Therapeutic Efficacy and Safety of Different Doses of Secukinumab in the Treatment of Medium and Severe Ankylosing Spondylitis ：A Meta-analysis
- VernacularTitle:不同剂量司库奇尤单抗治疗中、重度强直性脊柱炎疗效与安全性的Meta分析
- Author:
Xiaofeng PU
1
,
2
;
Liang LIU
2
;
Bimin FENG
2
;
Chengsong HE
3
;
Guojun WANG
1
Author Information
1. Dept. of Pharmacy，the Affiliated Hospital of Southwest Medical University，Sichuan Luzhou 646000，China
2. School of Pharmacy，Southwest Medical University，Sichuan Luzhou 646000，China
3. Dept. of Rheumatology and Immunology，the Affiliated Hospital of Southwest Medical Unive rsity，Sichuan Luzhou 646000，China
- Publication Type:Journal Article
- Keywords:
Secukinumab;
Medium and severe ankylosing spondylitis;
Therapeutic efficacy;
Safety;
Meta-analysis
- From:
China Pharmacy
2020;31(17):2146-2152
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE：To evaluate therapeutic e fficacy and safety of differen t doses of Secukinumab in the treatment of medium and severe ankylosing spondylitis （AS）， and to provide evidence-based reference for clinical treatment of AS. METHODS： Retrieved from Medline ， PubMed， Cochrane Library， Embase， VIP， CJFD， Wanfang database andpu- ClinicalTrials.gov， during the inception to March 2020， xiaofeng1205@outlook.com randomized controlled trials （RCTs）about different doses of secukinumab （75， 150， 300 mg） versus placebo in the treatment of medium and severe AS were collected. After data extraction of clinical studies met the inclusion criteria ，quality evaluation with Cochrane risk bias evaluation tool 5.1.0，Rev Man 5.3 statistical software was used for Meta-analysis of therapeutic efficacy [in the international society for the evaluation of spondyloarthritis scale ，the proportion of 20％ patients improved （ASAS20）；ASAS40；among 6 routine clinical areas related to AS，the scores of at least 5 areas improved by at least 20％，and there was no patients receiving treatment due to deterioration in other areas （ASAS 5/6）；remission value of Bath ankylosing spondylitis disease activity index （BASDAI）from baseline to 16th week，the proportion of the patients with the international society for the evaluation of ankylosing spondyloarthritis （ASAS PR ） score no higher than 2 in the 4 ASAS fields within the specified time] and safety [the incidence of withdrawal from treatment due to ADR，the incidence of serious ADR ，the incidence of general ADR （nasopharyngitis，headache，diarrhea）]. RESULTS ：A total of 5 RCTs were included ，involving 1 624 patients. Meta-analysis showed that ASAS 20 [total：OR＝2.62，95％CI（2.14，3.20），P＜ 0.000 01；75 mg：OR＝2.63，95％CI（1.28，5.40），P＝0.008；150 mg：OR＝2.58，95％CI（2.01，3.32），P＜0.000 01；300 mg：OR＝2.63，95％CI（1.37，5.06），P＝0.004]，ASAS40 [total：OR＝2.82，95％CI（2.13，3.74），P＜0.000 01；75 mg：OR＝ 3.14，95％CI（1.86，5.31），P＜0.000 1；150 mg：OR＝2.79，95％CI（1.85，4.20），P＜0.000 01；300 mg：OR＝2.73，95％CI （1.33，5.58），P＝0.006]，ASAS5/6 [total：OR＝3.82，95％CI（2.61，5.59），P＜0.000 01；75 mg：OR＝5.59，95％CI（3.29， 9.49），P＜0.000 01；150 mg：OR＝3.45，95％CI（2.08，5.70），P＜0.000 01；300 mg：OR＝3.85，95％CI（1.75，8.47），P＝ 0.000 8]，ASAS PR [total ：OR＝4.69，95％CI（3.07，7.16），P＜0.000 01；75 mg：OR＝5.48，95％CI（2.50，11.99），P＜0.000 1； 150 mg：OR＝3.71，95％CI（2.19，6.29），P＜0.000 01；300 mg：OR＝20.0，95％CI（2.58，155.14），P＝0.004] in trial group was significantly higher than control group ；BASDAI improvement [total ：WMD＝－1.15，95％CI（－1.50，－0.79），P＜0.000 01； 75 mg：WMD＝－1.40，95％CI（－2.08，－0.72），P＜0.000 1；150 mg：WMD＝－1.03，95％CI（－1.52，－0.54），P＜ 0.000 1；300 mg：WMD＝－1.20，95％CI（－2.03，－0.37），P＝0.005] of trial group were significantly higher than those of control group ，with statistical significance. The total incidence of nasopharyngitis in trial group [OR ＝1.77，95％CI（1.22，2.57）， P＝0.003] and 150 mg dose subgroup [OR ＝1.84，95％CI（1.18，2.86），P＝0.007] was significantly higher than control group ， without significant difference in other safety indexes among total and different dose subgroups （P＞0.05）. CONCLUSIONS ：75 mg，150 mg and 300 mg of secukinumab are all effective and well tolerated for medium and severe AS patients ，and 150 mg of secukinumab may increase the incidence of nasopharyngitis.
