Improvement across key psoriatic domains with TREMFYA^® (guselkumab)

Secondary Endpoints: Week 24, NRI

Joint^*†

32%

achieved joint improvement (ACR50)(78/248) vs 14% (35/246) for placebo in DISCOVER 2 (P<0.0001)^1,2

30%

achieved joint improvement (ACR50) (38/127) vs 9% (11/126) for placebo in DISCOVER 1 (P<0.0001)^1,3

Psoriasis^*†

69%

achieved clearer skin (PASI 90) (121/176) vs 10% (18/183) for placebo in DISCOVER 2²

50%

achieved clearer skin (PASI 90) (41/82) vs 12% (9/78) for placebo in DISCOVER 1³

Enthesitis^*†‡

50%

achieved complete resolution (LEI score=0)(114/230) vs 29% (75/255) for placebo pooled data from DISCOVER 1 and DISCOVER 2 (P=0.0301)²

Axial disease^*†§ǁ¶

40%

achieved a BASDAI50 response (34/84) vs 19% (21/110) for placebo pooled data from DISCOVER 1 and DISCOVER 2⁴

Dactylitis^*†#**

59%

achieved complete resolution (dactylitis score=0) (95/160) vs 42% (65/154) for placebo pooled data from DISCOVER 1 and DISCOVER 2 (P=0.0301)²

Nail data^{††‡‡§§}

PsO Pivotal Trials: prespecified other secondary analysis at Week 16, NRI

34%

VOYAGE 1 mean percent improvement from baseline NAPSI (target nail) (n=194) vs -0.9% (n=99) for placebo⁵

40%

VOYAGE 2 mean percent improvement from baseline NAPSI (target nail) (n=280) vs 2% (n=140) for placebo⁶

Of patients receiving TREMFYA^® (VOYAGE 1, n=329, and VOYAGE 2, n=469) in moderate to severe plaque PsO, 194 (VOYAGE 1) and 280 (VOYAGE 2) PsO patients presented with nail disease.

PASI 90, NAPSI, and BASDAI50 responses were not adjusted for multiplicity. Therefore, statistical significance has not been established.

ACR50 response in DISCOVER 1 and DISCOVER 2 was not part of sequential testing procedure but was prespecified to be tested upon achieving statistical significance for ACR20 at Week 24.

ACR=American College of Rheumatology; BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; LEI=Leeds Enthesitis Index; NAPSI=Nail Psoriasis Severity Index; NRI=nonresponder imputation; PASI=Psoriasis Area and Severity Index.

*Through Week 24, patients in DISCOVER 1 and DISCOVER 2 were considered to be nonresponders after meeting treatment failure (see study designs). After Week 24, treatment failure rules were not applied.

^†Patients with missing data were considered nonresponders.

^‡Among patients with LEI enthesitis score >0 at baseline.

^§Included patients with sacroiliitis at baseline who had either documented imaging confirmation of sacroiliitis in the past or pelvic X-ray confirmation of sacroiliitis at screening based on investigators’ judgment of presence/absence of sacroiliitis.

^||BASDAI is a subject self-assessment of axial disease, which asks patients to rate their symptoms on a scale of 0 to 10, with higher scores indicating greater disease severity.

^¶Patients with BASDAI >0 at baseline.

^#Among patients with dactylitis score >0 at baseline.

^**After Week 24, patients and doctors knew that all patients were on TREMFYA^® (open label with a blinded dosing interval), which may have affected the results.

^††In a subpopulation of patients with NAPSI (target nail) score >0 at baseline.

^‡‡Fingernail psoriasis was assessed using NAPSI, in which the nail most affected by psoriasis (target nail) is divided into quadrants and graded for psoriasis of the nail matrix (pitting, leukonychia, red spots in the lunula, and nail plate crumbling) and nail bed (onycholysis, splinter hemorrhages, oil drop discoloration, and nail bed hyperkeratosis) on a scale of 0 to 4 for a total score ranging from 0 to 8; a higher score indicates more severe disease.

^§§Limitation: All 10 fingernails may also be evaluated using NAPSI.

"The use of TREMFYA^® in my life at my age has given me a new and renewed outlook at life. The swelling, stiffness, and pain in my knees has improved. I can go upstairs, downstairs, and walk with less symptoms…_"

- Humberto, real TREMFYA^® patient