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Taltz ® (ixekizumab) injektion
Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska
Iritis is not listed as adverse drug reaction in the Taltz summary of product characteristics.1
No specific exclusion criteria for iritis were included in the pivotal phase 3 plaque psoriasis clinical trials.2
Patients with iritis were not specifically excluded in the COAST-X study.7
Treatment-emergent adverse events are defined as events that first occurred or worsened in severity, relative to baseline, at any time during a clinical study. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a TEAE of the type listed. Adverse events reported during the studies were not necessarily caused by the therapy and the frequencies do not reflect investigator assessment of causality.
This information is for reference only and is not a treatment recommendation. Decisions regarding the use of ixekizumab in patients with iritis (or any medical condition) should be made at the discretion of the prescribing physician using their best clinical judgment.
Iritis was not reported as a historical illness or preexisting condition in any patient randomized to ixekizumab through week 12 (N=2328) in UNCOVER -1, -2, and -3.4
Among all adult and pediatric plaque psoriasis trials (including phase 1, phase 2, and phase 3) (N=6645; 17,902.0) as of March 19, 2020, iritis was reported as a TEAE in 3 patients (0.0%)4
Iritis was not reported as preexisting or historical illness in any patient randomized to ixekizumab through week 24 in SPIRIT-P1, SPIRIT-P2, or SPIRIT-P3.4
Among all ixekizumab exposures across 4 psoriatic arthritis trials (N=1401; 2247.7 PY) as of March 19, 2020, iritis was reported as a TEAE in 1 patient (0.1%)4
Iritis was reported as a historical illness in 7 (1.9%) patients randomized to ixekizumab through week 16 in COAST-V and COAST-W.4
Iritis was reported as a preexisting condition in 1 (0.5%) patient randomized to ixekizumab in COAST-X.4
Among all ixekizumab exposures across 4 axSpA trials (including AS/r-axSpA and nr-axSpA) (N=932; 1792.2 PY), as of March 19, 2020, iritis was reported as a TEAE in 7 patients (0.8%).4
1Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2Gordon KB, Blauvelt A, Papp KA, et al; UNCOVER-1, UNCOVER-2, and UNCOVER-3 Study Groups. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711
3Nash 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
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5Deodhar A, Poddubnyy D, Pacheco-Tena C, et al; COAST-W Study Group. Efficacy and safety of ixekizumab in the treatment of radiographic axial spondyloarthritis: sixteen-week results from a phase III randomized, double-blind, placebo-controlled trial in patients with prior inadequate response to or intolerance of tumor necrosis factor inhibitors. Arthritis Rheumatol. 2019;71(4):599-611. http://dx.doi.org/10.1002/art.40753
6van der Heijde D, Cheng-Chung Wei J, Dougados M, et al; COAST-V Study Group. Ixekizumab, an interleukin-17A antagonist in the treatment of ankylosing spondylitis or radiographic axial spondyloarthritis in patients previously untreated with biological disease-modifying anti-rheumatic drugs (COAST-V): 16 week results of a phase 3 randomised, double-blind, active-controlled and placebo-controlled trial. Lancet. 2018;392(10163):2441-2451. http://dx.doi.org/10.1016/s0140-6736(18)31946-9
7Deodhar A, van der Heijde D, Gensler LS, et al; COAST-X Study Group. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial. Lancet. 2020;395(10217):53-64. http://dx.doi.org/10.1016/S0140-6736(19)32971-X
8Mease 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
9A 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 September 25, 2020. https://www.clinicaltrials.gov/ct2/show/NCT02584855
10A long term extension study of ixekizumab (LY2439821) in participants with axial spondyloarthritis. ClinicalTrials.gov identifier: NCT03129100. Updated November 4, 2020. Accessed January 20, 2021. https://www.clinicaltrials.gov/ct2/show/NCT03129100
AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis
axSpA = axial spondyloarthritis
bDMARD = biologic disease-modifying antirheumatic drug
EAIR = exposure adjusted incidence rate
IR = incidence rate
MedDRA = Medical Dictionary for Regulatory Activities
nr-axSpA = nonradiographic axial spondyloarthritis
PsA = psoriatic arthritis
PY = patient-years
Q2W = every 2 weeks
Q4W = every 4 weeks
TEAE = treatment-emergent adverse event
TE = treatment-emergent
TNF = tumor necrosis factor
Some dosing schedules shown in are not consistent with the approved dosing schedule for plaque psoriasis in the Taltz summary of product characteristics. Please refer to the Taltz summary of product characteristics for approved dosing.1
Datum fӧr senaste ӧversyn 2020 M10 20