Taltz ® (ixekizumab)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information.For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).

Safety of Taltz® (ixekizumab) in Patients from Psoriatic Arthritis Clinical Trials

An integrated safety analysis found that rates of treatment-emergent adverse events decreased over time with continued exposure to ixekizumab.

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en-GB

What are the General Safety Information from the Label?

Hypersensitivity: Ixekizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients (Sodium citrate, Citric acid Anhydrous, Sodium chloride, Polysorbate 80, Water for injections).1

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.1 

If a serious hypersensitivity reaction occurs, administration of ixekizumab should be discontinued immediately and appropriate therapy initiated.1

Infections: Ixekizumab is contraindiacted in patients with clinically important active infections (e.g. active tuberculosis).1

Treatment with ixekizumab is associated with an increased rate of infections such as upper respiratory tract infection, oral candidiasis, conjunctivitis, and tinea infections.1

Ixekizumab should be used with caution in patients with clinically important chronic infection or a history of recurrent infection. 1

Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.1

If an infection develops,

  • patients should be carefully monitored and 
  • ixekizumab discontinued if
    • the patient is not responding to standard therapy or if
    • the infection becomes serious.1

Ixekizumab should not be resumed until the infection resolves.1

Ixekizumab must not be given to patients with active tuberculosis (TB).1

  • Anti-TB therapy prior to initiation of ixekizumab in patients with latent TB should be considered.1

Inflammatory Bowel Disease (including Crohn's disease and ulcerative colitis): Cases of new or exacerbations of inflammatory bowel disease have been reported with ixekizumab. Ixekizumab is not recommended in patients with inflammatory bowel disease.1

If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, ixekizumab should be discontinued and appropriate medical management should be initiated.1

Immunizations: Ixekizumab should not be used with live vaccines. No data are available on the response to live vaccines; there are insufficient data on response to inactive vaccines.1

List of adverse reactions in clinical studies and postmarketing reports1

System organ class

Frequency

Adverse reaction

Infections and infestations

 

Very common

Upper respiratory tract infection

Common

Tinea infection, Herpes simplex (mucocutaneous)

Uncommon

Influenza, Rhinitis, Oral candidiasis, Conjunctivitis, Cellulitis 

Blood and lymphatic system disorders

Uncommon

Neutropenia, Thrombocytopenia

Immune system disorders

Uncommon

Angioedema

Rare

Anaphylaxis

Respiratory, thoracic and mediastinal disorders

Common

Oropharyngeal pain

Gastrointestinal disorders

Common

Nausea

Uncommon

Inflammatory bowel disease

Skin and subcutaneous disorders

Uncommon

Urticaria, Rash, Eczema,  

General disorders and administration site conditions

Very common

Injection site reactionsa

aSee section description of selected adverse reactions

Treatment-Emergent Adverse Events Reported in the Double-Blind Treatment Period of SPIRIT-P1 and -P2 Trial in Ixekizumab

The treatment-emergent adverse event (TEAE) incidences described may vary slightly from those listed in product labeling information. Any differences in incidences are dependent on factors such as the specific populations, dosing groups analyzed, and the cutoff dates for the analyses.

In ixekizumab clinical trials, an serious adverse event (SAE) was defined as any adverse event (AE) that was considered to be significant by the investigator, or that resulted in

  • death
  • initial or prolonged inpatient hospitalization
  • a life-threatening experience (that is, immediate risk of dying)
  • persistent or significant disability/incapacity, or
  • congenital anomaly/birth defect.2

Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious adverse drug events. Based on appropriate medical judgement, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes as listed in this definition.2

SPIRIT-P1 Safety Overview

The dosing schedule IXEQ2W mentioned in this response is not consistent with the approved dosing schedule for psoriatic arthritis in the Taltz summary of product characteristics. Please refer to the Taltz summary of product characteristics for approved dosing.1

No deaths were reported from baseline to week 24. The percentages of patients who reported a TEAE were greater in the ixekizumab groups (66.0%) and the adalimumab group (64%) compared with the placebo group (47.2%). Most TEAEs were mild or moderate in severity.3

