Here with you to help patients get through their day

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), 60% (P<0.0001), 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), 51% on COSENTYX 150 mg (n=100) (P<0.0001), 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 PASI^3,4

• 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:

• 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)

ENTHESITIS¹

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)

DACTYLITIS¹

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)

SKIN¹

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)

NAIL¹*

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).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.

Definitions

FACIT-F=Functional Assessment of Chronic Illness Therapy-Fatigue; MMRM=mixed-effect model repeated measure; PsA=psoriatic arthritis.

References

• 1.

  Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.

• 2.

  Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.

• 3.

  Data on file. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014.

• 4.

  Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; December 2021.

• 5.

  Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015.

• 6.

  Data on file. CAIN457F2312 Interim Study Report. Novartis Pharmaceuticals Corp; November 2015.

• 7.

  Mease P, van der Heijde D, Landewé R, et al. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis. 2018;77(6):890-897.

• a.

  Baraliakos X, Gossec L, Pournara E, et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021;80(5):582-590.

• b.

  Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.

• c.

  Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.

• d.

  Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.

• e.

  Data on file. CAIN457H2315 Data Analysis Report. Novartis Pharmaceuticals Corp; April 2020.

• f.

  Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.

• g.

  Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.

• h.

  Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.

• i.

  Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.

• j.

  Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010;69(7):1338-1341.

• k.

  Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.

• l.

  Data on file. CAIN457F2342 (FUTURE 5): 2-Year HAQ-DI biologic-naive data. Novartis Pharmaceuticals Corp; February 2021.

• m.

  Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; December 2021.

• n.

  Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020.

• o.

  Nash P, Mease PJ, McInnes IB, et al; on behalf of the FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47.

• p.

  Data on file. LTD Cosentyx Prescriber and Patient Counts. Novartis Pharmaceuticals Corp; July 2021.

• q.

  Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.