Treatment is for 5 months. br / Control (n = 14) br / Xolair placebo 150 mg to 375 mg, administered as above br / Use of additional medication (common to both groups): no information providedOutcomesPrimary outcomes (relevant to this review): br / Reported at 18?weeks (4 months) br / Serious adverse events br / Secondary outcomes (relevant to this review): br / Reported at 18?weeks (4 months) br / CT scan (scored using the Zinreich modification of the Lund Mackay scoring system) Nasal polyp score br / Other outcomes reported by the study: br / None reported Funding sourcesMassachusetts General Hospital (study sponsor) br / Genentech, Inc. Selection criteria Randomised controlled trials (RCTs) with at least three months follow\up?comparing biologics (currently, monoclonal antibodies) against placebo/no treatment in patients with chronic rhinosinusitis. Data collection and analysis We used standard Cochrane methodological procedures. Our primary outcomes were disease\specific health\related quality of life (HRQL), disease severity and serious adverse events (SAEs). The secondary outcomes were avoidance of surgery, extent of disease (measured by Rabbit polyclonal to ZNF33A endoscopic or computerised tomography (CT) score), generic HRQL and adverse events (nasopharyngitis, including sore throat). We used GRADE to assess the certainty of the evidence for each outcome. Main results We included eight RCTs. Of 986 adult participants, 984 had severe chronic rhinosinusitis nasal polyps; 43% to 100% of?participants also had asthma. Three biologics, with different targets, were evaluated: dupilumab, mepolizumab and omalizumab. All the studies were sponsored or supported by industry. nasal polyps,?using regular topical nasal steroids, dupilumab improves disease\specific HRQL compared to placebo, and reduces the extent of the disease as measured on a CT scan. It probably also improves 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. There may be little or no difference in the risk of nasopharyngitis. In comparable patients, mepolizumab may improve both disease\specific and generic HRQL. It is uncertain whether it reduces the need for surgery or improves nasal polyp scores. There may be little or no difference in the risk of nasopharyngitis.?It?is usually uncertain if there is a difference in symptom severity and the risk of serious adverse events. We are uncertain about the effects of omalizumab. Plain language summary Biologics for people with chronic rhinosinusitis What is the aim of this review? ‘Biologics’ is the name given to a new type of drug.?This type is increasingly being used to help people with diseases due to inflammation of body tissues.?The aim of this review is to see if any of these drugs are effective in treating people with ‘chronic rhinosinusitis’.?These patients have long\term problems with inflammation of the nose and sinuses.?This leads to them having blocked, stuffy, runny noses and pain in their cheeks.?They often DM4 need to use long\term steroid nasal sprays.?Some patients with chronic rhinosinusitis also get polyps in their nose.?These can make their symptoms worse. Key message One of the new biologics C called dupilumab C helps people with severe chronic rhinosinusitis who also have nasal polyps.?It makes their symptoms better and shrinks their polyps.?It does not seem to cause any severe side effects.?Another comparable drug C called mepolizumab C may do the same but we are less certain about that. What was studied in the review? We looked for trials where patients with chronic DM4 rhinosinusitis had been given either one of the new biologic drugs or a placebo (dummy) treatment.?They needed to have been treated for at least three months.?We looked for studies that measured the effect of the drug on people’s symptoms and their general health.? DM4 What are the main results of the review? Almost all the people studied in the trials had?is found. A living systematic review approach is appropriate for this review because: 1) the topic is important for health care decision\making; 2) there is uncertainty about the existing evidence; and 3) this is a rapidly developing field where new trials are being actively planned and completed. We will revisit the scope (population, intervention, comparison, outcomes) of the review yearly, or more frequently as appropriate, to ensure that new brokers or uses are included as this field develops. In addition to having more data on safety and efficacy, our understanding of how biologics work, the.