse events may be lower in the dupilumab group
The number of participants requiring nasal polyp surgery (actual or planned) during the treatment period is probably lower in those receiving dupilumab
Change in the extent of the disease using the Lund Mackay computerized tomography (CT) score (0 to 24, higher = worse) was ‐7.00 , a large effect favoring the dupilumab group.
There may be little or no difference in the risk of nasopharyngitis.
Anti‐IL‐5 mAb (mepolizumab) versus placebo/no treatment (all receiving intranasal steroids)
Two studies (137 participants) evaluated mepolizumab.
Disease‐specific HRQL measured with the SNOT‐22 at 25 weeks was 13.26 points lower (better) in participants receiving mepolizumab
It is very uncertain whether there is a difference in symptom severity: on a 0‐ to 10‐point VAS symptom severity was ‐2.03 lower in those receiving mepolizumab
It is very uncertain if there is a difference in the risk of serious adverse events
It is very uncertain whether or not the overall risk that patients still need surgery at the trial end is lower in the mepolizumab group
The difference in generic quality of life (EQ‐5D) was 5.68, favoring the mepolizumab group
There may be little or no difference in the risk of nasopharyngitis
Anti‐IgE mAb (omalizumab) versus placebo/no treatment (all receiving intranasal steroids)
Three very small studies (65 participants) evaluated omalizumab. The study very uncertain about the effect of omalizumab on disease‐specific HRQL, severe adverse events, the extent of disease (CT scan scores), generic HRQL and adverse effects.
Hence the authors concluded that in adults with severe chronic rhinosinusitis and nasal polyps, using regular topical nasal steroids, dupilumab improved disease‐specific HRQL compared to placebo, and reduces the extent of the disease as measured on a CT scan. It may also improve symptoms and generic HRQL and there is no evidence of an increased risk of serious adverse events. It may reduce the need for further surgery.
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