As Spring edges closer, rheumatology experts are preparing for The European Lupus Society’s 15th Annual European Lupus Meeting, which will place a keen focus on the most common form of the disease: systemic lupus erythematosus (SLE).
Physicians and researchers will descend on Lisbon, Portugal, between 4 and 7 March, where they will discuss the best treatments in SLE, with considerations of the best timings to use biologics across various patient scenarios.
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There has been an increasing number of targeted, disease-modifying therapies (DMTs) reaching the global SLE market, including AstraZeneca’s Saphnelo (anifrolumab) and GSK’s Benlysta (belimumab). Since their approval, both drugs are widely used across the lupus patient population.
Now, plenty more promising drugs are progressing through the pipeline, with the majority of drugs being evaluated currently in the early stages of clinical trials, according to GlobalData, the parent company of Clinical Trials Arena.
The late-stage pipeline including immunology figureheads like the Janus kinase (JAK) inhibitor, as well as novel mechanisms like blood dendritic cell antigen 2 (BDCA2) blockers and tyrosine kinase 2 (TYK2) inhibitors.
AbbVie eyes further immunology expansion for Rinvoq
AbbVie has long held a strong foothold in the immunology sector with Humira (adalimumab), which maintained its status as one of the best-selling drugs on the market for years before its patent expiry in 2023. Now, AbbVie’s JAK inhibitor Rinvoq (upadacitinib) is poised to strengthen the company’s hold in the disease area.
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By GlobalDataWhile Rinvoq is already secured US approval within nine indications, AbbVie is hoping to add SLE to the list through the Phase III SELECT-SLE study, (NCT05843643), which has enrolled an estimated 1,000 patients across 369 sites. The trial is set for primary completion in December 2026.
Though Dr Daniel Wallace, associate director of the Rheumatology Fellowship Program at Cedars-Sinai Medical Center, notes that while the 15mg daily dose of Rinvoq did not significantly impact SLE responder index 4 (SRI-4) scores in the Phase II SLEek study (NCT03978520), the 30mg dose did show benefit, and hopes this success will be replicated in the Phase III trial.
Dr Romy Kallas, rheumatologist and lupus specialist at the Hospital for Special Surgery in New York, echoes Wallace’s sentiments, adding:
“Physicians have good experience with Rinvoq, and there’s a large amount of safety data on the drug. In the SLEek trial, there were no cardiovascular or thromboembolic events that are often characteristic of the JAK inhibitor class, which is promising.”
Professor David Isenberg, President of the British Society for Rheumatology and professor of rheumatology at University College London (UCL), notes that JAK inhibition is a “perfectly valid” target to aim for in autoimmune diseases like SLE.
Despite this, Isenberg expressed his cautious optimism towards Rinvoq. “Many drugs in SLE fail at Phase III after showing promise in mid-stage trials, which is most likely down to a combination of larger patient cohorts in Phase III, as well as the high rate of placebo responses observed in lupus trials. Many years of failed studies has taught me to curb my excitement on Phase II results; I leave that to Phase III,” Isenberg states.
Biogen explores new MoA in late-stage litifilimab study
While Biogen has not traditionally been known for its immunology portfolio, the company has been making moves to stock up this area of its pipeline in recent years. As part of this, Biogen signed 30 immunology deals since 2020, as per GlobalData’s Pharmaceutical Intelligence Center.
Now, three of its immunology assets are in Phase III development, including the blood dendritic cell antigen 2 (BDCA2) receptor agonist, litifilimab, which is being evaluated in the TOPAZ-1 study (NCT04895241) in SLE. The study has enrolled 548 patients across 15 countries, with a primary completion date of 30 September 2026.
According to Kallas, litifilimab’s novel approach to drugging the type 1 interferon pathway will, theoretically, be safer than the mechanism employed by Saphnelo due to its heightened selectivity. “Saphnelo blocks the whole interferon system, while litifilimab only inhibits BDCA2 on a specific type of cell, allowing other elements of the type 1 interferon pathway to remain active and fight viral infection,” she comments.
