【medical-news】【资讯翻译】风湿性关节炎患者使用美罗华不易诱发严重感染
发布于 2012-11-16 · 浏览 2544 · IP 四川四川
这个帖子发布于 12 年零 182 天前，其中的信息可能已发生改变或有所发展。
http：//www.medpagetoday.com/MeetingCoverage/ACR/35895
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Serious infectious events associated with rituximab (Rituxan) remain consistently low in rheumatoid arthritis (RA) patients for nearly a decade after first treatment， researchers said here.
Infusion-related reaction was the most frequent adverse event； most were grade 1 or 2， were rarely serious， and generally occurred following the first infusion of the first course， according to Roland van Vollenhoven， MD， PhD， from the Karolinska Institute in Stockholm， and colleagues.
Over a 10-year observation period， the serious infection rate recorded among RA patients who received rituximab while enrolled in a global clinical trial was 3.8 per 100 patient-years， they reported at the American College of Rheumatology meeting.
The rate of serious infectious events for the 1，145 patients on rituximab for more than 5 years was 2.76 per 100-person-years， and the rate for the 818 placebo patients in the studies was 3.6 per 100-patient years， they said.
"We observed no increased risk of infections with rituximab，" van Vollenhoven said at his poster presentation. "No new safety signals were observed with increasing duration of exposure including in patients with more than 5 years of follow-up."
Serious infections may develop in this patient population because rituximab therapy can reduce immune system response.
The authors conducted a pooled observed case analysis of safety data from patients with moderate to severe， active RA who were treated with rituximab plus methotrexate. Their analysis included eight randomized clinical trials， two long-term， open-label extensions， and one open-label prospective study.
Each rituximab course consisted of either two infusions of 1，000 mg of rituximab or two 500 mg infusions delivered 2 weeks apart.
Repeat treatment was based on evidence of active disease. All patients received concomitant methotrexate at a dose of 10 to 25 mg a week. As of September 2011， patients had received up to 19 infusions through a 10-year period.
Serious opportunistic infection occurred at a rate of 0.05 events per 100 patient-years in rituximab patients and at a rate of 0.09 per year among placebo patients. Seven such infections occurred in the rituximab exposed individuals including two atypical pneumonias， one Candida infection， one Scedosporium lung infection， one Pneumocystis jiroveci pneumonia， and one fatal multifocal leukoencephalopathy. One P. jiroveci infection was observed among placebo patients.
Van Vollenhoven said the rates of myocardial infarction (0.40 per 100 patient-years) and malignancies were consistent with those observed in epidemiological data from other RA cohorts (0.48 to 0.59 per 100-patient years for MI).
"Looking at all of the data that is generated in all the rituximab studies， mainly in North America and Europe， [they] show no additional risk of cancer， which is always a concern with these biologic agents，" said Eric Matteson， MD， chief of rheumatology at the Mayo Clinic in Rochester， Minn.
"They also showed that the infection rates were not unusually high， and they stayed pretty stable over time，" he said. "I think that is a good message."
"This is good long-term data and reassures us about the safety and efficacy of rituximab，" added Matteson， who did not participate in the current study but was involved in one of the analyzed trials.
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Serious infectious events associated with rituximab (Rituxan) remain consistently low in rheumatoid arthritis (RA) patients for nearly a decade after first treatment， researchers said here.
Infusion-related reaction was the most frequent adverse event； most were grade 1 or 2， were rarely serious， and generally occurred following the first infusion of the first course， according to Roland van Vollenhoven， MD， PhD， from the Karolinska Institute in Stockholm， and colleagues.
Over a 10-year observation period， the serious infection rate recorded among RA patients who received rituximab while enrolled in a global clinical trial was 3.8 per 100 patient-years， they reported at the American College of Rheumatology meeting.
The rate of serious infectious events for the 1，145 patients on rituximab for more than 5 years was 2.76 per 100-person-years， and the rate for the 818 placebo patients in the studies was 3.6 per 100-patient years， they said.
"We observed no increased risk of infections with rituximab，" van Vollenhoven said at his poster presentation. "No new safety signals were observed with increasing duration of exposure including in patients with more than 5 years of follow-up."
Serious infections may develop in this patient population because rituximab therapy can reduce immune system response.
The authors conducted a pooled observed case analysis of safety data from patients with moderate to severe， active RA who were treated with rituximab plus methotrexate. Their analysis included eight randomized clinical trials， two long-term， open-label extensions， and one open-label prospective study.
Each rituximab course consisted of either two infusions of 1，000 mg of rituximab or two 500 mg infusions delivered 2 weeks apart.
Repeat treatment was based on evidence of active disease. All patients received concomitant methotrexate at a dose of 10 to 25 mg a week. As of September 2011， patients had received up to 19 infusions through a 10-year period.
Serious opportunistic infection occurred at a rate of 0.05 events per 100 patient-years in rituximab patients and at a rate of 0.09 per year among placebo patients. Seven such infections occurred in the rituximab exposed individuals including two atypical pneumonias， one Candida infection， one Scedosporium lung infection， one Pneumocystis jiroveci pneumonia， and one fatal multifocal leukoencephalopathy. One P. jiroveci infection was observed among placebo patients.
Van Vollenhoven said the rates of myocardial infarction (0.40 per 100 patient-years) and malignancies were consistent with those observed in epidemiological data from other RA cohorts (0.48 to 0.59 per 100-patient years for MI).
"Looking at all of the data that is generated in all the rituximab studies， mainly in North America and Europe， [they] show no additional risk of cancer， which is always a concern with these biologic agents，" said Eric Matteson， MD， chief of rheumatology at the Mayo Clinic in Rochester， Minn.
"They also showed that the infection rates were not unusually high， and they stayed pretty stable over time，" he said. "I think that is a good message."
"This is good long-term data and reassures us about the safety and efficacy of rituximab，" added Matteson， who did not participate in the current study but was involved in one of the analyzed trials.
最后编辑于 2022-10-09 · 浏览 2544
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