Industry Abstract Previews #ACR21 - Horizon, Aurinia, AstraZeneca Save
The pharmaceutical companies will feature the results of their pivotal clinical trials and data analyses at ACR Convergence 2021. Below is a listing of some of their best studies for you to review and look for in the meeting. Often these become the pivotal studies for regulatory approval and the annual congresses are their first look.
- AURORA 2 study: updated results from this continuation study evaluating the long-term safety and tolerability of voclosporin (LUPKYNIS) for the treatment of lupus nephritis (LN) in patients with systemic lupus erythematosus (SLE). Patients completing the 12 months AURORA 1 study were eligible to enroll in the AURORA 2 wherein they continue voclosporin at 23.7 mg twice daily or placebo, in combination with mycophenolate mofetil (MMF) at 1 g twice daily with either no or low-dose oral steroids, for an additional 24 months. A total of 216 LN patients continued into AURORA 2, with 116 patients in the voclosporin group and 100 patients in the control group, 90 and 78 patients, respectively, received 30 months of total treatment as of this interim analysis. In this second interim analysis, reductions in proteinuria were sustained with no impact on renal function in the voclosporin group, showing consistent outcomes over time. Final results from the AURORA 2 study are expected by the end of 2021. This is a plenary session presentation on Monday, Nov. 8 10:45 a.m. EST
- TULIP : 3 post hoc analyses of their Phase III trials of anifrolumab (SAPHNELO) added to standard of care therapy in active SLE patients. Anifrolumab was recently approved in the US for the treatment of adult patients with moderate to severe SLE. Future Phase III trials in SLE are planned testing subcutaneous delivery, and studies in lupus nephritis, cutaneous lupus erythematosus and myositis.
- Abstract 1741: Patients diagnosed within the last two years and those with established disease experienced a similar benefit with anifrolumab (14.4% improvement over standard therapy alone and 17.1%, respectively, as assessed by the BILAG–based Composite Lupus Assessment, or BICLA, at week 52). https://acrabstracts.org/abstract/anifrolumab-results-in-favorable-resp…
- Abstract 1739: Patients were separated into subgroups depending on which standard therapies they were receiving at baseline: OCS (82.0%), antimalarials (70.2%), and/or immunosuppressants (48.2%), with most patients receiving combinations of two or more types of standard therapy. SAPHNELO was associated with consistently higher BICLA response rates than standard of care alone, regardless of the type of baseline standard therapy use. https://acrabstracts.org/abstract/sle-treatment-history-and-anifrolumab…
- Abstract 1740: Biologic-naïve patients in the trials who received anifrolumab saw similar benefits across efficacy endpoints (measures of comprehensive disease activity, OCS taper and flare rate), to those previously treated with other biologics. https://acrabstracts.org/abstract/efficacy-of-anifrolumab-in-patients-w…