COSENTYX clinical trial end
points
FUTURE 2
FUTURE 2 studied a mixed population of
patients with PsA: 2/3 biologic-naive and 1/3 anti–TNF-α
inadequate responders3
-
ACR20 responses at Week 16 (NRI) in the mixed
population were 57% (P
<0.0001< /strong>), 60%
(P
<0.0001< /strong>), and 18%,
respectively, for COSENTYX 300 mg
(n=100), 150 mg (n=100),
and placebo (n=98)3,4
-
The primary end point of ACR20
responses at Week 24 (NRI) was achieved by 54% of
patients
on COSENTYX 300 mg (n=100) (P
<0.0001< /strong>), 51% on COSENTYX 150 mg
(n=100) (P
<0.0001< /strong>),
and 15% on placebo
(n=98)3,4
-
Skin lesions improved in patients with coexistent PsO
who received COSENTYX (n=99) compared with placebo
(n=43), as measured by the PASI3,4
-
Improvements in enthesitis and dactylitis scores were
observed in the COSENTYX group compared with placebo
at Week 244
FUTURE 5
FUTURE 5 studied a mixed population of patients with PsA:
more than 2/3 biologic-naive and 1/3 anti–TNF-α inadequate
responders1
JOINT1
ACR20 response rates (NRI) (primary end
point) were:
ENTHESITIS1
Complete resolution (LEI=0) in patients with enthesitis at
baseline (NRI):
DACTYLITIS1
Complete resolution (LDI=0) in patients with dactylitis at
baseline (NRI):
SKIN1
Patients who achieved PASI 90 (NRI):
NAIL1*
Reduction in nail disease (mNAPSI as observed) response rates
were†:
*Nail data in PsA
were consistent with those in the dedicated nail PsO
study, TRANSFIGURE. Improvement from
baseline NAPSI at Week 16 (primary end point) (repeated
measures analysis) was 46.1% for COSENTYX 300 mg (n=63)
and 11.7% for placebo (n=56) (P
<0.0001).5
†At baseline, mNAPSI scores
were 18.0 and 17.8 in the 300-mg and 150-mg arms,
respectively. At Week 16,
mNAPSI scores were 8.8 and 8.4 in the 300-mg and 150-mg
arms, respectively.1
Study designs
FUTURE 2 study design
FUTURE 2 was a multicenter, randomized, double-blind,
placebo-controlled trial that evaluated 397 adult patients
with active PsA (≥3 swollen and ≥3 tender joints) despite
use of NSAIDs, corticosteroids, or DMARDs. Patients
had a diagnosis for ≥5 years and received subcutaneous
COSENTYX 75 mg (n=99), 150 mg (n=100), 300 mg (n=100),
or placebo (n=98) at Weeks 0, 1, 2, 3, and 4, followed by
the same dose every 4 weeks thereafter. Patients who
received placebo were rerandomized to COSENTYX 150 mg or 300
mg every 4 weeks at Week 16 or Week 24 based on
responder status. Primary end point was the percentage of
patients with ACR20 response at Week 24. Study population
was mixed: 2/3 of patients were biologic-naive and 1/3 were
anti–TNF-α inadequate responders.3,4,6
FUTURE 5 study design
FUTURE 5 was a phase 3, multicenter, randomized,
double-blind, placebo-controlled trial that evaluated 996
adult
patients with active PsA. Patients were randomized to
receive subcutaneous COSENTYX 150 mg without load (n=222),
150 mg with load (n=220), 300 mg with load (n=222), or
placebo (n=332). Patients who received placebo were
rerandomized
to receive COSENTYX 150 mg or 300 mg every 4 weeks, based on
responder status at Week 16 (nonresponders) or Week
24 (responders). Primary end point was the percentage of
patients with ACR20 response at Week 16. Secondary end
points included change in mTSS at Week 24 from baseline.
Study population was mixed: more than 2/3 of patients
were biologic-naive and less than 1/3 were anti–TNF-α
inadequate responders (individual patients could have been
exposed to up to 3 TNF-α inhibitors).1,7
ACR=American College of
Rheumatology; LDI=Leeds Dactylitis Index; LEI=Leeds
Enthesitis Index; mNAPSI=modified Nail
Psoriasis Severity Index; mTSS=modified Total Sharp Score;
NAPSI=Nail Psoriasis Severity Index; NRI=nonresponder
imputation; PASI=Psoriasis Area and Severity Index;
PsA=psoriatic arthritis; PsO=plaque psoriasis; TNF=tumor
necrosis factor.