Discontinuation of the study drug due to AEs occurred infrequently (2.4% of all patients). SPIRIT-P1 Safety Overview During Double-Blind Treatment Period (Ixekizumab and Placebo Groups) presents the SPIRIT-P1 safety overview during the double-blind treatment period.3

SPIRIT-P1 Safety Overview During Double-Blind Treatment Period (Ixekizumab and Placebo Groups)3-5

 

PBO
(N=106)

ADA 40 mg Every 2 Weeksa
(N=101)

IXE Every 4 Weeksb
(N=107)

IXE Every 2 Weeksc
(N=102)

TEAE, n (%)

50 (4.2)

65 (64.4)

71 (66.4)d

67 (65.7)d

Mild

27 (25.5)

39 (38.6)

43 (40.2)d

41 (40.2)d

Moderate

21 (19.8)

25 (24.8)

24 (22.4)

21 (20.6)

Severe

2 (1.9)

1 (1.0)

4 (3.7)

5 (4.9)

SAEs, n (%)

2 (1.9)e

5 (5.0)f

6 (5.6)g

3 (2.9)h

Discontinuation due to AE, n (%)

2 (1.9)

2 (2.0)

2 (1.9)

4 (3.9)

AESI, n (%)i

36 (34.0)

45 (44.6)

52 (48.6)

56 (54.9)j

Infection

27 (25.5)

26 (25.7)

30 (28.0)

24 (23.5)

Any Candida infection

0

0

1 (0.9)

1 (1.0)

Active or reactivated tuberculosis

0

0

0

0

Injection site reactions

5 (4.7)

6 (5.9)

26 (24.3)d

27 (26.5)d

Hepatic event

7 (6.6)

13 (12.9)

5 (4.7)

9 (8.8)

Allergic reaction/hypersensitivity

3 (2.8)

5 (5.0)

2 (1.9)

5 (4.9)

Cytopenia (all types)

6 (5.7)

4 (4.0)

1 (0.9)

4 (3.9)

Neutropenia

0

0

0

1 (1.0)

Depression

0

1 (1.0)

2 (1.9)

1 (1.0)

Cerebrocardiovascular event

0

3 (3.0)

0

0

Malignancy

1 (0.9)

1 (1.0)

0

0

Abbreviations: ADA = adalimumab; AE = adverse event; AESI = adverse events of special interest; IXE = ixekizumab; MedDRA = Medical Dictionary for Regulatory Activities; PBO = placebo; SAE = serious adverse event; TEAE = treatment-emergent adverse event.

aThe adalimumab 40 mg every 2 weeks treatment arm served as active reference for comparison with placebo. The study was not powered to test equivalence or noninferiority of ixekizumab versus adalimumab.

bIxekizumab 80 mg every 4 weeks after a 160-mg starting dose.

cIxekizumab 80 mg every 2 weeks after a 160-mg starting dose.

dp≤.001 vs PBO (for ixekizumab groups).

eThe 2 SAEs were Bartholin's cyst and hepatic enzyme increased.

fFive patients reported a total of 6 SAEs (more than 1 event occurred in a single patient): cellulitis, pneumonia mycoplasmal, gastric ulcer, oesophagitis, carotid artery occlusion, and metrorrhagia.

gSix patients reported a total of 8 SAEs (more than 1 event occurred in a single patient): gastroenteritis, pancreatitis acute, posttraumatic headache, uterine polyp, cholelithiasis, fall, fibula fracture, and lumbar spinal stenosis.

hThree patients reported a total of 5 SAEs (more than 1 event occurred in a single patient): herpes zoster, esophageal candidiasis, impaired gastric emptying, cervical myelopathy, and acquired phimosis.

iReported as AEs and coded using MedDRA v17.1. Groups of AESIs are shown.

jp≤.01 vs PBO.

