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  • Anifrolumab showed benefit across different measur...

Anifrolumab showed benefit across different measures of skin and joint disease activity in patients with systemic lupus erythematosus.- AstraZeneca.

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Published:3rd Jun 2021
A new post-hoc analysis of pooled data from the TULIP Phase III clinical trials being presented at the annual European Congress of Rheumatology (EULAR 2021) showed anifrolumab was consistently associated with improvements in both skin rash and arthritis across three different disease measures each, compared to placebo, in patients with moderate to severe systemic lupus erythematosus (SLE).

The analysis examined disease manifestations in the two most commonly impacted organ domains in SLE. Anifrolumab is a potential first-in-class type I interferon inhibitor. For skin rash, the difference in response rates for anifrolumab versus placebo at week 52 were 13.5% SLE Disease Activity Index (SLEDAI), 15.5% British Isles Lupus Assessment Group index (BILAG) and 15.6% modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (mCLASI).

For arthritis, differences in response rates were 8.2% SLEDAI, 11.8% BILAG and 12.6% joint response. The most frequently reported adverse events for anifrolumab in the TULIP-1 and TULIP-2 trials were upper respiratory tract infection, bronchitis, infusion-related reactions and herpes zoster. TULIP-1, TULIP-2 in SLE :The pivotal TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) Phase III programme includes two trials, TULIP-1 and TULIP-2, that evaluated the efficacy and safety of anifrolumab versus placebo. Both were randomised, double-blinded, placebo-controlled trials in patients with moderate to severe autoantibody-positive SLE who were receiving standard therapy.

Standard therapy consisted of oral corticosteroids (OCS), antimalarials and immunosuppressants (methotrexate, azathioprine or mycophenolate mofetil, known as MMF). TULIP-2 demonstrated superiority across multiple efficacy endpoints versus placebo with both arms receiving standard therapy. In the trial, 362 eligible patients were randomised (1:1) and received 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 BILAG-Based Composite Lupus Assessment (BICLA) scale. In TULIP-1, 457 eligible patients were randomised (1:2:2) and received a fixed-dose intravenous infusion of 150mg anifrolumab, 300mg anifrolumab or placebo every four weeks, in addition to standard therapy.

The trial did not meet its primary endpoint based on the SLE Responder Index 4 (SRI4) composite measure. In SLE , along with the pivotal TULIP Phase III programme, anifrolumab continues to be evaluated in a long-term extension Phase III trial. A Phase II trial of anifrolumab in SLE using subcutaneous delivery has been completed.In addition, AstraZeneca is exploring the potential of anifrolumab in a variety of diseases where type I interferon plays a key role, including lupus nephritis, cutaneous lupus erythematosus and myositis. AstraZeneca’s application for anifrolumab in SLE is under review by regulatory authorities in the US, EU and Japan, with decisions anticipated in the second half of 2021. Anifrolumab is not currently approved in any country. See- Merrill JT, et al. "Anifrolumab Effects on Rash and Arthritis in Patients With SLE and Impact of Interferon Signal in Pooled Data From Phase III Trials". Oral presentation at: the 2021 European Alliance of Associations for Rheumatology (EULAR) European Congress of Rheumatology; 3 June 2021; virtual. Abstract ID: 1471.

Condition: Systemic Lupus Erythematosus
Type: drug

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