Johnson & Johnson (JNJ) just gave lupus patients something to feel optimistic about. The pharmaceutical giant shared topline results Tuesday from its Phase 2b JASMINE study testing nipocalimab in people with systemic lupus erythematosus, and the numbers look good enough to push the experimental drug into late-stage trials.

Let's break down what we're talking about here. Systemic lupus erythematosus (SLE) is a chronic autoimmune disease where your immune system essentially turns against you, attacking healthy tissues and organs throughout the body. We're talking joints, skin, kidneys, even the brain. Patients deal with severe fatigue, joint pain and swelling, and distinctive rashes including that characteristic butterfly-shaped rash across the face. It's not a minor inconvenience—an estimated 3 to 5 million people worldwide live with this condition, including roughly 450,000 Americans.

The 228-subject study hit its primary endpoint, which measured the percentage of patients achieving a response on the Systemic Lupus Erythematosus Responder Index at Week 24. That's a composite measure, and it showed statistical significance compared with placebo. Even better, nipocalimab also met key secondary and exploratory endpoints, including markers suggesting the drug could help patients reduce their steroid use—a big deal since steroids come with their own unpleasant side effects.

On the safety front, nipocalimab behaved consistently with previous Phase 2 studies, showing no new safety signals. That's exactly what you want to hear when you're hoping to take a drug into Phase 3.

Johnson & Johnson is making a bold claim here: this represents the first positive results for an investigational FcRn blocker treatment in SLE. If that holds up, it could position nipocalimab as a potential first-in-class therapy. Based on these topline results, the company plans to launch a Phase 3 program for the drug.

The Lupus Treatment Race

Of course, J&J isn't the only company chasing a better lupus treatment. The competitive landscape is crowded, though some players are reshuffling their priorities.

Last November, Cartesian Therapeutics (RNAC) announced it would pause development of Descartes-08 in SLE, including enrollment in its Phase 2 trial. The company decided to focus instead on myasthenia gravis (currently in Phase 3) and myositis, where it sees better opportunities.

UCB SA (UCBJY) and Biogen Inc. (BIIB) presented detailed Phase 3 results last June from their PHOENYCS GO study evaluating dapirolizumab pegol (DZP). Their data showed the investigational drug significantly improved disease activity and fatigue in SLE patients.

Meanwhile, Adicet Bio Inc. (ACET) released encouraging early safety and efficacy data in October from its Phase 1 trial of ADI-001 in autoimmune diseases. Adicet said it plans to request an FDA meeting to inform the design of a potentially pivotal Phase 2 trial for lupus nephritis or for lupus nephritis and SLE combined.

For context, lupus nephritis is kidney inflammation caused by lupus, and it's one of the more serious complications of the disease.

JNJ stock rose 0.46% to $205.26 on Tuesday following the announcement.