Short-term efficacy and safety of rituximab therapy in refractory systemic lupus erythematosus: results from the British Isles Lupus Assessment Group Biologics Register.
Short-term efficacy and safety of rituximab therapy in refractory systemic lupus erythematosus: results from the British Isles Lupus Assessment Group Biologics Register.
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DOI：
10.1093/rheumatology/kex395
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发表时间：
2018-03-01
期刊：
影响因子：
--
通讯作者：
British Isles Lupus Assessment Group Biologics Register
中科院分区：
文献类型：
--
作者：
McCarthy EM;Sutton E;Nesbit S;White J;Parker B;Jayne D;Griffiths B;Isenberg DA;Rahman A;Gordon C;D'Cruz DP;Rhodes B;Lanyon P;Vital EM;Yee CS;Edwards CJ;Teh LS;Akil M;McHugh NJ;Zoma A;Bruce IN;British Isles Lupus Assessment Group Biologics Register
描述英国需要生物治疗的系统性红斑狼疮患者的基线特征，并探索与利妥昔单抗(RTX)使用相关的短期疗效和感染率。对开始对难治性SLE进行生物治疗并同意加入BILAG-BR的患者进行了分析。分析基线特征、疾病活动性(BILAG 2004/SLEDAI-2K)和随访期间的感染率。6个月时，所有A和B评分均降至⩽1B评分，其他脏器系统无新的A/B评分。从2010年9月至2015年9月，270名系统性红斑狼疮患者接受了生物治疗，最常见的是雷公藤多苷(n=261)。250名(93%)患者在基线时每天口服糖皮质激素的中位数为10毫克(5-20毫克)。6个月的应答率为68%。基线时BILAG评分中值为15分(10-23分)，6个月时为3分(2-12分)(P<；0.0001)。智商中位数(SLEDAI-2K)由8(5-12)降至4(0-7)(P<；0.001)。49%的患者有反应。在6个月时，糖皮质激素的使用也减少到中位数7.5mg5-12 mg(P<；0.001)。发生严重感染26例(10%)，多见于RTX治疗后前3个月。早期非呼吸道感染的比例较高(优势比=1.98，95%CI：0.99，3.9；P=0.049)。RTX是安全的，与难治性SLE患者疾病活动性的改善有关，并伴随糖皮质激素使用量的减少。对输液后感染的早期警惕对于进一步提高治疗风险和效益非常重要。
To describe the baseline characteristics of SLE patients requiring biologic therapy in the UK and to explore short term efficacy and infection rates associated with rituximab (RTX) use. Patients commencing biologic therapy for refractory SLE and who consented to join BILAG-BR were analysed. Baseline characteristics, disease activity (BILAG 2004/SLEDAI-2K) and rates of infection over follow-up were analysed. Response was defined as loss of all A and B BILAG scores to ⩽ 1 B score with no new A/B scores in other organ systems at 6 months. Two hundred and seventy SLE patients commenced biologic therapy from September 2010 to September 2015, most commonly RTX (n = 261). Two hundred and fifty (93%) patients were taking glucocorticoids at baseline at a median [interquartile range (IQR)] oral dose of 10 mg (5–20 mg) daily. Response rates at 6 months were available for 68% of patients. The median (IQR) BILAG score was 15 (10–23) at baseline and 3 (2–12) at 6 months (P < 0.0001). The median (IQR) SLEDAI-2K reduced from 8 (5–12) to 4 (0–7) (P < 0.001). Response was achieved in 49% of patients. There was also a reduction in glucocorticoid use to a median (IQR) dose of 7.5 mg (5–12 mg) at 6 months (P < 0.001). Serious infections occurred in 26 (10%) patients, being more frequent in the first 3 months post-RTX therapy. A higher proportion of early infections were non-respiratory (odds ratio = 1.98, 95% CI: 0.99, 3.9; P = 0.049). RTX is safe and is associated with improvement in disease activity in refractory SLE patients with concomitant reductions in glucocorticoid use. Early vigilance for infection post-infusion is important to further improve treatment risks and benefits.
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影响因子：
2.6
作者：
Duxbury, B.;Combescure, C.;Chizzolini, C.
通讯作者：
Chizzolini, C.
影响因子：
--
作者：
Merrill, J. T.;Burgos-Vargas, R.;Nash, P.
通讯作者：
Nash, P.
影响因子：
--
作者：
Emery, P;Fleischmann, R;Shaw, TM
通讯作者：
Shaw, TM
影响因子：
158.5
作者：
Edwards, JCW;Szczepanski, L;Shaw, T
通讯作者：
Shaw, T
影响因子：
27.4
作者：
Bruce IN;O'Keeffe AG;Farewell V;Hanly JG;Manzi S;Su L;Gladman DD;Bae SC;Sanchez-Guerrero J;Romero-Diaz J;Gordon C;Wallace DJ;Clarke AE;Bernatsky S;Ginzler EM;Isenberg DA;Rahman A;Merrill JT;Alarcón GS;Fessler BJ;Fortin PR;Petri M;Steinsson K;Dooley MA;Khamashta MA;Ramsey-Goldman R;Zoma AA;Sturfelt GK;Nived O;Aranow C;Mackay M;Ramos-Casals M;van Vollenhoven RF;Kalunian KC;Ruiz-Irastorza G;Lim S;Kamen DL;Peschken CA;Inanc M;Urowitz MB
通讯作者：
Urowitz MB