Lupus is a chronic autoimmune disease that causes inflammation in tissues and organs throughout the body. Approximately 1.5 million Americans and at least 5 million people worldwide suffer from a form of lupus. While treatments have improved over the years, lupus remains difficult to diagnose and treat. Existing therapeutic options are limited and not effective for all patients. However, advances in understanding the mechanisms behind lupus have raised hopes for better treatments in the future. This article provides an overview of the current status of lupus therapeutics along with promising new therapies in development.
Standard Treatments
The current standard of care for lupus involves the use of anti-inflammatory and immunosuppressive drugs. Nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin and ibuprofen are commonly prescribed to reduce joint pain, fatigue, and fever associated with lupus. For patients with more severe or life-threatening organ involvement, stronger medications are used.
Corticosteroids like prednisone work to reduce overall inflammation in the body but can cause unpleasant side effects with long-term use such as weight gain, high blood pressure, bone loss, and infections. As a result, corticosteroids are typically used in combination with immunosuppressants. Immunosuppressive medications target specific parts of the immune system that are overactive in lupus. Common drugs prescribed include hydroxychloroquine, azathioprine, methotrexate, mycophenolate mofetil, and calcineurin inhibitors like cyclosporine. While these drugs can help control symptoms and reduce disease activity, they are not cure-all treatments and come with their own side effect risks. Many patients struggle to find an effective regimen and eventually experience treatment failure over time.
Promising New Therapies
Given these limitations of existing lupus treatments, scientists are actively researching new drugs that target specific pathways thought to drive lupus. Several promising candidates are now in clinical trials:
Belimumab: Sold under the brand name Benlysta®, belimumab was the first new lupus drug approved by the FDA in over 50 years when it received approval in 2011. It works by inhibiting B lymphocyte stimulator (BLyS) protein that contributes to overactive B cells in lupus. While modest in its effects, studies show belimumab can reduce lupus disease activity when added to standard therapy. It is generally well-tolerated with infusions every month.
Rituximab: A monoclonal antibody already FDA-approved for other diseases, rituximab targets and eliminates CD20-positive B cells. Several clinical trials found rituximab helped reduce joint inflammation, rash, and other symptoms in people with moderate to severe lupus. The drug did carry risks of infusion reactions and infections. Later-stage trials are ongoing.
Tocilizumab: This interleukin-6 (IL-6) receptor antagonist works to counter the effects of the pro-inflammatory IL-6 cytokine. A Phase III trial showed tocilizumab may help control joint inflammation and reduce flare-ups when added to standard treatment. The drug did increase risk of infections, so careful management is needed.
Anifrolumab: Known mechanisms contributing to lupus therapeutics include interferon-alpha (IFNα) signaling pathways that are abnormally activated. Anifrolumab works by blocking IFNα receptor 1, reducing downstream effects. Phase III trials found anifrolumab helped reduce lupus symptoms and lowered flares compared to placebo when added to standard care. The drug was generally well-tolerated.
Additional agents in clinical testing target pathways such as IFNγ, IL-12/IL-23, Bruton’s tyrosine kinase (BTK), toll-like receptors, and more. Scientists are also exploring stem cell therapies, gene therapies, and monoclonal antibodies against novel targets. Results thus far offer hope that new combination or adjunctive therapies will significantly advance care.
Challenges Remain
While biomedical progress provides growing optimism, challenges persist for developing safe and effective lupus therapeutics. Lupus is a heterogeneous disease, and different molecular mechanisms may drive symptoms in different individuals. This complexity makes it difficult to identify drugs that work universally for all lupus patients. Trials often show only modest benefits on top of standard treatment. Identifying reliable biomarkers to predict who will respond best to certain therapies remains an area of active investigation.
Safety must also be carefully monitored given the autoimmune nature of lupus and the fact most patients are women of childbearing age. Developing therapies with the best benefit-risk profiles will require large, well-designed clinical research inclusive of diverse patient populations. Even with FDA approval, access and affordability barriers can limit real-world effectiveness of new lupus drugs for many patients. Overall, while the future appears brighter, much work lies ahead to translate scientific advances into meaningful solutions.
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