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Taltz ® (ixekizumab) injektion
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No overall difference in safety risk was observed between patients with and without previous exposure to biologics in ixekizumab psoriasis clinical trials.1
This information is for reference only and is not a treatment recommendation. Safety and efficacy of ixekizumab in patients who reported an allergic reaction with secukinumab have not been studied. Decisions regarding the use of ixekizumab in patients who reported an allergic reaction with secukinumab should be made at the discretion of the prescribing physician using their best clinical judgment.
Ixekizumab Label Information Related to Hypersensitivity
Ixekizumab is contraindicated in patients with serious hypersensitivity to the active substance or to any of the excipients listed in the Taltz summary of product characteristics.2
Serious hypersensitivity reactions, including some cases of anaphylaxis, angioedema, urticaria and, rarely, late (10-14 days following injection) serious hypersensitivity reactions including widespread urticaria, dyspnea and high antibody titres have been reported. If a serious hypersensitivity reaction occurs, administration of ixekizumab should be discontinued immediately and appropriate therapy initiated.2
Previous Exposures to Secukinumab in a Study of Continuous Ixekizumab Q2W Dosing
Thirteen (13/1227) patients enrolled in IXORA-P reported previous treatment with secukinumab.3 Patients who received secukinumab within a washout period of <5 months were excluded from the trial.4 It is unknown whether any of these 13 patients previously experienced an allergic reaction with secukinumab.
A continous dosing schedule IXEQ2W is 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.2
Independent Retrospective Review on Switching From Secukinumab to Ixekizumab
A multicenter retrospective chart review in patients with plaque psoriasis with prior exposure to secukinumab examined efficacy and safety outcomes of subsequent treatment with ixekizumab. Inclusion criteria included all consecutive patients who
were 18 years or older
had moderate-to-severe plaque psoriasis, and
were treated with ixekizumab therapy following discontinuation of secukinumab.5
This study was not sponsored by Lilly.
Of the 31 patients who met inclusion criteria, 10 experienced an AE to secukinumab. Of those 10 patients, 5 (50%) experienced an AE to ixekizumab. Conversely, of the 21 patients who did not experience an AE to secukinumab, 6 (19.4) experienced an AE to ixekizumab.5
Two patients reported a postinjection systemic reaction and 1 patient reported a dermatitic rash (peri-orbital) with ixekizumab. The article did not specify whether these AEs were allergic reactions or how many patients reported an allergic reaction with secukinumab.5
The authors concluded that safety outcomes with secukinumab did not correlate with ixekizumab safety outcomes.5
Secukinumab was not yet marketed when the pivotal clinical trials of ixekizumab for the treatment of PsO were initiated (UNCOVER-1, -2, and -3). In these 3 pivotal trials, previous participation in any study investigating other IL-17 antagonists was a criterion for exclusion.6 Brief descriptions of study designs are available at the end of this response (see ).
Patients with previous exposure to IL-17 inhibitors were allowed to enroll in IXORA-P, a study of continuous ixekizumab Q2W dosing in patients with moderate-to-severe PsOs. Patients were excluded if they had inadequate response to an IL-17 inhibitor.4
Patients were excluded from pivotal phase 3 active PsA (SPIRIT-P1 and SPIRIT-P2) trials if they had previous exposure to any IL-17 inhibitor or participated in any trial investigating other IL-17 inhibitors.1,7
Patients were excluded from pivotal phase 3 AS/r-axSpA (COAST-V, COAST-W, and COAST-X) trials if they had previous exposure to any IL-17 inhibitor or participated in any trial investigating other IL-17 inhibitors.1
3. Papp KA, Blauvelt A, Sullivan J, et al. Efficacy of ixekizumab in patients previously treated with IL-17 inhibitors. Poster presented at: 26th Meeting of the European Academy of Dermatology and Venereology (EADV); September 13-17, 2017; Geneva, Switzerland.
