EULAR2007. Abstract No: OP0011.

D. van der Heijde?¹, C. Lukas?¹, S. Fatenejad?², R. Landewe?¹.

¹Rheumatology, University Hospital, Maastrict, Netherlands,?²Research and Development, Wyeth, Collegeville, United States

背景：雙盲試驗(yàn)中vdHSharp評(píng)分變化呈負(fù)數(shù)提示有效的治療可以修復(fù)關(guān)節(jié)。在單關(guān)節(jié)水平進(jìn)行研究能幫助進(jìn)一步理解關(guān)節(jié)修復(fù)過(guò)程。

目的：如果真的存在關(guān)節(jié)修復(fù)(repair)，判斷修復(fù)是否偏好發(fā)生于無(wú)腫脹或腫脹有改善的關(guān)節(jié)。

方法：TEMPO試驗(yàn)第1年MTX單用組(M)、Etanercept+MTX組(M+E)患者手/腕和足部攝片后，對(duì)所有單關(guān)節(jié)的判讀結(jié) 果進(jìn)行評(píng)估。采用vdHSharp評(píng)分系統(tǒng)，對(duì)治療和攝片順序均不知曉的兩位讀片師各自對(duì)所有平片重復(fù)判讀兩次。計(jì)算單關(guān)節(jié)骨侵蝕評(píng)分變化，并與單關(guān)節(jié)腫 脹評(píng)分變化相關(guān)聯(lián)。單關(guān)節(jié)修復(fù)的評(píng)判：四次判讀中至少有一次為負(fù)數(shù)變化而其它判讀變化結(jié)果均為零(即無(wú)進(jìn)展)。每關(guān)節(jié)骨侵蝕變化均數(shù)，是通過(guò)減去基線均數(shù) 而得。

結(jié)果：共計(jì)11159個(gè)單關(guān)節(jié)中，判讀為有修復(fù)的為557個(gè)，其中553個(gè)同時(shí)有腫脹評(píng)分。下表顯示各種腫脹評(píng)分變化在"修復(fù)關(guān)節(jié)"組、?"無(wú)修復(fù)關(guān)節(jié)"組中的分布。修復(fù)組無(wú)腫脹關(guān)節(jié)共計(jì)234個(gè)，其中12個(gè)有殘余腫脹，222個(gè)無(wú)腫脹。腫脹改善即評(píng)分變化為負(fù)數(shù)的關(guān)節(jié)共計(jì)318個(gè)，僅36?個(gè)有殘余腫脹。與無(wú)修復(fù)相比，修復(fù)與腫脹改善顯著相關(guān)(p<0.0001)。

持續(xù)腫脹組骨侵蝕變化均數(shù)(95%可信區(qū)間)如下，基線無(wú)破壞組為0.03 [0.01，0.04]，基線有破壞組為0.06 [–0.02，0.14])，而無(wú)腫脹或腫脹改善組患者的更低，基線無(wú)破壞組為0.01[0.00，0.01]，基線有破壞組為-0.09[-0.11，-0.06]。基線有骨侵蝕時(shí)，骨侵蝕變化均數(shù)只在無(wú)腫脹或腫脹改善亞組呈顯著負(fù)數(shù)變化。

結(jié)論：骨侵蝕修復(fù)幾乎只出現(xiàn)在腫脹改善或腫脹消失組。持續(xù)腫脹關(guān)節(jié)中的骨破壞仍在進(jìn)展，尤其是基線已有骨損害者。這項(xiàng)觀察研究進(jìn)一步確證了骨侵蝕負(fù)數(shù)變化是骨修復(fù)的反映。

表. ?治療1年后修復(fù)組和無(wú)修復(fù)組的腫脹變化關(guān)節(jié)數(shù)和百分比

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[2007] [OP0011] REPAIR OF EROSIONS OCCURS ALMOST EXCLUSIVELY IN DAMAGED JOINTS WITHOUT SWELLING: POST HOC ANALYSIS OF RADIOGRAPHIC DATA FROM YEAR 1 OF THE TEMPO STUDY

D. van der Heijde?¹, C. Lukas?¹, S. Fatenejad?², R. Landewe?¹

¹Rheumatology, University Hospital, Maastrict, Netherlands,?²Research and Development, Wyeth, Collegeville, United States

Background:?Negative van der Heijde-Sharp (SvdH) change scores obtained under blinded time-sequence conditions suggest that effective therapies may result in joint repair. Investigation at the single-joint level could provide further understanding of the repair process.

Objectives:?To determine whether repair – if it truly exists – preferentially occurs in joints with no swelling or improvement in swelling.

Methods:?Single-joint readings of radiographic images of the hands/wrists and feet from patients in year 1 of the TEMPO trial (the methotrexate-only group [M] and the methotrexate+etanercept group [M+E]) were evaluated. Using the SvdH scoring, 2 readers blinded to treatment and true-time sequence independently assessed each of the radiographs twice. Single-joint change scores in erosions were calculated and coupled with change in single-joint swelling scores. Repair in a joint was considered to have occurred if there was a negative erosion change score in at least 1 of the 4 potential readings with the remaining readings showing zero, ie, no progression. Mean erosion change scores per joint were calculated by taking the mean score from the first reading by each reader.

Results:?Of the 11,159 single joints, 557 showed repair. For 553 of these, swelling scores were also available. The table shows the distribution of change in swelling in joints showing "repair" versus "no repair". Of the 234 joints without change in swelling in the repair group, 12 had residual swelling and 222 had no swelling. Of the 318 joints with improvement in swelling (ie negative change), only 36 had residual swelling. Repair was significantly more associated with improvement in swelling than no repair (p<0.0001).

Mean change in erosion scores (95% confidence interval [CI]) were lower in patients with no swelling or improvement in swelling (group without baseline damage 0.01 [0.00, 0.01]; group with baseline damage –0.09 [–0.11; -0.06]) compared with patients with persistent swelling (group without baseline damage 0.03 [0.01, 0.04]; group with baseline damage 0.06 [–0.02, 0.14]). The mean change in erosion score was statistically significantly negative only in the subgroup of joints with absent or improving swelling, while erosions were present at baseline.

Conclusion:?Repair of erosions occurs almost exclusively in damaged joints that show either improvement of swelling, or that have no swelling at all. Progression occurs in joints with persistent swelling, preferably if there is already damage present. This observation adds to the validity that negative joint scores are a reflection of repair.

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Citation:?Ann Rheum Dis 2007;66(Suppl II):54