SPIRIT-P1 Safety Overview Across All Treatment Periods Through Week 156 (All Ixekizumab Exposure Safety Population) presents TEAEs reported across all treatment periods during SPIRIT-P1 up to week 156. The majority of TEAEs were mild-to-moderate in severity.6

SPIRIT-P1 Safety Overview Across All Treatment Periods Through Week 156 (All Ixekizumab Exposure Safety Population)6

Event, n (%) [IR]

IXE 80 mg Every 4 Weeks
(N=197; PY=449)

IXE 80 mg Every 2 Weeks
(N=189; PY=440)

TEAEa

171 (87) [38.1]

167 (88) [38.0]

Mild

58 (29) [12.9]

77 (41) [17.5]

Moderate

95 (48) [21.1]

69 (37) [15.7]

Severe

18 (9) [4.0]

21 (11) [4.8]

Viral upper respiratory infection

29 (15) [6.5]

25 (13) [5.7]

Upper respiratory infection

31 (16) [6.9]

22 (12) [5.0]

Injection site reaction

21 (11) [4.7]

24 (13) [5.5]

Bronchitis

14 (7) [3.1]

17 (9) [3.9]

Injection site erythema

10 (5) [2.2]

18 (10) [4.1]

Diarrhea

8 (4) [1.8]

13 (7) [3.0]

Hypertension

11 (6) [2.4]

10 (5) [2.3]

Headache

12 (6) [2.7]

9 (5) [2.0]

Back pain

13 (7) [2.9]

8 (4) [1.8]

Urinary tract infection

14 (7) [3.1]

7 (4) [1.6]

SAE

36 (18.3) [8.0]

23 (12.2) [5.2]

Serious infections 

8 (4) [1.8]

3 (2) [0.7]

Deaths 

1 (<1) [0.2]

0

Discontinuation due to AE, including death

18 (9) [4.0]

25 (13) [5.7]

Adverse events of special interest 

Infections

110 (56) [24.5]

109 (58) [24.8]

Candida infections

6 (3) [1.4]

5 (3) [1.1]

Injection site reactions

42 (21) [9.3]

46 (24) [10.5]

Hepatic event

19 (10) [4.2]

26 (14) [5.9]

Allergic reaction/hypersensitivity events

11 (6) [2.4]

20 (11) [4.5]

Cerebrocardiovascular events

9 (5) [2.0]

11 (6) [2.5]

Depression

4 (2) [0.9]

6 (3) [1.4]

Interstitial lung disease

0

0

Malignancies

3 (2) [0.7]

2 (1) [0.5]

Ulcerative colitis

0

1 (<1) [0.2]

Abbreviations: AE = adverse event; IR = incidence rates; IXE = ixekizumab; PY = patient-years; SAE = serious adverse event; TEAE = treatment-emergent adverse event.

aSafety population consists of all patients who received at least 1 dose of ixekizumab during the study. The baseline for ixekizumab exposure safety population was the time of the first ixekizumab dose.

SPIRIT-P2 Safety Overview

No deaths were reported from baseline to week 24. There were higher numbers of patients with 1 or more TEAEs in both ixekizumab groups compared with the placebo group. Most TEAEs were mild or moderate in severity.7

Discontinuation of the study drug due to AEs occurred in 5.2% of all patients.7 SPIRIT-P2 Safety Overview During 24-Week Double-Blind Treatment Period presents SPIRIT-P2 safety overview.

SPIRIT-P2 Safety Overview During 24-Week Double-Blind Treatment Period7

Event, n (%) 

PBO
Every 2 Weeks
(N=118)

IXE 80 mg
Every 4 Weeks
(N=107)

IXE 80 mg
Every 2 Weeks
(N=102)

TEAE

76 (64)

83 (68) 

90 (73)

Mild

32 (27)

48 (39)

43 (35)

Moderate

42 (36)

31 (25)

38 (31)

Severe

2 (2)

4 (3)

9 (7)

SAE

4 (3)a

3 (2)b

8 (7)c

Adverse events of special interestd

Infection

35 (30.0)

47 (39)

47 (38)

Any Candida infection

0

2 (2)

6 (5)

Active or reactivated tuberculosis

0

0

0

Injection site reactions

5 (4)

14 (11)

29 (24)

Hepatic event

2 (2)

2 (2)

5 (4)

Allergic reaction/hypersensitivity

1 (1)

8 (7)

9 (7)

