ADHERE REAL Study to Assess Real-World Effectiveness of Efgartigimod in CIDP

A prospective, multicenter real-world study, dubbed ADHERE REAL (NCT07264426), will evaluate the effectiveness of subcutaneous efgartigimod PH20 (Vyvgart Hytrulo; argenx) in adults with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The study will also characterize patients' treatment journeys and health care resource utilization.¹

Efgartigimod is an FDA-approved, human IgG1 antibody Fc fragment that blocks the neonatal Fc receptor (FcRn), reducing IgG recycling and lowering circulating IgG levels. Presented at the 2026 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting, held September 29 to October 2, in Orlando, Florida, ADHERE REAL is intended to extend findings from the registrational ADHERE trial into routine clinical practice.

Presented by lead author Jana Zschüntzsch, MD, senior consultant for neurology at University Medical Center Göttingen, the study will enroll adults with CIDP across the US and Germany. Patients must be efgartigimod PH20–naïve at screening and initiate treatment as part of routine care. Clinician-assessed and patient-reported outcomes will be collected at regular intervals, along with any changes in treatment or dosage and any relapses. Because the study is noninterventional, treatment decisions will be left to patients and their physicians. Each participant will be followed for up to 2 years from the first efgartigimod dose.²

Effectiveness will be assessed through change over time in several measures, including the adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT) disability score and the Inflammatory Rasch-built Overall Disability Scale (I-RODS). Data will be collected through patient questionnaires, nurse assessments, and medical record review. Investigators will also report the proportions of participants who relapse and who show evidence of clinical improvement.

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Treatment journey assessments will capture disease course, comorbidities, CIDP treatments, treatment modifications, and the timing and rationale for those changes. Health care resource utilization will be measured by the frequency, duration, and reasons for provider follow-up visits, emergency department visits, and hospitalizations. As of December 2025, 12 participants had been enrolled in Germany, and enrollment had begun in the US.¹

The real-world study builds on ADHERE (NCT04281472), a previously completed multistage, randomized-withdrawal, double-blind, placebo-controlled phase 2 trial conducted at 146 sites across Asia-Pacific, Europe, and North America. Of 322 participants who entered the open-label stage A of ADHERE, 214 (66%) had confirmed evidence of clinical improvement. In stage B, 221 participants were randomized to weekly efgartigimod PH20 1000 mg or placebo.

In ADHERE, relapse occurred in 27.9% of those receiving efgartigimod vs 53.6% of those receiving placebo (hazard ratio, 0.39; 95% CI, 0.25-0.61; P <.001). Treatment-emergent adverse events occurred in 64% of the efgartigimod group vs 56% of the placebo group, and serious events occurred in 5% of each group.³ On the basis of these data, the FDA approved efgartigimod alfa and hyaluronidase-qvfc for adults with CIDP in June 2024, making it the first FcRn blocker approved for the condition.⁴

Current European Academy of Neurology/Peripheral Nerve Society guidelines recommend intravenous immunoglobulin or corticosteroids for induction therapy, with plasma exchange as the next option if those are ineffective.⁵ Real-world data may be needed to clarify how FcRn blockade performs outside the controlled, responder-enriched setting of a randomized-withdrawal trial.

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REFERENCES
1. Zschüntzsch J, Aldridge J, Allen J, et al. Real-world effectiveness and use of efgartigimod in chronic inflammatory demyelinating polyradiculoneuropathy: ADHERE REAL study design. Presented at: 2026 AANEM Annual Meeting; September 29-October 2, 2026; Orlando, FL. Abstract 420.
2. Real-world efgartigimod effectiveness in CIDP: a prospective study. ClinicalTrials.gov identifier: NCT07264426. Updated 2026. Accessed September 29, 2026. https://clinicaltrials.gov/study/NCT07264426
3. Allen JA, Lin J, Basta I, et al. Safety, tolerability, and efficacy of subcutaneous efgartigimod in patients with chronic inflammatory demyelinating polyradiculoneuropathy (ADHERE): a multicentre, randomised-withdrawal, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2024;23(10):1013-1024. doi:10.1016/S1474-4422(24)00309-0
4. argenx announces FDA approval of Vyvgart Hytrulo for chronic inflammatory demyelinating polyneuropathy. News release. argenx. June 21, 2024. Accessed September 29, 2026. https://www.argenx.com/news/argenx-announces-fda-approval-vyvgart-hytrulo-chronic-inflammatory-demyelinating-polyneuropathy
5. Van den Bergh PYK, van Doorn PA, Hadden RDM, et al. European Academy of Neurology/Peripheral Nerve Society guideline on diagnosis and treatment of chronic inflammatory demyelinating polyradiculoneuropathy: Report of a joint Task Force-Second revision. J Peripher Nerv Syst. 2021;26(3):242-268. doi:10.1111/jns.12455