根據DAS做出的系統性治療可改善類風濕性關節炎的結果
作者:Laurie Barclay, MD
出處:WebMD醫學新聞
January 4, 2010 — 根據發表於2010年1月Annals of the Rheumatic Diseases期刊的研究結果,對於最近發生類風濕性關節炎而接受傳統治療的病患,根據疾病活動度(DAS)做出的系統性治療可以有明顯較佳的臨床改善,也可能可以減少關節損傷之惡化。
阿肯色醫學科學大學風濕科助理教授Nasim A. Khan醫師受邀發表獨立評論時向Medscape Rheumatology表示,此研究提供進一步的證據支持類風濕性關節炎的客觀評估,採用疾病活動狀態(例如降低或緩解疾病活動狀態)達到一個目標來決定治療決策,而顯著改善類風濕性關節炎病患的臨床結果。不幸的是,多數接受例行臨床照護的類風濕性關節炎病患並未客觀地評估疾病活動度,治療決策是根據主治醫師的形態印象而定。本研究足以改變這類實務,可改善類風濕性關節炎病患的臨床結果。
荷蘭Leiden大學醫學中心Y.P.M. Goekoop-Ruiterman的研究者表示,研究目標是比較根據DAS的系統性治療和例行性照護對於最近發生類風濕性關節炎之病患的效果。病患接受根據「BeSt study」這個比較各種治療策略之隨機控制試驗的傳統抗風濕治療方法(A組;n = 234人),或者根據兩個早期關節炎門診的療法(B組;n = 201人)。
A組病患接受根據DAS的系統性治療,目標為校正達到低疾病活動度,即DAS≦2.4,B組病患由醫師判斷接受的治療,檢測的結果包括健康評估問卷(HAQ)的供能性能力、28個關節的疾病活動度(DAS28)以及Sharp/van der Heijde影像學分數(SHS)。
兩組的人口統計學特徵相似,開始時,HAQ的平均值為1.4,相較於B組,A組的疾病期間中位數較長(0.5 vs 0.4 年;P = .016)、平均DAS28較高(6.1 vs 5.7;P < .001)、類風濕因子為陽性的病患較多(66% vs 42%;P < .001)、患部有侵蝕的病患較多(71% vs 53%;P < .001)。
一年後,A組的平均HAQ改善了0.7,B組為0.5 (P = .029),緩解(定義為DAS2小於2.6)百分比分別是31% 和18% (P <. 005)。A組SHS惡化中位數為2.0,而預期的惡化是7.0,B組中,SHS惡化中位數為1.0,預期的惡化是4.4。
作者們寫道,對於最近發生類風濕性關節炎而接受傳統治療的病患,根據DAS做出的系統性治療可以有顯著較佳的臨床改善,也可能可以減少關節損傷之惡化。
Khan醫師指出,本研究的強度在於,一年時有多數研究對象有各項結果的追蹤資料,DAS評估可以由受過訓練的研究護士進行,由兩位對研究不知情的放射師獨立對治療組和一系列影像進行惡化評估判讀。
不過,Khan醫師也指出一些研究限制。
他表示,儘管有類似的納入規範,根據DAS治療組與例行照護組在開始時的類風濕性關節炎疾病活動度與不佳預後因素(RF-陽性與X光檢查關節損傷)的評估上有顯著不同。
Khan醫師也指出,兩組病患所使用的藥物有顯著差異,例行照護組的病患比較不常接受methotrexate,而比較常使用低劑量prednisone。
Khan醫師指出,再者,也不清楚例行照護組病患的醫師在決定治療決策時,是否有根據DAS或DAS28進行疾病活動度評估,這些因素可能會影響到根據DAS治療相較於例行照護的影響評估。
被問及其他研究需要時,Khan醫師指出,類風濕性關節炎活動度的6個現有指標應彼此加以比較。美國類風濕學會在2008年建議,根據這6個指標評估類風濕性關節炎活動度而決定所使用的疾病修飾抗風濕藥物,但是,這些指標之中,彼此最好有一些適度協調。
Khan醫師結論表示,雖然客觀地評估類風濕性關節炎的疾病活動度很重要,還不清楚應該發展哪些指標或確認哪些指標對於病患照護最適當。需要後續研究以釐清這些指標的相對可用性與可替代性,以及評估共病症等因素對於類風濕性關節炎活動度評估的影響。此外,需進行後續研究以瞭解目前的治療方式在影像學上的長期臨床結果。
荷蘭健康保險學院(College Voor Zorgverzekeringen)資助本研究,其他資金來自Schering-Plough、BV以及Centocor。部份研究作者宣告與Schering-Plough有各種財務關係。 Khan 醫師宣告沒有相關資金上的往來。
Systematic DAS-Driven Therapy May Improve Outcomes in Rheumatoid Arthritis
By Laurie Barclay, MD
Medscape Medical News
January 4, 2010 — In patients with recent-onset rheumatoid arthritis receiving traditional treatment, treatment systematically driven by Disease Activity Score (DAS) was associated with significantly better clinical improvement and possibly with reduced progression of joint damage, according to the results of a study reported in the January 2010 issue of Annals of the Rheumatic Diseases.
