10. A Real-World Evaluation of the Impact of One Intravenous Immunoglobulin Product on Patients with Chronic Inflammatory Demyelinating Polyneuropathy – Tolerability, Reported Outcomes, Satisfaction

Background: Intravenous immunoglobulin (IVIG) therapy is a complex therapy used to treat many neurological disorders including chronic inflammatory demyelinating polyneuropathy (CIDP). CIDP is an autoimmune disorder in which the body’s immune system attacks the myelin sheath surrounding the nerve cells throughout the peripheral nervous system causing paresthesia, weakness, loss of reflexes, loss of balance, altered ambulation and loss of sensation in the affected extremities. IVIG is a common treatment modality for patients with CIDP. IVIG carries the possibility of many reported adverse effects including headache, fatigue, flu-like symptoms and other systemic effects. This study examines 83 patients with a primary diagnosis of CIDP and analyzes tolerability, patient outcomes and patient reported experience using one 10% immunoglobulin product.

Purpose: Does the use of the study 10% IG product when used in CIDP patients yield a low incidence of adverse effects and do patients receiving this therapy report improvement in symptoms and demonstrated improved outcomes? This project was implemented to evaluate the overall effectiveness of a specific IG product on patients with CIDP with minimal reported adverse effects. We surmise that the use of this product results in a low incidence of adverse events and reported improvement in patient outcomes. This provider services patients with various neurological diseases and a large number with CIDP. Looking at the outcome of our practices will help to improve care for many patients.

Methods: This provider, a national infusion company and specialty pharmacy, evaluated 83 patients receiving the 10% IVIG product, (Gammaplex®, not approved in the US for CIDP), administered over a 2-year period. During this time 2,652 patient encounters occurred. A total of 86,980 grams of IG were dispensed at an average of 32.8 grams/visit. 96% of the participants received pre-medications. The mean age for the participants was 61.43 years. Data were extrapolated from the multi-therapy skilled nursing visits received electronically and from a therapy related satisfaction survey developed and sent to all patients via survey monkey.

Results: Adverse reactions occurring during the infusion were reported in 1.96% of the visits. Post infusion reactions reported 0 to 72 hours after completion of the infusion were reported in 14.9%. The two most prevalent complications included headache (4.4%) and fatigue (6.8%). The positive impact reported by patients receiving this 10% IVIG included increased energy, improved ability to participate in ADL’s, overall improvement in disease symptoms and decreased disease progression. The negative effects included loss of personal and work time and financial burden. Additionally, feedback on patient reported response to therapy is elicited on each visit encounter. Patients reported noted improvement in symptoms in 8.91% of the visit encounters, maintenance of symptoms in 87.6% and decline was reported in 2.9%. Reported infusion frequencies ranged from weekly to every 4 weeks and varied by participant. Patients (50%) reported wear-off effect within one week of their next infusion and 50% reported that the benefits lasted through to the next infusion.

Discussion: This provider utilizes the Karnofsky Performance Status Scale, the Inflammatory Rasch-built Overall Disability Scale (I-RODS) and the Inflammatory Neuropathy Cause and Treatment Disability Score (INCAT) to assess therapy related outcomes. Out of the 83 patients included in this study, 26 patients fully participated consistently following our protocol for monitoring outcomes initially and every six months. Improvement in outcome is defined as 10% or greater increase from baseline. Five patients (19.2%) showed improvement in all three outcomes measures, 18 (69.3%) patients maintained their same level of wellness and 3 out of 26 (11.5%) had reported deterioration.

Conclusions: The 10% IVIG product evaluated appears to be well tolerated in our study patients, with minimal side effects. Preliminary results of our study show that it often resulted in a low incidence of adverse effects and reported improvement or prevention further progression of disease.