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A phase I/IIa study on intra-articular injection of holmium-166-chitosan complex for the treatment of knee synovitis of rheumatoid arthritis

Authors
 Jungsik Song  ;  Chang Hee Suh  ;  Yong Beom Park  ;  Seung Hoon Lee  ;  Nae Chun Yoo  ;  Jong Doo Lee  ;  Kyoung Hwan Kim  ;  Soo Kon Lee 
Citation
 European Journal of Nuclear Medicine, Vol.28(4) : 489-497, 2001 
Journal Title
 European Journal of Nuclear Medicine 
ISSN
 0340-6997 
Issue Date
2001
Abstract
Previous animal studies have established that the intra-articular injection of holmium-166-chitosan complex (DW-166HC) causes effective necrosis of the inflamed synovium with little leakage of radioactivity from the injected joint. Based on these findings, we conducted a phase I/IIa study to examine the biodistribution of DW-166HC and to assess the safety of DW-166HC for the treatment of knee synovitis in patients with rheumatoid arthritis (RA). A total of 16 patients [1 man, 15 women; median age 49 (range 36–65) years] who had RA knee synovitis refractory to disease-modifying antirheumatic drug treatments of >3 months' duration were randomly assigned to three treatment groups with different radiation doses of DW-166HC: 370 MBq (n=6), 555 MBq (n=5) and 740 MBq (n=5). In each treatment group, blood and urine radioactivity were analysed by beta counter and biodistribution of the injected DW-166HC was evaluated using a gamma scan camera. Clinical assessment was done according to three variables (evaluation method): knee joint pain (visual analogue scale), range of motion (goniometry) and joint swelling (circumference of knee joint). The duration of follow-up observation was 3 months. Following the intra-articular injection of DW-166HC, the blood radioactivity was little changed from the baseline measurement and the accumulated radioactivity excreted in urine was minimal. Gamma scan study indicated that most of the injected radiochemical was localized within the injected joint cavity, and the extra-articular leakage was negligible at 24 h after the injection: brain, 0.3%; lung, 0.6%; abdomen, 0.7%; and pelvis, 0.8%. Major adverse events were transient post-injection knee joint pain and swelling. These results suggest that DW-166HC might be a safe agent for radiation synovectomy, particularly for the treatment of knee synovitis of RA, and further trials in a larger patient population are warranted to evaluate the therapeutic efficacy of DW-166HC.
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/142746
DOI
10.1007/s002590000470
Appears in Collections:
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실)
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Nuclear Medicine (핵의학교실)
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Pharmacology (약리학교실)
Yonsei Authors
김경환(Kim, Kyung Hwan) ; 박용범(Park, Yong Beom) ; 이수곤(Lee, Soo Kon) ; 이종두(Lee, Jong Doo)
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Full Text
http://link.springer.com/article/10.1007%2Fs002590000470
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