Safety results established across 2 pivotal HS studies¹

SUNSHINE and SUNRISE

Primary end point results at Week 16¹

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

SUNSHINE¹

• 41.3% for COSENTYX Q4W (n=180) 

• 44.5% for COSENTYX Q2W (n=181) 

• 29.4% for placebo (n=180)

SUNRISE¹

• 42.5% for COSENTYX Q4W (n=180) 

• 38.3% for COSENTYX Q2W (n=180) 

• 26.1% for placebo (n=183)

Week 16 data presented are the results of an FDA-requested analysis of the SUNSHINE and SUNRISE trials.²

Secondary end point results at Week 16³

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.³

SUNNY clinical trial extension

Primary end point results at Year 2⁴

Time to loss of response (LOR) through Week 104 in patients who were HiSCR50 responders at Week 52 from core trials.

LOR risk reduction 

• 30%* for  COSENTYX Q4W-Q4W vs for COSENTYX Q4W-PBO 

• 13%^† for COSENTYX Q2W-Q2W vs for COSENTYX Q2W-PBO

The end point, which was newly defined and non-validated in trials, was not met.

~42% of the total patients on COSENTYX maintained HiSCR50 when meeting LOR criteria^4‡

Study designs

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.^3,5

The SUNNY trial extension is a 4-year, multicenter, double-blind, randomized withdrawal trial. The study population included subjects who had completed the entire treatment period in the SUNSHINE and SUNRISE trials (core study). Subjects were defined as either HiSCR responders (subjects who achieved at least a 50% decrease in AN count with no increase in the number of abscesses and in the number of draining fistulae [HiSCR50]) compared to the weighted average of the baseline and screening visits of the core studies (n=391), or HiSCR non-responders (subjects who did not achieve HiSCR50) compared to the weighted average of the baseline and screening visits of the core studies (n=308). HiSCR non-responders were not randomized and were assigned to the open-label COSENTYX 300 mg Q2W regimen. HiSCR responders were randomized into a COSENTYX arm or a placebo arm. Depending on the treatment received by the subject from Weeks 16 to 52 of the core study, they were randomized to either COSENTYX 300 mg Q4W (n=121), COSENTYX 300 mg Q2W (n=136), or placebo (Q4W-PBO n=63; Q2W-PBO n=71). The treatment period between Weeks 52 and 104 was blinded. The primary end point was time to LOR, defined as a 50% increase or greater in AN when compared with the average AN count of the 3 previous visits or the Year 1 visit^§ (whichever was lower) and a ≥3 increase in absolute AN. If at a regular or unscheduled visit, the subject experiences at least a 30% increase in AN compared to the average AN count from the 3 previous visits or the Week 52 visit, whichever is lower with an increase of at least 2 AN, the subject should be reassessed within 2 to 4 weeks. A further increase in the AN count of at least 2 AN would be considered a LOR also. If the 3 previous visits include visits from core studies, the AN counts from the core study will be included in the average. Other exploratory end points included HiSCR50 over time vs baseline of the core trials, skin pain response/NRS30 (≥30% reduction of pain)^|| vs baseline of the core trials, and DLQI (quality of life) response^¶ vs baseline of the core trials.⁶

*HR: 0.70, 95% CI: 0.47-1.05.
^†HR: 0.87, 95% CI: 0.59-1.29.
^‡Based on an exploratory analysis of HiSCR50 responders. No clinical or statistical conclusions can be drawn.
^§If a patient experienced a ≥30% increase in AN count vs the average AN count from 3 previous visits (including core visits) or the Week 52 visit (whichever was lower), and an increase of a ≥2 in the absolute AN count, they were reassessed within 2-4 weeks. A further increase of ≥2 in AN count at the reassessment visit was also considered LOR.^6
||Defined as a ≥30% reduction and ≥2-point reduction in skin pain from baseline in the Patient’s Global Assessment of Skin Pain at worst on a continuous NRS in patients with a core baseline NRS ≥3.^7
¶DLQI response vs baseline of the core trials: Defined as a ≥5-point decrease in total DLQI score.

References

1. Data on file. SUNNY Clinical Study Program Data Tables. Novartis Pharmaceuticals Corp; July 2023.
2. Data on file. AIN457 (secukinumab) Response to FDA Information Request. Novartis Pharmaceuticals Corp; July 2023.
3. 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 and Supplementary Appendices.
4. Data on file. CAIN457M2301 Clinical Study Report. Novartis Pharmaceuticals Corp; May 2024.
5. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
6. Data on file. CAIN457M2301E1 Clinical Study Report. Novartis Pharmaceuticals Corp; March 2024.
7. Data on file. CAIN457M2302E1 Clinical Study Report. Novartis Pharmaceuticals Corp; May 2024.