Publication: Efficacy and safety of rituximab biosimilar in refractory lupus
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Issued Date
2020-11-02
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ISSN
20538790
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2-s2.0-85095859772
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Mahidol University
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SCOPUS
Bibliographic Citation
Lupus Science and Medicine. Vol.7, No.1 (2020)
Suggested Citation
Nantakarn Pongtarakulpanit, Prapaporn Pisitkun, Pintip Ngamjanyaporn Efficacy and safety of rituximab biosimilar in refractory lupus. Lupus Science and Medicine. Vol.7, No.1 (2020). doi:10.1136/lupus-2020-000442 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/59984
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Title
Efficacy and safety of rituximab biosimilar in refractory lupus
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Abstract
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. Aims To characterise patients with refractory SLE receiving rituximab biosimilar (CT-P10) and to explore short-term efficacy and safety associated with rituximab biosimilar use. Methods We retrospectively analysed data from the medical records of patients with refractory SLE who received CT-P10 in Ramathibodi Hospital, Mahidol University, Thailand. Baseline characteristics, disease activity (modified Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)), response to treatment at 6 months after CT-P10 and infection over 6 months were recorded. Results Thirty-two patients with SLE received CT-P10 from April 2018 to June 2019. Of these, 29 (90.6%) were female and the mean±SD age was 36.8±15.2 years. The median (IQR) disease duration was 9.5 (1.3-13.0) years. All patients received glucocorticoid treatment and used 1.7±0.1 immunosuppressive agents at baseline, excluding antimalarial drugs. Baseline Systemic Lupus International Collaborating Clinics Damage Index score was 0.5 (0.0-1.0). Overall response, which was defined as a reduction in the modified SLEDAI score of ≥4, was achieved in 25.0% of patients at 6 months. The modified SLEDAI score reduced from 4 (1.3-8.0) at baseline to 1 (0.0-5.8) at 6 months (p=0.005). Response by active organ involvement was 71.8%. Serious infection occurred in four patients (12.5%), resulting in one death. The median time of onset of infection after CT-P10 infusion was 35.5 (17.0-72.5) days. Conclusion Rituximab biosimilar is associated with improvement in active organ involvement in patients with refractory SLE. Infection occurred early after rituximab biosimilar infusion.