Promise of Additional Lupus Therapies Highlighted at ACR 2021 Annual Meeting

November 9, 2021

Results of clinical trials testing many existing and potential lupus treatments were highlighted at the American College of Rheumatology’s annual meeting ACR Convergence 2021, November 3-9. Bringing you the most relevant news for our lupus community, following are summaries of key research presented at the meeting:

New Data on Approved Lupus Treatments

More Positive Results for Anifrolumab (Saphnelo™)
Anifrolumab, now FDA-approved under the brand name Saphnelo, also targets type I interferons. At the 2021 ACR meeting, researchers presented further evidence that the drug is effective. Looking at both Phase 3 trials (TULIP-1 and TULIP-2), investigators found an improvement in symptoms, as evaluated by a standard measurement tool called BICLA, among those patients treated with anifrolumab no matter what other medications they previously took or were currently receiving. Patients in the study had received at least one immunomodulatory therapies and most had received oral steroids, antimalarials and/or immunosuppressants. ACR 2021 Abstract

Belimumab (Benlysta) Works Well With or Without Steroids
Belimumab (Benlysta) made history in 2011 as the first new lupus drug approved in 50 years with four trials showing its effectiveness in SLE. In 2020, Benlysta set another milestone as the first treatment approved for lupus nephritis. An analysis of the Phase 3 BLISS-LN trial presented at ACR showed that the addition of belimumab to standard therapy for active lupus nephritis improved kidney outcomes compared with placebo regardless of whether the patient had also received steroids as their first treatment. ACR 2021 Abstract

Belimumab (Benlysta) Plus Rituxumab Decreases Autoantibody in DNA Cells
This Phase 3 study showed that adding rituximab (Rituxan™) –an approved medication for rheumatoid arthritis –to treatment with beliumumab (Benlysta) did not significantly improve disease control or disease remission. However, those patients who began the study with a high level of the autoantibody that targets DNA within cells, Anti-dsDNA, and received rituximab in addition to belimumab, did show a significant decrease in this level than those with beliumumab and placebo. ACR 2021 Abstract

Voclosporin (Lupykinis™) Sustains Kidney Benefits at 30 Months
Approved in 2021 under the brand name LupkynisTM, voclosporin is a treatment for lupus nephritis, the kidney inflammation that affects about half of patients with lupus. The drug quashes potentially harmful T cells and prevents certain kidney cells from dying. Interim results from the longer-term AURORA 2 extension trial showed that at up to 30 months, the addition of voclosporin meaningfully lessened the amount of protein in the urine of patients who were also treated with standard of care mycophenolate mofetil and low doses of steroids. Excess protein in the urine, a condition known as proteinuria, is a marker to evaluate kidney damage. ACR 2021 Abstract

Positive Results for  Investigational Lupus Treatments

Iberdomide – Potential Drug for Lupus and Cancer
A drug that is also being tested for cancer also appears to reduce disease severity in lupus according to a phase II, randomized trial sponsored by Bristol-Myers Squibb and conducted in part by LRA’s Lupus Clinical Investigators Network (LuCIN) managed by Lupus Therapeutics. The drug, iberdomide, works differently from other potential lupus treatments because it helps destroy two proteins that may spur immune cells to malfunction in lupus.

New results of a Phase 2 trial showed that the several benefits of treatment with iberdomide were sustained at 52 weeks and comparable to that seen at 24 weeks. In addition, certain subsets of patients showed better response to iberdomide at 52 weeks than at 24 weeks. Iberdomide also continued to be well-tolerated at 52 weeks with no increase in adverse events. ACR 2021 Abstract

Investigational Drug from Biogen Appears to Inhibit Type I Interferon Production
The immune system molecules called type I interferons are one of the main culprits in lupus. The investigational drug BIIB059 is thought to inhibit production of interferon. Results presented from the Phase 2 randomized controlled study report that at 52 weeks, BIIBO59 reduced by 48% versus 22% with placebo, the number of joints that were tender and/or swollen in lupus patients who began the study with at least four tender and four swollen joints. This is an update to data presented at ACR 2020 of the study at 24 weeks which showed a 15% reduction in the number of joints affected by lupus. Phase 2 studies aim to test effectiveness and safety of a potential drug. ACR 2021 Abstract

Baricitinib Improved Disease Activity
Another Phase 2 study found that Baricitinib (BARI), an oral, selective Janus kinase (JAK)1 and JAK2 inhibitor, improved disease activity in adults with SLE receiving standard background therapy. Investigators believe that the drug targets B-cells which produce antibodies including those that may promote lupus. (ACR 2021 Abstract)

Other presentations at ACR pointed to the promise of additional investigational treatments including Efavaleukin Alfa (ACR 2021 Abstract) which inhibits the immune signaling molecule interleukin 2, and BMS-986256 which inhibits another part of the immune system – Toll-like Receptors 7 and 8. ACR 2021 Abstract

Promise for the Future
After a dearth of new treatments in a decade, the past year has brought three new treatments for people with lupus and lupus nephritis. With support from patients, families, donors, academic researchers, clinicians and the pharmaceutical industry, the pace of discovery is accelerating and the wait for new treatments is anticipated to be much shorter. The LRA and our clinical research affiliate Lupus Therapeutics are proud of our continued leadership role in fueling this renaissance of innovation and will keep our global lupus community updated as the momentum of progress delivers more ways to manage this challenging and complex disease.