Efficacy and safety of mepolizumab in Korean patients with severe eosinophilic asthma from the DREAM and MENSA studies

Background/Aims@#The efficacy and safety of mepolizumab in patients with severe eosinophilic asthma has been evaluated in a global clinical trial programme. This post hoc analysis assesses the efficacy and safety of mepolizumab in Korean patients. @*Methods@#Data from Korean patients in the Phase III, placebo-controlled, randomised DREAM (MEA112997/NCT01000506) and MENSA (MEA115588/ NCT01691521) studies were included. Patients ≥ 12 years old with severe eosinophilic asthma received mepolizumab (DREAM: 75, 250 or 750 mg intravenously [IV]; MENSA: 75 mg IV or 100 mg subcutaneously [SC]), or placebo every 4 weeks for 52 weeks (DREAM) or 32 weeks (MENSA). The primary outcome was the rate of clinically significant asthma exacerbations. Secondary outcomes included forced expiratory volume in 1 second (FEV1), Asthma Control Questionnaire (ACQ) and St George’s Respiratory Questionnaire (SGRQ) scores (MENSA only). Blood eosinophil counts (BEC) and safety were assessed throughout. @*Results@#Reductions in the rate of clinically significant asthma exacerbations were observed with the approved (100 mg SC) and bioequivalent (75 mg IV) doses of mepolizumab in Korean patients who participated in DREAM and MENSA. In MENSA, trends for improvements from baseline at week 32 in pre-bronchodilator FEV1 (75 mg IV group), ACQ-5 and SGRQ scores (in both treatment groups) were seen versus placebo in Korean patients. Incidence of on-treatment adverse events was similar in Korean patients versus non-Korean patients as were observed reductions from baseline in BEC. @*Conclusions@#Mepolizumab treatment provided clinical benefits for Korean patients with severe eosinophilic asthma; the safety profile is consistent with the overall population.

Prophylactic Antibiotics Therapy after Splenectomy / 임상소아혈액종양

BACKGROUND: Patients who are born without spleen or who have impaired splenic function due to disease or splenectomy become vulnerable to sepsis caused by bacteria. Overwhelming post-splenectomy infection (OPSI) occurs at an estimated incidence of 0.23-0.42% per year with a lifetime risk of 5%. The risk of OPSI with encapsulated bacteria is generally considered greatest in the first 2 years after splenectomy but the increased risk remains lifelong. Because vaccination doesn't completely protect against infection with encapsulated bacteria that prevent OPSI, use of prophylactic antibiotics are recommended for prevention of infection after splenectomy. METHODS: A retrospective review of 41 patients who underwent splenectomy from January 1990 to December 2012 in Inje University Busan Paik Hospital were identified through the medical records. RESULTS: Of 41 patients, 100% (41/41) were vaccinated in pneumococcal vaccines, 27% (11/41) were vaccinated in HIB vaccines. Prophylactic antibiotics (penicillin G benzathine IM every 4 weeks) were prescribed in 73% (30/41) of patients. We could not find any septic events. CONCLUSION: Because of the high mortality, the fulminant course, and the refractoriness to common treatment of overwhelming infections caused by encapsulated bacteria, prevention through vaccination and antibiotic prophylaxis is the basis of the management of patients who have had splenectomy or have hyposplenism. Prophylactic antibiotics using Penicillin G benzathine every 4 weeks is effective for preventing septic events in splenectomized patients. But further improvement in coverage of recommended vaccines and continuous prophylactic antibiotics after splenectomy is needed to reduce the risk of serious infection.

Prophylactic Antibiotics Therapy after Splenectomy / 임상소아혈액종양

BACKGROUND: Patients who are born without spleen or who have impaired splenic function due to disease or splenectomy become vulnerable to sepsis caused by bacteria. Overwhelming post-splenectomy infection (OPSI) occurs at an estimated incidence of 0.23-0.42% per year with a lifetime risk of 5%. The risk of OPSI with encapsulated bacteria is generally considered greatest in the first 2 years after splenectomy but the increased risk remains lifelong. Because vaccination doesn't completely protect against infection with encapsulated bacteria that prevent OPSI, use of prophylactic antibiotics are recommended for prevention of infection after splenectomy. METHODS: A retrospective review of 41 patients who underwent splenectomy from January 1990 to December 2012 in Inje University Busan Paik Hospital were identified through the medical records. RESULTS: Of 41 patients, 100% (41/41) were vaccinated in pneumococcal vaccines, 27% (11/41) were vaccinated in HIB vaccines. Prophylactic antibiotics (penicillin G benzathine IM every 4 weeks) were prescribed in 73% (30/41) of patients. We could not find any septic events. CONCLUSION: Because of the high mortality, the fulminant course, and the refractoriness to common treatment of overwhelming infections caused by encapsulated bacteria, prevention through vaccination and antibiotic prophylaxis is the basis of the management of patients who have had splenectomy or have hyposplenism. Prophylactic antibiotics using Penicillin G benzathine every 4 weeks is effective for preventing septic events in splenectomized patients. But further improvement in coverage of recommended vaccines and continuous prophylactic antibiotics after splenectomy is needed to reduce the risk of serious infection.

Prophylactic Antibiotics Therapy after Splenectomy / 임상소아혈액종양

BACKGROUND: Patients who are born without spleen or who have impaired splenic function due to disease or splenectomy become vulnerable to sepsis caused by bacteria. Overwhelming post-splenectomy infection (OPSI) occurs at an estimated incidence of 0.23-0.42% per year with a lifetime risk of 5%. The risk of OPSI with encapsulated bacteria is generally considered greatest in the first 2 years after splenectomy but the increased risk remains lifelong. Because vaccination doesn't completely protect against infection with encapsulated bacteria that prevent OPSI, use of prophylactic antibiotics are recommended for prevention of infection after splenectomy.METHODS: A retrospective review of 41 patients who underwent splenectomy from January 1990 to December 2012 in Inje University Busan Paik Hospital were identified through the medical records.RESULTS: Of 41 patients, 100% (41/41) were vaccinated in pneumococcal vaccines, 27% (11/41) were vaccinated in HIB vaccines. Prophylactic antibiotics (penicillin G benzathine IM every 4 weeks) were prescribed in 73% (30/41) of patients. We could not find any septic events.CONCLUSION: Because of the high mortality, the fulminant course, and the refractoriness to common treatment of overwhelming infections caused by encapsulated bacteria, prevention through vaccination and antibiotic prophylaxis is the basis of the management of patients who have had splenectomy or have hyposplenism. Prophylactic antibiotics using Penicillin G benzathine every 4 weeks is effective for preventing septic events in splenectomized patients. But further improvement in coverage of recommended vaccines and continuous prophylactic antibiotics after splenectomy is needed to reduce the risk of serious infection.