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What is Taltz (ixekizumab)?
Taltz (ixekizumab) is a type of injectable biologic drug called a humanized interleukin-17A antagonist used to treat moderate to severe plaque psoriasis in patients who are candidates for phototherapy or medications that are absorbed into the bloodstream (systemic therapy).
Scientists believe psoriasis is caused by an increase in the production of T-lymphocytes in response to the attachment of a stimulant, such as interleukin, to the lymphocyte. Stimulated T-lymphocytes cause skin cells to grow rapidly, and the rapid growth of the skin cells produces the skin plaques of psoriasis.
Taltz reduces symptoms of psoriasis (inflammation and excessive production of skin cells) by attaching to IL-17A, preventing it from binding and activating T-lymphocytes.
Common side effects of Taltz include:
- injection site reactions,
- upper respiratory tract infections,
- tinea infections (such as ringworm, athlete's foot and jock itch),
- runny or stuffy nose,
- oral thrush,
- and conjunctivitis.
Serious side effects of Taltz include:
- inflammatory bowel disease (Crohn's disease, ulcerative colitis),
- antibody development against ixekizumab,
- low white blood cell count,
- low platelet count (thrombocytopenia),
- and serious infections.
Drug interactions of Taltz include live vaccines because patients may develop active disease from the live viruses contained in the vaccine due to their weakened immune system. Taltz may indirectly alter blood levels of warfarin, cyclosporine, and other drugs metabolized by liver enzymes called CYP450 because the formation of these liver enzymes is affected by the level of interleukins.
Use of Taltz in pregnant women has not been adequately evaluated. It is unknown if Taltz is secreted in breast milk or if there are effects on the nursing infant. Consult your doctor before breastfeeding.
What are the important side effects of Taltz (ixekizumab)?
Common side effects include:
Other important side effects include:
Possible serious side effects include:
- Inflammatory bowel disease (Crohn's disease, ulcerative colitis)
- Antibody development against ixekizumab
- Low white blood count
- Low platelet count (thrombocytopenia)
- Serious infections
Ixekizumab increases the risk of infections. Therefore, patients should be evaluated for a history of latent or active tuberculosis infections. Patients with active tuberculosis infection should not receive Ixekizumab.
Taltz (ixekizumab) side effects list for healthcare professionals
The following adverse drug reactions are discussed in greater detail in other sections of the label:
- Hypersensitivity Reactions
- Inflammatory Bowel Disease
Clinical Trials Experience
Because clinical trials are conducted under widely varying and controlled conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Weeks 0 To 12
Three placebo-controlled trials in subjects with plaque psoriasis were integrated to evaluate the safety of Taltz compared to placebo for up to 12 weeks. A total of 1167 subjects (mean age 45 years; 66% men; 94% White) with plaque psoriasis received Taltz (160 mg at Week 0, 80 mg every 2 weeks [Q2W] for 12 weeks) subcutaneously. In two of the trials, the safety of Taltz (use up to 12 weeks) was also compared with an active comparator, U.S. approved etanercept.
In the 12-week, placebo-controlled period, adverse events occurred in 58% of the Taltz Q2W group (2.5 per subject-year of follow-up) compared with 47% of the placebo group (2.1 per subject-year of follow-up). Serious adverse events occurred in 2% of the Taltz group (0.07 per subject-year of follow-up), and in 2% of the placebo group (0.07 per subject-year of follow-up).
Table 1 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the Taltz group than in the placebo group during the 12-week placebo-controlled period of the pooled clinical trials.
Table 1: Adverse Reactions Occurring in ≥1% of the Taltz Group and More Frequently than in the Placebo Group in the Plaque Psoriasis Clinical Trials through Week 12
|Adverse Reactions||Taltz 80 mg Q2W|
(N=1167) n (%)
|Injection site reactions||196 (17)||32 (11)||26 (3)|
|Upper respiratory tract infectionsa||163 (14)||23 (8)||101 (13)|
|Nausea||23 (2)||1 (<1)||5 (1)|
|Tinea infections||17 (2)||0||1 (<1)|
|a Upper respiratory tract infections cluster includes nasopharyngitis and rhinovirus infection.|
b U.S. approved etanercept.
Adverse reactions that occurred at rates less than 1% in the Taltz group and more frequently than in the placebo group during the 12-week induction period included rhinitis, oral candidiasis, urticaria, influenza, conjunctivitis, inflammatory bowel disease, and angioedema.
Weeks 13 To 60
A total of 332 subjects received the recommended maintenance regimen of Taltz 80 mg dosed every 4 weeks.
