SPIRIT-P1, SPIRIT-P2, SPIRIT-P3 Common Criteria1,2,6

• Male or female patients aged 18 years or older
• Established diagnosis of PsA (of at least 6 months' duration) and currently met the CASPAR criteria
• Active PsA defined as the presence of ≥3 tender and ≥3 swollen joints
• Active psoriatic skin lesions (plaque) or a documented history of plaque psoriasis
• If male, must agree to use a reliable method of birth control or remain abstinent during the study
• If female, must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

• Current use of more than one cDMARD
• Use of cDMARDs other than MTX, leflunomide, sulfasalazine, or hydroxychloroquine in the 8 weeks prior to study baseline. If taking MTX, leflunomide, sulfasalazine, or hydroxychloroquine, must have been on a stable dosec for at least 8 weeks prior to baseline.
• Previous use of natalizumab or other agents that target alpha-4-integrin
• Previous treatment with IL-17– or IL-12/23–targeted therapy.
• Previous participation in any study with IL-17 antagonists, including ixekizumab
• History of drug-induced psoriasis
• Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
• Evidence of active vasculitis or uveitis
• Serious disorder or illness other than PsAd
• Serious infection within the past 3 months
• Breastfeeding or nursing (lactating) women
• History of malignant disease (other than non-melanoma skin cancer or in situ cervical carcinoma, successfully treated and with no recurrences within the past 5 years)
• Positive test result for hepatitis B, hepatitis C, or HIV
• Liver function or hematology test results outside of predefined limits

SPIRIT-P1 (bDMARD-Naïve) Additional Criteria1,5

• At least 1 PsA-related definite joint erosion on hand or foot x-rays or a CRP level >6 mg/L at screening

• Concurrent or prior treatment with any bDMARDs for PsA or psoriasis, including investigational therapies (such as TNF inhibitor–, IL-1–, IL-6–, IL-12/23p40–, T cell–, or B cell–targeted therapies) or have received denosumab.
• Inadequate response to ≥4 cDMARDs (such as MTX, leflunomide, azathioprine, cyclosporine, hydroxychloroquine, gold salts, and sulfasalazine) prescribed alone or in combination for a minimum of 3 months

SPIRIT-P2 (TNF-Experienced) Additional Criteria2,5

• Prior treatment with 1 or more cDMARDs (MTX, sulfasalazine, leflunomide, or hydroxychloroquine)
• Prior treatment with at least 1 and not more than 2 TNF inhibitors, discontinued due to either an inadequate response or documented intolerance

• Inadequate response to >2 bDMARDs
• Concurrent or recent use of any biologic agent within the following washout periods: etanercept <28 days; infliximab, adalimumab, certolizumab pegol, or alefacept <60 days; golimumab <90 days; rituximab <12 months; or any other biologic agent or small molecule <5 half-lives prior to study baseline

SPIRIT-P3 (bDMARD-Naïve) Additional Criteria4,5

• Prior treatment with 1 or more cDMARDs (MTX, sulfasalazine, leflunomide, hydroxychloroquine, or cyclosporine) with documented inadequate response (at least 12 weeks of therapy) or intolerance

• Concurrent or prior treatment with any bDMARDs for PsA or psoriasis including investigational therapies (such as TNF inhibitor–, IL-1–, IL-6–, IL-12/23p40–, T cell–, or B cell–targeted therapies, or Janus kinase inhibitors)
• Inadequate response to greater than or equal to 4 cDMARDs (such as MTX, leflunomide, azathioprine, cyclosporine, hydroxychloroquine, gold salts, and sulfasalazine) prescribed alone or in combination for a minimum of 3 months

Psoriasis

Evidence of current psoriasis, a family history of psoriasis, or a personal history of psoriasis

Current psoriasis defined as psoriatic skin or scalp disease present today as judged by a rheumatologist or dermatologist, OR

2

A personal history of psoriasis defined as a history of psoriasis that may be obtained from a family physician, patient, rheumatologist, dermatologist, or other qualified healthcare provider, OR

1

A family history of psoriasis defined as a history of psoriasis in a first- or second-degree relative according to patient report.

1

Nail involvement 

Typical psoriatic nail dystrophy, including pitting, onycholysis, and hyperkeratosis observed on current physical examination.

1

Negative rheumatoid factor

A negative test result for the presence of rheumatoid factor by any method except latex.

1

Dactylitis

Either current dactylitis, defined as swelling of an entire digit, or a history of dactylitis recorded by a rheumatologist.

1

New bone formation

Radiographic evidence of juxta-articular new bone formation appearing as ill-defined ossification near joint margins, but excluding osteophyte formation, on plain radiographs of the foot or hand.

1