SUNSHINE and SUNRISE

Primary end point results at Week 16¹
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.²

Secondary end point results at Week 16²
The proportion of patients with flares over 16 weeks

SUNSHINE

• 75% of patients had zero flares for COSENTYX Q4W (n=180)

• 64% for placebo (n=180) (P=0.0076)

Data presented are from the SUNSHINE trial: The same results were not seen in SUNRISE.²

SUNNY clinical trial extension 
Primary end point results at Year 2³
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%^* COSENTYX Q4W-Q4W vs COSENTYX Q4W-PBO 

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

The end point, which was newly defined and nonvalidated in trials, was not met.

~42% of the total patients on COSENTYX maintained HiSCR50 when meeting LOR criteria.^3‡

MATURE

MATURE study in adult patients with moderate to severe PsO⁴

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 PsA⁵

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)

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.^6,7

The SUNNY clinical 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 nonresponders (subjects who did not achieve HiSCR50) compared to the weighted average of the baseline and screening visits of the core studies (n=308). HiSCR nonresponders were not randomized and were assigned to the open-label COSENTYX 300 mg Q2W regimen. HiSCR responders were randomized 2:1 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 up to Week 104 in subjects who were HiSCR responders at Week 52 in the core studies, 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 ≥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.³

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 12.⁴

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).^5,8

^*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. 
^§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.^3 
||DLQI response vs baseline of the core trials: Defined as a ≥5-point decrease in total DLQI score.³

ACR, American College of Rheumatology; AN, abscesses and inflammatory nodules; BSA, body surface area; DLQI, Dermatology Life Quality Index; FDA, US Food and Drug Administration; HiSCR, Hidradenitis Suppurativa Clinical Response; HR, hazard ratio; HS, hidradenitis suppurativa; IGA mod 2011, Investigator’s Global Assessment modified 2011; LD, loading dose; LOR, loss of response; mTSS, modified Total Sharp Score; NRS, numeric rating scale; PASI, Psoriasis Area and Severity Index; PBO, placebo; PsA, psoriatic arthritis; PsO, plaque psoriasis; Q2W, every 2 weeks; Q4W, every 4 weeks; TNF, tumor necrosis factor.

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. Data on file. CAIN457M2301E1 Clinical Study Report. Novartis Pharmaceuticals Corp; March 2024.
4. 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
5. 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.
6. 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.
7. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
8. Data on file. CAIN457F2342 (FUTURE 5): Clinical Study Report. Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.