Cherin Patrick, Tadmouri Abir, de Jaeger Christophe, Pindi Sala Taylor, Crave Jean-Charles
Department of Internal Medicine, Pitié-Salpetrière Hospital Group, 47-83 Boulevard de l'hôpital, 75013, Paris, France.
ClinSearch, HEOR department, Malakoff, France.
Ther Adv Musculoskelet Dis. 2018 Oct 7;10(10):201-207. doi: 10.1177/1759720X18787765. eCollection 2018 Oct.
Immunoglobulin (Ig) therapy is used to treat a wide range of immunodeficiencies and autoimmune diseases; While, its clinical benefit has been demonstrated in several studies, Ig therapy is associated with a risk of systemic adverse effects. As such, Onset of renal impairment, including acute renal failure, osmotic nephrosis and renal insufficiency, after immunoglobulin administration is rare, but is one of the most significant concerns related to intravenous Ig use at immunomodulatory doses. However, only few studies have investigated the safety of subcutaneous Ig (SCIg) in relation to these rare conditions. The aim of this prospective study is to describe the safety of SCIg (Gammanorm), specifically with regards to renal function, in inflammatory myopathies including mainly polymyositis (PM), dermatomyositis (DM) and inclusion body myositis (IBM). Twenty-four cases were included: 10 patients with PM, 6 with IBM, 5 with DM, 2 with mixed connective-tissue disease (MCTD) and 1 patient with scleromyositis. SCIg was given two to three times per week at 2 g/kg/month in all patients. Patients were treated for a mean duration of 24.6 ± 11.4 months (range 8-37 months) and received a median of 78 SCIg infusions. Renal function was stable over the study period in all patients. High-dose SCIg was well tolerated; the treatment was not withdrawn during the first year in any patient for safety issues. These results suggest that the use of high-dose SCIg is generally feasible and safe in patients with inflammatory myopathies.
免疫球蛋白(Ig)疗法用于治疗多种免疫缺陷和自身免疫性疾病;虽然其临床益处已在多项研究中得到证实,但Ig疗法存在全身不良反应的风险。因此,免疫球蛋白给药后发生肾功能损害,包括急性肾衰竭、渗透性肾病和肾功能不全的情况很少见,但却是与免疫调节剂量静脉注射Ig使用相关的最重大问题之一。然而,只有少数研究调查了皮下注射Ig(SCIg)在这些罕见情况下的安全性。这项前瞻性研究的目的是描述SCIg(Gammanorm)在主要包括多发性肌炎(PM)、皮肌炎(DM)和包涵体肌炎(IBM)的炎性肌病中的安全性,特别是关于肾功能方面。共纳入24例患者:10例PM患者、6例IBM患者、5例DM患者、2例混合性结缔组织病(MCTD)患者和1例硬化性肌炎患者。所有患者每周皮下注射SCIg两到三次,剂量为2 g/kg/月。患者的平均治疗时间为24.6±11.4个月(范围8 - 37个月),接受SCIg注射的中位数为78次。在研究期间所有患者的肾功能均保持稳定。高剂量SCIg耐受性良好;在第一年没有任何患者因安全问题而停药。这些结果表明,高剂量SCIg在炎性肌病患者中通常是可行且安全的。