Table 1.

Overview of the clinical trials^a

Study	Study description	Population	Treatments according to study periodb	Statusc
SPIRIT‐P1 (ClinicalTrials.gov identifier: NCT01695239), pivotal, phase III	Multicenter, randomized, double‐blind, active and placebo‐controlled, parallel‐group study followed by long‐term extension; primary end point at week 24	Adult bDMARD‐naive patients with active PsA (meet CASPAR criteria and ≥3 of 68 tender and ≥3 of 66 swollen joints, ≥1 disease‐related hand or foot joint erosion, or a CRP level >6 mg/liter)	Double‐blind placebo‐controlled treatment period (week 0 to week 24)IXE 80 mg Q4WIXE 80 mg Q2WADA 40 mg Q2WPlaceboExtended and long‐term treatment period (week 24 to week 156)IXE 80 mg Q4WIXE 80 mg Q2W	24‐ and 52‐week analyses completed; ongoing long‐term extension treatment period
SPIRIT‐P2 (ClinicalTrials.gov identifier: NCT02349295), pivotal, phase III	Multicenter, randomized, double‐blind, placebo‐controlled, parallel‐group study followed by long‐term extension; primary end point at week 24	Adult patients who are both bDMARD‐and cDMARD‐experienced and have active PsA (meet CASPAR criteria, and ≥3 of 68 tender and ≥3 of 66 swollen joints)	Double‐blind placebo‐controlled treatment period (week 0 to week 24)IXE 80 mg Q4WIXE 80 mg Q2WPlaceboExtension treatment period (week 24 to week 156)IXE 80 mg Q4WIXE 80 mg Q2W	24‐week analysis completed; ongoing extension treatment period (week 52 database lock and analysis completed)
SPIRIT‐P3 (ClinicalTrials.gov identifier: NCT02584855), support, phase III§	Multicenter, randomized, double‐blind withdrawal study, preceded by 36‐week open‐label treatment period	Adult patients with active PsA (meet CASPAR criteria, ≥3 of 68 tender, and ≥3 of 66 swollen joints) who are cDMARD‐inadequate responders and also bDMARD‐naive	Open‐label treatment period (week 0 to weeks 36–64)IXE 80 mg Q2WRandomized double‐blind withdrawal period (after week 36)Patients meeting MDA for 3 months and had received IXE 80 mg Q2W for ≥6 monthsdIXE 80 mg Q2WPlaceboPatients who no longer met MDA and had received IXE 80 mg Q2WdPatients who did not meet MDAdIXE 80 mg Q2W	Ongoing

^abDMARD = biologic disease‐modifying antirheumatic drug; PsA = psoriatic arthritis; CASPAR = Classification Criteria for Psoriatic Arthritis; CRP = C‐reactive protein; cDMARD = conventional DMARD; MDA = minimal disease activity.

^bDuring week 16 in SPIRIT‐P1 and SPIRIT‐P2, inadequate responders received rescue therapy as defined in the protocols, which is a modification of allowed concomitant medications. At week 16, inadequate responders who were originally assigned to adalimumab (ADA) or placebo were re‐randomized 1:1 to receive either ixekizumab (IXE) 80 mg every 2 weeks (Q2W) or every 4 weeks (Q4W), and those who were originally assigned to IXE 80 mg Q2W or Q4W continued their originally assigned dosing regimen up to week 24.

^cStatus at the time of the data cutoff date for the safety summary described in this report.

Safety data from the open‐label treatment period of SPIRIT‐P3 are included in the analyses presented in the safety summary described in this report.

^dAccording to a report by Coates et al 27, “A patient is classified as achieving minimal disease activity (MDA) when meeting 5 of the 7 following criteria: tender joint count ≤1; swollen joint count ≤1; Psoriasis Activity and Severity Index ≤1 or body surface area ≤3; patient pain visual analog score (VAS) score ≤15; patient global disease activity VAS ≤20; Health Assessment Questionnaire ≤0.5; tender entheseal points ≤1.”