During the maintenance period (Weeks 13 to 60), adverse events occurred in 80% of subjects treated with Taltz (1.0 per subject-year of follow-up) compared to 58% of subjects treated with placebo (1.1 per subject-year of follow-up). Serious adverse events were reported in 4% of subjects treated with Taltz (0.05 per subject-year of follow-up) and none in the subjects treated with placebo.
Weeks 0 To 60
Over the entire treatment period (Weeks 0 to 60), adverse events were reported in 67% of subjects treated with Taltz (1.4 per subject-year of follow-up) compared to 48% of subjects treated with placebo (2.0 per subject-year of follow-up). Serious adverse events were reported in 3% of subjects treated with Taltz (0.06 per subject-year of followup), and in 2% of subjects treated with placebo (0.06 per subject-year of follow-up).
Specific Adverse Drug Reactions
Injection Site Reactions
The most frequent injection site reactions were erythema and pain. Most injection site reactions were mild-tomoderate in severity and did not lead to discontinuation of Taltz.
In the 12-week, placebo-controlled period of the clinical trials in plaque psoriasis, infections occurred in 27% of subjects treated with Taltz (1.2 per subject-year of follow-up) compared to 23% of subjects treated with placebo (1.0 per subject-year of follow-up). Serious infections occurred in 0.4% of subjects treated with Taltz (0.02 per subject-year of follow-up) and in 0.4% of subjects treated with placebo (0.02 per subject-year of follow-up).
During the maintenance treatment period (Weeks 13 to 60), infections occurred in 57% of subjects treated with Taltz (0.70 per subject-year of follow-up) compared to 32% of subjects treated with placebo (0.61 per subject-year of follow-up). Serious infections occurred in 0.9% of subjects treated with Taltz (0.01 per subject-year of follow-up) and none in the subjects treated with placebo.
Over the entire treatment period (Weeks 0 to 60), infections were reported in 38% of subjects treated with Taltz (0.83 per subject-year of follow-up) compared to 23% of subjects treated with placebo (1.0 per subject-year of follow-up). Serious infections occurred in 0.7% of subjects treated with Taltz (0.02 per subject-year of follow-up), and in 0.4% of subject treated with placebo (0.02 per subject-year of follow-up).
Laboratory Assessment Of Cytopenia
Over the entire treatment period (Weeks 0 to 60), neutropenia occurred in 11% of subjects treated with Taltz (0.24 per subject-year of follow-up) compared to 3% of subjects treated with placebo (0.14 per subject-year of follow-up). In subjects treated with Taltz, the incidence rate of neutropenia during Weeks 13 to 60 was lower than the incidence rate during Weeks 0 to 12.
In the 12-week, placebo-controlled period, neutropenia ≥ Grade 3 (<1,000 cells/mm²) occurred in 0.2% of the Taltz group (0.007 per subject-year of follow-up) compared to 0.1% of the placebo group (0.006 per subject-year of follow-up). The majority of cases of neutropenia were either Grade 2 (2% for Taltz 80 mg Q2W versus 0.3% for placebo; ≥1,000 to <1,500 cells/mm²) or Grade 1 (7% for Taltz 80 mg Q2W versus 3% for placebo; ≥1,500 cells/mm² to <2,000 cells/mm²). Neutropenia in the Taltz group was not associated with an increased rate of infection compared to the placebo group.
Ninety eight percent of cases of thrombocytopenia were Grade 1 (3% for Taltz 80 mg Q2W versus 1% for placebo; ≥75,000 cells/mm² to <150,000 cells/mm²). Thrombocytopenia in subjects treated with Taltz was not associated with an increased rate of bleeding compared to subjects treated with placebo.
Active Comparator Trials
In the two clinical trials that included an active comparator, the rate of serious adverse events during weeks zero to twelve was 0.7% for U.S. approved etanercept and 2% for Taltz 80 mg Q2W, and the rate of discontinuation from adverse events was 0.7% for U.S. approved etanercept and 2% for Taltz 80 mg Q2W. The incidence of infections was 18% for U.S. approved etanercept and 26% for Taltz 80 mg Q2W. The rate of serious infections was 0.3% for both Taltz 80 mg Q2W and U.S. approved etanercept.
Taltz was studied in two placebo-controlled trials in patients with psoriatic arthritis. A total of 678 patients were studied (454 patients on Taltz and 224 on placebo). A total of 229 patients in these trials received Taltz 160 mg at Week 0, followed by 80 mg every 4 weeks (Q4W). Overall, the safety profile observed in patients with psoriatic arthritis treated with Taltz Q4W is consistent with the safety profile in patients with plaque psoriasis with the exception of the frequencies of influenza (1.3%) and conjunctivitis (1.3%).
