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Taltz ® (ixekizumab) injection
80 mg/mL
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How does TALTZ® (ixekizumab) compare with HUMIRA® (adalimumab) for Psoriatic Arthritis?
Ixekizumab was superior to adalimumab in achievement of the simultaneous primary endpoint of ACR50 and PASI 100 at week 24.
Ixekizumab vs Adalimumab in Psoriatic Arthritis
Ixekizumab vs Adalimumab SPIRIT-H2H Efficacy Results
Primary Outcome: Simultaneous Achievement of ACR50 and PASI 100 at Week 24
Ixekizumab showed superior efficacy to adalimumab based on the primary outcome of the SPIRIT-H2H trial, simultaneous achievement of American College of Rheumatology (ACR) 50 and Psoriasis Area and Severity Index (PASI) 100 responses at week 24. The primary endpoint at week 24 was gated to control for type-1 error. As shown in Percentage of Patients Who Achieved Simultaneous ACR50 and PASI 100 in SPIRIT-H2H Through 52 Weeks by Treatment Week, NRI, significant differences in achieving simultaneous ACR50 and PASI 100 responses were observed as early as week 8 and continued through week 52.1,2
Abbreviations: ACR50 = 50% improvement from baseline in American College of Rheumatology Index; ADA = adalimumab; IXE = ixekizumab; NRI = nonresponder imputation; PASI 100 = 100% improvement from baseline in Psoriasis Area and Severity Index; W24 = week 24; W52 = week 52.
* p<.01 vs ADA.
† p<.05 vs ADA.
‡ p<.001 vs ADA.
Major Secondary Endpoints: Achievement of ACR50 and PASI 100 at Week 24
As measured by ACR50, ixekizumab was noninferior to adalimumab (noninferiority margin, -12.0%) with no statistically significant differences in ACR50 response between the treatment arms through week 52 (Percentage of Patients Who Achieved ACR50 in SPIRIT-H2H Through 52 Weeks by Treatment Week, NRI).1,2
Abbreviations: ACR50 = 50% improvement from baseline in American College of Rheumatology Index; ADA = adalimumab; IXE = ixekizumab; NRI = nonresponder imputation; W24 = week 24; W52 = week 52.
The PASI 100 response was significantly greater in the ixekizumab treatment group than in the adalimumab treatment arm with statistically significant differences observed at the first PASI assessment at week 4 and every assessment through week 52 (see Percentage of Patients Who Achieved PASI 100 Response in SPIRIT-H2H Through 52 Weeks by Treatment Week, NRI).1,2
Abbreviations: ADA = adalimumab; IXE = ixekizumab; NRI = nonresponder imputation; PASI 100 = 100% improvement from baseline in Psoriasis Area and Severity Index; W24 = week 24; W52 = week 52.
* p≤.001 vs ADA.
A listing of additional secondary outcomes is available in the following manuscript - https://doi.org/10.1136/annrheumdis-2019-215386.1
The 2 major secondary endpoints at week 24 were gated to control for type-1 error.1
Ixekizumab vs Adalimumab SPIRIT-H2H Safety Results
In SPIRIT-H2H, the safety profiles of ixekizumab and adalimumab were consistent with previously reported results and approved label information.1 SPIRIT-H2H: Summary of Adverse Events Through 52 Weeks provides a summary of adverse events through 52 weeks of the SPIRIT-H2H trial.
|
Ixekizumab |
Adalimumab |
TEAEs |
209 (73.9) |
194 (68.6) |
Mild |
95 (33.6) |
85 (30.0) |
Moderate |
105 (37.1) |
89 (31.4) |
Severe |
9 (3.2) |
20 (7.1) |
SAEs |
12 (4.2) |
35 (12.4) |
Deaths |
0 |
0 |
Discontinuation due to AE |
12 (4.2) |
21 (7.4) |
Adverse events of special interest |
||
Infections |
119 (42.0) |
111 (39.2) |
Serious infections |
5 (1.8) |
8 (2.8) |
Candida infections |
7 (2.5) |
3 (1.1) |
Injection-site reactions |
30 (10.6) |
10 (3.5) |
Inflammatory bowel disease |
2 (0.7)a |
0 |
Ulcerative colitis |
0 |
|
Crohn's disease |
0 |
|
Allergic reactions/hypersensitivity |
11 (3.9)d |
13 (4.6) |
Malignancies |
0 |
4 (1.4) |
Cerebrocardiovascular events |
5 (1.8) |
7 (2.5) |
Depression |
5 (1.8) |
9 (3.2) |
Cytopenias |
9 (3.2) |
12 (4.2) |
Abbreviations: AE = adverse event; EPIMAD = Epidemiologique des Maladies de l'Appareil Digestif; IBD = inflammatory bowel disease; SAE = serious adverse event; TEAE = treatment-emergent adverse event.
