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Efficacy

ACR RESPONSES

In Clinical Trials of Patients with Active Psoriatic Arthritis

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Taltz provided significant improvement in joint symptoms at week 24, as measured by ACR201,3

Primary endpoint=ACR20 response at week 24.

Nonresponder imputation (NRI) of intent-to-treat population through week 52. After Week 24, patients knew they were taking active treatment, but remained blind to the dose until the last patient completed week 24. The uncontrolled extension period of the study has limitations (eg, no placebo comparisons, patients remaining in the study may be those with better results).

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.

In SPIRIT-P2 (TNFi-experienced) (Taltz 80 mg every 4 weeks n=122; placebo n=118), 53% of Taltz patients achieved ACR20 at week 24 vs 20% for placebo. Additionally, 35% and 22% of Taltz patients achieved ACR50 and ACR70, respectively, at week 24 vs 5% and 0% for placebo.

ACR20/50/70=American College of Rheumatology 20%/50%/70% response rate.

Select Important Safety Information

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.

In Clinical Trials of Patients with Active Psoriatic Arthritis

FOR TNFi-EXPERIENCED PATIENTS WITH PSORIATIC ARTHRITIS

Taltz provided significant improvement in joint symptoms at week 24, as measured by ACR20, in patients who had an intolerance to or failed 1 or 2 TNF inhibitors1

Primary endpoint=ACR response at week 24

Nonresponder imputation (NRI) of intent-to-treat population through week 24.

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.

In SPIRIT-P1 (biologic-naive) (Taltz 80 mg every 4 weeks n=107, placebo n=106), 58% of Taltz patients achieved ACR20 at week 24 vs 30% for placebo. Additionally, 40% and 23% of Taltz patients vs 15% and 6% for placebo achieved ACR50 and ACR70, respectively, at week 24.

TNFi=tumor necrosis factor inhibitor; NRI=nonresponder imputation; ACR20/50/70=American College of Rheumatology 20%/50%/70% response rate.

Select Important Safety Information

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.

Structure

In Clinical Trials of Patients with Active Psoriatic Arthritis

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Taltz inhibited progression of structural joint damage in patients at week 16 vs placebo.1,4,5

Primary endpoint=ACR20 response at week 24.

Inhibition of progression of structural damage was assessed radiographically and expressed as the mean change in mTSS and its components, the joint space narrowing score and bone erosion score, at week 24 vs baseline. The mTSS score was modified for psoriatic arthritis by addition of hand distal interphalangeal (DIP) joints.

mTSS=modified Total Sharp Score; MMRM=mixed-effect model of repeated measure.

SPIRIT-P2 (TNFi-experienced) did not include an assessment of radiographic progression.

Select Important Safety Information

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.

DactylITis and enthesitis

In Clinical Trials of Patients with Active Psoriatic Arthritis

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Treatment with Taltz resulted in improvement in dactylitis in patients with pre-existing dactylitis2,5,6

The data presented were from post hoc analyses and were not type-I error-controlled; therefore, treatment differences between Taltz and placebo cannot be regarded as statistically significant. Mean baseline LDI-B was 73.0 for Taltz and 62.7 for placebo.

Primary endpoint=ACR20 response at week 24.

In SPIRIT-P2 (TNFi-experienced) (Taltz 80 mg every 4 weeks n=28, mean baseline=31.5; placebo n=14, mean baseline=37.3), 68% and 75% of Taltz patients had complete resolution of dactylitis at weeks 12 and 24, respectively, vs 36% and 21% for placebo.

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.

LDI-B=Leeds Dactylitis Index-Basic.

Select Important Safety Information

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.

In Clinical Trials of Patients with Active Psoriatic Arthritis

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Taltz showed improvement in enthesitis in patients with pre-existing enthesitis2,5,6

The data presented were from post-hoc analyses and were not type-I error-controlled; therefore, treatment differences between Taltz and placebo cannot be regarded as statistically significant. In addition the mean change from baseline in LEI score at week 12 (pre-specified endpoint in SPIRIT-P1) was error-controlled, but was not statistically significant compared to placebo.

