Taltz Citrate-Free: The same active ingredient with significantly less injection site pain vs the original formulation^1*
^*P<.0001; 3.5 vs 25.2 based on VAS 0-100

Psoriatic Arthritis Safety

Data at weeks 24 and 52

IN PSORIATIC ARTHRITIS TRIALS

Common adverse events in pooled SPIRIT-P1 and -P2 trials that occurred through week 52^2,3

Table Image 1 — Adverse Events that Occurred in ≥2% of Taltz Patients and More Frequently Than With Placebo Through Week 24

Adverse Events
Taltz 80mg every 4 weeks (n=229) n (%)
Placebo (n=224) n (%)

Overall injection site reactions* Taltz 80mg every 4 weeks (n=229) n (%)40 (17.5%) Placebo (n=224) n (%)10 (4.5%)

Mild injection site reactions Taltz 80mg every 4 weeks (n=229) n (%)34 (14.8%) Placebo (n=224) n (%)6 (2.7%)

Moderate injection site reactions Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%) Placebo (n=224) n (%)3 (1.3%)

Severe injection site reactions Taltz 80mg every 4 weeks (n=229) n (%)1 (0.4%) Placebo (n=224) n (%)1 (0.4%)

Upper respiratory tract infections^† Taltz 80mg every 4 weeks (n=229) n (%)31 (13.5%) Placebo (n=224) n (%)25 (11.2%)

Diarrhea Taltz 80mg every 4 weeks (n=229) n (%)7 (3.1%) Placebo (n=224) n (%)6 (2.7%)

Headache Taltz 80mg every 4 weeks (n=229) n (%)10 (4.4%) Placebo (n=224) n (%)4 (1.8%)

Sinusitis Taltz 80mg every 4 weeks (n=229) n (%)9 (3.9%) Placebo (n=224) n (%)5 (2.2%)

Urinary tract infections Taltz 80mg every 4 weeks (n=229) n (%)8 (3.5%) Placebo (n=224) n (%)5 (2.2%)

Cough Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%) Placebo (n=224) n (%)4 (1.8%)

Back pain Taltz 80mg every 4 weeks (n=229) n (%)7 (3.1%) Placebo (n=224) n (%)2 (0.9%)

Oropharyngeal pain Taltz 80mg every 4 weeks (n=229) n (%)7 (3.1%) Placebo (n=224) n (%)1 (0.4%)

Arthralgia Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%) Placebo (n=224) n (%)2 (0.9%)

Tonsillitis Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%) Placebo (n=224) n (%)0 (0%)

Adverse Events that Occurred in ≥2% of Taltz Patients and More Frequently Than With Placebo Through Week 52 (cont'd)

Adverse Events
Taltz 80mg every 4 weeks (n=229) n (%)

Overall injection site reactions* Taltz 80mg every 4 weeks (n=229) n (%)44 (19.2%)

Mild injection site reactions Taltz 80mg every 4 weeks (n=229) n (%)36 (15.7%)

Moderate injection site reactions Taltz 80mg every 4 weeks (n=229) n (%)7 (3.1%)

Severe injection site reactions Taltz 80mg every 4 weeks (n=229) n (%)1 (0.4%)

Upper respiratory tract infections^† Taltz 80mg every 4 weeks (n=229) n (%)55 (24.0%)

Diarrhea Taltz 80mg every 4 weeks (n=229) n (%)7 (3.1%)

Headache Taltz 80mg every 4 weeks (n=229) n (%)13 (5.7%)

Sinusitis Taltz 80mg every 4 weeks (n=229) n (%)12 (5.2%)

Urinary tract infections Taltz 80mg every 4 weeks (n=229) n (%)15 (6.6%)

Cough Taltz 80mg every 4 weeks (n=229) n (%)7 (3.1%)

Back pain Taltz 80mg every 4 weeks (n=229) n (%)14 (6.1%)

Oropharyngeal pain Taltz 80mg every 4 weeks (n=229) n (%)8 (3.5%)

Arthralgia Taltz 80mg every 4 weeks (n=229) n (%)6 (2.6%)

Tonsillitis Taltz 80mg every 4 weeks (n=229) n (%)7 (3.1%)

Psoriatic arthropathy Taltz 80mg every 4 weeks (n=229) n (%)9 (3.9%)

Bronchitis Taltz 80mg every 4 weeks (n=229) n (%)7 (3.1%)

Muscle spasms Taltz 80mg every 4 weeks (n=229) n (%)6 (2.6%)

