More patients are seeking treatment for conditions that require immunoglobulin (Ig) therapy, but delays in diagnosis and treatment, as well as dissatisfaction with the quality of their care, remain a significant problem, according to a new survey from the Immunoglobulin National Society (IgNS).
The survey is the first of its kind, assessing patients’ infusion experience, safety, efficacy, access and outcomes across all diagnoses and routes of administration, and all sites of care, according to senior author Luba Sobolevsky, PharmD, the president and CEO of IgNS. The survey was developed by IgNS Patient 360, a dedicated education and research advocacy arm of the society.
“The Patient 360 Survey is an ongoing longitudinal study that IgNS has conducted for the last five years,” Dr. Sobolevsky said. The goals are to assess Ig therapy patient outcomes based on numerous end points and criteria, including efficacy, safety, tolerability, adherence, treatment interventions, interruptions, complications, quality of clinical care and continuity of care.
Dr. Sobolevsky and her colleagues analyzed data from adult respondents who completed the survey between May and July 2024, and presented the results in two posters at the IgNS 2024 National Conference, in Washington, D.C. The first poster (abstract 121) examined the impact of diagnostic delays and the infusion experience of patients. The study population consisted of 167 respondents who had primary immunodeficiency (PID) with or without an autoimmune comorbidity; 49 with a neuromuscular disorder; 42 with a rheumatologic disorder, and 24 who reported receiving Ig therapy for other conditions.
Overall, patients reported significant delays in diagnosis, but PID patients experienced the most significant delays, with an average of 17.74 years from first symptoms to diagnosis, compared with two to five years for other conditions (P<0.01). Among the patients with PID, the most frequently reported symptoms that led to their diagnosis were unspecified chronic infections, frequent rounds of antibiotics, sinus infections and respiratory infections (71%, 62%, 60% and 59%, respectively).
“There is an overall lack of education and training of physicians about PI,” and the index of suspicion is low, Dr. Sobolevsky told Specialty Pharmacy Continuum. The lack of nationally accepted noted screening criteria for non-immunologists that would guide patient assessments may contribute to diagnostic delays, she added. Furthermore, the fragmentation of healthcare may cause providers to miss data on frequent infections, rounds of antibiotics, hospitalizations, recurrent invasive procedures and other PI-related factors, she said.
Site-of-Care Considerations
The second poster (abstract 122) examined the influence of the site of care (home vs. infusion center) on the quality and safety of IV immunoglobulin (IVIG), based on the same patient cohort from the Patient 360 Survey. Patients who received IVIG at an infusion center reported significantly lower quality of care than when they received care at home (demonstrated by a decrease of 1.3 points on an 11-point scale; P<0.001).
Patients reported significantly lower quality of care from ambulatory infusion center (AIC) nurses than from nurses delivering at-home Ig care (P<0.05), along withn lower confidence in nurses’ skills and abilities when they were treated at an infusion center versus home (P<0.01). Nurses at infusion centers also were perceived as significantly less skilled and knowledgeable than those at home sites of care (P<0.05).
Patients’ experiences of their Ig treatment also were less satisfactory at infusion centers compared with home care. For example, patients at infusion centers were significantly less likely than those treated at home to have their vital signs assessed by a nurse and significantly more likely to have faster infusion rates to shorten their infusion times (P<0.001 and P<0.01, respectively).
In addition, patients at infusion centers/suites were less likely to receive follow-up after infusion than those receiving care at home (P<0.001). Overall, patients with neuromuscular diagnoses reported significantly more IVIG side effects than patients with PI, with averages of four and 2.4, respectively (P<0.01).
Next Steps: Spreading the Word
The Patient 360 Survey results offer clinicians and other key stakeholders new insights into patients’ experiences with Ig therapy, Dr. Sobolevsky noted. Ideally, those insights will promote investment in better strategies for organizations providing these treatments, she pointed out. To help achieve that goal, Dr. Sobolevsky and her colleagues are preparing a manuscript based on the new survey findings, which will be shared with patient members at the annual IgNS Patient 360 Conference. The virtual meeting will take place March 8-9, and is the only national conference developed by Ig therapy patients, she noted.
“Additionally, we will be publishing the first-ever IgNS Standards of Practice for Patients,” Dr. Sobolevsky told Specialty Pharmacy Continuum. “Based on the IgNS National Standards of Practice for Clinicians, this patient-focused publication will provide comprehensive information about Ig therapy; inform the patients about appropriate clinical practice parameters; set expectations for the pre-, during- and post-infusion period; and empower the patients to become active participants in their Ig therapy care.”
‘A Great Look Into Real-World Data’
Asked to comment on both posters, Leslie Myers, PharmD, IgCP, noted that the studies “give a great look into real-world data self-reported from the patients, which can have some bias but typically proves to be very accurate for patient perception regarding their therapy.” (At the time of the interview, Dr. Myers was an independent Ig expert, but is now an integrated clinical services manager at CSI Pharmacy.)
The difference in perceived quality of care and knowledge from the AIC nurses was striking, added Dr. Myers, who was not involved in the surveys. Given the reliance on self-reports, it remains unclear whether the deficits are real or reflect a need for more education, understanding and explanation of how the AIC is different, she said. To improve the treatment experience at infusion centers, the AIC could provide additional education for less knowledgeable nursing providers, and the nurses could show proof of further education to patients at the time of a visit, she suggested.
The lack of access to Ig specialty care contributing to long delays in diagnosis is a concern, Dr. Myers acknowledged. “However, I think the biggest contributor to delay may be the fragmented healthcare system and the inability to follow a patient’s journey, including test and lab results if your healthcare facility uses a different provider,” she said.
A possible solution “would be to have the same AIC nurse see the same patients consistently, if possible.” More specialized care from nurses trained in specific therapies could improve the patient experience as well, Dr. Myers added.
The sources reported no relevant financial disclosures.
This article is from the October 2025 print issue.