Mean baseline LEI was 2.7 for Taltz patients and 2.9 for placebo.9

Primary endpoint=ACR20 response at week 24.

In SPIRIT-P2 (TNFi-experienced) in patients with LEI >0 (Taltz 80 mg every 4 weeks n=68, mean baseline=2.9; placebo n=69, mean baseline=2.9), LEI=0 at week 24, a prespecified, error-controlled endpoint, was not statistically significant vs placebo. At weeks 12 and 24, 28% and 35% of patients receiving Taltz had LEI=0, respectively, vs 29% and 22% for placebo.

LEI=Leeds Enthesitis Index.

Select Important Safety Information

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.

concomitant MTX use

In Clinical Trials of Patients with Active Psoriatic Arthritis

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

ACR20 response vs placebo with or without concomitant methotrexate1,7

With concomitant MTX
Taltz (n=57), placebo (n=59)

Without concomitant MTX
Taltz (n=50), placebo (n=47)

All patients were allowed to remain on stable background therapy.

Nonresponder imputation (NRI) of intent-to-treat population through week 24.

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.

In SPIRIT-P2 (TNFi-experienced) (Taltz 80 mg every 4 weeks n=48; placebo n=40), 50% of Taltz patients achieved ACR20 with concomitant MTX at week 24 vs 18% for placebo. Additionally (Taltz n=74; placebo n=78), 55% of Taltz patients achieved ACR20 without MTX use at week 24 vs 21% for placebo.8

All patients in SPIRIT-P2 previously treated with at least 1 cDMARD (methotrexate, sulfasalazine, leflunomide, or hydroxychloroquine).8

cDMARD=conventional disease-modifying antirheumatic drug.

Select Important Safety Information

INFLAMMATORY BOWEL DISEASE

During Taltz treatment, monitor patients for onset or exacerbation 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.

References

  1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.
  2. Mease PJ, van der Heijde D, Ritchlin CT, et al; on behalf of 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;76:79-87.
  3. Désirée van der Heijde, Dafna Gladman, Mitsumasa Kishimoto, et al. Efficacy and Safety of Ixekizumab in Patients with Active Psoriatic Arthritis: 52-week Results from a Phase 3 Study (SPIRIT-P1). The Journal of Rheumatology, 2018; 45:3; doi:10.3899/jrheum.170429.
  4. Data on file. Lilly USA, LLC. TAL20171026B.
  5. Nash P, Kirkham B, Okada M, et al; on behalf of 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;389:2317-2327.
  6. Nash P, Kirkham B, Okada M, et al; on behalf of 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-2 phase 3 trial. Lancet. 2017;389:2317-2327. Supplementary appendix.
  7. Data on file. Lilly USA, LLC. TAL20170919A.
  8. Data on file. Lilly USA, LLC. TAL20171026A.
  9. Data on file. Lilly USA, LLC. TAL20171002A.

psoriatic arthritis

In Clinical Trials of Patients with Active Psoriatic Arthritis

FOR BIOLOGIC-NAIVE PATIENTS WITH PSORIATIC ARTHRITIS

Treatment with TALTZ resulted in an improvement in psoriatic skin lesions1-4,6

In SPIRIT-P1, among patients with sPGA≥3 at baseline (Taltz 80 mg every 4 weeks n=52; placebo n=41) 75% of patients taking Taltz achieved sPGA 0,1 at week 12 vs 7% of patients who received placebo. Additionally, 31% of patients receiving Taltz achieved sPGA 0 vs 2% for placebo.

Nonresponder imputation (NRI) of intent-to-treat population through week 12.

Primary endpoint=ACR20 at week 24.

