Search results for: omalizumab

Authors: Shanza Akram, Samir Salah, Imran Saleem, Jassim Abdou, Ashraf Al Zaabi

Abstract:

Estimated prevalence of asthma in UAE is around 10% (900,000 people). Patients with persistent symptoms despite using high dose ICS plus a second controller +/- Oral steroids are considered to have severe asthma. Omalizumab (Xolair) is an anti-IgE monoclonal antibody approved as add-on therapy for severe allergic asthma. The objective of our study was to obtain baseline characteristics of our local cohort, to determine the efficacy of omalizumab based on clinical outcomes pre and post 52 weeks of treatment and to assess safety and tolerability. Medical records of patients receiving omalizumab therapy for asthma at Zayed Military Hospital, Abu Dhabi were retrospectively reviewed. Patients fulfilling the criteria for severe allergic asthma as per GINA guidelines were included. Asthma control over 12 months pre and post omalizumab were analyzed by taking into account the number of exacerbations, hospitalizations, maintenance of medication dosages, the need for reliever therapy and PFT’s. 21 patients (5 females) with mean age 41 years were included. The mean duration of therapy was 22 months. 19 (91%) patients had Allergic Rhinitis/Sinusitis. Mean serum total IgE level was 648 IU/ml (65-1859). 11 (52%) patients were on oral maintenance steroids pre-treatment. 7 patients managed to stop steroids on treatment while 4 were able to decrease the dosage. Mean exacerbation rate decreased from 5 per year pre-treatment to 1.36 while on treatment. The number of hospitalizations decreased from a mean of 2 per year to 0.9 per year. Reliever inhaler usage decreased from mean of 40 to 15 puffs per week.2 patients discontinued therapy, 1 due to lack of benefit (2 doses) and 2nd due to severe persistent side effects. Patient compliance was poor in some cases. Treatment with omalizumab reduced the number of exacerbations, hospitalizations, maintenance and reliever medications, and is generally well tolerated. Our results show that there is room for improved documentation in terms of symptom recording and use of rescue medication at our institution. There is also need for better patient education and counseling in order to improve compliance.

Keywords: asthma, exacerbations, omalizumab, IgE

Procedia PDF Downloads 344

Authors: Shanza Akram, Samir Salah, Imran Saleem, Ashraf Alzaabi, Jassim Abdou

Abstract:

Introduction: 300 million people worldwide are affected by asthma .In UAE, prevalence is around 10% (900,000 people).Patients with persistent symptoms despite using high dose ICS plus a second controller +/- OCS are considered to have severe asthma. Omalizumab (Xolaire) an IgE monoclonal antibody is approved as add on therapy for severe allergic asthma. Objective: To determine the efficacy of omalizumab based on clinical outcomes in our cohort of patient pre and post 52 weeks of treatment to assess safety and tolerability of treatment. Methods: Medical records of patients receiving omalizumab therapy for asthma at ZMH ,Abu Dhabi were retrospectively analyzed.Patients fulfilling the criteria of severe allergic asthma as per GINA guidelines were included. Asthma control over 12 months prior to and 12 months after commencement of omalizumab therapy was analysed by taking into account the number of exacerbations and hospitalizations in addition to maintenance of medication dosages, need for rescue reliever therapy and pulmonary function testing. Results: Total cohort of 21 patient (5 females), average age 41 years and av length of therapy 22 months were included. Seven patients (total 11/52%) managed to stop steroids on treatment while four were able to decrease the dosage. Mean exacerbation rate decreased from five/ year pre treatment to 1.36 while on treatment. Number of hospitalizations decreased from mean of two per year to 0.9 per year. Rescue reliever inhaler usage decreased from mean of 40 puffs to 15 puffs per week. 2 patients discontinued therapy, 1 due to lack of benefit (2 doses) and 2nd due to severe persistent side effects including local irritation, severe limb and joint pains after 6 months. Conclusion: Treatment with omalizumab showed effect in terms of reduced number of exacerbations, maintenance therapy and reliever medications. However, no improvement was seen in PFTs.There is room for improved documentation in terms of symptom recording and use of rescue medicationas as well as for better patient education and counselling in order to improve compliance.

Keywords: asthma, omalizumab, severe allergic asthma, UAE

Procedia PDF Downloads 265

Authors: Ibraheem Husain, Abul Kalam Najmi, Karishma Chester

Abstract:

First-in-human (FIH) studies are a critical step in clinical development of any molecule that has shown therapeutic promise in preclinical evaluations, since preclinical research and safety studies into clinical development is a crucial step for successful development of monoclonal antibodies for guidance in pharmaceutical industry for the treatment of human diseases. Therefore, comparison between USFDA and nine pharmacologically guided approaches (PGA) (simple allometry, maximum life span potential, brain weight, rule of exponent (ROE), two species methods and one species methods) were made to determine maximum recommended starting dose (MRSD) for first in human clinical trials using four drugs namely Denosumab, Bevacizumab, Anakinra and Omalizumab. In our study, the predicted pharmacokinetic (pk) parameters and the estimated first-in-human dose of antibodies were compared with the observed human values. The study indicated that the clearance and volume of distribution of antibodies can be predicted with reasonable accuracy in human and a good estimate of first human dose can be obtained from the predicted human clearance and volume of distribution. A pictorial method evaluation chart was also developed based on fold errors for simultaneous evaluation of various methods.

Keywords: clinical pharmacology (CPH), clinical research (CRE), clinical trials (CTR), maximum recommended starting dose (MRSD), clearance and volume of distribution

Procedia PDF Downloads 346