Taltz is approved to treat adult patients with:
*SPIRIT-P1 at week 24 (Taltz 80 mg every 4 weeks n=107; placebo n=106).
†SPIRIT-P2 at week 24 (Taltz 80 mg every 4 weeks n=122; placebo n=118).
Inadequate responders (<20% improvement in tender and in swollen joint counts) at week 16 were analyzed as nonresponders after week 16 until the primary endpoint.
Primary endpoint=ACR20 response at week 24.
In SPIRIT-P1 (biologic-naive, ≥3% BSA) (Taltz 80 mg every 4 weeks n=73, placebo n=67) and SPIRIT-P2 (TNFi-experienced, ≥3% BSA) (Taltz 80 mg every 4 weeks n=68, placebo n=67), 75% and 57% of patients receiving Taltz achieved PASI 75, respectively, at week 12 vs 8% and 10% of patients taking placebo.2,3
In SPIRIT-P1, among patients with sPGA ≥3 at baseline (Taltz n=52, placebo n=41) 75% of patients taking Taltz achieved sPGA 0,1 at week 12 vs 7% of patients who received placebo. In SPIRIT-P2, among patients with sPGA≥3 at baseline (Taltz n=60, placebo n=55), 63% of patients taking Taltz achieved sPGA 0,1 at week 12 vs 4% of patients who received placebo.4
‡Defined as BSA ≥10%.
§UNCOVER-2 at week 12 (Taltz n=351; placebo n=168).
Co-primary endpoints=PASI 75 and sPGA 0,1 at week 12.
Taltz patients in UNCOVER-1 (Taltz 80 mg every 2 weeks n=433; placebo n=431) and UNCOVER-3 (Taltz 80 mg every 2 weeks n=385; placebo n=193) achieved similar results: 89% and 87% of Taltz patients achieved PASI 75 vs 4% and 7% for placebo. Additionally, 71% and 68% of Taltz patients achieved PASI 90 vs 1% and 3% for placebo, and 35% and 38% achieved PASI 100 vs 0% and 0% for placebo. Also, 82% and 81% of Taltz patients achieved sPGA 0,1 vs 3% and 7% for placebo.4
ACR20/50/70=American College of Rheumatology 20%/50%/70% response rate; BSA=body surface area; TNFi=tumor necrosis factor inhibitor; PASI=Psoriasis Area and Severity Index; sPGA=static Physician's Global Assessment.
References
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Psoriatic Arthritis:
Taltz is indicated for the treatment of adult patients with active psoriatic arthritis.
Plaque Psoriasis:
Taltz is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.
Infections
Taltz may increase the risk of infection. In clinical trials of patients with plaque psoriasis, the Taltz group had a higher rate of infections than the placebo group (27% vs 23%). A similar increase in risk of infection was seen in placebo-controlled trials of patients with psoriatic arthritis. Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.
Pre-Treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Taltz. Do not administer to patients with active TB infection. Initiate treatment of latent TB prior to administering Taltz. Closely monitor patients receiving Taltz for signs and symptoms of active TB during and after treatment.
Hypersensitivity
Serious hypersensitivity reactions, including angioedema and urticaria (each ≤0.1%), occurred in the Taltz group in clinical trials. Anaphylaxis, including cases leading to hospitalization, has been reported in post-marketing use with Taltz. If a serious hypersensitivity reaction occurs, discontinue Taltz immediately and initiate appropriate therapy.
Inflammatory Bowel Disease
During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease. Crohn’s disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group (Crohn’s disease 0.1%, ulcerative colitis 0.2%) than in the placebo group (0%) during clinical trials in patients with plaque psoriasis.
Immunizations
Prior to initiating therapy with Taltz, consider completion of all age-appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with Taltz.
Most common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections. Overall, the safety profile observed in patients with psoriatic arthritis was consistent with the safety profile in patients with plaque psoriasis, with the exception of influenza and conjunctivitis.
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By using the Taltz Savings Card ("Card"), you attest that you meet the eligibility criteria and will comply with the Terms and Conditions described below:
Offer void where prohibited by law. This offer is invalid for patients without commercial insurance coverage or those whose prescription claims are eligible to be reimbursed, in whole or in part, by any governmental program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medigap, DOD, VA, TRICARE/CHAMPUS, or any state patient or pharmaceutical assistance program. If you live in Massachusetts, the Card expires on the earlier of: (i) the expiration date of this card (12/31/2021); (ii) the date an AB-rated generic equivalent for Taltz becomes available; or (iii) June 30, 2019, absent a change in Massachusetts state law. If you live in California, the card expires on the earlier of: (i) the expiration date of this card (12/31/2021) or (ii) the date an FDA approved therapeutically equivalent for Taltz or over the counter product with the same active ingredients becomes available. Available only in the US and Puerto Rico for residents of the US and Puerto Rico.
By accepting this offer, you agree that if you are required to do so under the terms of your insurance coverage for this prescription or are otherwise required to do so by law, you should notify your insurance carrier of your redemption of this Card. This offer is not valid with any other program, discount, incentive, or similar offer involving Taltz. It is prohibited for any person to sell, purchase, or trade; or to offer to sell, purchase or trade; or to counterfeit this Card. This offer may be terminated, rescinded, revoked or amended by Lilly USA, LLC, at any time without notice. This Card is not health insurance. This Card expires on 12/31/2021. Patients must first use their card by 12/31/2018 and are eligible for savings for up to 36 months of therapy.
