Nipocalimab Offers Rapid Response, Favorable Safety in wAIHA: Irina Murakhovskaya, MD

Nipocalimab (Imaavy; Johnson & Johnson) may offer patients with warm autoimmune hemolytic anemia (wAIHA) a faster, better-tolerated alternative to current standard therapies, according to findings from the phase 2/3 ENERGY trial presented at the European Hematology Association 2026 Congress by investigator Irina Murakhovskaya, MD.

In an interview at the meeting with The American Journal of Managed Care^®, Murakhovskaya emphasized the substantial burden wAIHA places on patients beyond its clinical manifestations. The disease's unpredictable flares make it difficult for patients to maintain stable employment or fulfill family responsibilities, with its impact compounded by the need for frequent treatments, blood transfusions, and laboratory monitoring.

She noted that corticosteroids remain the first-line standard of care for wAIHA based on expert opinion alone, with no successful randomized controlled trials to date. Therefore, the ENERGY (NCT04119050) trial was designed to assess whether nipocalimab could produce a durable hemoglobin response in patients with wAIHA; secondary end points included improvement in fatigue and tapering of corticosteroid dose.

Among the trial's most notable findings, she highlighted nipocalimab's speed of onset. Rituximab, commonly used off-label in the second- or first-line setting, can take up to 3 months to produce a response, whereas nipocalimab generated responses as early as week 1. Murakhovskaya described this as a potential breakthrough, given its capacity to spare patients prolonged steroid exposure and long-term transfusion dependence.

From a safety standpoint, the ENERGY trial demonstrated that nipocalimab was safe and well-tolerated, unlike rituximab, which carries risks of infection and impaired vaccine response.

“…having a medication that preserves your immune functions and only affects [immunoglobulin G] in a reversible manner is very important,” Murakhovskaya concluded.