Initiatory Approach On Clinical Assessment And Evaluation Of Etanercept In The Treatment Of Ankylosing Spondylitis

Objective:1. To assess the different measures of spine mobility and enthesitis which most responsive to change;2. Try to evaluate and validate the Patient Acceptable Symptom State (PASS) in Chinese Ankylosing Spondylitis patients.3.To evaluate the efficacy of etanercept in active ankylosing spondylitis (AS) and investigate the potential parameters which may predict clinical response.Methods:153 patients with active AS were randomly assigned to receive once-weekly subcutaneous injections of etanercept (50 mg) or placebo for 6 weeks. Then both groups were treated with etanercept for another 6 weeks. Recorded spine pain,morning stiffness, PGA, BASDAI, BASFI, BASMI,score for peripheral-joint tenderness/swelling and El at baseline.week 2,4,6,10,8 and 12;Examined ESR,CRP and PLT at baseline,week 2,6,10 and 12;The last 31 patients finished PASS,FACIT (Functional Assessment of Chronic Illness Therapy),ASQoL(AS Quality of Life) and SF-36;They also received spine morbility measure.Rusults:1.After therapy the scores of BASMI-3,BASMI-11,BASMI-Linear,EDASMI had no significant improvement,except EDASMI-Linear (p=0.0027).2.The Spearman correlation coefficients of San Francisco,MASES,Berlin and SPARCC indices were 0.8694,0.8499,0.711 and 0.6763 respectively,compared with Mander index.3.At week 12,18 patients answered yes(+) to PASS and 13 patients answer no(-) to PASS. Contributors to PASS showed PGA,BASDAI,CRP and using NSAIDs. But no significant diference between PASS(+) patients and PASS(-) patients in low back pain,PGA,BASDAI,BASFI,BASMI, ESR,CRP,PLT,FACIT,ASQoL and SF-36,except morning stiffness.Compared with ASAS improvement,BASDAI20 and BASDAI50 criterias PASS lack good consistency.4.At week 6,58.3% of patients in the etanercept group reached the primary end point of ASAS20, compared with 21.1% of patients receiving placebo (P=0.0001). The secondary measures were improved in the etanercept group.2.After etanercept therapy the scores of FACIT,ASQoL and AS SF-36 were be im-proved significantly.3. Logistic regression analysis showed combination with NSAIDs predicted ASA-S20 response at week 2. Elder, shorter disease duration, high arthritis score and rapid response predicted ASAS40 response at week 6.And age,morning stiffness,nocturnal pain and spine mobility were the parameters to predict ASAS40 response at week 12 in AS patients treated with etanercept.Conclusion:1. For assessment of spine mobility EDASMI-Linear may show small change more sensitively.2. San Francisco index. had excellent correlation with Mander index, the operati-on was easy.3.Though PASS question was easy to perform,it could not reflect the state of AS and coincide with standard assessments.4. Etanercept can improve symptoms of AS rapidly and significantly, and enhance the quality of life in patients with AS.5. Use etanercept combining with NSAIDs may improve the state of AS more slowly.Perhaps for elder,shorter disease duration, severe arthritis and rapid response patients etanercept was more suitable. Conversely younger patients or with shorter morning stiffness,serious nocturnal back pain and poor spine mobility may responsed for etanercept therapy slowly and hardly.