_{^{For your adult patients with PsO at risk for developing PsA}}
 
The largest number of patients studied among IL antagonists¹*

Pivotal ERASURE trial in adults with moderate to severe PsO¹

Coprimary end points: PASI 75 and IGA 0/1 at Week 12.
For COSENTYX 300 mg (n=245) 

• 82% achieved PASI 75 

• 65% achieved IGA 0/1

Adult patients on COSENTYX 150 mg (n=245) or placebo (n=248) achieving PASI 75 (71% vs 4%) and IGA 0/1 (51% vs 2%) at Week 12, respectively. P<0.001 for all comparisons.^1,2

Pivotal FIXTURE trial in adults with moderate to severe PsO¹

Coprimary end points: PASI 75 and IGA 0/1 at Week 12. 
For COSENTYX 300 mg (n=327) 

• 76% achieved PASI 75 

• 62% achieved IGA 0/1

Adult patients on COSENTYX 150 mg (n=327) or placebo (n=326) achieving PASI 75 (67% vs 5%) and IGA 0/1 (51% vs 3%) at Week 12, respectively. P<0.001 for all comparisons.^1,2

SCULPTURE Core and SCULPTURE Extension in adults with moderate to severe PsO³

SCULPTURE Core: The primary end point was noninferiority of the retreatment at SoR regimen vs the FI regimen for maintaining PASI 75 at Week 52 in patients who were PASI 75 responders at Week 12.^3*

5-year results for patients treated with COSENTYX 300 mg FI (n=168)³:

• 75% of patients who entered the extension study at Year 1 completed the study at 
Year 5

• 89% had PASI 75 at Year 5 (89% at Year 1)

• 41% had PASI 100 at Year 5 (44% at Year 1)

In the COSENTYX 300-mg FI group of the core study, patients received COSENTYX 300 mg every 4 weeks. At Week 12, 90% of patients in the 300-mg FI arm achieved PASI 75. PASI 75 responders at Week 12 were eligible to enter the maintenance period. 78% of patients who continued COSENTYX 300-mg FI maintained PASI 75 and 60% achieved PASI 90 at Week 52. At Week 52, patients could continue in the extension study regardless of PASI 75 response and received the same blinded maintenance regimen and dose up to the end of Year 3. Extension study was unblinded from Year 3 through Year 5.^3,4

• Data presented are as observed—patients with missing data at a specific time point are not included in the analysis. The as-observed analysis included patients who completed an assessment at each visit only³

• As with open-label extensions, patients who lose response or are unable to tolerate treatment are likely to discontinue treatment, which may raise the proportion of responders in the overall population

*Maintenance of PASI 75 response was assessed at Week 52 for patients on the FI regimen. For patients on the retreatment-as-needed regimen, PASI 75 response was assessed at Week 52 for those who required active treatment at Week 40, or at Week 40 for those who did not require active treatment at Week 40.³

Study designs 

ERASURE and FIXTURE were multicenter, randomized, double-blind, placebo-controlled trials. ERASURE evaluated 738 adult patients who received subcutaneous COSENTYX 150 mg (n=245), COSENTYX 300 mg (n=245), or placebo (n=248). FIXTURE evaluated 1306 adult patients who received COSENTYX 150 mg (n=327), COSENTYX 300 mg (n=327), placebo (n=326), or a biologic active control: etanercept (n=323). All patients were adults with moderate to severe plaque psoriasis who had BSA ≥10%, PASI score ≥12, and IGA mod 2011 score ≥3 and were candidates for systemic therapy or phototherapy. Patients received treatment at Weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter. Patients randomized to receive placebo who were nonresponders at Week 12 and did not achieve PASI 75 were then rerandomized to receive COSENTYX 300 mg or 150 mg. Coprimary end points were PASI 75 and IGA 0 or 1 (clear or almost clear).^1,5,6

SCULPTURE Core was a randomized, double-blind, multicenter trial assessing PASI response and maintenance of response in patients with moderate to severe plaque psoriasis on either an FI regimen (every 4 weeks) or on a retreatment at SoR regimen. All patients had a BSA of ≥10%, PASI score ≥12, and IGA mod 2011 score ≥3 and were candidates for systemic therapy or phototherapy. Primary end point was noninferiority of the retreatment at SoR regimen vs the FI regimen for maintaining PASI 75 at Week 52 in patients who were PASI 75 responders at Week 12. Initial dosing (weekly) was at baseline and Weeks 1, 2, 3, 4, and 8. In the SoR arms, patients received COSENTYX at Week 12 and then every 4 weeks from the start of relapse (≥20% loss of maximum PASI improvement vs baseline and a loss of PASI 75 response) until they achieved PASI 75 again.⁷

SCULPTURE Extension was a multicenter, double-blind, and open-label (from Week 156 through Week 260) extension study. Patients who completed 52 weeks of the SCULPTURE Core study were eligible to continue the same COSENTYX dose and regimen in the extension to Week 156. At Week 156, the study was unblinded and, based on investigator judgment, patients could switch dosing regimens (from SoR to FI regimen and from COSENTYX 150 mg to 300 mg). Primary objective was to assess long-term safety and tolerability of COSENTYX in patients who completed treatment in the core studies. Other objectives included efficacy over time with respect to PASI 50/75/90.⁸

BSA, body surface area; FI, fixed interval; IGA, Investigator’s Global Assessment; IGA mod 2011, Investigator's Global Assessment modified 2011; PASI, Psoriasis Area and Severity Index; PsO, plaque psoriasis; SoR, start of relapse.

References

1. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
2. Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis—results of two phase 3 trials. N Engl J Med. 2014;371(4):326-338.
3. Mrowietz U, Leonardi CL, Girolomoni G, et al. Secukinumab retreatment-as-needed versus fixed-interval maintenance regimen for moderate to severe plaque psoriasis: a randomized, double-blind, noninferiority trial (SCULPTURE). J Am Acad Dermatol. 2015;73(1):27-36.
4. Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018;32(9):1507-1514.
5. Data on file. AIN457A2302 Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013.
6. Data on file. AIN457A2303 Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013.
7. Data on file. CAIN457A2304 Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013.
8. Data on file. 4-Year Interim Report. Study CAIN457A2304E1. Novartis Pharmaceuticals Corp; December 2016.