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 responders⁵

• ACR20 responses at Week 16 (NRI) in the mixed population were 57% (P<0.0001), 60% (P<0.0001), and 18%, respectively, for COSENTYX 300 mg (n=100), 150 mg (n=100), and placebo (n=98)^3,5

• 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), 51% on COSENTYX 150 mg (n=100) (P<0.0001), and 15% on placebo (n=98)^3,5

• Skin lesions improved in patients with coexistent PsO who received COSENTYX (n=99) compared with placebo (n=43), as measured by the PASI^3,5

• Improvements in enthesitis and dactylitis scores were observed in the COSENTYX group compared with placebo at Week 24³

FUTURE 5

FUTURE 5 studied a mixed population of patients with PsA: more than 2/3 biologic-naive and less than 1/3 anti–TNF-α inadequate responders²

JOINT²

ACR20 response rates (NRI) (primary end point) were:

• 63% for COSENTYX 300 mg (n=222) (P<0.0001)

• 56% for COSENTYX 150 mg (n=220) (P<0.0001)

• 27% for placebo (n=332)

ENTHESITIS²

Complete resolution (LEI=0) in patients with enthesitis at baseline (NRI):

• 56% for COSENTYX 300 mg (n=140)

• 55% for COSENTYX 150 mg (n=141)

• 35% for placebo (n=192)

DACTYLITIS²

Complete resolution (LDI=0) in patients with dactylitis at baseline (NRI):

• 66% for COSENTYX 300 mg (n=82)

• 57% for COSENTYX 150 mg (n=80)

• 32% for placebo (n=124)

SKIN²

Patients who achieved PASI 90 (NRI):

• 54% for COSENTYX 300 mg (n=110)

• 37% for COSENTYX 150 mg (n=125)

• 9% for placebo (n=162)

NAIL^2*

Reduction in nail disease (mNAPSI as observed) response rates were^†:

• 51% for COSENTYX 300 mg (n=125)

• 53% for COSENTYX 150 mg (n=128)

• 11% for placebo (n=203)

*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).<sup>6

†</sup>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.²

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.^3,5,7

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).^2,4

ACR, American College of Rheumatology; DMARD, Disease modifying antirheumatic drugs; 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; NSAID, Non-steroidal anti-inflammatory drugs;  PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis; TNF, tumor necrosis factor.