PT  - JOURNAL ARTICLE
AU  - Vollenhoven, Ronald van
TI  - 22 New and approved therapies for SLE: Anifrolumab
AID  - 10.1136/lupus-2022-la.22
DP  - 2022 Apr 01
TA  - Lupus Science & Medicine
PG  - A12--A12
VI  - 9
IP  - Suppl 1
4099  - http://lupus.bmj.com/content/9/Suppl_1/A12.2.short
4100  - http://lupus.bmj.com/content/9/Suppl_1/A12.2.full
SO  - Lupus Sci Med2022 Apr 01; 9
AB  - Painstaking research over more than two decades has demonstrated the essential role that activation of the type 1 interferon system plays in a considerable subset of patients with systemic lupus erythematosus (SLE). Based on these observations down-regulation of this system became a logical therapeutic goal. Following limited success with anti-interferon monoclonal antibodies, the monoclonal antibody anifrolumab, which binds the type 1 interferon receptor and thereby interferes with the ligands’ binding to that receptor, was developed successfully in a clinical trial program. The Phase 2 data and subsequent Phase 3 data, taken in aggregate, were accepted by regulators as sufficiently strong evidence for efficacy, and acceptable safety, for the compound to be approved for use in patients with active SLE. Several salient points from these trials include:Efficacy was more consistently demonstrated using the BICLA than with the SRI–4Efficacy was seen in both skin and joints, the most prevalent manifestations in these trialsAmong adverse events, herpes zoster seemed most clearly elevated for anifrolumab compared with placeboMore learnings from these trials, beyond initial efficacy and safety, have also been reported and will provide additional information in the future. Learning ObjectivesDescribe the scientific rationale and mechanisms of action of anifrolumabExplain the main efficacy data from the anifrolumab clinical trials programmeExplain of the main safety data from the anifrolumab clinical trials programmeDiscuss what additional learnings have emerged and will likely emerge from these clinical trials