Sodium pentosan polysulfate resulted in cartilage improvement in knee osteoarthritis--an open clinical trial

Kumagai K, Shirabe S, Miyata N, Murata M, Yamauchi A, Kataoka Y, Niwa M · BMC Clinical Pharmacology

Effusions settled quickly in all cases; knee flexion improved from 132° to 141–145° (significant at every visit), pain on stairs and after range-of-motion exercise fell by roughly 60% from week 8 to week 52, and pain on walking at clinic visits from week 11; serum C2C fell 19–22%, significant at weeks 11 and 24. The WOMAC total score did not change significantly from baseline at any visit. Weight-bearing radiographs at one year showed neither improvement nor degeneration, and with no control arm none of it is attributable to the drug.

Population

20 women with knee OA, mean age 63 (35–80), Kellgren-Lawrence grade 2 in 18 and grade 3 in 2, Nagasaki University Hospital

Intervention

Two test injections (25 mg, then 50 mg) followed by 6 weekly subcutaneous injections of PPS 2 mg/kg (SP54), a planned total of 12 mg/kg, followed to one year

Comparator

None (single-arm, open-label)

Limitations

Open-label, uncontrolled, 20 patients, 18 of them grade 2; the title's 'cartilage improvement' is a blood marker and the WOMAC did not move; clotting times were prolonged one hour after each injection (highest aPTT 61.7 s, INR 1.47). The drug was supplied by bene GmbH and the study planned with the advice of PPS's developer; no competing interests declared.