Table 1

Overview of the prospective studies with targeted immunosuppressive agents in giant cell arteritis (GCA)

Study author/ sponsorTargetLevel of evidenceTargeted immunosuppressive agentGC start dosage
/taper
Classification criteriaDisease stage
(total N)
Primary end pointPrimary end point met (YES/NO)Duration of follow-up
Villiger et al22IL-6RCTTocilizumab i.v.
8 mg/kg or placebo 1 x/4 wk until 52 wk
1 mg/kg/day+taper to 0.1 mg/kg/day by wk 12+taper to 0ACR1990 and
TAB + or
MRA+
New-onset
Relapsing
(30)
Complete remission rate at a GC dose of 0.1 mg/kg/day at 12 wkYES
85% vs 40% p=0.03
GC sparing
52 wk
Stone et al23IL-6RCTTocilizumab s.c.
162 mg four arms:
1 x/wk +26 wk GC
1 x/2wk +26 wk GC placebo +26 wk GC placebo +52 wk GC
20–60 mg/day +
26-or 52 wk taper
ACR1990, PMR and
TAB + or PET+
New-onset Relapsing
(251)
GC-free remission rate at 52 wk in each TCZ group vs placebo 26 wk GCYES
56% and 53% vs 14% p<0.001
GC sparing
52 wk
Christ et al26IL-6Open-labelTocilizumab i.v.
1×8 mg/kg followed by s.c. 162 mg 1 x/wk
500 mg methyl-prednisolone i.v.
during 3 days
ACR1990, PMR and
TAB + or PET+
New-onset (18)Remission within 31 daysNO
mean time to first remission: 11.1 wk
52 wk
Schmidt et al30IL-6RCTSirukumab three arms20–60 mg/day+standard taperHigh ESR/CRP and cranial or PMR clinic and TAB/imaging+New-onset
Relapsing
(161)
Sustained remission rate at 52 wkUnclear
Only 17.4% reached 52 wk
52 wk early terminated
Conway et al38IL-12/
IL-23
Open-labelUstekinumab s.c.
90 mg at wk 0, 4, then 1 x/12 wk
Median 20 mg/day+standard taperACR1990 or imaging+Relapsing (25)GC dose prior to ustekinumab vs GC dose at 52 wkYES
20 vs 5 mg/day p<0.001
52 wk
Matza et al39IL-12/
IL-23
Open-labelUstekinumab s.c.
90 mg at wk 0, 4, 12, 20, 28, 36, 44
20–60 mg/day +
24 wk taper
GCA or PMR-symptoms and TAB/imaging+New-onset
Relapsing
(13)
GC-free remission rate at 52 wkNO
23%
52 wk early terminated
Venhoff et al36IL17(A)RCTSecukinumab s.c. 300 mg or placebo at wk 0, 1, 2, 3, 4, then1x/4 wk26 wk taperACR1990 or imaging+New-onset
Relapsing (50)
Sustained remission rate at 28 wkYES
70% vs 20%
52 wk
Langford et al42T cellRCTAbatacept i.v.
10 mg/kg open-label, then at 12 wk randomised
28 wk taperACR1990New-onset
Relapsing
(49)
Relapse-free survival rate at 12 moYES
48% vs 31% p=0.049
12 mo
Koster et al41JAK 1/2Open-labelBaricitinib
4 mg/day
10–30 mg/day+standard taperTAB + or imaging+Relapsing (15)Safety (frequency of AE and SAE)YES52 wk
Cid et al40GM-CSFRCTMavrilimumab s.c.
150 mg 1 x/2 wk or placebo
20–60 mg/day+26 wk taperTAB + or imaging+New-onset
Relapsing (70)
The time to first adjudicated flare by week 26YES
NE vs 25.1 wk p=0.0263
26 wk
Hoffman et al19TNF-αRCTInfliximab i.v. 5 mg/kg or placebo at week 0, 2, 6 then 1 x/8 wk40–60 mg/day+22 wk taperACR1990New onset
(44)
Relapse-free rate through 22 wkNO
43% vs 50% p=0.65
No GC-sparing
22 wk early terminated
Seror et al20TNF-αRCTAdalimumab s.c.
40 mg 1 x/2 wk or placebo during 10 wk
0.7 mg/kg/day+standard taperACR1990
partly TAB+
New onset
(70)
Remission rate on less than 0.1 mg/kg GC at 26 wkNO
59% vs 50% p=0.46
No GC-sparing
26 wk
Martinez et al21TNF-αRCTEtanercept s.c.
25 mg 2 x/wk or placebo
Median 15 mg/day+standard taperTAB+New onset Relapsing (17)GC-free remission rate at 12 monthsNO
50% vs 22%
GC-sparing
12 mo
  • AE, adverse events; CRP, C reactive protein; ESR, erythrocyte sedimentation rate; GC, glucocorticoids; i.v., intravenously; mo, month; MRA, MR angiography; NE, not estimable; PET, positron emission tomography; PMR, polymyalgia rheumatica; RCT, randomised controlled trial; SAE, serious AEs; s.c., subcutaneous; TAB, temporal artery biopsy; TCZ, tocilizumab; TNF, tumour necrosis factor; wk, week.