In SPIRIT-P2 (TNFi-experienced, ≥3% BSA) (Taltz 80 mg every 4 weeks n=68, placebo n=67), 57% of Taltz patients achieved PASI 75 at week 12 vs 10% for placebo. Additionally, 38% and 19% of Taltz patients achieved PASI 90 and PASI 100, respectively, at week 12 vs 6% and 6% for placebo. 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. Additionally, 23% of Taltz patients achieved sPGA 0 vs 2% for placebo.

PASI=Psoriasis Area Severity Index; BSA=body surface area.

Select Important Safety Information

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.

In Clinical Trials of Patients with Active Psoriatic Arthritis

For TNFi-EXPERIENCED PATIENTS WITH PSORIATIC ARTHRITIS

Taltz improved skin symptoms, as measured by PASI 75 and sPGA 0,1 at week 12, in patients who had an intolerance to or failed 1 or 2 TNF inhibitors1-5

In SPIRIT-P2, among patients with sPGA ≥3 at baseline (Taltz 80 mg every 4 weeks n=60, placebo n=55), 63% of patients taking Taltz achieved sPGA 0,1 at week 12 vs 4% of patients who received placebo. Additionally, 23% of patients receiving Taltz achieved sPGA 0 vs 2% for placebo.

Nonresponder imputation (NRI) of intent-to-treat population through week 12.

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 at week 24.

In SPIRIT-P1 (biologic-naive, ≥3% BSA) (Taltz 80 mg every 4 weeks n=73; placebo n=67), 75% of Taltz patients achieved PASI 75 at week 12 vs 8% for placebo. Additionally, 52% and 32% of Taltz patients achieved PASI 90 and PASI 100, respectively, at week 12 vs 2% and 2% for placebo. Among patients with sPGA ≥3 at baseline (Taltz 80 mg every 4 weeks n=52, placebo n=41), 75% of patients taking Taltz achieved sPGA 0,1 at week 12 vs 7% of patients who received placebo. Additionally, 31% of patients receiving Taltz achieved sPGA 0 vs 2% for placebo.

PASI=Psoriasis Area Severity Index; TNF=tumor necrosis factor; BSA=body surface area.

Select Important Safety Information

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.

Plaque Psoriasis

In Clinical Trials of Patients with Moderate to Severe Plaque Psoriasis

Taltz can provide high levels of clearance—even complete resolution of plaques (PASI 100) is possible1

In UNCOVER-2, 83% of patients taking Taltz 80 mg every 2 weeks achieved clear or almost clear skin (sPGA 0,1) vs 2% who received placebo.

  • In the 3 pivotal trials, examination of age, gender, race, body weight, and previous treatment with a biologic did not identify differences in response to Taltz among these subgroups at week 121
Additional Results

In UNCOVER-1 (Taltz n=433; placebo n=431) and UNCOVER-3 (Taltz n=385; placebo n=193), Taltz patients 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.

sPGA=static Physician's Global Assessment.

Taltz is the first and only interleukin-17A (IL-17A) antagonist approved for moderate to severe plaque psoriasis that includes PASI 100 in the Prescribing Information.1

Select Important Safety Information

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.

References

  1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.
  2. Mease PJ, van der Heijde D, Ritchlin CT, et al; on behalf of 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;76:79-87.
  3. Nash P, Kirkham B, Okada M, et al; on behalf of the 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;389:2317-2327.
  4. Nash P, Kirkham B, Okada M, et al; on behalf of 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-2 phase 3 trial. Lancet. 2017;389:2317-2327. Supplementary appendix.
  5. Data on file. Lilly USA, LLC. TAL20171127A.
  6. Data on file. Lilly USA, LLC. TAL20170215BB.
  7. Data on file. Lilly USA, LLC. TAL20171023A.

In Clinical Trials of Patients with Moderate to Severe Plaque Psoriasis

Reassure your patients* that consistent results can be maintained with Taltz at week 601

Of the patients who completed 60 weeks of treatment without relapse (sPGA ≥3) or discontinuation (n=147), 92% maintained clear or almost clear skin (sPGA 0,1) at week 60 based on an observed analysis.