Cytopenia (all types)

6 (5.7)

1 (0.9)

4 (3.9)

Neutropenia

0

0

1 (1.0)

Depression

3 (3)

2 (2)

2 (2)

Cerebrocardiovascular event

2 (2)

0

0

Malignancy

1 (0.9)

0

0

Discontinuation due to AE 

6 (5)

5 (4)

8 (7)

Abbreviations: AE = adverse event; IXE = ixekizumab; PBO = placebo; SAE = serious adverse event; TEAE = treatment-emergent adverse event.

aFour patients reported a total of 5 SAEs (more than 1 event occurred in a single patient): abdominal pain, femoral neck fracture, tendon rupture, adnexa uteri cyst, and peripheral arterial occlusive disease.

bThree patients reported a total of 4 SAEs (more than 1 event occurred in a single patient): vertigo, myofascial pain syndrome, prostate cancer, and cervicobrachial syndrome.

cEight patients reported a total of 10 SAEs (more than 1 event occurred in a single patient): abscess jaw, anal abscess, perirectal abscess, iron deficiency anemia, vertigo, anal fistula, foot fracture, diabetes mellitus, spontaneous abortion, and uterine prolapse.

dFour patients reported a total of 5 SAEs (more than 1 event occurred in a single patient): abdominal pain, femoral neck fracture, tendon rupture, adnexa uteri cyst, and peripheral arterial occlusive disease.

SPIRIT-P2: Treatment-Emergent Adverse Events Reported During Weeks 0 to 156 presents safety data in patients initially randomized to ixekizumab through 156 weeks was consistent with the known safety profile of ixekizumab. Most TEAEs were mild or moderate in severity, and the most commonly reported TEAEs were infections and injection site reactions. Of 337 patients, 38 patients (5.9%) discontinued from the study due to an AE, and 3 deaths were reported.8

SPIRIT-P2: Treatment-Emergent Adverse Events Reported During Weeks 0 to 1568

Event, n (IR)

IXE Every 4 Weeks
(N=168; PY=345.1)

IXE Every 2 Weeks
(N=169; PY=298.9)

TEAEs

141 (40.9)

145 (48.5)

Mild

41 (11.9)

43 (14.4)

Moderate

85 (24.6)

74 (24.8)

Severe

15 (4.3)

28 (9.4)

SAEs

19 (5.5)

23 (7.7)

Discontinuation due to AEa

17 (4.9)

21 (7.0)

Deathsa

1 (0.3)

2 (0.7)

Infections 

112 (32.5)

101 (33.8)

Serious infection

5 (1.4)

5 (1.7)

ISR

25 (7.2)

42 (14.1)

Discontinuation due to ISR

1 (0.3)

1 (0.3)

IBDb

1 (0.3)c

0

Abbreviations: AE = adverse event; IBD = inflammatory bowel disease; IR = incidence rate per 100 patient-years; ISR = injection site reaction; IXE = ixekizumab; PY = patient-years; SAEs = serious adverse events; TEAEs = treatment-emergent adverse events.

aDeaths are also included as SAEs and study discontinuations owing to AEs.

bIdentified by Medical Dictionary for Regulatory Activities terms based on investigator; cases were reviewed by an independent committee of experts for adjudication.

cReported by investigator and not confirmed by adjudication.

Integrated Safety Data Across 4 Psoriatic Arthritis Clinical Trials of Ixekizumab

The integrated safety dataset includes data through March 2022 from 4 clinical trials in patients with active psoriatic arthritis (PsA), including pivotal phase 3 trials SPIRIT-P1 and -P2, phase 3 trial SPIRIT-P3, and phase 4 trial SPIRIT-H2H (N=1401, accounting for 2247.7 patient years [PYs] of total ixekizumab exposure). The safety profile of ixekizumab is consistent with the known safety profile in patients with PsA, with no new or unexpected safety events detected.9

Treatment-Emergent Adverse Events and Serious Adverse Events in All Treatment Periods in All Psoriatic Arthritis Ixekizumab Exposures Integrated Analysis Set Through March 202210