Depression Taltz 80mg every 4 weeks (n=229) n (%)6 (2.6%)

Pharyngitis Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%)

Hypertension Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%)

Osteoarthritis Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%)

Aspartate aminotransferase Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%)

Cystitis Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%)

Fatigue Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%)

Infections Through Week 24

Taltz 80mg every 4 weeks (n=229) n (%)
Placebo (n=224) n (%)

Infections Taltz 80mg every 4 weeks (n=229) n (%)77 (33.6%) Placebo (n=224) n (%)62 (27.7%)

Serious Infections Taltz 80mg every 4 weeks (n=229) n (%)1 (0.4%) Placebo (n=224) n (%)0 (0%)

Infections Through Week 52

Taltz 80mg every 4 weeks (n=229) n (%)

Infections Taltz 80mg every 4 weeks (n=229) n (%)112 (48.9%)

Serious Infections Taltz 80mg every 4 weeks (n=229) n (%)3 (1.3%)

Adverse Events	Taltz 80mg every 4 weeks (n=229) n (%)	Placebo (n=224) n (%)
Overall injection site reactions*	Taltz 80mg every 4 weeks (n=229) n (%)40 (17.5%)	Placebo (n=224) n (%)10 (4.5%)
Mild injection site reactions	Taltz 80mg every 4 weeks (n=229) n (%)34 (14.8%)	Placebo (n=224) n (%)6 (2.7%)
Moderate injection site reactions	Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%)	Placebo (n=224) n (%)3 (1.3%)
Severe injection site reactions	Taltz 80mg every 4 weeks (n=229) n (%)1 (0.4%)	Placebo (n=224) n (%)1 (0.4%)
Upper respiratory tract infections^†	Taltz 80mg every 4 weeks (n=229) n (%)31 (13.5%)	Placebo (n=224) n (%)25 (11.2%)
Diarrhea	Taltz 80mg every 4 weeks (n=229) n (%)7 (3.1%)	Placebo (n=224) n (%)6 (2.7%)
Headache	Taltz 80mg every 4 weeks (n=229) n (%)10 (4.4%)	Placebo (n=224) n (%)4 (1.8%)
Sinusitis	Taltz 80mg every 4 weeks (n=229) n (%)9 (3.9%)	Placebo (n=224) n (%)5 (2.2%)
Urinary tract infections	Taltz 80mg every 4 weeks (n=229) n (%)8 (3.5%)	Placebo (n=224) n (%)5 (2.2%)
Cough	Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%)	Placebo (n=224) n (%)4 (1.8%)
Back pain	Taltz 80mg every 4 weeks (n=229) n (%)7 (3.1%)	Placebo (n=224) n (%)2 (0.9%)
Oropharyngeal pain	Taltz 80mg every 4 weeks (n=229) n (%)7 (3.1%)	Placebo (n=224) n (%)1 (0.4%)
Arthralgia	Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%)	Placebo (n=224) n (%)2 (0.9%)
Tonsillitis	Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%)	Placebo (n=224) n (%)0 (0%)

Adverse Events	Taltz 80mg every 4 weeks (n=229) n (%)
Overall injection site reactions*	Taltz 80mg every 4 weeks (n=229) n (%)44 (19.2%)
Mild injection site reactions	Taltz 80mg every 4 weeks (n=229) n (%)36 (15.7%)
Moderate injection site reactions	Taltz 80mg every 4 weeks (n=229) n (%)7 (3.1%)
Severe injection site reactions	Taltz 80mg every 4 weeks (n=229) n (%)1 (0.4%)
Upper respiratory tract infections^†	Taltz 80mg every 4 weeks (n=229) n (%)55 (24.0%)
Diarrhea	Taltz 80mg every 4 weeks (n=229) n (%)7 (3.1%)
Headache	Taltz 80mg every 4 weeks (n=229) n (%)13 (5.7%)
Sinusitis	Taltz 80mg every 4 weeks (n=229) n (%)12 (5.2%)
Urinary tract infections	Taltz 80mg every 4 weeks (n=229) n (%)15 (6.6%)
Cough	Taltz 80mg every 4 weeks (n=229) n (%)7 (3.1%)
Back pain	Taltz 80mg every 4 weeks (n=229) n (%)14 (6.1%)
Oropharyngeal pain	Taltz 80mg every 4 weeks (n=229) n (%)8 (3.5%)
Arthralgia	Taltz 80mg every 4 weeks (n=229) n (%)6 (2.6%)
Tonsillitis	Taltz 80mg every 4 weeks (n=229) n (%)7 (3.1%)
Psoriatic arthropathy	Taltz 80mg every 4 weeks (n=229) n (%)9 (3.9%)
Bronchitis	Taltz 80mg every 4 weeks (n=229) n (%)7 (3.1%)
Muscle spasms	Taltz 80mg every 4 weeks (n=229) n (%)6 (2.6%)
Depression	Taltz 80mg every 4 weeks (n=229) n (%)6 (2.6%)
Pharyngitis	Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%)
Hypertension	Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%)
Osteoarthritis	Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%)
Aspartate aminotransferase	Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%)
Cystitis	Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%)
Fatigue	Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%)

