Study on the use of non-specific immunoglobulins in patients treated at Vall d'Hebron University Hospital, Bellvitge Hospital and Germans Trias i Pujol Hospital, collected in the CatSalut's patient and treatment registry (RPT). (VDH-IGG-2021-03)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J06BA) Immunoglobulins, normal human
• Medical condition to be studied:
  Dermatomyositis

  Guillain-Barre syndrome

  Myasthenic syndrome

  Myasthenia gravis

  Chronic inflammatory demyelinating polyradiculoneuropathy

  Multifocal motor neuropathy

  Stiff person syndrome

  Pancytopenia

  Systemic lupus erythematosus

  Kawasaki's disease
• Additional medical condition(s):
  Erythrocyte aplasia associated to parvovirus B19, hypogammaglobulinemia secondary to myeloma and chronic lymphocytic leukemia, and post-bone marrow transplantation. Primary and secondary antibody deficiency, including transplant patients, toxic shock syndrome, necrotizing fasciitis, prophylaxis for varicella zoster virus, vasculitis, pemphigoid, toxic epidermal necrolysis and bullous diseases.

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  Overall objective: - To describe the use of immunoglobulins in HUVH, HUB and HGTiP. - To validate the indications for the use of immunoglobulins in the RPT of three third level hospitals belonging to Catsalut.
• Outcomes:
  Use of immunoglobulins and level of evidence for indications (authorized, not authorized with scientific evidence, not authorized and not accepted).
• Data analysis plan:
  Standard descriptive calculations for qualitative and quantitative variables will be used. The median of general characteristics and treatment duration will be calculated. The gender distribution is also mapped out. The calculations are made with the patients who switch. The number of switches, the mean time between switching and the number of switches per patient are mapped out. The proportion of patients for each indication will be calculated as well as the proportion of patients in each group. Information will also be calculated by person-month. For the RPT validation of the diagnosis the information recorded in the electronic health record, SAP of the participating hospitals, will be used as “gold standard”. The positive predictive value is used for validation of the RPT. To make sure the validation is reliable the Cohen's kappa score and percent agreement will be calculated. Results will be stratified by age, sex, IgG, level of evidence and center.