"This study provides further evidence in support of the data that objective assessment of rheumatoid arthritis disease activity and using a goal to achieve a target disease activity state (such as low disease activity state or remission) to make therapeutic decisions leads to significant improvement in clinical outcomes for rheumatoid arthritis patients," Nasim A. Khan, MD, assistant professor of rheumatology at the University of Arkansas for Medical Sciences in Little Rock, told Medscape Rheumatology when asked for independent comment. "Unfortunately, most patients with rheumatoid arthritis in routine clinical care are not evaluated objectively for disease activity, and treatment decisions are made based on gestalt impressions of the treating doctor. This study provides further impetus to change such practices to improve clinical outcomes for rheumatoid arthritis patients."
The goal of this study, by Y.P.M. Goekoop-Ruiterman, from Leiden University Medical Centre in Leiden, the Netherlands, and colleagues, was to compare the efficacy of treatment systematically driven by DAS vs routine care in patients with recent-onset rheumatoid arthritis. Participants were receiving traditional antirheumatic therapy from either the BeSt study, a randomized controlled trial comparing different treatment strategies (group A; n = 234), or from 2 Early Arthritis Clinics (group B; n = 201).
Patients in group A had systematic, DAS-driven treatment adjustments aiming to achieve low disease activity, defined as DAS ? 2.4. Physician judgment determined treatment of patients in group B. Outcomes included functional ability measured with the Health Assessment Questionnaire (HAQ), Disease Activity Score in 28 joints (DAS28), and Sharp/van der Heijde radiographic score (SHS).
Demographic characteristics were similar in both groups, and mean baseline HAQ was 1.4. Compared with group B, group A had a longer median disease duration (0.5 vs 0.4 years; P = .016), higher mean DAS28 (6.1 vs 5.7; P < .001), more patients who tested positive for rheumatoid factor (66% vs 42%; P < .001), and more patients with erosions (71% vs 53%; P < .001).
After 1 year, mean HAQ improvement was 0.7 in group A and 0.5 in group B (P = .029), and the percentage in remission, defined as a DAS28 of less than 2.6, was 31% vs 18% (P <. 005), respectively. Median SHS progression in group A was 2.0 vs an expected progression of 7.0. In group B, median SHS progression was 1.0 vs an expected progression of 4.4.
"In patients with recent-onset rheumatoid arthritis receiving traditional treatment, systematic DAS-driven therapy results in significantly better clinical improvement and possibly improves the suppression of joint damage progression," the study authors write.
Strengths of this study noted by Dr. Khan are that 1-year follow-up data on all outcomes of interest were available for the vast majority of the study patients, DAS assessment was performed by trained research nurses, and radiographic progression assessment was done independently by 2 readers blinded to treatment group and sequence of films.
However, Dr. Khan also noted several study limitations.
"Despite similar enrollment criteria, the DAS-driven therapy group and routine care group differed significantly upon baseline assessment in rheumatoid arthritis disease activity and adverse prognostic factors (RF-positivity and radiographic joint damage)," he said.
Dr. Khan also noted significant differences in the medications received by patients in the 2 groups. Patients in the routine care group less often received methotrexate and more often received low-dose prednisone.
"Furthermore, it is not clear whether disease activity assessment by DAS or DAS28 was available or performed by the treating doctor at the time of therapeutic decision for the patients in the routine care group," Dr. Khan added. "These factors may have masked the true impact of DAS-driven therapy compared to routine care."
When asked about additional research needed, Dr. Khan pointed out that the 6 available indices of rheumatoid arthritis activity should be compared with one another. The American College of Rheumatology 2008 recommendations for the use of disease-modifying antirheumatic drugs suggest using any of the 6 indices to assess rheumatoid arthritis disease activity, but some of these indices have, at best, a moderate agreement with one another.
"While objective assessment of RA [rheumatoid arthritis] disease activity is important, it remains unclear which of the several indices that have been developed and validated for this purpose is optimum for patient care," Dr. Khan concludes. "Further research is needed to clarify the comparative utility and interchangeability of these indices and impact of factors such as comorbidity burden on rheumatoid arthritis activity assessment. Also, further studies are needed for the long term clinical effect of the radiographic progression observed with current treatments."
The Dutch College of Health Insurances (College Voor Zorgverzekeringen) funded this study, with additional funding provided by Schering-Plough, BV, and Centocor. Some of the study authors have disclosed various financial relationships with Schering-Plough. Dr. Khan has disclosed no relevant financial relationships.
Ann Rheum Dis. 2010;69:65-69.