However, Kallas has mixed opinions on the drug’s efficacy; largely down to the results of the Phase II LILAC study (NCT02847598), which she believes showed limited benefits in global disease measures – despite good results for skin and joints. In the trial, 36 patients (56%) given litifilimab achieved SRI-4 response, compared with 16 (29%) of patients in the placebo group.
To experience a strong uptake in SLE, Kallas believes that it must also demonstrate its impact on global disease activity, corticosteroid reductions and number of flares.
Director of the Yale Lupus Program, Dr Fotios Koumpouras, believes that the data thus far suggests litifilimab’s strong efficacy in cutaneous lupus erythematosus (CLE) – a disease for which there are no specifically approved treatments. “Current promising data also suggests meaningful effectiveness in treating SLE, but CLE symptoms affect an estimated 70-85% of patients with SLE,” Koumpouras iterates.
Isenberg also touted the drug’s efficacy in patients with joint manifestations based on the available data, though he says he has not heard much about litifilimab from other rheumatologists.
BMS sets Sotyktu up for SLE label expansion
Alongside AbbVie and Biogen, Bristol Myers Squibb (BMS) is also looking to capture a slice of the SLE market with its plaque psoriasis therapy, Sotyktu (deucravacitinib), which GlobalData forecasts will become a blockbuster drug in 2028.
BMS is exploring the potential of the tyrosine kinase 2 (TYK2) inhibitor in the POETYK SLE-1 and POETYK SLE-2 (NCT05617677; NCT05620407) studies, which have enrolled 516 and 513 patients, respectively, and are set for primary completion in October 2026.
According to Wallace, TYK2 inhibition via an oral small molecule like Sotyktu is a highly promising approach in SLE, as the molecule “works immediately” for a patient. “The drug’s short half-life and potential anti-inflammatory impacts are also a benefit,” he adds. Alongside these perks, Wallace believes that Sotyktu could hold advantages over the traditional JAK inhibition approach harnessed by Rinvoq, as it does not interfere with coagulation.
However, Wallace cautions that the benefits of TYK2 inhibitors for patients with SLE can “wear off to some degree within a year or so”, potentially reducing their efficacy on a long-term basis. In Wallace’s experience of prescribing the drug off-label, he also recounts some patients having bad reactions to Sotyktu – though these patients were in the minority.
Koumpouras also sees the appeal of Sotyktu and adds that ongoing trials “indicate the potential for robust, multi-domain SLE efficacy with meaningful treatment response across skin, joints and global disease activity measurements”.
Telitacicept turns heads, but global uptake stalls
Another targeted SLE therapy already making an impact in China is RemeGen’s B-lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL)-targeting telitacicept, which gained approval in 2023.
Since then, US-based biotech Vor Bio bought the rights to telitacicept outside of China for up to $4bn. While Vor was originally planning to progress the therapy’s development outside of China in SLE through the REMESLE-1 and REMESLE-2 (NCT05306574; NCT06456567) studies, these trials were later terminated or withdrawn due to “sponsor business decisions,” as per ClinicalTrials.gov.
According to Isenberg, study results on telitacicept coming out of China have been “sensationally” good; so good in fact, that he found them hard to believe. However, now that more data and information on the drug’s side effects are available, Isenberg believes the drug “may well have a good future” on the SLE market – subject to proving its efficacy across a global population.
Wallace also touts the potential of telitacicept, which he says is backed by “very promising” data thus far. However, he believes it is too soon to tell how the drug might perform outside of China.
Koumpouras adds that Phase III efficacy data on telitacicept has shown potential as a “robust treatment for high disease states as evaluated by standard SLE measurement tools”.
While telitacicept is garnering interest among experts, it is yet to be seen if Vor Bio will choose to reinvigorate its global SLE programme for the drug in the future. Clinical Trials Arena approached Vor Bio for comment as to whether the programme would return, but the company did not respond.
