Rheumatology Department, Besançon Hospital, University Hospital Jean Minjoz, Boulevard Fleming, 25000 Besançon, France.
Joint Bone Spine. 2010 Mar;77(2):142-5. doi: 10.1016/j.jbspin.2010.01.008. Epub 2010 Feb 19.
To report our experience with rituximab therapy in patients with rheumatoid arthritis (RA) and a history of severe or recurrent bacterial infections.
Retrospective observational study in five rheumatology departments experienced in the use of biotherapies. Patients were included if they had RA and a history of severe or recurrent bacterial infection (requiring admission and/or intravenous antimicrobial therapy) that contraindicated the introduction or continuation of TNFalpha antagonist therapy.
Of 161 RA patients given rituximab in the five study centers, 30 met the inclusion criteria, 23 females and seven males with a mean age of 58.4+/-11.8 years and a mean disease duration of 11.4+/-13.9 years. Among them, 22 had rheumatoid factors and 21 had received TNFalpha antagonist therapy (one agent in 15 patients, two in five patients and three in one patient). Prior infections were as follows: septicemia, n=2; lower respiratory tract infection or lung abscess, n=12; prosthesis infection, n=3; septic arthritis, n=3; endocarditis, n=1; pyelonephritis, n=2; osteitis, n=4; and various skin infections (erysipelas, cellulitis or skin abscess), n=6. Of these 33 infections, 21 occurred during TNFalpha antagonist therapy. During rituximab therapy, all patients received concomitant glucocorticoid therapy (mean dosage, 12+/-7.9 mg/day). The number of rituximab cycles was one in 13 patients, two in seven patients and three or more in 10 patients. Mean time from the single or last serious infection and the first rituximab infusion was 20.1+/-18.7 months. Mean follow-up since the first rituximab infusion was 19.3+/-7.4 months. During follow-up, six (20%) patients experienced one infection each. Immunoglobulin levels after rituximab therapy were within the normal range.
Rituximab therapy was well tolerated in 24 (80%) of 30 patients with RA and a history of severe or recurrent bacterial infection. In everyday practice, rituximab therapy seems safe with regard to the recurrence of infectious episodes. However, longer follow-ups are needed.
报告我们在类风湿关节炎（RA）且有严重或复发性细菌感染史的患者中应用利妥昔单抗治疗的经验。
在 5 个有生物制剂应用经验的风湿病科进行的回顾性观察性研究。如果患者有 RA 且有严重或复发性细菌感染（需要住院和/或静脉用抗菌治疗）病史，以致不能开始或继续 TNFα拮抗剂治疗，则入选该研究。
在 5 个研究中心接受利妥昔单抗治疗的 161 例 RA 患者中，有 30 例符合纳入标准，其中 23 例为女性，7 例为男性，平均年龄 58.4±11.8 岁，平均病程 11.4±13.9 年。其中，22 例患者类风湿因子阳性，21 例患者曾接受 TNFα拮抗剂治疗（15 例患者应用 1 种药物，5 例患者应用 2 种药物，1 例患者应用 3 种药物）。既往感染包括：败血症 2 例，下呼吸道感染或肺脓肿 12 例，假体感染 3 例，化脓性关节炎 3 例，心内膜炎 1 例，肾盂肾炎 2 例，骨炎 4 例，各种皮肤感染（丹毒、蜂窝织炎或皮肤脓肿）6 例。在这些 33 次感染中，21 次发生在 TNFα拮抗剂治疗期间。在利妥昔单抗治疗期间，所有患者均同时接受糖皮质激素治疗（平均剂量 12±7.9mg/天）。13 例患者接受 1 个疗程，7 例患者接受 2 个疗程，10 例患者接受 3 个或更多疗程。从单次或末次严重感染到首次利妥昔单抗输注的时间平均为 20.1±18.7 个月。自首次利妥昔单抗输注以来的平均随访时间为 19.3±7.4 个月。随访期间，有 6 例（20%）患者各发生 1 次感染。利妥昔单抗治疗后免疫球蛋白水平在正常范围内。
在 30 例有 RA 且有严重或复发性细菌感染史的患者中，利妥昔单抗治疗有 24 例（80%）患者耐受良好。在日常实践中，利妥昔单抗治疗似乎不会增加感染复发的风险，但需要更长时间的随访。
