Study in focus 1: Anifrolumab in active SLE¹

Post hoc analysis of pooled Treatment of Uncontrolled Lupus via the Interferon Pathway (TULIP-1) and TULIP-2 phase 3 trial data in patients with moderate to severe SLE receiving standard therapy is summarised here. Lupus Low Disease Activity State (LLDAS) was defined as: SLE Disease Activity Index 2000 ≤4 without major organ activity, no new disease activity, Physician’s Global Assessment ≤1, prednisone ≤7.5 mg/day and no non-standard immunosuppressant dosing. Time to first LLDAS attainment was compared between groups using Cox regression modelling and responses were compared using logistic regression. At week 52, 30.0% of anifrolumab-treated patients and 19.6% of placebo were in LLDAS (OR 1.8, 95% CI 1.3 to 2.5, p=0.0011). Compared with placebo, anifrolumab treatment was associated with earlier LLDAS attainment (time to first LLDAS, HR 1.76, 95% CI 1.35 to 2.30, p<0.0001), increased cumulative time in LLDAS (p<0.0001) and higher likelihood of sustained LLDAS (p<0.001). Anifrolumab treatment was also associated with higher rates of Definition of Remission in SLE remission at week 52 (15.3% vs 7.6%; OR 2.2, 95% CI 1.4 to 3.6, p=0.0013). These results suggest the potential utility of anifrolumab in a treat-to-target paradigm for the management of SLE.

Study in focus 2: Risankizumab for active psoriatic arthritis (PsA): 52-week results from the KEEPsAKE 1 study²

Long-term efficacy, safety and tolerability of Risankizumab, a humanized immunoglobulin G1 monoclonal antibody against IL-23 p19 was evaluated in KEEPsAKE 1 trial. It was a 24-week double-blind, placebo-controlled, parallel-group treatment period (period 1) and an open-label extension treatment period from week 24 through week 208 (period 2). In period 1, patients were randomized 1:1 to receive subcutaneous Risankizumab 150 mg or placebo at weeks 0, 4 and 16. Period 2 started at week 24, and to maintain blinding of treatment in period 1, patients who were randomized to Risankizumab received blinded placebo at week 24, and patients who were randomized to placebo received the first dose of blinded Risankizumab at week 24. At week 28, all patients received open-label Risankizumab 150 mg every 12 weeks through week 208.

At week 24 (period 1), significantly greater proportions of patients in the Risankizumab arm achieved the primary end point of ACR (American College of Rheumatology) 20 response compared with placebo (NRI-C, 57.3% vs 33.5%; P < 0.001). With continuous Risankizumab treatment (period 1 and 2), the proportion of patients achieving ACR20 response increased from week 24 (57.3%) to week 52 (70.0%) and similarly, ACR50 responses increased from 33.4% at week 24 to 43.3% at week 52, and the ACR70 response rate increased from 15.3% to 25.9% (P<0.001 for both ACR 50 & ACR 70). At 52 weeks, in the Risankizumab arm, the proportions of patients with resolution of enthesitis and resolution of dactylitis were 55.0% and 76.1%, respectively, demonstrating maintenance from week 24. In addition, PASI 90 response by week 52 was 67.8% and Minimal disease activity (MDA) response increased from 25.0% at week 24 to 37.9% at week 52. Risankizumab was generally well tolerated, with a long-term safety profile remaining stable relative to week 24. This study supports the use of Risankizumab in patients with active PsA who have inadequate response, intolerance or contraindication to csDMARDs.

References

1. Morand EF, Abreu G, Furie RA, Golder V, Tummala R. 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.
2. Kristensen LE, Keiserman M, Papp K, McCasland L, White D, Lu W et al. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study. Rheumatology (Oxford). 2023 Jun 1;62(6):2113-2121.