Unlike many other autoimmune diseases, in systemic lupus erythematosus (SLE) there are only two targeted biological therapies approved to choose between, namely belimumab and anifrolumab. Each is approved for the treatment of moderate to severe active SLE, and the 2023 European Alliance of Associations for Rheumatology (EULAR), guidelines recommend consideration of biological therapy in first line treatment. But how are we to choose which one to use first in each patient? Assuming equal access and cost, our decisions are based largely on clinical trial and long-term extension data, with some additional information from investigator-initiated studies.
The case for using anifrolumab as first line biologic in SLE rests on several points of difference from belimumab. First, the available data suggest the potential for a fast onset of action for anifrolumab, with pooled data from the phase 3 trials showing separation between placebo and anifrolumab as early as 4 weeks in some domains.1 Secondly, anifrolumab was efficacious in mucocutaneous, musculoskeletal, and haematological domains, suggesting the potential for broad effects in SLE; importantly, efficacy in lupus nephritis has not yet been demonstrated.1 Thirdly, glucocorticoid sparing effects of anifrolumab were robustly demonstrated.2 Fourthly, anifrolumab is the only drug shown to increase attainment of remission in SLE; increased LLDAS was also demonstrated.3 Finally, the long-term extension study of anifrolumab, the first in SLE to include a long term placebo-control group, showed good tolerance, low rates of serious adverse events, and prolonged reduction in disease activity and glucocorticoid use; prolonged attainment of LLDAS has been reported in abstract form.4
Together these data suggest that anifrolumab treatment can induce broad, deep, and lasting effects on SLE disease activity and achieve steroid sparing.
Morand EF, et al. Efficacy of anifrolumab across organ domains in patients with moderate-to-severe systemic lupus erythematosus: a post-hoc analysis of pooled data from the TULIP-1 and TULIP-2 trials. Lancet Rheumatol. 2022;4(4): E282-E292. doi: 10.1016/S2665-9913(21)00317-9.
Bruce IN, et al. Sustained glucocorticoid tapering in the phase 3 trials of anifrolumab: a post hoc analysis of the TULIP-1 and TULIP-2 trials. Rheumatology (Oxford). 2023 Apr 3;62(4):1526–1534. doi: 10.1093/rheumatology/keac491.
Morand EF, et al. Lupus low disease activity state attainment in the phase 3 TULIP trials of anifrolumab in active systemic lupus erythematosus. Ann Rheum Dis. 2023 May;82(5):639–645. doi: 10.1136/ard-2022-222748.
Kalunian KC, et al. A randomized, placebo-controlled phase iii extension trial of the long-term safety and tolerability of anifrolumab in active systemic lupus erythematosus. Arthritis Rheumatol. 2023 Feb;75(2):253–265. doi: 10.1002/art.42392.
Increased understanding of the efficacy and safety data for anifrolumab in SLE clinical trials and long-term extension
Increased awareness of key points of difference between anifrolumab and belimumab, potentially including onset of action and attainment of remission
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