Note: Safety data were analyzed on all randomized patients, according to assigned treatment, who received ≥1 dose of study drug.
aEpidemiologique des Maladies de l'Appareil Digestif criteria for adjudication of suspected IBD define "probable" and "definite" classifications as confirmed cases. Only 1 case met the EPIMAD criteria of confirmed IBD.
bEvent was reported as colitis ulcerative and was adjudicated as possible ulcerative colitis. It did not meet the EPIMAD criteria of confirmed inflammatory bowel disease.
c Event was reported as colitis and was adjudicated as probable Crohn's disease.
dOne case was a potential anaphylaxis. The patient experienced mild injection site pain, cough, and dizziness at the baseline visit. The events resolved on the same day.
Ixekizumab vs Adalimumab SPIRIT-H2H Study Design
Design and Dosing Arms
SPIRIT-H2H (N=566) is a 52-week randomized, open-label, parallel-group, phase 3b/4 clinical trial with blinded assessor to evaluate the efficacy and safety of ixekizumab with that of adalimumab in patients with active psoriatic arthritis (≥3 tender joint count and ≥3 swollen joint count) and plaque psoriasis (body surface area [BSA] ≥3%) at baseline who are biologic disease-modifying antirheumatic drug-naïve. The blinded assessors were not allowed to know the patients' treatment allocation or to be otherwise involved in the study procedures. To be qualified as a blinded assessor, a minimum of 1-year of experience using the instrument tools was required.4
For patients randomized to ixekizumab who met the study’s definition of moderate-to-severe psoriasis, ixekizumab was administered 80 mg every 2 weeks (Q2W) from week 2 to 12 after a 160 mg starting dose at week 0, and every 4 weeks (Q4W) thereafter. For all other patients randomized to ixekizumab, dosing was ixekizumab 80 mg Q4W after a 160-mg starting dose at week 0.1
For patients randomized to adalimumab who met the study’s definition of moderate-to-severe psoriasis, adalimumab was administered 80 mg at week 0, followed by 40 mg Q2W starting at week 1. For all other patients randomized to adalimumab, dosing was adalimumab 40 mg Q2W.1
Randomization was stratified by concomitant conventional disease-modifying antirheumatic drug (cDMARD) use at baseline and moderate-to-severe plaque psoriasis involvement at baseline (defined in this study as meeting all 3 criteria: PASI ≥12, static physician's global assessment [sPGA] ≥3, and BSA ≥10%).1
Patient Population
Enrolled patients (N=566) had active psoriatic arthritis (defined as the presence of at least 3 tender and at least 3 swollen joints) and plaque psoriasis with BSA ≥3%, had an inadequate response to at least one cDMARD, and were bDMARD-naïve.1
After week 24 database lock and initial analysis run, a medical inconsistency in baseline PASI data was identified. Although 9 patients were assessed as PASI=0 at baseline, those patients fulfilled the criteria for having psoriasis as assessed by a BSA ≥3%. Therefore, these patients were judged as PASI 100 responders if they achieved an absolute PASI=0 and BSA=0 at postbaseline visits. Multiple analyses were conducted to assess the robustness of this approach.1
Enclosed Prescribing Information
References
The published references below are available upon request by contacting 1-800-545-5979 (1-800-LillyRx).
1Mease PJ, Smolen JS, Behrens F, et al; SPIRIT H2H Study Group. A head-to-head comparison of the efficacy and safety of ixekizumab and adalimumab in biological-naïve patients with active psoriatic arthritis: 24-week results of a randomised, open-label, blinded-assessor trial. Ann Rheum Dis. 2020;79(1):123-131. https://doi.org/10.1136/annrheumdis-2019-215386
2Smolen JS, Mease P, Tahir H, et al. Multicentre, randomised, open-label-parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52. Ann Rheum Dis. 2020;79(10):1310-1319. http://dx.doi.org/10.1136/annrheumdis-2020-217372
3Smolen J, Nash P, Tahir H, et al. A head-to-head comparison of ixekizumab and adalimumab in biologic-naïve patients with active psoriatic arthritis: efficacy and safety outcomes from a randomized, open-label, blinded assessor study through 52 weeks. Poster presented at: American College of Rheumatology Annual Meeting; November 8-13, 2019; Atlanta, Georgia.
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: August 05, 2021