Immunologic Response to Secukinumab in Plaque Psoriasis

Inclusion Criteria

• Ability to provide written informed consent and comply with the protocol.
• At least 18 years of age.
• Diagnosis of predominately plaque psoriasis for at least 6 months prior to enrollment.
• Subject is considered a candidate for phototherapy or systemic therapy
• PASI ≥ 12
• PGA ≥ 3
• 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.
• Subject is unlikely to conceive (male, post-menopausal, or using adequate oral contraceptive therapy or IUD).
• Physical exam within clinically acceptable limits.

Exclusion Criteria

• Subject is unable to provide written informed consent or comply with the protocol.
• Subject is younger than 18 years of age.
• Subject has predominately non-plaque form of psoriasis.
• Subject with mild psoriasis (PASI<12 and PGA<3) or is not a candidate for phototherapy or systemic treatments.
• Subject has drug-induced psoriasis.
• Subject with current, or a history of, severe psoriatic arthritis well controlled on current therapy.
• Subjects with a serum creatinine level exceeding 176.8 μmol/L (2.0 mg/dl).
• Screening total white blood cell (WBC count) < 2,500/μl, platelets < 100,000/μl, neutrophils < 1,500/μl, or hemoglobin <8.5 g/dl.
• 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.
• History of an ongoing, chronic or recurrent infectious disease including past medical history record of HIV, hepatitis B or hepatitis C.
• 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.
• History of known or suspected intolerance to any of the ingredients of the investigational study product.