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safety and efficacy of Octagam 10% in patients
with DM (NCT02728752); and an open label study
of subcutaneous immunoglobulin in patients with
DM (NCT02271165).
Tocilizumab, an interleukin-6 (pro-
inflammatory cytokine) receptor antagonist, is
approved for the treatment of rheumatoid
arthritis and systemic juvenile idiopathic
arthritis. 12 The ongoing tocilizumab study is a
multicentre, randomised, placebo-controlled trial
to determine effectiveness of tocilizumab in the
treatment of patients with refractory adult PM
and DM (NCT02043548).
Abatacept, a modulator of T-cell activation by
binding to CD80 and CD86 molecules on antigen-
presenting cells, thereby blocking interaction
with CD28 on T cells, 13 is approved for the
treatment of adult rheumatoid arthritis,
polyarticular juvenile idiopathic arthritis and
psoriatic arthritis. Recently, results of a
randomised, open-label, ‘delayed-start’ treatment
trial in DM/PM were published (ARTEMIS;
NCT01315938). In this pilot study, treatment with
abatacept resulted in lower disease activity in
nearly half of the patients (42%). In patients with
repeat muscle biopsies, an increased frequency of
Foxp3+ Tregs at six months suggested a positive
effect of treatment in muscle tissue. 14 Abatacept is
currently being studied in a randomised, double-
blinded, controlled pilot trial to evaluate the
efficacy and safety of subcutaneous abatacept in
treating interstitial lung disease associated with
anti-synthetase syndrome (NCT03215927); in an
open label study of abatacept for the treatment of
refractory juvenile DM (NCT02594735) and Phase
III, randomised, double blind clinical trial to
evaluate efficacy and safety of abatacept in adults
with active IIM (NCT02971683). The later study is
unique in that it includes not only DM and PM
but also IMNM cases and adult JDM patients as
well.
Siponimod is a selective modulator of
sphingosine 1-phosphate receptor (S1P1,5) that
inhibits the movement of lymphocytes out of
lymph nodes. 15 A double-blind, randomised,
placebo-controlled study of siponimod in patients
with active DM (NCT02029274) completed
recruitment in 2016 and a previous multicentre
double-blind, placebo controlled study of
siponimod in PM (NCT01801917) was prematurely
stopped in 2016 due to slow recruitment and
small sample size.
Ajulemic acid (JBT-101) is a synthetic
compound that selectively binds to the
cannabinoid receptor type 2 (CB2) 16 promoting
anti-inflammatory and anti-fibrotic effects by
increasing production of PGJ2 (an endogenous
anti-inflammatory ligand) and decreasing
collagen neosynthesis by fibroblasts. 17
Ajulemic acid is currently being studied in
a Phase II, double-blinded, randomised,
placebo-controlled study to investigate the
safety, tolerability and efficacy in patients
with DM (NCT02466243).
Interferon (IFN)-Kinoid is an inactivated form
of IFNα2b that has been studied as a therapeutic
vaccine in patients with systemic lupus
erythematosus. It has been shown to induce
a polyclonal response against most of the IFNα
subtypes, decreasing IFN and B cell-associated
transcripts. 18 It is currently being studied in a
single-blind, randomised, proof of concept study
to evaluate the production of anti-IFNα antibodie