Safety Profile of Ixazomib in Patients with Relapsed/Refractory Multiple Myeloma in Japan: An All-case Post-marketing Surveillance

被引:5
作者
Kakimoto, Yoshihide [1 ]
Hoshino, Miyako [2 ]
Hashimoto, Mikiko [2 ]
Hiraizumi, Masaya [3 ]
Shimizu, Kohei [4 ]
Chou, Takaaki [5 ,6 ]
机构
[1] Takeda Pharmaceut Co Ltd, Japan Oncol Business Unit, Japan Med Affairs, Tokyo, Japan
[2] Takeda Pharmaceut Co Ltd, Japan Pharma Business Unit, Japan Med Off, Tokyo, Japan
[3] Takeda Pharmaceut Co Ltd, Takeda Dev Ctr Japan, Pharmacovigilance, Tokyo, Japan
[4] Takeda Pharmaceut Co Ltd, Takeda Dev Ctr Japan, Biostat, Tokyo, Japan
[5] Niigata Canc Ctr Hosp, Dept Internal Med, Niigata, Japan
[6] Gen Inc Fdn, Niigata Kenshin Plaza, Hlth Med Prevent Assoc, Niigata, Japan
关键词
multiple myeloma; ixazomib; proteasome inhibitor; post-marketing all-case surveillance; adverse drug reaction; safety; RISK; LENALIDOMIDE; INFECTION;
D O I
10.2169/internalmedicine.7768-21
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective To evaluate the safety profile of ixazomib combined with lenalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM) in clinical practice in Japan through an all-case post-marketing surveillance. Methods This was a nationwide non-interventional observational study conducted in Japan. The study included all patients who received ixazomib from May 24 to September 24, 2017. Ixazomib was administered to RRMM patients according to the Japanese package insert. All enrolled patients were observed until the completion of the sixth treatment cycle or until ixazomib discontinuation. The patient treatment course, including adverse events (AEs), was reported. Results The safety analysis set included 741 patients; the median age was 71 (range 35-92) years old, and the median number of prior treatment lines was 3 (range 1-30). Adverse drug reactions (ADRs) occurred in 572 (77.2%) patients, most commonly being thrombocytopenia (49.9%), diarrhea (29.2%), and nausea (12.4%). Serious ADRs occurred in 193 (26.0%) patients, most commonly being thrombocytopenia (9.9%) and diarrhea (5.9%). Thrombocytopenia, severe gastrointestinal disorders, infections, skin disorders, and peripheral neuropathy were prespecified as ADRs of clinical importance; the frequency of these ADRs (grade >= 3) were 28.5%, 9.4%, 7.4%, 2.2%, and 1.3%, respectively. Treatment discontinuation was most common with thrombocytopenia and severe gastrointestinal disorders (49 and 43 patients, respectively). Eleven patients died due to ADRs (16 events). Conclusion These results suggest that ixazomib has a tolerable safety profile in clinical practice in Japan. However, close AE management for thrombocytopenia and gastrointestinal disorders should be considered.
引用
收藏
页码:1337 / 1343
页数:7
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