Omalizumab in patients with NSAIDs-exacerbated respiratory disease.

BACKGROUND: The association of acetylsalicylic acid (ASA) intolerance, chronic rhinosinusitis with nasal polyps (CRSwNP), asthma, or chronic urticaria is known as NSAID-exacerbated respiratory disease (N-ERD). N-ERD patients often suffer from recurrent nasal polyps, severe asthma or also from urticaria. The aim of the present study was to retrospectively analyze the clinical efficacy of anti-IgE antibody treatment with omalizumab in patients with confirmed N-ERD. METHODS: In the open trial with patients receiving verum patients with CRSwNP, confirmed N-ERD by oral or nasal ASA challenges, asthma or chronic urticaria were included in the study. Rhinological and pulmonary parameters were evaluated before and after 3, 6 and 9 months of therapy by rhinological questionnaires (CRS VAS-scores and RSOM-31), nasal polyp (NP)-, ACT-scores and FEV1 values. Urticaria activity was monitored clinically. N-ERD patients with aspirin desensitization were included as control group (follow-up 9 months). RESULTS: In the omalizumab group 16 patients were included (10 female, 6 male, mean age 51 yrs). CRS symptoms, RSOM-31- and NP-score decreased significantly following omalizumab therapy compared to baseline. The ACT-score (MV 16.5 to 20.6) and FEV1values (MV 80 % to 89 %) improved significantly. No urticaria symptoms were reported after 3 months. Oral prednisolone therapy was required in one case and a repeated nasal sinus surgery in an additional case due to progression of NP. In the control group (8 female, 8 male, mean age 45 yrs) the NP-score was unchanged. CONCLUSIONS: Omalizumab is an effective therapy option in N-ERD patients in a 9 month study period.

[Nasal provocation with increased ASA dose: improved "non-steroidal anti-inflammatory drugs (NSAIDs)-exacerbated disease" (N­ERD) detection rate in chronic rhinosinusitis patients]. / Nasale ASS-Provokationen mit erhöhter Dosierung: verbesserte Detektionsrate der ASS-Intoleranz bei chronischer Rhinosinusitis.

BACKGROUND: Analgesic intolerance (AI) is an important diagnostic feature of disease progression in patients with chronic rhinosinusitis (CRS) accompanied by nasal polyps (CRSwNP) and asthma. OBJECTIVE: The aim of the present study was to determine whether increasing the concentration of acetylsalicylic acid (ASA) used in the diagnostic nasal challenge would improve detection of ASA intolerance (NSAIDs-exacerbated respiratory disease, N­ERD). METHODS: Patients with CRSwNP, asthma, and with (CRSwNP-AAI, n = 20) or without (CRSwNP-A, n = 15) anamnestically reported AI, as well as control subjects with CRS but no nasal polyps, asthma, or AI (n = 15), were challenged nasally with 16 mg ASA and, in case of a negative result, with 25 mg of ASA. RESULTS: In CRSwNP-AAI subjects, the challenge with 16 mg ASA resulted in detection of AI in 80% of cases; increasing the challenge of ASA to 25 mg improved the AI detection to 95%. In CRSwNP-A subjects, the detection of AI increased from 40% (16 mg ASA) to 53% (25 mg ASA). In the control group, no reaction to nasal ASA challenge was detected. No difference in the diagnosis of positive reactions after provocation was found when using the German vs. the European recommended evaluation criteria. Mild pulmonary symptoms occurred in 2 (10%) CRSwNP-AAI patients following the 16 mg ASA challenge. CONCLUSION: In patients with CRSwNP, asthma, and anamnestic AI, nasal provocation can effectively confirm the diagnosis of N­ERD and can also be recommended for patients with recurrent CRSwNP and asthma but without reported AI. Increasing the ASA challenge to 25 mg increases the overall detection rate.