Secukinumab Vs Ustekinumab (CLEAR

STUDY) Summary

STUDY DESIGN

Randomized, double blind, head to head phase 3b study comparing secukinumab and ustekinumab to
week 52

STUDY METHOD

676 patients were randomly assigned, 337 patients with secukinumab and 339 patients with
Ustekinumab.

OBJECTIVES

Primary objective – To demonstrate the superiority of secukinumab to ustekinumab at week 16 respect

to the proportion of the subject with improvement in PASI 90.

Secendary objective – To demonstrate the superiority of secukinumab to ustekinumab with respect to

PASI 90 response at 52 weeks.

ASSESSMENTS

Efficacy with respect to PASI 75/90/100 and IGA mod 2011 0/1 (clear/almost clear skin); patient
reported psoriasis related symptoms of pain, itching and scaling; health related quality of life (HRQOL)
were aslo evaluated.

RESULTS

Primary objective - Secukinumab demonstrated superiority in PASI 90 response at week 16,

secukinumab 79% vs ustekinumab 57.6%, P<.0001.

Secondary objective – Secukinumab demonstrated superiority to ustekinumab as assessed by PASI 90 at

week 52. As per nonresponder imputation NRI analysis – secukinumab 74.9% vs ustekinumab 60.6%, P
= .0001. And as per multiple imputation – secukinumab 76.2% vs ustekinumab 60.6%, P<.0001.

Overall secukinumab showed a greater decreased improvement when it comes to Pain, itiching and
scaling. Pain 80.1% vs 58.8%, itching 77.6% vs 68.3% , scaling 82.6% vs 71.8%.

Secukinumab exhibited greater mean percentage improvement in DLQI and all subscale scores. At week
52, 71.6% of subjects on secukinumab vs 59.2% on ustekinumab (P=.0008).
INCLUSIONS & EXCLUSIONS

18 years and above with moderate to severe plaque psoriasis having a PASI 12 , IGA mod 2011 score of 3
for moderate or 4 for severe. And more than 10% of the body surface area affected, poorly controlled
psoriasis with topical, photo, and systemic therapy.

Exclusions were non plaque psoriasis; previous exposure to biologics directly targeting IL-17A, IL-17
receptor A, or IL-12/IL-23; history of malignancy within 5 years; any medical or psychiatric condition that
in the investigator’s opinion would preclude adherence to the protocol.

SAFETY & ADVERE EVENTS

The most common AE in both groups were nasopharyngitis. Infections were mild to moderate and
nonserious therefore treatment discontinuation is not needed. The majority of candida infections were
oral infections and all were mild to moderate. There were no reports of new or reactivated cases of
tuberculosis, inflammatory bowel disease, or neutropenia grades 3 or 4.

CONCLUSION

The head to head, double blind 52 week CLEAR study confirms the sustained and superior efficacy of
secukinumab to ustekinumab in clearing skin of patients with moderate to severe plaque psoriasis, with
a favorable safety profile. The CLEAR study demonstrated superior clinical efficacy with secukinumab
translates into significantly greater improvement of patient quality of life compared with that of
ustekinumab.