Taltz was studied in two placebo-controlled trials in patients with ankylosing spondylitis. A total of 566 patients were studied (376 patients on Taltz and 190 on placebo). A total of 195 patients in these trials received Taltz 80 or 160 mg at Week 0, followed by 80 mg every 4 weeks (Q4W). Overall, the safety profile observed in patients with ankylosing spondylitis treated with Taltz Q4W is consistent with the safety profile in patients with plaque psoriasis.
As with all therapeutic proteins there is the potential for immunogenicity with Taltz. The assay to test for neutralizing antibodies has limitations detecting neutralizing antibodies in the presence of ixekizumab; therefore, the incidence of neutralizing antibodies development could be underestimated.
Plaque Psoriasis Population
By Week 12, approximately 9% of subjects treated with Taltz every 2 weeks developed antibodies to ixekizumab. Approximately 22% of subjects treated with Taltz at the recommended dosing regimen developed antibodies to ixekizumab during the 60-week treatment period. The clinical effects of antibodies to ixekizumab are dependent on the antibody titer; higher antibody titers were associated with decreasing drug concentration and clinical response.
Of the subjects who developed antibodies to ixekizumab during the 60-week treatment period, approximately 10%, which equates to 2% of subjects treated with Taltz at the recommended dosing regimen, had antibodies that were classified as neutralizing. Neutralizing antibodies were associated with reduced drug concentrations and loss of efficacy.
Psoriatic Arthritis Population
For subjects treated with Taltz 80 mg every 4 weeks for up to 52 weeks (PsA1), 11% developed anti-drug antibodies, and 8% had confirmed neutralizing antibodies.
Ankylosing Spondylitis Population
For patients treated with Taltz 80 mg every 4 weeks for up to 16 weeks (AS1, AS2), 5.2% developed anti-drug antibodies, and 1.5% had neutralizing antibodies.
The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to Taltz across indications or with the incidences of antibodies to other products may be misleading.
The following adverse reactions have been identified during post-approval use of Taltz. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Taltz exposure.
Immune system disorders: anaphylaxis.
What drugs interact with Taltz (ixekizumab)?
Avoid use of live vaccines in patients treated with Taltz.
Cytochrome P450 Substrates
The formation of CYP450 enzymes can be altered by increased levels of certain cytokines (e.g., IL-1, IL-6, IL-10, TNFα, IFN) during chronic inflammation. Thus, Taltz, an antagonist of IL-17A, could normalize the formation of CYP450 enzymes.
Therefore, upon initiation or discontinuation of Taltz in patients who are receiving concomitant drugs which are CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for effect (e.g., for warfarin) or drug concentration (e.g., for cyclosporine) and consider dosage modification of the CYP450 substrate.
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Picture of Psoriasis 2
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Silvery-white scaly plaque, sharply demarcated, of irregular configuration. See a picture of Psoriasis Vulgaris Palms and learn...
Picture of Guttate Psoriasis
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Picture of Inverse Psoriasis
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Pustular psoriasis is an uncommon form of psoriasis. See a picture of Pustular Psoriasis and learn more about the health topic.
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Related Disease Conditions
Psoriasis is a long-term skin condition that may cause large plaques of red, raised skin, flakes of dry skin, and skin scales. There are several types of psoriasis, including psoriasis vulgaris, guttate psoriasis, inverse psoriasis, and pustular psoriasis. Symptoms vary depending on the type of psoriasis the patient has. Treatment of psoriasis may include creams, lotions, oral medications, injections and infusions of biologics, and light therapy. There is no cure for psoriasis.
Scalp Psoriasis (Psoriasis of the Scalp)
Scalp psoriasis causes red, raised, scaly patches that may extend from the scalp to the forehead and the back of the neck and ears. Symptoms and signs include itching, hair loss, flaking, silvery scales, and red plaques. Treatment includes topical medicated shampoos, creams, gels, oils, ointments, and soaps, medications, and light therapy.
What Is the Best Treatment for Psoriasis?
Psoriasis is an incurable chronic autoimmune disorder of the skin that causes patches of thick, flaky, scaly skin, mostly around the scalp, knees, and elbows, though any skin surface may be involved. Some people experience only small patches while others have red, inflamed skin and think scaly patches all over the body. The exact cause of psoriasis is not clear, but it isn’t contagious.
Is Psoriasis Contagious?
Psoriasis is an incurable skin disease that causes reddish patches of skin topped with a thick layer of dry silvery scales. Psoriasis cannot spread and is not contagious.
Treatment & Diagnosis
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.