SPIRIT-P1 (N=417) and SPIRIT-P2 (N=363) were phase 3, randomized, double-blind, placebo-controlled trials to evaluate the efficacy and safety of Taltz compared with placebo in patients with active psoriatic arthritis. Patients in SPIRIT-P1 were biologic-naive. Patients in SPIRIT-P2 were tumor necrosis factor (TNFi)-experienced, having had an inadequate response and/or intolerance to 1 or 2 prior TNFis. In both trials, the primary efficacy endpoint was the proportion of patients achieving ACR20 response at week 24. All patients were ≥18 years of age and had ≥3 swollen and ≥3 tender joints. Patients were randomized to placebo or Taltz 80 mg every 2 or 4 weeks following a 160 mg starting dose. In SPIRIT-P1, an active reference arm of adalimumab 40 mg every 2 weeks was included. Patients in all study arms were allowed to continue taking stable background medications during the trial. Inadequate responders (as defined by blinded criteria of <20% improvement in tender and in swollen joint counts) at week 16 received rescue therapy and were analyzed as nonresponders after week 16 until the primary endpoint. After receiving rescue therapy, inadequate responders in the placebo and adalimumab arms were re-randomized to Taltz 80 mg every 2 or 4 weeks. Nonresponder imputation (NRI) methods were used for categorical efficacy analyses during the double-blind treatment period.
The Taltz plaque psoriasis clinical program included 3 randomized, double-blind, placebo-controlled trials to evaluate the efficacy and safety of Taltz. All patients were ≥18 years of age and had plaque psoriasis with a body surface area involvement of ≥10%, a static Physician’s Global Assessment (sPGA) score ≥3, and a Psoriasis Area Severity Index (PASI) score ≥12, and were candidates for phototherapy or systemic therapy. Participants were randomized to receive placebo or Taltz 80 mg every 2 weeks following a 160 mg starting dose. In UNCOVER-2 and -3, an additional arm of US-approved etanercept (50 mg twice weekly) was included. Co-primary efficacy endpoints were proportion of patients with an sPGA 0,1 and at least a 2-point improvement from baseline and proportion of patients achieving PASI 75 (at least a 75% reduction in the PASI composite score) at week 12. Nonresponder imputation (NRI) methods were used for categorical efficacy analyses.
Patients originally randomized to Taltz who were responders at week 12 (ie, sPGA 0,1) in UNCOVER-1 and -2 were re-randomized to either Taltz 80 mg every 4 weeks or placebo for an additional 48 weeks. Patients who relapsed (sPGA ≥3) at any time during the maintenance period were classified as nonresponders at week 60.
*Pay no more than $25 monthly and as little as $5 monthly. $5 Monthly offer subject to a maximum annual benefit of $16,000. $25 Monthly offer subject to a monthly and annual cap of usual and customary pharmacy charges. If you meet program eligibility requirements, have commercial insurance, and your insurance provider covers Taltz, you are eligible to pay $5 monthly. If you meet program eligibility requirements, have commercial insurance, and your insurance provider denies coverage for Taltz after 2 requests for coverage attempts, you are eligible to pay $25 monthly. To participate in the $25 monthly program, eligible patients will need to contact Taltz Together to verify eligibility. To continue to participate in the $25 program, patients who qualify for the $25 monthly program are required to have a new benefits investigation and request for coverage completed 3 months post program initiation, 6 months post program initiation, and then every 6 months thereafter, as well as in January of every year, to verify coverage status and potential eligibility for the $5 monthly program. Card activation for both the $5 and $25 monthly programs is good for up to 24 months from patient qualification into the program. Subject to the terms and conditions of the program, patients may be eligible to re-enroll provided they continue to meet program criteria.
†Eligibility Criteria: By using the Taltz Savings Card (“Card”), you attest that you meet the eligibility criteria and will comply with the Terms and Conditions described below:
Offer void where prohibited by law. This offer is invalid for patients without commercial insurance coverage or those whose prescription claims are eligible to be reimbursed, in whole or in part, by any governmental program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medigap, DOD, VA, TRICARE/CHAMPUS, or any state patient or pharmaceutical assistance program. If you live in Massachusetts, the Card expires on the earlier of: (i) the expiration date of this Card (December 31, 2018); (ii) the date an AB-rated generic equivalent for Taltz becomes available; or (iii) July 1, 2017, absent a change in Massachusetts state law. Available only in the US and Puerto Rico for residents of the US and Puerto Rico.
By accepting this offer, you agree that if you are required to do so under the terms of your insurance coverage for this prescription or are otherwise required to do so by law, you should notify your insurance carrier of your redemption of this Card. This offer is not valid with any other program, discount, incentive, or similar offer involving Taltz. It is prohibited for any person to sell, purchase or trade; or to offer to sell, purchase or trade; or to counterfeit this Card. This offer may be terminated, rescinded, revoked, or amended by Lilly USA, LLC, at any time without notice. This Card is not health insurance. This Card expires on 12/31/2018. Patients must first use their Card by 12/31/2016 and are eligible for savings for up to 24 months of therapy.