	Taltz 80mg every 4 weeks (n=229) n (%)	Placebo (n=224) n (%)
Infections	Taltz 80mg every 4 weeks (n=229) n (%)77 (33.6%)	Placebo (n=224) n (%)62 (27.7%)
Serious Infections	Taltz 80mg every 4 weeks (n=229) n (%)1 (0.4%)	Placebo (n=224) n (%)0 (0%)

	Taltz 80mg every 4 weeks (n=229) n (%)
Infections	Taltz 80mg every 4 weeks (n=229) n (%)112 (48.9%)
Serious Infections	Taltz 80mg every 4 weeks (n=229) n (%)3 (1.3%)

Overall, the safety profile in patients with psoriatic arthritis (PsA) treated with Taltz is consistent with the safety profile in patients with plaque psoriasis (PsO). The exception is the higher frequency of influenza (Taltz=1.3%, placebo=0.4%) and conjunctivitis (Taltz=1.3%, placebo=0%) in the PsA safety population vs the plaque psoriasis (PsO) safety population.

^*The most frequent injection site reactions were erythema and pain. Most injection site reactions were mild to moderate in severity. Discontinuation due to injection site reactions at 24 weeks in the Taltz Q4W arm were 0.4% and 0.4% for placebo.

^†Upper respiratory tract infections cluster includes nasopharyngitis and rhinovirus infection. Pooled safety data from SPIRIT-P1 and SPIRIT-P2 clinical trials.

IN PSORIATIC ARTHRITIS TRIALS

Adverse events of special interest from pooled SPIRIT-P1 and -P2 trials through week 52^3,4

Table Image 2 — Adverse Events of Special Interest Through Week 24

Adverse Events
Taltz 80mg every 4 weeks (n=229) n (%)
Placebo (n=224) n (%)

Allergic reactions/
hypersensitivities^† Taltz 80mg every 4 weeks (n=229) n (%)10 (4.4%) Placebo (n=224) n (%)4 (1.8%)

Malignancy-related^‡ Taltz 80mg every 4 weeks (n=229) n (%)2 (0.9%) Placebo (n=224) n (%)0 (0%)

Depression Taltz 80mg every 4 weeks (n=229) n (%)4 (1.7%) Placebo (n=224) n (%)3 (1.3%)

*Candida* infections Taltz 80mg every 4 weeks (n=229) n (%)3 (1.3%) Placebo (n=224) n (%)0 (0%)

Oral candidiasis Taltz 80mg every 4 weeks (n=229) n (%)1 (0.4%) Placebo (n=224) n (%)0 (0%)

MACE Taltz 80mg every 4 weeks (n=229) n (%)0 (0%) Placebo (n=224) n (%)0 (0%)

Crohn’s disease/ulcerative colitis^§ Taltz 80mg every 4 weeks (n=229) n (%)0 (0%) Placebo (n=224) n (%)0 (0%)

Adverse Events of Special Interest Through Week 52

Adverse Events
Taltz 80mg every 4 weeks (n=229) n (%)

Allergic reactions/hypersensitivities^† Taltz 80mg every 4 weeks (n=229) n (%)15 (6.6%)

Malignancy-related^‡ Taltz 80mg every 4 weeks (n=229) n (%)2 (0.9%)

Depression Taltz 80mg every 4 weeks (n=229) n (%)6 (2.6%)

Candida infections Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%)

Oral candidiasis Taltz 80mg every 4 weeks (n=229) n (%)1 (0.4%)

MACE Taltz 80mg every 4 weeks (n=229) n (%)0 (0%)

Crohn’s disease/ulcerative colitis^§ Taltz 80mg every 4 weeks (n=229) n (%)0 (0%)

