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【商业翻译—医师报约稿】Tocilizumab Found Effecti
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Tocilizumab Found Effective in Treating Rheumatoid Arthritis in Phase 3 Trial
Paula Moyer, MA
June 18, 2007 (Barcelona) — Patients with rheumatoid arthritis (RA) benefit from treatment with the investigative interleukin (IL)-6 inhibiting agent tocilizumab (Actemra, Roche Pharmaceuticals), according to a team of investigators who presented their findings here at the annual meeting of the European Congress of Rheumatology (EULAR).
"Interleukin-6 plays a pivotal role in mediating both local and systemic manifestations of rheumatoid arthritis," said principal investigator Josef Smolen, MD, chair of the rheumatology department at the Medical University of Vienna, in Austria, in his presentation. "Thus, IL-6 receptor inhibition represents a promising new approach to the treatment of rheumatoid arthritis." He noted that no IL-6 inhibitor is yet available to treat RA.
In a phase 3 study, the Tocilizumab Pivotal Trial in Methotrexate Inadequate Responders (OPTION), Dr. Smolen and his coinvestigators randomized 623 subjects to receive tocilizumab, at doses of either 8 mg/kg or 4 mg/kg, or placebo. All treatments were administered by intravenous infusion every 4 weeks. The OPTION trial was conducted at 73 sites in 17 countries.
The participants continued to receive concomitant oral or parenteral methotrexate at their prestudy dose of 10 to 25 mg weekly throughout the trial. However, they discontinued all other disease-modifying anti-rheumatic drugs at the time of enrollment. All patients had moderate to severe active RA that persisted despite long-term treatment with methotrexate. The investigators wanted to determine the percentage of patients who had a 20% improvement according to American College of Rheumatology criteria (ACR20 response) at 24 weeks.
At week 24, ACR20 responses occurred in 58.5% of patients in the 8 mg/kg group, 47.9% in the 4 mg/kg group, and 26.5% in the placebo group (P = .0001 for both doses of tocilizumab vs placebo), Dr. Smolen said. The team also found that 22% of those in the 8 mg/kg group achieved ACR70 responses, and that 43.9% achieved ACR50 responses. Among those in the placebo group, 2% achieved ACR70 and 10.8% achieved ACR50 responses.
The investigators also found significant reductions in the Disease Activity Score in 28 joints (DAS28). The 24-week DAS28 score decreased an average of 3.43 in the 8 mg/kg group, 2.63 the 4 mg/kg group, and 1.55 in the placebo group (P < .0001). At 24 weeks, significantly more patients in both tocilizumab groups had a good or moderate EULAR response than in the placebo group (P < .0001). Good or moderate response occurred in 79.5% of the 8 mg/kg group, 61.9% of the 4 mg/kg group, and 34.8% of the placebo group.
Although the overall frequency of adverse events was similar in all 3 groups, the investigators documented serious infections in 6 patients in the 8 mg/kg group, 3 patients in the 4 mg/kg group, and 2 patients in the placebo group. Serious infections were those that required hospitalization or intravenous antimicrobial therapy.
"IL-6 is a very proinflammatory protein, and this study suggests that if you block IL-6, you get more improvement than in placebo-treated patients," said Iain McInnes, MD, chairman of the EULAR Scientific Committee and professor of rheumatology at the University of Glasgow, in Scotland, in an interview. Dr. McInnes was not involved in the study.
"We have good reason to believe that IL-6 plays an important role in RA," he said. "It's a new target and this gives us an opportunity to go places with someone for whom anti-TNF [tumor necrosis factor] agents have failed. If the drug makes it through the licensing process and we see no untoward adverse effects, we may find it useful. Rheumatologists should remember that tocilizumab is not licensed yet, and we don't know where it will fit into the rheumatoid protocol. But the exciting thing is a new target. The more targets we have, the better success we will have in managing RA."
The study was funded by Roche, which collaborates with Chugai Pharmaceutical in the manufacture of Actemra. Dr. Smolen reported no relevant financial relationship.
EULAR 2007: Abstract OP0117. Presented June 15, 2007. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领 译文：1129
Tocilizumab Found Effective in Treating Rheumatoid Arthritis in Phase 3 Trial
Paula Moyer, MA
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