Q3 2020 Sales Performance
GSK'165 (GM-CSF antagonist): phase III programme
in rheumatoid arthritis started in July 2019
Encouraging Ph II data presented at
ACR October 2018 demonstrating marked
clinical response
CDAI response using the phase II EOW dosing regimen
Three pivotal studies ongoing
Study 201790: Innovative design including JAKI active comparator
Placebo + MTX
gsk
L5 mean (SE) change from baseline in CDM
-10
-15
1-4.95
-6.59
-Placebo
MTX-IR
→GSK3196165 22.5 mg
GSK3196165 150mg weekly + MTX
GSK3196165 90mg weekly +MTX
Tofacitinib 5mg BID + MTX
GSK3196165 45 mg
Screening
-GSK3196165 90 mg
-20
-17.14***
GSK3196165 135 mg
-25
-23.23***
GSK3196165 180 mg
W-6
-30
***p<0.001 vs placebo
Significant unmet need remains in RA
-
Around 50% of patients do not achieve low
disease activity criteria within 12 months of
aTNF treatment¹
45% of patients report daily pain and pain is
the key driver in 25% of switches to
biological and oral therapies²
WO
W 12
W 24
Primary Endpoint: ACR20 vs placebo
W 12 endpoint visit & re-randomise all
Placebo to active
W 24 X-ray
W 52
End of study
treatment and X-ray
Primary endpoint
ACR20 vs placebo at W 12
Key secondaries include
Target population
Pain and CDAI vs active comparator
Administration
Post first line targeted therapy
Weekly via a subcutaneous injection with a choice of autoinjector or
prefilled syringe
210791 52 week duration with tofacitinib active comparator
Two further pivotal studies of similar
design will include biologic-IR patients 202018 24 week duration with sarilumab active comparator
Sources: 1. Gerd R Burmester and Janet E Pope. Novel treatment strategies in rheumatoid arthritis. Lancet 2017; 389: 2338-48; 2. Targeted treatments for rheumatoid arthritis, Adelphi RA DSP 2016
MTX = methotrexate, IR = inadequate response, CDAI = clinical disease activity index, EOW = every other week
61View entire presentation