Anifrolumab Phase III trial(TULIP 2) meets primary endpoint in systemic lupus erythematosus

AstraZeneca announced that the Phase III TULIP 2 trial for anifrolumab, a potential new medicine for the treatment of systemic lupus erythematosus (SLE), met its primary endpoint, achieving a statistically-significant and clinically-meaningful reduction in disease activity versus placebo, with both arms receiving standard of care. The reduction was measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52.

The BICLA requires improvement in all organs with disease activity at baseline with no new flares. The safety profile of anifrolumab was consistent with previous trials. TULIP 2 was the second Phase III trial designed to assess the safety and efficacy of anifrolumab as a treatment for adults with moderate-to-severe SLE. The positive BICLA response in TULIP 2 was consistent with a pre-specified analysis of the previous Phase III TULIP 1 trial, which did not meet its primary endpoint of SLE Responder Index 4 (SRI4). Data from TULIP 1 and TULIP 2 will be submitted for presentation at a forthcoming medical meeting.

About the Phase III TULIP programme : The pivotal TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) programme includes two Phase III clinical trials, TULIP 1 and TULIP 2, which evaluated the efficacy and safety of anifrolumab versus placebo in patients with moderately-to-severely active autoantibody-positive SLE who were receiving standard of care treatment. Results from TULIP 1 were announced in August 2018. TULIP 2 randomised 373 eligible patients (1:1) to receive a fixed-dose intravenous infusion of 300mg anifrolumab or placebo every four weeks. TULIP 2 assessed the effect of anifrolumab in reducing disease activity, as measured by the BICLA. The BICLA was chosen as the primary endpoint for TULIP 2 following a full evaluation of TULIP 1 and is an established measurement for disease activity in adults with SLE. TULIP 1 randomised 460 eligible patients (1:2:2) to receive a fixed-dose intravenous infusion of 150mg anifrolumab, 300mg anifrolumab or placebo every four weeks. TULIP 1 assessed the effect of anifrolumab in reducing disease activity, as measured by the SRI4. In addition, the TULIP programme includes a Phase III long-term extension trial in SLE and a Phase II trial in lupus nephritis.