Abstract

Background/Aims

To investigate the impact of subcutaneous (SC) and intravenous (IV) belimumab on disease response in patients with SLE in the Newcastle cohort, including corticosteroid-sparing effect and disease activity as measured by SLEDAI and the proportion of patients achieving LLDAS)/DORIS* remission. To review patients who had been switched from SC to IV belimumab to assess for improvements in disease response.

Methods

A retrospective, longitudinal study of SLE patients treated with belimumab at NUTH was conducted. Disease activity (SLEDAI), prednisolone dose, and any change in conventional DMARDs were assessed at baseline, 6 months and 12 months, and the trend evaluated. This information was also used to assess whether LLDAS/DORIS* remission was achieved at 6 months and 12 months. For patients receiving IV rather than SC belimumab, qualitative data were collected from clinical notes to assess the reasons for this and the outcome on disease.

Results

171/671 SLE patients had ever received a biologic. 35 patients had ever received belimumab, with 21 currently receiving treatment with belimumab. The medication was generally well tolerated with no unexpected side effects documented. Treatment with belimumab led to corticosteroid reduction from baseline in 78.3% (18/23) of patients at 6 months and 90% (18/20) at 12 months, with a median reduction of 3.75mg (IQR: 1 - 6.5) at 6 months and 5mg (IQR: 3-9.25) at 12 months. SLEDAI score improved in 95.7% (22/23) of cases at 6 months, with a median improvement of 6 points (IQR: 4-9) and SLEDAI score improved in 100% (22/22) at 12 months compared to baseline with a median improvement of 9 points (IQR: 4.5-10). Clinical DORIS remission* was achieved in 4% (1/25) of patients at 6 months and 26.1% (6/23) of patients at 12 months. LLDAS remission* was achieved in 28% (7/25) of patients at 6 months and 56.5% (13/23) of patients at 12 months. 26/35 patients received SC belimumab and 8/26 were switched back to IV belimumab due to disease flare. In 3/8 cases the disease was better controlled on switching to IV belimumab, 3/8 cases were inconclusive and in 2/8 cases there was no improvement.

Conclusion

Overall, treatment with belimumab led to a clinically meaningful improvement in SLEDAI scores and reduction in prednisolone dose, with LLDAS achieved in 28% of patients on belimumab at 6 months and 56.5% at 12 months. DORIS remission was achieved in 4% of patients on belimumab at 6 months and 26.1% at 12 months. Review of patients who had been switched from SC to IV belimumab provided anecdotal evidence that IV belimumab may be more effective than SC belimumab at controlling SLE symptoms in some patients.

*SELENA-SLEDAI physician global assessment not collected at Newcastle Upon Tyne Hospitals therefore excluded when calculating whether LLDAS/DORIS clinical remission was achieved.

Disclosure

E. McClen: None. J. Vila: None. J. Heaney: None. A. Lorenzi: None. E. Kidd: None. K. Walker: None. J. Norris: None. B. Griffiths: None.

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