Event, n (%) [IR]a

Pooled IXE
(N=1401; PY=2247.7)

Patients with ≥1 TEAEb

1131 (80.7) [50.3]c

Mild

461 (32.9) [20.5]

Moderate

556 (39.7) [24.7]

Severe

114 (8.1) [5.1]

Patients with ≥1 SAE

134 (9.6) [6.0]

Deathsd

6 (0.4) [0.3]

Discontinuation due to AEe

115 (8.2) [5.1]

Abbreviations: AE = adverse event; IR = incidence rate; IXE = ixekizumab; PY = patient-years; SAE = serious adverse event; TEAE = treatment-emergent adverse event.

aIncidence rate per 100 PYs.

bPatients with multiple occurrences of the same event were counted under the highest severity.

cThe most commonly reported TEAEs (IR per 100 PYs) were nasopharyngitis (9.0), upper respiratory tract infection (8.3), and injection site reactions (6.9).

dIncluded cardiovascular (n=2), metastatic renal cell carcinoma (n=1), cerebrocardiovascular (n=1), pneumonia (n=1), and drowning (n=1).

eIncludes death.

Adverse Events of Special Interest in All Treatment Periods in All Psoriatic Arthritis Ixekizumab Exposures Integrated Analysis Set Through March 202210,11

Event, n (%) [IR]

Pooled IXE
(N=1401; PY=2247.7)

Infections

759 (54.2) [33.8]

Serious infections

28 (2.0) [1.2]

Candida infections

45 (3.2) [2.0]

Potential opportunistic infections

40 (2.9) [1.8]

Injection site reactionsab

260 (18.6) [11.6]

Hepatic reactionsc

112 (8.0) [5.0]

Allergic/hypersensitivity reactions 

102 (7.3) [4.5]

Cytopeniasd

56 (4.0) [2.5]

Inflammatory bowel disease (adjudicated)ef

3 (0.2) [0.1]

MACE (adjudicated)

12 (0.9) [0.5]

Malignancies

15 (1.1) [0.7]

Depressiong

37 (2.6) [1.6]

Suicidal behavior/self-injury

1 (0.1) [0.0]

Abbreviations: IR = incidence rate; IXE = ixekizumab; MACE = major adverse cerebrocardiovascular events; MedDRA = Medical Dictionary for Regulatory Activities; PY = patient-years; SMQ = Standardized MedDRA Query.

aBroad according to SMQ classification.

bMost injection site reactions were mild: 207 (14.8%).

cThe most common hepatic reactions were alanine aminotransferase increased (n=37), aspartate aminotransferase increased (n=28), gamma-glutamyltransferase increased (n=21), and hepatic steatosis (n=21).

dBroad according to SMQ classification. The most common cytopenias were neutropenia (n=29), leukopenia (n=18), and neutrophil count decreased (n=9).

eThe data represent cases classified as “definite” and “probable” per external adjudication.

fThree patients had events of inflammatory bowel disease confirmed by adjudication. One patient had more than 1 event. Crohn's disease (n=2); ulcerative colitis (n=1).

gBroad, according to SMQ or sub-SMQ classification.

The rates of TEAEs decreased over time with continued exposure to ixekizumab up to 3 years.9 The rates of SAEs and discontinuations due to AEs were low and stable over time (Incidence Rates of Select Categories of Adverse Events at 1-Year Intervals Up To 3 Years of Treatment in Patients Exposed to Ixekizumab in the Psoriatic Arthritis Clinical Development Program).11,12

Incidence Rates of Select Categories of Adverse Events at 1-Year Intervals Up To 3 Years of Treatment in Patients Exposed to Ixekizumab in the Psoriatic Arthritis Clinical Development Program11,12

Figure description: Exposure-adjusted incidence rates are presented for all  treatment-emergent adverse events, all serious adverse events, discontinuations due to adverse events, serious infections, injection site reactions, allergic/hypersensitivity reactions, malignancies, major adverse cardiac events, and inflammatory bowel disease. The rates of treatment-emergent adverse events decreased over time with continued exposure to ixekizumab up to 3 years. The rates of serious adverse events and discontinuations due to adverse events were low and stable over time. The data points on the graph are the exposure-adjusted incidence rate (95% confidence interval)/100 patient-years at successive year intervals from year 0 to year 3.

