Defining Treatment Success and Switching Treatment in CIndU

This episode, "Defining Treatment Success in CIndU Beyond Clinical Trial Endpoints," features the panel examining how success should be measured once patients leave the trial setting.

Dr. Cotter observes that RemIND defined treatment success as a binary endpoint, while real-world care rarely works that way. He asks the panelists how they define success in practice.

Dr. Finklea values rigid endpoints because they set clear expectations, but she also looks at change from baseline and patient-reported outcomes. She highlights the Urticaria Control Test (UCT) as an easy, four-question tool that takes about 30 seconds. It also provides actionable guidance. A score of 16, the maximum, means control is excellent and therapy might even be reduced, such as tapering antihistamines. Scores of 12 to 16 represent the target range. Scores below 12 indicate inadequate control and signal the need to advance therapy. She also notes other patient-reported measures and the CRUSE smartphone app for patients who prefer digital tracking.

Dr. Trotter considers patient-reported outcomes the most important measure. Clinical trial benchmarks are worth striving for, but improvement short of a benchmark can still be clinically meaningful. She compares this with atopic dermatitis and psoriasis, where patient experience may diverge from score changes. In routine practice she often skips formal scales and asks about flare frequency, itch, and whether patients can work, attend school, and function. These informal questions still give her valuable insight, because the patient's satisfaction ultimately defines success.

Dr. Cotter offers his own simple test. He asks patients whether they are doing what they want to do in their lives. He describes an adolescent with solar urticaria who wants to play soccer or go camping, and a teen afraid to meet friends at the mall. If patients are returning to those activities, or moving in that direction, he considers treatment on track.

Dr. Cotter asks how Dr. Finklea approaches a patient with a UCT score below 12 on advanced therapy. She weighs safety, efficacy, comorbidities, age, and patient preferences when choosing among omalizumab, dupilumab, and remibrutinib. None of their safety profiles concerns her, so shared decision-making drives the choice.

Dr. Trotter has combined therapies off label, using samples because insurance coverage is the biggest obstacle. She explains that immune-mediated diseases often involve more than one pathway. She added remibrutinib to dupilumab for a patient reluctant to switch, partly because of anaphylaxis concerns, and the patient achieved complete response.

On side effects, Dr. Finklea gives the example of conjunctivitis on dupilumab. She does not require a washout and starts the new therapy immediately. Some patients on dual therapy ask which drug is really helping, prompting conversations about stepping down.

Dr. Cotter stresses onset of action when switching. Moving from a rapid-onset oral agent to one needing 12 to 24 weeks could create a gap in control. Dr. Finklea adds that omalizumab responds quickly in type I disease but may take three months in type IIb disease, which relies on receptor downregulation.

Up next, in "Updated Urticaria Guidelines and Emerging Mechanisms in CIndU," the experts review where the latest international guidelines place advanced therapies and which mechanisms are on the horizon.