Evaluation of the effectiveness of using prednisolone, tacrolimus, and intravenous immunoglobulin combination therapy on immune-mediated necrotizing myopathy-A non-randomized, observational research

Int J Rheum Dis. 2024 Mar;27(3):e15124. doi: 10.1111/1756-185X.15124.

Abstract

Objective: To recruit immune-mediated necrotizing myopathy (IMNM) patients with extramuscular manifestations who were refractory to initial therapy with either monotherapy with prednisolone or dual therapy with prednisolone and immunosuppressants. These patients subsequently received a combination of prednisolone, tacrolimus, and intravenous immunoglobulin (IVIG), and the efficacy of this treatment regimen was assessed in patients with IMNM.

Method: ①Clinical data and treatment measures are as follows: This study enrolled IMNM patients who were treated at the Neurology Department of the First Medical Center of PLA General Hospital from April 2020 to May 2023. These patients received a combination therapy of prednisolone, tacrolimus, and IVIG. ②Observational indicators included manual muscle test for 8 groups of muscles (MMT-8), muscle enzyme levels (creatine kinase (CK), lactate dehydrogenase (LDH), alanine aminotransferase (ALT), aspartate aminotransferase (AST)), and myositis disease activity assessment tool (MDAAT).

Results: This study enrolled eight patients. All observational indicators declined after treatment compared to before treatment, and these changes were statistically significant. Moreover, extramuscular manifestations also ameliorated compared to before treatment.

Conclusion: The combination therapy of prednisolone, tacrolimus, and IVIG has demonstrated favorable efficacy in IMNM and broadened the treatment options for this disease. However, the results still require further validation by large-scale and randomized controlled studies.

Keywords: immune‐mediated necrotizing myopathy; intravenous immunoglobulin; prednisolone; tacrolimus.

MeSH terms

  • Autoantibodies
  • Autoimmune Diseases* / drug therapy
  • Humans
  • Immunoglobulins, Intravenous / adverse effects
  • Muscle, Skeletal
  • Myositis* / diagnosis
  • Myositis* / drug therapy
  • Prednisolone / adverse effects
  • Tacrolimus / adverse effects

Substances

  • Prednisolone
  • Immunoglobulins, Intravenous
  • Tacrolimus
  • Autoantibodies