Table 2.
Overview of Biologics in GCA
| Biologic | Target | Level of Evidence | Study Results | Study Limitations |
|---|---|---|---|---|
| Tocilizumab | IL-6 | 2 RCTs | Villiger et al (2016)52 30 patients 77% new onset Relapse-free week 52 85% tocilizumab + GC 20% GC alone GiACTA - Stone et al (2017)13 251 patients 47% new onset Remission week 52 Tocilizumab weekly + 26weeks GC 56% Tocilizumab every 2weeks + 26weeks GC 53% 26weeks GC alone 14% 52weeks GC alone 18% |
Villiger et al (2016)52 Singe centre and small numbers Not blinded to CRP results GC stopped after 6 months No discontinuation data Limited imaging GIACTA- Stone et al (2017)13 No discontinuation data Lack of imaging data Short duration of follow-up Concern that vascular disease may progress despite clinical remission |
| Sirukumab | IL-6 | RCT | Schmidt et al (2020)54 Numerically lower rate of flares in sirukumab group | Terminated early |
| Sarilumab | IL-6 | RCT | Commenced but suspended (NCT03600805) | |
| Abatacept | T-cell | RCT | Langford et al (2017)62 41 patients 56% new onset Abatacept induction for all randomised at month 3 to abatacept + GC versus GC alone Relapse-free week 52 Abatacept + GC 48% GC alone 31% |
Modest effect All received abatacept Abatacept ineffective in Takayasu’s arteritis |
| Ustekinumab | IL-12/IL-23 | Open Label | Conway et al (2016, 2018)17,57 25 patients All refractory GCA Median GC dose decreased from 20mg to 5mg at week 52 No relapses on ustekinumab Imaging evidence of improvement Matza et al 13 patients 39% new onset 23% remission free at week 52 |
Conway et al(2016, 2018)17,57 Unblinded No control group Small numbers Single centre Matza et al Unblinded No control group Small numbers Single centre |
| Secukinumab | IL-17 | Case reports | Rotar et al (2018)74 Sammut et al (2018)75 Effective in 2 cases | Case report data only |
| Adalimumab | TNF-α | RCT | Seror et al (2014)60 70 patients All new onset Remission week 26 GC + adalimumab 59% GC alone 50% |
New-onset patients only Excluded ischaemic manifestations |
| Infliximab | TNF-α | RCT | Hoffmann et al (2007)59 44 patients All new onset Relapse-free 52 weeks Infliximab + GC 43% GC alone 50% |
Small numbers New-onset patients only Study terminated early |
| Etanercept | TNF-α | RCT | Martinez-Taboada et al (2008)61 17 patients All in remission on GC with GC-related adverse events GC remission week 52 Etanercept + GC 50% GC alone 22% |
Small numbers High discontinuation rate – 11/19 patients |
| Anakinra | IL-1β | Case series Ongoing RCT | Ly et al (2014)70 3 refractory GCA patients; remission in all 3 GiAnT (NCT02902731) |
Case report data only at present |
| Gevokizumab | IL-1β | RCT | Commenced but cancelled | |
| Rituximab | B-cells | Case reports | Bhatia et al (2005)68 Mayrbaeurl et al (2007)69 Effective in 2 refractory cases | Case report data only |
| Baricitinib | JAK | Open-label study ongoing | (NCT03026504) | |
| Upadacitinib | JAK | RCT ongoing | SELECT-GCA (NCT03725202) | |
| Tofacitinib | JAK | Laboratory data only | ||
| Mavrilimumab | GM-CSF | RCT ongoing | Cid et al (2020)73 Sustained remission at week 26 in 83% with mavrilimumab compared to 50% with placebo (NCT03827018) | Preliminary data, presented, not published |