- Lupus is an autoimmune disease that causes a range of symptoms, some of which can be serious.
- It is more common in women, who represent 90% of cases.
- Once doctors have confirmed the diagnosis, they use treatments such as steroids to reduce inflammation, prevent organ damage and reduce symptom flare-ups. However, these treatments can have side effects, especially with long-term use.
- Now two drug trials have shown promise for treating lupus.
- In a long-term phase 3 trial, anifrolumab, an intravenous monoclonal antibody, and in a phase 2 trial, deucravacitinib, an oral treatment, were found to be both safe and effective.
Autoimmune diseases occur when the body’s immune system, which defends itself against disease, begins to attack healthy tissue.
One of the most common autoimmune diseases is lupus, the most common form of which is
Lupus affects around 5000000 people around the world, and it occurs much more often in women than in men.
Common symptoms of lupus include:
- muscle and joint pain
- a butterfly-shaped rash on the face
- sun sensitivity
To treat lupus doctors may prescribe hydroxychloroquine, which is also a malaria drug, corticosteroids, and immunosuppressants. People with systemic lupus erythematosus also benefit from a healthy diet and avoid smoking and excessive alcohol consumption.
Now in a long-term Phase 3 drug trial whose results appear in the journal
“This study found no long-term safety issues using anifrolumab to treat [systemic lupus erythematosus] – a chronic disease – which implies that the clinician can prescribe this treatment over a long period of time with little fear that patients will develop long-term adverse effects, also called side effects.
– Dr. Kazem KazempourCEO and President, Amarex Clinical Research
And in a phase 2 drug trial, the results of which also appear in
The long-term extension study followed previous work looking at anifrolumab as a treatment for systemic lupus erythematosus. The
Anifrolumab is a fully human monoclonal antibody that inhibits the signaling of all
This 3-year trial explored the safety and tolerability of anifrolumab in people with systemic lupus erythematosus who had completed previous TULIP trials. This is the first double blind, placebo– long-term controlled trial of this medicinal product in patients with systemic lupus erythematosus.
The 547 participants in the long-term extension study had received different drug regimens in previous TULIP trials – placebo, 150 milligrams (mg) of anifrolumab or 300 mg of anifrolumab. All participants who had previously received either dose of anifrolumab (324 people) now received 300 mg of anifrolumab intravenously every 4 weeks.
Those who had previously received a placebo were randomly assigned to 300 mg anifrolumab or a placebo. Of this group, 111 received anifrolumab in the long-term extension study, with the remaining 112 continuing to receive placebo.
The extension study was designed to reflect real-world clinical practice, allowing investigators to add or modify basic standard care treatment during the trial, therefore some participants remained on glucocorticoids or immunosuppressants, but the numbers were similar in each group.
To assess the safety of anifrolumab, researchers recorded the number of serious adverse events that occurred throughout the study. They then recorded the total number of adverse events per 100 patient-years, or exposure-adjusted incidence rates.
In the long-term extension study, in the anifrolumab groups, the exposure-adjusted incidence rates for any adverse event were 33.1 compared to 37.6 for the placebo group. For serious adverse events, the figures were 8.5 for anifrolumab and 11.2 for placebo.
When evaluating effectiveness, researchers found greater mean improvement in symptoms in the anifrolumab 300 mg group than in the placebo group. This improvement was sustained, with disease activity remaining low in the anifrolumab group throughout the study.
Participants who received anifrolumab were also able to reduce glucocorticoid treatment. Long-term use of glucocorticoids has been associated with
“These data show an acceptable long-term safety profile of anifrolumab in [systemic lupus erythematosus] in addition to sustained improvements in disease activity and reduction in glucocorticoid use. Taken together, the results support the favorable benefit-risk profile of anifrolumab over the long term as a treatment option for patients with moderate to severe disease. [systemic lupus erythematosus].”
– Dr. Kazem Kazempour
Corresponding author on the phase 3 trial, Dr. Hussein Al-Mossawifrom AstraZeneca, noted that “management of systemic lupus erythematosus is challenging, due to the complexity of the disease itself, as well as treatments such as oral corticosteroids which can reduce disease activity, but also impose a significant burden to patients when used at high doses long term.”
“These new data from the TULIP extension trial – the longest placebo-controlled clinical trial in lupus to date – confirm the benefit-risk profile of anifrolumab observed in previous trials, now over 4 years” , he commented.
Dr. Kazempour agreed:
“Based on the above long-term safety, tolerability, and efficacy data, yes, anifrolumab appears to be an effective treatment for patients with lupus. The results of this study are significant because they are based on a large “randomized, placebo-controlled” clinical trial conducted at 176 study sites in 24 countries.
“This study provides the evidence needed for anifrolumab to be adopted as a long-term add-on treatment for [systemic lupus erythematosus] […] Further evidence will be needed post-marketing to confirm an even longer long-term safety and efficacy profile,” he added.
The second study also obtained encouraging results in the treatment of SLE.
In this 32-week phase 2 trial of the oral treatment deucravacitinib, those taking the active drug showed greater improvement in symptoms and similar rates of adverse events to placebo.
Participants at all doses of deucravacitinib responded better than those on placebo, but the effect was greater in those receiving the lowest trial dose of 3 mg twice daily. These participants showed a 58%
So, for those living with lupus, the future may soon be brighter.