title: Open-label study on treatment with 20 % subcutaneous IgG administration in polymyositis and dermatomyositis.
abstract: The objective of this study is to describe the benefit of 20 % subcutaneous infusions of immunoglobulin (SCIg) in patients with dermatomyositis (DM) or polymyositis (PM) after a switch from previous 16 % SCIg treatment. Eight patients with DM or PM, who met the Bohan and Peter's criteria, previously treated with 16 % SCIg, were switched to weekly 20 % SCIg infusions (Hizentra®; CSL Behring) at doses equivalent to their previous subcutaneous treatment. A standardised protocol was used to evaluate patients, disease activity and treatment response. The disease remained stable in three and improved in four other patients, as documented by increased Medical Research Council scores and normal serum CK levels. No relapse of disease occurred. Local reactions were mild and self-limiting. No serious adverse events were reported. The mean duration of infusion per week was significantly lower compared to the mean duration of the 16 % SCIg preparation. A specifically designed questionnaire documented the patients' satisfaction with treatment. The weekly administration of 20 % SCIg is effective in maintaining a quiescent disease in patients with DM or PM with no increased safety concerns. SCIg therapy is particularly attractive for patients because it does not require venous access and hospitalisation and requires less assistance from healthcare provider services.
  
  
  CONCLUSIONS
  The administration of 20 % SCIg was beneficial and safe in maintaining a quiescent disease and in inducing a complete remission in moderately active disease in patients with DM or PM. The treatment with 20 % SCIg led to the possibility to discontinue and to reduce the use of glucocorticoids and/or the immunosuppressants. Patients reported their satisfaction in terms of contact with health professionals, quality of treatment-related information and administration convenience, with an improved quality of life.
authors.affiliation: Clinica Medica, Dipartimento di Scienze Cliniche e Molecolari, Università Politecnica delle Marche & Ospedali Riuniti, Ancona, Italy, m.g.danieli@univpm.it.
authors.forename: Maria Giovanna
authors.initials: MG
authors.lastname: Danieli
authors.forename: Romina
authors.initials: R
authors.lastname: Moretti
authors.forename: Simona
authors.initials: S
authors.lastname: Gambini
authors.forename: Luca
authors.initials: L
authors.lastname: Paolini
authors.forename: Armando
authors.initials: A
authors.lastname: Gabrielli
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D015331:Cohort Studies; D003882:Dermatomyositis / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000008:administration & dosage*; D007155:Immunologic Factors / Q000008:administration & dosage*; D055104:Infusions, Subcutaneous; D008875:Middle Aged; D017060:Patient Satisfaction; D017285:Polymyositis / Q000188:drug therapy; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: C558471:Hizentra; D007074:Immunoglobulin G; D007155:Immunologic Factors