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

Jungsik Song, Chang Hee Suh, YongBeom Park, Seung Hoon Lee, Nae Chun Yoo, Jong Doo Lee, Kyoung Hwan Kim, Soo Kon Lee

Research output: Contribution to journalArticle

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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 anti-rheumatic 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.

Original languageEnglish
Pages (from-to)489-497
Number of pages9
JournalEuropean Journal of Nuclear Medicine
Volume28
Issue number4
DOIs
Publication statusPublished - 2001 Apr 12

Fingerprint

Intra-Articular Injections
Synovitis
Rheumatoid Arthritis
Knee
Radioactivity
Knee Joint
Joints
Arthralgia
Therapeutics
Urine
Radiation
Injections
Gamma Cameras
Antirheumatic Agents
DW 166HC
(166)holmium-chitosan complex
Synovial Membrane
Articular Range of Motion
Pelvis
Visual Analog Scale

All Science Journal Classification (ASJC) codes

  • Radiology Nuclear Medicine and imaging

Cite this

Song, Jungsik ; Suh, Chang Hee ; Park, YongBeom ; Lee, Seung Hoon ; Yoo, Nae Chun ; Lee, Jong Doo ; Kim, Kyoung Hwan ; Lee, Soo Kon. / A phase I/IIa study on intra-articular injection of holmium-166-chitosan complex for the treatment of knee synovitis of rheumatoid arthritis. In: European Journal of Nuclear Medicine. 2001 ; Vol. 28, No. 4. pp. 489-497.
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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 anti-rheumatic 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.",
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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. / Song, Jungsik; Suh, Chang Hee; Park, YongBeom; Lee, Seung Hoon; Yoo, Nae Chun; Lee, Jong Doo; Kim, Kyoung Hwan; Lee, Soo Kon.

In: European Journal of Nuclear Medicine, Vol. 28, No. 4, 12.04.2001, p. 489-497.

Research output: Contribution to journalArticle

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AU - Song, Jungsik

AU - Suh, Chang Hee

AU - Park, YongBeom

AU - Lee, Seung Hoon

AU - Yoo, Nae Chun

AU - Lee, Jong Doo

AU - Kim, Kyoung Hwan

AU - Lee, Soo Kon

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