Abbreviations: AE = adverse event; IR = incidence rate; PY = patient-years; SAE = serious adverse event; TEAE = treatment-emergent adverse event.

a Adjudicated cases. Three patients had events of inflammatory bowel disease confirmed by adjudication. One patient had more than 1 event.

Hypersensitivity Reactions and Ixekizumab

Across 4 pooled PsA trials with data through March 2022, the incidence rate (IR) of hypersensitivity was 4.5 per 100 PYs. No cases of anaphylaxis were reported.9,11

All reported events of allergic reaction/hypersensitivity were mild-to-moderate, with the exception of one severe case. The most frequently reported events were

  • rash (1.4%, exposure-adjusted incidence rate [EAIR]=0.8)
  • eczema (1.1%, EAIR=0.7)
  • drug hypersensitivity (0.7%, EAIR=0.4), and
  • allergic rhinitis (0.7%, EAIR=0.4).11 

Two serious events, one case of angio-edema and one of bronchospasm, were reported. Both patients have recovered.

Allergic reaction or hypersensitivity events were more frequently reported after 1 day of injection and before the next one.11

Rare events consistent with anaphylactic reactions (estimated ≥0.01% and <0.1%) have been identified during postapproval use of ixekizumab. 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 relationship to ixekizumab exposure.2

Infections and Ixekizumab

Across 4 PsA clinical trials as of March 2022, the proportion of patients with

  • any infections was 54.2% [IR=33.8/100 PYs of exposure]
  • serious infections was 2.0% [IR=1.2/100 PYs of exposure], and
  • Candida infections was 3.2% [IR=2.0/100 PYs of exposure].10

Most cases of infections were mild or moderate. The most common types of infections (EAIR >2.0) were

  • nasopharyngitis (14%)
  • upper respiratory tract infection (13%)
  • bronchitis (7%)
  • sinusitis (6%)
  • urinary tract infection (5%), and
  • pharyngitis (4%).11

Forty patients (2.9%, EAIR=1.8) experienced opportunistic infections, which were

  • oral candidiasis (n=16)
  • esophageal candidiasis (n=2)
  • oral fungal infection (n=6)
  • localized herpes zoster (n=16), and
  • one case of hepatitis B reactivation in a patient concomitantly using sulfasalazine.10,11

Of the patients receiving annual TB testing, 35 who were originally negative at baseline had a positive test (2.5%, EAIR=1.6). Per study protocol, 10 patients discontinued due to positive TB test. The 25 patients who remained in the study received treatment for latent TB infection prior to resuming the study drug.11 

The majority of new cases of latent TB were in patients from countries at high risk of TB. None of the cases of latent TB resulted in death, and the existing latent cases did not exhibit signs of active disease.11 

Malignancies and Ixekizumab

Across 4 pooled PsA trials as of March 2022, 15 patients reported malignancies with an EAIR of 0.7, including 8 patients with non-melanoma skin cancer (NMSC) and 7 with malignancies other than NMSC.11

Overall, 7 cases were serious, with

  • 1 fatal event
  • 3 recovered events
  • 2 not recovered event, and
  • 1 is recovering.11

    Treatment-emergent adverse event of malignancy was the reason for discontinuation of the study drug for 8 patients. The mean time from start of the treatment to onset of malignancy was 509.8 days.11

    Inflammatory Bowel Disease and Ixekizumab

    Across 4 pooled PsA trials as of March 2022, the IR of adjudicated IBD was EAIR of 0.1 and included 3 patients (2 patients with CD, and 1 with UC). The patients did not have a history of IBD.9

    One patient with moderate CD 183 days after starting study drug, did not recover and discontinued the study drug. One patient with an onset of moderate CD 113 days after starting study drug was recovering and resolving at time of database lock. One patient reported 5 events of UC (4 reported as mild or moderate, 1 as severe). The first 4 events recovered, and the fifth event outcome was unknown. Time to onset of the first event at 351 days after initiating the study drug.11