Adverse Events	Taltz 80mg every 4 weeks (n=229) n (%)	Placebo (n=224) n (%)
Allergic reactions/ hypersensitivities^†	Taltz 80mg every 4 weeks (n=229) n (%)10 (4.4%)	Placebo (n=224) n (%)4 (1.8%)
Malignancy-related^‡	Taltz 80mg every 4 weeks (n=229) n (%)2 (0.9%)	Placebo (n=224) n (%)0 (0%)
Depression	Taltz 80mg every 4 weeks (n=229) n (%)4 (1.7%)	Placebo (n=224) n (%)3 (1.3%)
Candida infections	Taltz 80mg every 4 weeks (n=229) n (%)3 (1.3%)	Placebo (n=224) n (%)0 (0%)
Oral candidiasis	Taltz 80mg every 4 weeks (n=229) n (%)1 (0.4%)	Placebo (n=224) n (%)0 (0%)
MACE	Taltz 80mg every 4 weeks (n=229) n (%)0 (0%)	Placebo (n=224) n (%)0 (0%)
Crohn’s disease/ulcerative colitis^§	Taltz 80mg every 4 weeks (n=229) n (%)0 (0%)	Placebo (n=224) n (%)0 (0%)

Adverse Events	Taltz 80mg every 4 weeks (n=229) n (%)
Allergic reactions/hypersensitivities^†	Taltz 80mg every 4 weeks (n=229) n (%)15 (6.6%)
Malignancy-related^‡	Taltz 80mg every 4 weeks (n=229) n (%)2 (0.9%)
Depression	Taltz 80mg every 4 weeks (n=229) n (%)6 (2.6%)
Candida infections	Taltz 80mg every 4 weeks (n=229) n (%)5 (2.2%)
Oral candidiasis	Taltz 80mg every 4 weeks (n=229) n (%)1 (0.4%)
MACE	Taltz 80mg every 4 weeks (n=229) n (%)0 (0%)
Crohn’s disease/ulcerative colitis^§	Taltz 80mg every 4 weeks (n=229) n (%)0 (0%)

Certain adverse events, such as MACE and malignancy, require longer observation periods and larger patient exposure to ascertain risk. Lilly is conducting continued long-term safety studies, including post-marketing studies, to continue to evaluate the safety of Taltz.

^†No confirmed cases of anaphylaxis in clinical trials. All incidents of allergic reactions/hypersensitivity were non-anaphylactic.

^‡Includes all patients with ≥1 Treatment Emergent Adverse Event (TEAE), including nonmelanoma skin cancer (NMSC) and prostate cancer.

^§Incidents of inflammatory bowel disease events were reported in the plaque psoriasis trial safety population with Taltz.

Patients with uncontrolled Ulcerative Colitis (UC) or Crohn's disease were excluded from the studies; however, patients with a personal or family history of UC/Crohn's were allowed in the study.

MACE=major adverse cerebrocardiovascular event.

Long-term data

Long-term safety across Taltz^3,5-8,12 demonstrated with more than 5 years of data in 8,000+ adult patients across 23 trials

Consistent results in adult patients across PsA, PsO, and axSpA populations

AEs of Special Interest: IR per 100 PYs^5-10

Table Image 3 — **AEs of special interest:** IR per 100 PYs[1-6]

All Taltz PsA (N=1401) PY=2247.6 as of March 2020
All Taltz axSpA (N=932) PY=1792.2 as of March 2021
All Taltz adult PsO (N=6449) PY=17,598.6 as of March 2020

Serious Infections All Taltz PsA (N=1401) PY=2247.6 as of March 20201.2 All Taltz axSpA (N=932) PY=1792.2 as of March 20211.1 All Taltz adult PsO (N=6449) PY=17,598.6 as of March 20201.3

*Candida* infections All Taltz PsA (N=1401) PY=2247.6 as of March 20202.0 All Taltz axSpA (N=932) PY=1792.2 as of March 20211.2 All Taltz adult PsO (N=6449) PY=17,598.6 as of March 20201.9

Opportunistic infections All Taltz PsA (N=1401) PY=2247.6 as of March 20201.8 All Taltz axSpA (N=932) PY=1792.2 as of March 20210.8 All Taltz adult PsO (N=6449) PY=17,598.6 as of March 20203.1

Hypersensitivity All Taltz PsA (N=1401) PY=2247.6 as of March 20204.5 All Taltz axSpA (N=932) PY=1792.2 as of March 20214.2 All Taltz adult PsO (N=6449) PY=17,598.6 as of March 20205.2

