Tocilizumab: A novel humanized anti-interleukin 6 (IL-6) receptor antibody for the treatment of patients with non-RA systemic, inflammatory rheumatic diseases

Figures & data

Table I. Case reports using TCZ.

Disease	Title	Patients (n)	Outcome
Adult-onset Still's disease (AOSD)	Tocilizumab in refractory adult Still's disease	14	see review
Amyloidosis	Rapid improvement of AA amyloidosis with humanized anti-interleukin 6 receptor antibody treatment	1	positive
	Tocilizumab dramatically ameliorated life-threatening diarrhea due to secondary amyloidosis associated with rheumatoid arthritis	1	positive
Ankylosing spondylitis (AS)	Mixed response to tocilizumab for ankylosing spondylitis	1	positive
	Tocilizumab in a patient with ankylosing spondylitis and Crohn’s disease refractory to TNF antagonists	1	positive
Giant cell arteritis (GCA)	Biologic treatment of large-vessel vasculitides	3	positive
	Tocilizumab: a novel therapy for patients with large-vessel vasculitis	6	see review
Multiple myeloma (MM)	Establishment of a new interleukin-6 (IL-6) receptor inhibitor applicable to the gene therapy for IL-6-dependent tumor	Murine model
Polymyalgia rheumatica (PMR)	The polymyalgia rheumatica activity score in daily use: proposal for a definition of remission	1	positive
	Tocilizumab ameliorates clinical symptoms in polymyalgia rheumatica	1	positive
Relapsing polychondritis (RP)	Sustained response to tocilizumab, anti-interleukin-6 receptor antibody, in two patients with refractory relapsing polychondritis	2	positive
Remitting seronegative symmetrical synovitis with pitting edema-syndrome (RS3PE-syndrome)	Treatment of a patient with remitting seronegative, symmetrical synovitis with pitting oedema with a humanized anti-interleukin-6 receptor antibody, tocilizumab	1	positive
Systemic juvenile idiopathic arthritis (sJIA)	FDA: Licensed since April 2011; EMA: Licensed since August 2011
Systemic lupus erythematosus (SLE)	Tocilizumab in systemic lupus erythematosus: data on safety, preliminary efficacy, and impact on circulating plasma cells from an open-label phase I dosage-escalation study	16	see review
Systemic sclerosis (SSc)	The skin of patients with systemic sclerosis softened during the treatment with anti-IL-6 receptor antibody tocilizumab	2	positive
Takayasu arteritis (TA)	Successful treatment of a patient with Takayasu arteritis using a humanized anti-interleukin-6 receptor antibody	1	positive

Table II. On-going studies.

Disease	Trial status	Primary completion date
Amyloidosis	No trials on-going
AOSD	Study status unknown
AS	A randomized, double-blind, placebo-controlled study of TCZ for patients with AS who have failed treatment with NSAIDs has been suspended	The estimated primary completion date would have been April 2013
	A randomized, double-blind, placebo-controlled Study of RoActemra/Actemra (TCZ) in patients with AS who have had an inadequate response to previous TNF antagonist therapy has been suspended	The estimated primary completion date would have been April 2014
GCA	A phase II, randomized, double-blind, placebo-controlled study of TCZ in patients with GCA is on-going	Estimated primary completion date: March 2013
MM	No trials on-going
PMR	A 15-month open-label, phase IIa study of TCZ to treat PMR is on-going	Estimated primary completion date was: January 2012
RP	A single patient study to treat RP with TCZ is on-going	Estimated primary completion date was: January 2012
RS3PE-syndrome	No trials on-going
sJIA	A randomized, placebo-controlled study of RoActemra/Actemra (TCZ) in patients with active systemic juvenile idiopathic arthritis is on-going but not recruiting yet	Estimated primary completion date was: October 2011
SLE	No trials on-going
SSc	A multicenter, phase II, randomized, double-blind, placebo-controlled, two-arm, parallel-group study of RoActemra/Actemra (TCZ) versus placebo in patients with systemic sclerosis is going to recruit in the near future	Estimated primary completion date: May 2015
TA	No trials on-going