4. Supplementary Appendix to: Langley RG, Papp K, Gooderham M, et al Efficacy and safety of continuous every-2-week dosing of ixekizumab over 52 weeks in patients with moderate-to-severe plaque psoriasis in a randomized phase III trial (IXORA-P). Br J Dermatol. 2018;178(6):1315-1323. https://onlinelibrary.wiley.com/doi/abs/10.1111/bjd.16426
5. Georgakopoulos JR, Phung M, Ighani A, et al. Biologic switching between interleukin 17A antagonists secukinumab and ixekizumab: a 12-week multicenter, retrospective study. J Eur Acad Dermatol Venereol. 2019:33(1):e7-e8. https://dx.doi.org/10.1111/jdv.15100
6. Gordon KB, Blauvelt A, Papp KA, et al. 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
7. Nash P, Kirkham B, Okada M, et al. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomized, 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
8. Langley RG, Papp K, Gooderham M, et al. Efficacy and safety of continuous every-2-week dosing of ixekizumab over 52 weeks in patients with moderate-to-severe plaque psoriasis in a randomized phase III trial (IXORA-P). Br J Dermatol. 2018;178(6):1315-1323. http://dx.doi.org/10.1111/bjd.16426
9. Mease PJ, van der Heijde D, Ritchlin CT, et al. 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
10. A long-term efficacy and safety study of ixekizumab (LY2439821) in participants with active psoriatic arthritis (SPIRIT P3). ClinicalTrials.gov identifier: NCT02584855. Updated November 6, 2018. Accessed March 13, 2019. https://www.clinicaltrials.gov/ct2/show/NCT02584855?term=SPIRIT-P3&rank=1.
11. van der Heijde D, Cheng-Chung Wei J, Dougados M, et al. 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
12. Deodhar A, Poddubnyy D, Pacheco-Tena C, et al. 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
13. A study of ixekizumab (LY2439821) in participants with nonradiographic axial spondyloarthritis (COAST-X). ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/NCT02757352. Updated August 27, 2019. Accessed November 1, 2019.
AE = adverse event
AS/r-axSpA = ankylosing spondylitis/radiographic axial spondyloarthritis
bDMARD = biologic disease-modifying antirheumatic drug
IL-17 = interleukin-17
Lilly = Eli Lilly and Company
nr-axSpA = nonradiographic axSpA
PsA = psoriatic arthritis
PsO = psoriasis
Q2W = every 2 weeks
UNCOVER-1, -2, and -3 (N=3866) phase 3 trials in moderate-to-severe plaque psoriasis were integrated to evaluate the safety of ixekizumab in comparison to placebo up to 12 weeks after treatment initiation.
The phase 3 trials examined the efficacy and safety of ixekizumab compared with placebo and etanercept (UNCOVER-2 and -3) during induction treatment and vs placebo in maintenance (UNCOVER-1 and -2).6
IXORA-P (N=1227) is a phase 3, 52-week double-blind trial in patients with moderate-to-severe plaque psoriasis patients that examined the efficacy and safety of continuous ixekizumab Q2W dosing over 52 weeks.8
Psoriatic Arthritis Trials
SPIRIT-P1 (N=417) is a phase 3, 24-week double-blind, placebo-controlled trial with an active reference arm in patients with active PsA who are naïve to bDMARDs with an extension period of up to 3 years.9
SPIRIT-P2 (N=363) is a phase 3, 24-week double-blind, placebo-controlled trial in patients with active PsA and an inadequate response or intolerance to TNF inhibitors, with an extension period of up to 3 years.7
SPIRIT-P3 (N=570) consists of a 36-week open-label period followed by a randomized double-blind withdrawal period from week 36 to week 104. This trial is being conducted in patients naïve to bDMARDs.10
Axial Spondyloarthritis Trials
COAST-V (N=341) is a phase 3, 16-week double-blind, placebo-controlled trial with an active reference arm and an extension period to 52 weeks in patients with active AS/r-axSpA who are naive to bDMARDs.11
COAST-W (N=316) is a phase 3, 16-week double-blind, placebo-controlled trial with an extension period to 52 weeks in patients with active AS/r-axSpA and an inadequate response or intolerance to 1 or 2 TNF inhibitors.12
COAST-X (N=305) is a phase 3, 52-week double-blind, placebo-controlled trial in patients with nr-axSpA who are naive to bDMARDs.13
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Datum fӧr senaste ӧversyn 2019 M06 20