Immunologic Response to Secukinumab in Plaque Psoriasis

Quantitative analysis of the immunologic changes in immune cell populations will be performed
after secukinumab treatment in 15 patients at weeks 2, 4, and 12 compared to baseline week 0.
The immunologic profiles in psoriasis patients will also be compared to healthy control skin
surgical discard specimens (n=10). The number of differentially expressed genes in each cell
population will be quantified by RNA-seq at weeks 2, 4, 12 after secukinumab compared to
baseline.

Inclusion Criteria:

1. Ability to provide written informed consent and comply with the protocol.

2. At least 18 years of age.

3. Diagnosis of predominately plaque psoriasis for at least 6 months prior to enrollment.

4. Subject is considered a candidate for phototherapy or systemic therapy

5. PASI ≥ 12

6. PGA ≥ 3

7. Subject has a negative Quantiferon Gold, or if positive undergoes CXR. If CXR
negative, subject initiated prophylactic therapy with isoniazid for a course of 9
months with one month of therapy completed prior to first dose of secukinumab.

8. Subject is unlikely to conceive (male, post-menopausal, or using adequate oral
contraceptive therapy or IUD).

9. Physical exam within clinically acceptable limits.

Exclusion Criteria:

1. Subject is unable to provide written informed consent or comply with the protocol.

2. Subject is younger than 18 years of age.

3. Subject has predominately non-plaque form of psoriasis.

4. Subject with mild psoriasis (PASI<12 and PGA<3) or is not a candidate for phototherapy
or systemic treatments.

5. Subject has drug-induced psoriasis.

6. Subject with current, or a history of, severe psoriatic arthritis well controlled on
current therapy.

7. Subjects with a serum creatinine level exceeding 176.8 μmol/L (2.0 mg/dl).

8. Screening total white blood cell (WBC count) < 2,500/μl, platelets < 100,000/μl,
neutrophils < 1,500/μl, or hemoglobin <8.5 g/dl.

9. Evidence of active tuberculosis infection as defined by a positive QuantiFERON TB-Gold
test (QFT) with a positive chest X-ray at screening, or untreated latent tuberculosis
defined by positive QFT with a negative chest X-ray without prophylactic therapy with
isoniazid for a course of 9 months with one month of therapy completed prior to first
dose of secukinumab.

10. History of an ongoing, chronic or recurrent infectious disease including past medical
history record of HIV, hepatitis B or hepatitis C.

11. Subjects possess other diagnoses that, in the investigator's opinion, preclude him/her
from safely participating in this study or interfere with the evaluation of the
subject's psoriasis.

12. History of known or suspected intolerance to any of the ingredients of the
investigational study product.