MACE All Taltz PsA (N=1401) PY=2247.6 as of March 20200.5 All Taltz axSpA (N=932) PY=1792.2 as of March 20210.3 All Taltz adult PsO (N=6449) PY=17,598.6 as of March 20200.5

Malignancies All Taltz PsA (N=1401) PY=2247.6 as of March 20200.7 All Taltz axSpA (N=932) PY=1792.2 as of March 20210.4 All Taltz adult PsO (N=6449) PY=17,598.6 as of March 20200.8

Adjudicated IBD^*

Crohn’s disease All Taltz PsA (N=1401) PY=2247.6 as of March 20200.1 All Taltz axSpA (N=932) PY=1792.2 as of March 20210.3 All Taltz adult PsO (N=6449) PY=17,598.6 as of March 20200.1

Ulcerative colitis All Taltz PsA (N=1401) PY=2247.6 as of March 20200.0 All Taltz axSpA (N=932) PY=1792.2 as of March 20210.5 All Taltz adult PsO (N=6449) PY=17,598.6 as of March 20200.1

Injection site reactions^† (based on the original formulation) All Taltz PsA (N=1401) PY=2247.6 as of March 202011.6 All Taltz axSpA (N=932) PY=1792.2 as of March 20217.4 All Taltz adult PsO (N=6449) PY=17,598.6 as of March 20205.5

^*Data on all suspected IBD, as identified by events potentially indicative of ulcerative colitis or Crohn’s disease, were adjudicated according to EPIMAD criteria by an external clinical review committee of gastroenterologists with IBD expertise.
^†This is an HLT (high-level MEDDRA term).

**Taltz-treated adult population:**

Among the 4 PsA trials, the mean duration of exposure was 586.4 days, with up to 3 years of exposure.^6,10

Among the 4 axSpA (AS and nr-axSpA) trials, the mean duration of exposure was 702.4 days, with up to 3 years of exposure.¹¹

Among the 15 adult PsO trials, the mean duration of exposure was 996.7 days, with over 5 years of exposure.^5,12

The most frequent injection site reactions were erythema and pain. Most injection site reactions were mild to moderate in severity and did not lead to discontinuation of Taltz.³

No contraindications/warnings in patients with moderate to severe heart failure.³

**No boxed warnings or routine lab monitoring required.^3‡**

Certain adverse events, such as MACE and malignancy, require longer observation periods and larger patient exposure to ascertain risk. Lilly is conducting continued long-term safety studies, including post-marketing studies, to continue to evaluate the safety of Taltz.

In the reported safety population across clinical trials, not all patients received the recommended dosing regimen consistent with the FDA-approved label.

^‡During Taltz treatment, monitor patients for signs and symptoms of infection and for onset or exacerbation of inflammatory bowel disease. During and after treatment with Taltz, monitor patients for active tuberculosis (TB) infection.

PsA=psoriatic arthritis; PsO=psoriasis; axSpA=axial spondyloarthritis; AS=ankylosing spondyloarthritis; nr-axSpA=non-radiographic axial spondyloarthritis; AE=adverse event; IR=incidence rate; PY=patient-year; MACE=major adverse cardiovascular event; IBD=inflammatory bowel disease; EPIMAD=Registre Epidemiologique des Maladies de l'Appareil Digestif.

