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：雙盲試驗中vdHSharp評分變化呈負數提示有效的治療可以修復關節。在單關節水平進行研究能幫助進一步理解關節修復過程。

目的：如果真的存在關節修復(repair)，判斷修復是否偏好發生于無腫脹或腫脹有改善的關節。

方法：TEMPO試驗第1年MTX單用組(M)、Etanercept+MTX組(M+E)患者手/腕和足部攝片后，對所有單關節的判讀結 果進行評估。采用vdHSharp評分系統，對治療和攝片順序均不知曉的兩位讀片師各自對所有平片重復判讀兩次。計算單關節骨侵蝕評分變化，并與單關節腫 脹評分變化相關聯。單關節修復的評判：四次判讀中至少有一次為負數變化而其它判讀變化結果均為零(即無進展)。每關節骨侵蝕變化均數，是通過減去基線均數 而得。

結果：共計11159個單關節中，判讀為有修復的為557個，其中553個同時有腫脹評分。下表顯示各種腫脹評分變化在"修復關節"組、?"無修復關節"組中的分布。修復組無腫脹關節共計234個，其中12個有殘余腫脹，222個無腫脹。腫脹改善即評分變化為負數的關節共計318個，僅36?個有殘余腫脹。與無修復相比，修復與腫脹改善顯著相關(p<0.0001)。

持續腫脹組骨侵蝕變化均數(95%可信區間)如下，基線無破壞組為0.03 [0.01，0.04]，基線有破壞組為0.06 [–0.02，0.14])，而無腫脹或腫脹改善組患者的更低，基線無破壞組為0.01[0.00，0.01]，基線有破壞組為-0.09[-0.11，-0.06]?；€有骨侵蝕時，骨侵蝕變化均數只在無腫脹或腫脹改善亞組呈顯著負數變化。

結論：骨侵蝕修復幾乎只出現在腫脹改善或腫脹消失組。持續腫脹關節中的骨破壞仍在進展，尤其是基線已有骨損害者。這項觀察研究進一步確證了骨侵蝕負數變化是骨修復的反映。

表. ?治療1年后修復組和無修復組的腫脹變化關節數和百分比

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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