Short-term efficacy and safety of rituximab therapy in refractory systemic lupus erythematosus: Results from the British Isles Lupus Assessment Group Biologics Register
Rheumatology Dec 08, 2017
McCarthy EM, et al. - This inquiry was set up to determine 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. With RTX use, concomitant reductions in glucocorticoid use were noted in addition to improvement in disease activity in refractory SLE patients, with no reported safety concerns. For further improving treatment risks and benefits, early vigilance for infection post-infusion is crucial.
Methods
- An analysis was performed on patients commencing biologic therapy for refractory SLE and who consented to join BILAG-BR, focusing on baseline characteristics, disease activity (BILAG 2004/SLEDAI-2K) and rates of infection over follow-up.
- 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.
Results
- Data reported the commencement of biologic therapy by 270 SLE patients from September 2010 to September 2015, most commonly RTX (n = 261).
- Glucocorticoids intake at baseline, at a median [interquartile range (IQR)] oral dose of 10 mg (5–20 mg) daily, was reported in 250 (93%) patients.
- For 68% of patients, response rates at 6 months were available.
- At baseline, the reported median (IQR) BILAG score was 15 (10–23), which was 3 (2–12) at 6 months (P < 0.0001).
- Researchers noted that the median (IQR) SLEDAI-2K attenuated from 8 (5–12) to 4 (0–7) (P < 0.001).
- Data revealed that in 49% of patients, response was achieved.
- At 6 months, glucocorticoid use got reduced to a median (IQR) dose of 7.5 mg (5–12 mg) (P < 0.001).
- The occurrence of serious infections was reported in 26 (10%) patients, and the frequency of these was more in the first 3 months post-RTX therapy.
- In addition, researchers noted that a higher proportion of early infections were non-respiratory (odds ratio = 1.98, 95% CI: 0.99, 3.9; P=0.049).
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