Immunoglobulins for primary or secondary immunodeficiency or for immunomodulation in neurological autoimmune diseases: insights from the prospective SIGNS registry

Abstract

Aim Outside the context of clinical trials, there is a lack of data on the management and long-term outcomes of patients with primary or secondary antibody deficiency (PID and SID), or those with neurological autoimmune diseases (AID) treated with immunoglobulins (IG). Methods SIGNS is a large-scale prospective observational cohort study with up to 550 patients in currently 50 sites throughout Germany. It investigates treatment patterns, effectiveness, quality of life and long-term outcomes of IG administered for PID, SID or AID. The study identifier at ClinTrials.Gov is NCT01287689. Results Of 306 patients currently included (1 Nov 2011),

Management of patients with malignancies and secondary immunodeficiencies treated with immunoglobulins in clinical practice: Long‐term data of the SIGNS study

“…Patients with SID due to CLL, MM, indolent lymphoma, and other malignancies such as non‐Hodgkin lymphoma or HIV (substitution owing to infection or to tumours related to HIV) were identified and selected. Patient characteristics including underlying malignancy and disease outcomes were documented . Visits were documented about every 6 months, and the observation period was at least 2 years per patient.…”

“…SIGNS (Assessment of immunoglobulins in a long-term noninterventional study) is a prospective, observational study (registry type), with consecutive inclusion of eligible patients. 26 The study was performed in agreement with the Declaration of Helsinki in its latest revision, and according to the principles of Good Epidemiological Practice (GEP). It was approved by the ethics committee of the Medical Faculty of the Technical University of Dresden and further local ethics committees in Germany.…”

“…Patient characteristics including underlying malignancy and disease outcomes were documented. 26,29 Visits were documented about every 6 months, and the observation period was at least 2 years per patient.…”

Treatment of patients with multifocal motor neuropathy with immunoglobulins in clinical practice: the SIGNS registry

“…Study design SIGNS (assessment of IG treatment in a longterm noninterventional study) is an ongoing prospective, observational study (registry type), with consecutive inclusion of eligible patients [Kirch et al 2012]. The study is performed in agreement with the Declaration of Helsinki in its latest revision, and according to the principles of good epidemiological practice.…”

“…Patients of either gender and of any age group were eligible for documentation if they received any IG preparation as long-term therapy or as newly initiated therapy for neurological autoimmune disease. In addition, primary and secondary immunodeficiencies were documented in the registry [Kirch et al 2010[Kirch et al , 2012. Visits were scheduled every 6 months, and the intended observation period was at least 2 years per patient.…”