_{^{For your adult patients with PsO or moderate to severe HS}}

Choose COSENTYX^® for proven relief with fast and lasting results^1-3*

MATURE

MATURE study in adult patients with moderate to severe PsO¹

Coprimary end points: PASI 75 at Week 12, IGA mod 2011 0/1 response at Week 12

For COSENTYX 300-mg UnoReady Pen

• 95% of those who used the UnoReady Pen achieved PASI 75

• 76% of those who used the UnoReady Pen achieved IGA 2011 0/1

FUTURE 5

FUTURE 5 in adults with PsA²

Primary end point: ACR20 at Week 16

• Two-thirds biologic-naive and one-third anti–TNF-α-exposed

• More than half (52%) of patients also had PsO affecting ≥3% of BSA

For COSENTYX 300 mg

• 63% (n=222) (P<0.0001)

For COSENTYX 150 mg with LD

• 56% (n=220) (P<0.0001)

vs 27% for placebo (n=332)

SUNSHINE and SUNRISE

Primary end point results at Week 16³

Percent of patients who reduced the number of inflammatory nodules and abscesses by half (with no increase in abscesses or draining tunnels) (HiSCR50).

SUNSHINE

• 41.3% for COSENTYX Q4W (n=180)

• 44.5% for COSENTYX Q2W (n=181)

• 29.4% for placebo (n=180)

SUNRISE

• 42.5% for COSENTYX Q4W (n=180)

• 38.3% for COSENTYX Q2W (n=180)

• 26.1% for placebo (n=183)

Data presented are the results of an FDA-requested analysis of the SUNSHINE and SUNRISE trials.

Secondary end point results at Week 16⁴

The proportion of patients with flares over 16 weeks

SUNRISE

• 84% of patients had zero flares for COSENTYX Q4W (n=180)

• 63% for placebo (n=183) (P=0.0049)

Data presented are from the SUNRISE trial: the same results were not seen in SUNSHINE.⁴

Study designs

MATURE was a 52-week, multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of the 300-mg COSENTYX UnoReady Pen in 145 adult patients with moderate to severe PsO. For treatment period 1 (randomization through Week 12 predose), patients were randomized 2:2:1:1 to either COSENTYX 300-mg (2-mL) UnoReady Pen, COSENTYX 300-mg 2 x 150-mg (2 x 1-mL) prefilled syringes (PFS), placebo UnoReady Pen (2 mL), or placebo (2 x 1-mL) PFS. For treatment period 2 (Week 12 through Week 52), patients who did not achieve PASI 90 in the placebo groups were switched to their corresponding active drug arms. All arms started with 4 once-weekly loading doses, followed by dosing every 4 weeks. Patients switched from placebo to active drug repeated the loading doses. The primary end point was the efficacy of COSENTYX 300-mg UnoReady Pen vs placebo with respect to both PASI 75 and IGA mod 2011 0 or 1 response (coprimary end point) at Week 12.¹

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 two-thirds of patients were biologic-naive and less than one-third were anti–TNF-⍺ inadequate responders (individual patients could have been exposed to up to 3 TNF-⍺ inhibitors).^2,5

SUNSHINE and SUNRISE were identical, multicenter, randomized, placebo-controlled, double-blind phase 3 trials. In both trials, patients were randomly assigned to receive COSENTYX 300 mg Q2W or Q4W or placebo. SUNSHINE evaluated 541 adult patients: 181 received COSENTYX 300 mg Q2W, 180 received COSENTYX 300 mg Q4W, and 180 received placebo. SUNRISE evaluated 543 adult patients: 180 received COSENTYX 300 mg Q2W, 180 received COSENTYX 300 mg Q4W, and 183 received placebo. All patients were adults with moderate to severe HS (defined as a total of ≥5 inflammatory lesions affecting ≥2 distinct anatomical areas) for ≥1 year. The primary end point was the proportion of patients with an HS clinical response, defined as a decrease in AN count by ≥50% with no increase in the number of abscesses or in the number of draining fistulae at Week 16 compared with baseline. Co-secondary end points were AN50, flares, and NRS30 at Week 16.^4,6

ACR, American College of Rheumatology; AN, abscesses and inflammatory nodules; BSA, body surface area; HiSCR, Hidradenitis Suppurativa Clinical Response; LD, loading dose; IGA mod 2011, Investigator’s Global Assessment modified 2011; mTSS, modified Total Sharp Score; MI, multiple imputation; NRS, numeric rating scale; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; Q2W, every 2 weeks; Q4W, every 4 weeks; TNF, tumor necrosis factor.

References

1. Sigurgeirsson B, Browning J, Tyring S, et al. Secukinumab demonstrates efficacy, safety, and tolerability upon administration by 2 ml autoinjector in adult patients with plaque psoriasis: 52-week results from MATURE, a randomized, placebo-controlled trial. Dermatol Ther. 2022;35(3):e15285. doi:10.1111/dth.15285
2. 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.
3. Data on file. SUNNY Clinical Study Program Data Tables. Novartis Pharmaceuticals. Corp; July 2023.
4. Kimball AB, Jemec GBE, Alavi A, et al. Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials. Lancet. 2023;401(10378):747-761.
5. Data on file. CAIN457F2342 (FUTURE 5): Clinical Study Report. Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
6. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.