Patients who achieved clear or almost clear skin (sPGA 0,1) after initial treatment with Taltz 80 mg every 2 weeks were re-randomized at week 12 to receive either Taltz 80 mg every 4 weeks (n=181) or placebo (n=203).

*Patient responders at week 12.

NRI=Nonresponder imputation.

sPGA=static Physician's Global Assessment.

Taltz is the first and only interleukin-17A (IL-17A) antagonist approved for moderate to severe plaque psoriasis that includes PASI 100 in the Prescribing Information.1

Select Important Safety Information

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.

References

  1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.
  2. Mease PJ, van der Heijde D, Ritchlin CT, et al; on behalf of 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;76:79-87.
  3. Nash P, Kirkham B, Okada M, et al; on behalf of the 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;389:2317-2327.
  4. Nash P, Kirkham B, Okada M, et al; on behalf of 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-2 phase 3 trial. Lancet. 2017;389:2317-2327. Supplementary appendix.
  5. Data on file. Lilly USA, LLC. TAL20171127A.
  6. Data on file. Lilly USA, LLC. TAL20170215BB.
  7. Data on file. Lilly USA, LLC. TAL20171023A.

In Clinical Trials of Patients with Moderate to Severe Plaque Psoriasis

PASI 75, PASI 90, and PASI 100 Results at Weeks 60, 108, and 1567

Induction Period and Open-Label Extension

156 Week Data
156 Week Data

In an mNRI analysis of patients receiving Taltz at week 60, 89% of patients achieved PASI 75, 77% of patients achieved PASI 90, and 57% of patients achieved PASI 100. In an mNRI analysis of patients receiving Taltz at weeks 108 and 156, 84% and 81% of patients achieved PASI 75, 69% and 66% of patients achieved PASI 90, and 48% and 45% of patients achieved PASI 100. mNRI of intent-to-treat population through week 156. mNRI analysis imputes missing data due to study drug (eg, inadequate response, adverse event, or lack of efficacy) as nonresponse; whereas, missing data due to other reasons (eg, missed visits, lost to follow up) is included as a predicted value based on statistical modeling of observed data.

Patient and site personnel were blinded to study treatment until all patients completed week 12 or discontinued. The open label extension phase of the study has limitations (eg, no placebo comparison, patients remaining in the extension phase may be those with better results).

Analyses from UNCOVER-3, outcomes through week 156 mNRI and observed are post-hoc.

*A subset of moderate to severe plaque psoriasis patients from UNCOVER-3 who received a 160 mg starting dose of Taltz at week 0, followed by 80 mg every 2 weeks through week 12, followed by 80 mg every 4 weeks

Nx=observed population at week 156.

mNRI=modified nonresponder imputation.

Taltz is the first and only interleukin-17A (IL-17A) antagonist approved for moderate to severe plaque psoriasis that includes PASI 100 in the Prescribing Information.1

Select Important Safety Information

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.

References

  1. Taltz [package insert]. Indianapolis, IN: Eli Lilly and Company; 2017.
  2. Mease PJ, van der Heijde D, Ritchlin CT, et al; on behalf of 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;76:79-87.
  3. Nash P, Kirkham B, Okada M, et al; on behalf of the 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;389:2317-2327.
  4. Nash P, Kirkham B, Okada M, et al; on behalf of 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-2 phase 3 trial. Lancet. 2017;389:2317-2327. Supplementary appendix.
  5. Data on file. Lilly USA, LLC. TAL20171127A.
  6. Data on file. Lilly USA, LLC. TAL20170215BB.
  7. Data on file. Lilly USA, LLC. TAL20171023A.
Indication and Important Safety Information

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.

IMPORTANT SAFETY INFORMATION

Contraindications

Taltz is contraindicated in patients with a previous serious hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.

Warnings and Precautions

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.

Adverse Reactions

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.

Please click to access the Prescribing Information and Medication Guide. Please see Instructions for Use included with the device.

IX HCP ISI 01DEC2017