Journal of the neurological sciences · 2026
Diagnostic adjudication of potential participants with chronic inflammatory demyelinating polyradiculoneuropathy in the ADHERE trial of subcutaneous efgartigimod PH20.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Donofrio Peter D, Gorson Kenneth C, Hofman Erik, Karam Chafic, Kira Jun-Ichi, Kostera-Pruszczyk Anna, Léger Jean-Marc, Nobile-Orazio Eduardo, Attarian Shahram, Markov Martin, Tse Anissa, De Roeck Arne, Lewis Richard A
Аннотация
BACKGROUND: Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is a rare, acquired, immune-mediated polyneuropathy that is commonly misdiagnosed. The global, pivotal ADHERE trial pioneered the use of a diagnostic adjudication committee (DAC) to verify accurate CIDP diagnosis for potential participants.
METHODS: The committee consisted of nine independent experts with extensive experience in CIDP diagnosis, trained to review existing evidence for CIDP in patient medical records. Enrollment eligibility was confirmed when 2 of 2 adjudicators agreed on a definite or probable CIDP diagnosis, as defined by the 2010 European Federation of Neurological Societies-Peripheral Nerve Society criteria (2/2 agreement; phase 1). Participants were not enrolled if both adjudicators determined that the eligibility criteria were not met. When the two adjudicators disagreed, a third adjudicator (the DAC Chair or designee) provided a 2 out of 3 majority vote (phase 2).
RESULTS: Of the 560 cases reviewed, 391/560 (69.8%) were determined to have definite/probable CIDP and 169/560 (30.2%) did not meet diagnostic eligibility for ADHERE. Of all enrolled participants with phase 1 adjudication data (n = 340), 277 (81.5%) were confirmed with a 2/2 agreement on diagnostic eligibility (phase 1); 50 participants who were determined to have definite/probable CIDP failed other inclusion/exclusion criteria and were not eligible for ADHERE. The top reasons for disagreement between adjudicators in phase 1 were differences in assessment of clinical and electrodiagnostic criteria.
CONCLUSION: Use of a DAC addressed the limitation of CIDP misdiagnosis and increased the likelihood that the ADHERE trial included participants with confirmed CIDP.
METHODS: The committee consisted of nine independent experts with extensive experience in CIDP diagnosis, trained to review existing evidence for CIDP in patient medical records. Enrollment eligibility was confirmed when 2 of 2 adjudicators agreed on a definite or probable CIDP diagnosis, as defined by the 2010 European Federation of Neurological Societies-Peripheral Nerve Society criteria (2/2 agreement; phase 1). Participants were not enrolled if both adjudicators determined that the eligibility criteria were not met. When the two adjudicators disagreed, a third adjudicator (the DAC Chair or designee) provided a 2 out of 3 majority vote (phase 2).
RESULTS: Of the 560 cases reviewed, 391/560 (69.8%) were determined to have definite/probable CIDP and 169/560 (30.2%) did not meet diagnostic eligibility for ADHERE. Of all enrolled participants with phase 1 adjudication data (n = 340), 277 (81.5%) were confirmed with a 2/2 agreement on diagnostic eligibility (phase 1); 50 participants who were determined to have definite/probable CIDP failed other inclusion/exclusion criteria and were not eligible for ADHERE. The top reasons for disagreement between adjudicators in phase 1 were differences in assessment of clinical and electrodiagnostic criteria.
CONCLUSION: Use of a DAC addressed the limitation of CIDP misdiagnosis and increased the likelihood that the ADHERE trial included participants with confirmed CIDP.