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Taltz ® (ixekizumab) injection
80 mg/mL
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What were the inclusion and exclusion criteria in Taltz® (ixekizumab) clinical trials for the treatment of psoriatic arthritis?
Key inclusion and exclusion criteria for the phase 3 ixekizumab trials in patients with active psoriatic arthritis are included in this response.
Ixekizumab: Inclusion and Exclusion Criteria in Psoriatic Arthritis Trials
SPIRIT-P1 (N=417) was a phase 3, 24-week double-blind, placebo-controlled trial with an active reference arm, conducted in patients with active psoriatic arthritis who were naïve to biologic disease-modifying antirheumatic drugs (bDMARDs) with an extension period of up to 3 years.1
SPIRIT-P2 (N=363) was a phase 3, 24-week double-blind, placebo-controlled trial, conducted in patients with active psoriatic arthritis and an inadequate response or intolerance to tumor necrosis factor inhibitors, with an extension period of up to 3 years.2
SPIRIT-P3 (N=394) consisted of a 36-week open-label period followed by a randomized double-blind withdrawal period from week 36 to week 104. This trial was conducted in patients who were naïve to bDMARDs.3
Key Inclusion and Exclusion Criteria in Phase 3 Psoriatic Arthritis Clinical Trials provides key inclusion and exclusion criteria for the phase 3 SPIRIT clinical trials. For additional details on inclusion and exclusion criteria for SPIRIT-P1 and SPIRIT-P2 clinical trials, see the online supplements for the published manuscripts.1,2 www.clinicaltrials.gov provides additional details on the SPIRIT-P3 trial.4
Key Inclusion Criteriaa |
Key Exclusion Criteriab |
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Abbreviations: bDMARD = biologic disease-modifying antirheumatic drug; CASPAR = Classification for Psoriatic Arthritis; cDMARD = conventional disease-modifying antirheumatic drug; CRP = C-reactive protein; HIV = human immunodeficiency virus; IL = interleukin; MTX = methotrexate; PsA = psoriatic arthritis; TNF = tumor necrosis factor.
aPatients were eligible to be included in the trials only if they met all the key inclusion criteria.
bPatients were excluded from the trials if they met any of the exclusion criteria.
cPermitted cDMARD doses were oral or parenteral MTX (10-25 mg/wk), leflunomide (20 mg/d), sulfasalazine (up to 3 g/day), and hydroxychloroquine (up to 400 mg/d).
dPatients were excluded if they had the presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders at screening that, in the opinion of the investigator, posed an unacceptable risk if participating in the study.
CASPAR Inclusion Criteria
As listed in Classification Criteria for Psoriatic Arthritis, patients were required to have a diagnosis of psoriatic arthritis, as defined by the Classification for Psoriatic Arthritis (CASPAR) criteria, in all 3 clinical trials. In order to meet CASPAR criteria, patients must have an established inflammatory articular disease in addition to a total score of at least 3 points from the 5 categories described in Classification Criteria for Psoriatic Arthritis. Current psoriasis was assigned a score of 2 points, and all other features were assigned a score of 1 point each.7
Category |
Description |
Points |
Psoriasis |
Evidence of current psoriasis, a family history of psoriasis, or a personal history of psoriasis |
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Current psoriasis defined as psoriatic skin or scalp disease present today as judged by a rheumatologist or dermatologist, OR |
2 |
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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 |
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A family history of psoriasis defined as a history of psoriasis in a first- or second-degree relative according to patient report. |
1 |
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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 |
Abbreviation: CASPAR = Classification for Psoriatic Arthritis.
aIn order to meet CASPAR criteria, patients must have an established inflammatory articular disease in addition to a total score of at least 3 points from the 5 categories.
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Mease PJ, van der Heijde D, Ritchlin CT, et al; SPIRIT-P1 Study Group. Ixekizumab, an interleukin-17A specific monoclonal antibody, for the treatment of biologic-naive patients with active psoriatic arthritis: results from the 24-week randomised, double-blind, placebo-controlled and active (adalimumab)-controlled period of the phase III trial SPIRIT-P1. Ann Rheum Dis. 2017;76(1):79-87. http://dx.doi.org/10.1136/annrheumdis-2016-209709
2Nash P, Kirkham B, Okada M, et al; SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017;389(10086):2317-2327. http://dx.doi.org/10.1016/S0140-6736(17)31429-0
3Coates LC, Pillai SG, Tahir H, et al; SPIRIT-P3 Study Group. Withdrawing ixekizumab in patients with psoriatic arthritis who achieved minimal disease activity: results from a randomized, double-blind withdrawal study. Arthritis Rheumatol. 2021;73(9):1663-1672. https://doi.org/10.1002/art.41716
4A long-term efficacy and safety study of ixekizumab (LY2439821) in participants with active psoriatic arthritis (SPIRIT P3). ClinicalTrials.gov identifier: NCT02584855. Updated November 15, 2019. Accessed August 8, 2023. https://www.clinicaltrials.gov/ct2/show/NCT02584855
5Data on file, Eli Lilly and Company and/or one of its subsidiaries.
6A long-term efficacy and safety study of ixekizumab (LY2439821) in participants with active psoriatic arthritis (SPIRIT P3). ClinicalTrials.gov identifier: NCT02584855. Updated November 15, 2019. Accessed June 18, 2020. https://www.clinicaltrials.gov/ct2/show/NCT02584855?term=SPIRIT-P3&rank=1
7Taylor W, Gladman D, Helliwell P, et al. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum. 2006;54(8):2665-2673. http://dx.doi.org/10.1002/art.21972
Date of Last Review: August 07, 2023