	All Taltz PsA (N=1401) PY=2247.6 as of March 2020	All Taltz axSpA (N=932) PY=1792.2 as of March 2021	All Taltz adult PsO (N=6449) PY=17,598.6 as of March 2020
Serious Infections	All Taltz PsA (N=1401) PY=2247.6 as of March 20201.2	All Taltz axSpA (N=932) PY=1792.2 as of March 20211.1	All Taltz adult PsO (N=6449) PY=17,598.6 as of March 20201.3
Candida infections	All Taltz PsA (N=1401) PY=2247.6 as of March 20202.0	All Taltz axSpA (N=932) PY=1792.2 as of March 20211.2	All Taltz adult PsO (N=6449) PY=17,598.6 as of March 20201.9
Opportunistic infections	All Taltz PsA (N=1401) PY=2247.6 as of March 20201.8	All Taltz axSpA (N=932) PY=1792.2 as of March 20210.8	All Taltz adult PsO (N=6449) PY=17,598.6 as of March 20203.1
Hypersensitivity	All Taltz PsA (N=1401) PY=2247.6 as of March 20204.5	All Taltz axSpA (N=932) PY=1792.2 as of March 20214.2	All Taltz adult PsO (N=6449) PY=17,598.6 as of March 20205.2
MACE	All Taltz PsA (N=1401) PY=2247.6 as of March 20200.5	All Taltz axSpA (N=932) PY=1792.2 as of March 20210.3	All Taltz adult PsO (N=6449) PY=17,598.6 as of March 20200.5
Malignancies	All Taltz PsA (N=1401) PY=2247.6 as of March 20200.7	All Taltz axSpA (N=932) PY=1792.2 as of March 20210.4	All Taltz adult PsO (N=6449) PY=17,598.6 as of March 20200.8
Adjudicated IBD^*
Crohn’s disease	All Taltz PsA (N=1401) PY=2247.6 as of March 20200.1	All Taltz axSpA (N=932) PY=1792.2 as of March 20210.3	All Taltz adult PsO (N=6449) PY=17,598.6 as of March 20200.1
Ulcerative colitis	All Taltz PsA (N=1401) PY=2247.6 as of March 20200.0	All Taltz axSpA (N=932) PY=1792.2 as of March 20210.5	All Taltz adult PsO (N=6449) PY=17,598.6 as of March 20200.1
Injection site reactions^† (based on the original formulation)	All Taltz PsA (N=1401) PY=2247.6 as of March 202011.6	All Taltz axSpA (N=932) PY=1792.2 as of March 20217.4	All Taltz adult PsO (N=6449) PY=17,598.6 as of March 20205.5

SELECT IMPORTANT SAFETY INFORMATION
Taltz is contraindicated in patients with a previous hypersensitivity reaction, such as anaphylaxis, to ixekizumab or to any of the excipients.
Warnings and precautions include infections, pre-treatment evaluation for tuberculosis, hypersensitivity, inflammatory bowel disease, and immunizations. The most common adverse reactions (≥1%) associated with Taltz treatment are injection site reactions, upper respiratory tract infections, nausea, and tinea infections.

References: 1. Chabra S, Gill BJ, Gallo G, et al. Ixekizumab citrate-free formulation: results from two clinical trials. Adv Ther. 2022;Epub (Incl Suppl Inf):1-11, 1-4. https://doi.org/10.1007/s12325-022-02126-0 . 2. Data on file. Lilly USA, LLC. DOF-IX-US-0088. 3. Taltz. Prescribing Information. Lilly USA, LLC. 4. Data on file. Lilly USA, LLC. DOF-IX-US-0096. 5. Data on file. Lilly USA, LLC. DOF-IX-US-0256. 6. Sesin C, Gallo G, Gellett AM, et al. Safety of ixekizumab in patients with psoriatic arthritis: an integrated analysis of 4 clinical trials. Presented at European League Against Rheumatism (EULAR) 2021 Virtual Meeting; June 2-5, 2021. 7. Schwartzman S, Deodhar A, Combe B, et al. Safety profile of ixekizumab for the treatment of psoriatic arthritis and axial spondyloarthritis up to 3 years: an updated integrated safety analysis. Arthritis Rheumatol. 2021;73 (suppl 10). 2021 ACR Meeting abstract 1893. 8. Data on file. Lilly USA, LLC. DOF-IX-US-0298. 9. Data on file. Lilly USA, LLC. DOF-IX-US-0302. 10. Data on file. Lilly USA, LLC. DOF-IX-US-0305. 11. Data on file. Lilly USA, LLC. DOF-IX-US-0299. 12. Data on file. Lilly USA, LLC. DOF-IX-US-0267.

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 adult 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 adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis. 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
Patients treated with Taltz may be at an increased risk of inflammatory bowel disease. In clinical trials, Crohn's disease and ulcerative colitis, including exacerbations, occurred at a greater frequency in the Taltz group than the placebo group. During Taltz treatment, monitor patients for onset or exacerbations of inflammatory bowel disease and if IBD occurs, discontinue Taltz and initiate appropriate medical management.

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 profiles observed in adult patients with psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and pediatric patients with plaque psoriasis were consistent with the safety profile in adult patients with plaque psoriasis, with the exception of influenza and conjunctivitis in psoriatic arthritis and conjunctivitis, influenza, and urticaria in pediatric psoriasis.

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

IX HCP ISI 07MAY2020

INDICATIONS

Taltz is indicated for adults with active psoriatic arthritis (PsA), for adults with active ankylosing spondylitis (AS), and for adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. Taltz is also indicated for patients aged 6 years or older with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.