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Taltz ® (ixekizumab)
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Safety of Taltz® (ixekizumab) in psoriatic arthritis
An integrated safety analysis found that rates of treatment-emergent adverse events decreased over time with continued exposure to ixekizumab.
Table of contents
General safety information from the label
The therapy with Taltz is associated with adverse drug reactions, such as injection site reactions and upper respiratory tract reactions.1
For complete information, please refer to the Taltz Summary of Product Characteristics, in particular the sections1:
- 4.4 Special warnings and precautions for use
- 4.8 Undesirable effects
Below, you will find information about the most common adverse events reported in clinical trials of ixekizumab for the treatment of psoriatic arthritis.
Treatment-emergent adverse events reported in the SPIRIT-P1 and -P2 Trials
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
|
PBO |
ADA 40 mg Every 2 Weeksa |
IXE Every 4 Weeksb |
IXE Every 2 Weeksc |
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
Event, n (%) [IR] |
IXE 80 mg Every 4 Weeks |
IXE 80 mg Every 2 Weeks |
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.
Event, n (%) |
PBO |
IXE 80 mg |
IXE 80 mg |
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
Event, n (IR) |
IXE Every 4 Weeks |
IXE Every 2 Weeks |
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.
Combined safety data from 4 psoriatic arthritis clinical trials
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 2022 includes the TEAEs, SAEs, deaths, and discontinuations due to an AE as of March 2022.9
Event, n (%) [IR]a |
Pooled IXE |
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 2022 includes the numbers of TEAEs of special interest as of March 2022.9
Event, n (%) [IR] |
Pooled IXE |
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] |
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] |
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).10,11
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
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.9,10
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).10
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.10
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
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].9
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%).10
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.9,10
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.10
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.10
Malignancies
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.10
Overall, 7 cases were serious, with
- 1 fatal event
- 3 recovered events
- 2 not recovered event, and
- 1 is recovering.10
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.10
Inflammatory bowel disease
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.9,12
- 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.10
Laboratory assessments of neutropenia
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).11
References
1Taltz [summary of product characteristics]. Eli Lilly and Company (Ireland) Limited, Ireland [UK]
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, Lebwohl M, et al. Long-term safety of Ixekizumab in adults with psoriasis, psoriatic arthritis, or axial spondyloarthritis: a post-hoc analysis of final safety data from 25 randomized clinical trials. Arthritis Res Ther. 2024;26(1):49. https://doi.org/10.1186/s13075-023-03257-7
10Deodhar 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
11Sesin C, Gallo G, Gellett AM, et al. Safety of ixekizumab in patients with psoriatic arthritis: an integrated analysis of 4 clinical trials. Ann Rheum Dis. 2021;80(suppl 1):789. European League Against Rheumatism Virtual Congress abstract POS1033. https://doi.org/10.1136/annrheumdis-2021-eular.567
12Deodhar 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.
Links to references and third-party websites are provided solely for your convenience and to facilitate easy access to the sources cited.
Date of Last Review: 02 November 2022