    Laboratory Assessments of Neutropenia and Ixekizumab

    Low-grade neutropenia has been commonly observed in patients receiving ixekizumab. However, grade ≥3 neutropenia (<1000 cells/mm3) has been observed infrequently in patients receiving ixekizumab. In general, neutropenia was transient and did not require discontinuation of ixekizumab and was not associated with an increased frequency of infections.2

    Across 4 pooled PsA trials as of March 2022 (N=1401; PY=2247.7), neutropenia was reported in 29 (2.1%) patients (IR=1.3 per 100 PYs of exposure).12

    References

    1Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland

    2Data on file, Eli Lilly and Company and/or one of its subsidiaries.

    3Mease PJ, van der Heijde D, Ritchlin CT, et al; 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(1):79-87. http://dx.doi.org/10.1136/annrheumdis-2016-209709

    4Mease PJ, van der Heijde D, Ritchlin CT, et al. Efficacy of ixekizumab in patients with psoriatic arthritis: results of a phase 3 randomized, double-blind, active- and placebo-controlled study. Poster presented at: 74th Annual Meeting of the American Academy of Dermatology; March 4-8, 2016; Washington, D.C.

    5Mease PJ, van der Heijde D, Ritchlin CT, et al. A randomized, double-blind, active- and placebo-controlled phase 3 study of efficacy and safety of ixekizumab, adalimumab, and placebo therapy in patients naïve to biologic disease modifying anti-rheumatic drugs with active psoriatic arthritis. Arthritis Rheumatol. 2015;67(suppl 10):997. 2015 ACR/ARHP Annual Meeting abstract 997. https://acrabstracts.org/abstract/a-randomized-double-blind-active-and-placebo-controlled-phase-3-study-of-efficacy-and-safety-of-ixekizumab-adalimumab-and-placebo-therapy-in-patients-naive-to-biologic-disease-modifying-anti/.

    6Chandran V, van der Heijde D, Fleischmann RM, et al. Ixekizumab treatment of biologic-naïve patients with active psoriatic arthritis: 3-year results from a phase III clinical trial (SPIRIT-P1). Rheumatology (Oxford). 2020;59(10):2774-2784. https://doi.org/10.1093/rheumatology/kez684

    7Nash P, Kirkham B, Okada M, et al; 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(10086):2317-2327. http://dx.doi.org/10.1016/S0140-6736(17)31429-0

    8Gratacós J, Turkiewicz A, Dokoupilova E, et al. Efficacy and safety of ixekizumab in patients with psoriatic arthritis and inadequate response to TNF inhibitors: 3-year results from a phase 3 study (SPIRIT-P2). Poster presented at: European League Against Rheumatism (Virtual); June 3-6, 2020.

    9Deodhar A, Blauvelt A, Schwartzman S, et al. Long-term safety of ixekizumab in adult patients with psoriasis, psoriatic arthritis, and axial spondyloarthritis. Poster presented at: American College of Rheumatology/ARP - 2022 Annual Scientific Meeting; November 10-14, 2022; Philadelphia, Pennsylvania.

    10Deodhar A, Blauvelt A, Schwartzman S, et al. Long-term safety of ixekizumab in adult patients with psoriasis, psoriatic arthritis, and axial spondyloarthritis. Abstract presented at: American College of Rheumatology/ARP - 2022 Annual Scientific Meeting; November 10-14, 2022; Philadelphia, Pennsylvania. Accessed October 5, 2022. https://acrabstracts.org/abstract/long-term-safety-of-ixekizumab-in-adult-patients-with-psoriasis-psoriatic-arthritis-and-axial-spondyloarthritis/

    11Deodhar AA, Combe B, Accioly AP, et al. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022;81(7):944-950. https://doi.org/10.1136/annrheumdis-2021-222027

    12Sesin C, Gallo G, Gellett AM, et al. Safety of ixekizumab in patients with psoriatic arthritis: an integrated analysis of 4 clinical trials. Poster presented at: European League Against Rheumatism Virtual Congress; June 2-5, 2021.

    Date of Last Review: 02 November 2022


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