Taltz ® (ixekizumab) injektion

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Taltz® (ixekizumab): Effekt hos tidigare användare av Secukinumab i plackpsoriasis

Behanslingssvar på ixekizumab hos patienter som hade ett otillräckligt svar på secukinumab har inte utvärderats av Lilly.

SE_cFAQ_IXE424_Z1_COSENTYX_PREVIOUS_USERS_EFFICACY_PsO
SE_cFAQ_IXE424_Z1_COSENTYX_PREVIOUS_USERS_EFFICACY_PsO
en-GB

Independent Retrospective Reviews of Patients Switched From Secukinumab to Ixekizumab

Independent Retrospective Reviews of Patients Who Failed Secukinumab Therapy for Psoriasis and Subsequently Received Ixekizumab summarizes independent retrospective analyses of the safety and efficacy of ixekizumab in patients previously exposed to secukinumab. These studies were not sponsored by Lilly.

Independent Retrospective Reviews of Patients Who Failed Secukinumab Therapy for Psoriasis and Subsequently Received Ixekizumab

Study Type

Inclusion Criteria

Number of Patients

Efficacy Assessment

Safety Assessment

Multicenter, retrospective chart review1

  • 18 years  of age or older
  • moderate-to-severe psoriasis
  • treated with ixekizumab therapy following discontinuation of secukinumab

31

22 patients (71.0%) achieved PASI 75 or PGA of 0/1 after 12 weeks of ixekizumab

11 patients (35.5%) experienced ≥1 AE

Single center, retrospective analysis2

  • moderate-to-severe psoriasis vulgaris (BSA >10 or PASI >10 and DLQI >10 as defined by European consensus and German guidelines)
  • previously treated with 3 or more biologics
  • primary (not achieving ≥50 PASI) and/or secondary (losing initial efficacy during treatment) failure to secukinumab
  • switched directly from secukinumab to ixekizumab

12

12 patients (100%) achieved PASI 90 and 7 patients (58.3%) achieved PASI 100 after 12 weeks of ixekizumab treatment

2 patients (16.7%) experienced adverse reactions

Multicenter, retrospective observational study3

  • plaque-type psoriasis
  • treated with ixekizumab following discontinuation of secukinumab treatment

69

At week 12

  • 56 patients (81.2%) achieved PASI 75
  • 50 patients (72.4%) achieved PASI 90, and
  • 28 patients (40.5%) achieved PASI 100

 

Fifty of the 69 patients (72.4%) reached 24 weeks of ixekizumab treatment. At week 24

  • 40 patients (80%) achieved PASI 75
  • 34 patients (68%) achieved PASI 90, and
  • 19 patients (38%) achieved PASI 100

4 patients (5.8%) experienced injection site reactions

No other AEs were included in the manuscript

Single center, retrospective observational study4

  • moderate-to-severe psoriasis
  • secukinumab to ixekizumab switch

25

At the end of the surveillance period

  • 15 patients (68%) achieved PASI 75
  • 9 patients (41%) achieved PASI 90, and
  • 5 patients (23%) achieved PASI 100

Not included

Retrospective study5

  • moderate-to-severe psoriasis
  • incomplete initial response or loss of efficacy with secukinumab subsequently treated with ixekizumab

14

At week 16, 13 patients (92.9%) had PGA of 0/1

Not included

Multicenter, retrospective observational study6

  • moderate-to-severe psoriasis
  • failed to adequately respond to secukinumab (subset of patients in the study)

26 (subset of patients in the study)

At week 12

  • 77% of patients achieved PASI 75
  • 54% achieved PASI 90, and 
  • 42% achieved PASI 100

At week 24

  • 80% achieved PASI 75
  • 54% achieved PASI 90, and
  • 46% achieved PASI 100.

Not included

Multicenter, retrospective chart review7

  • adult patients with psoriasis
  • treated ≥3 months with ixekizumab after secukinumab discontinuation

30

70% responded to ixekizumab after 12 weeks of treatment as measured by PASI 75 and/or PGA (0,1)

9 patients (30%) experienced an AE

Multicenter, retrospective study8

  • PASI ≥10 at baseline
  • nonresponse to secukinumab and consecutively switched to ixekizumab (subset of patients in the study)

18 (subset of patients in the study)

After 12 weeks, 9 patients (50%) achieved ≥PASI 75

Not included

Multicenter, retrospective observational study9

  • adult patients with moderate-to-severe plaque psoriasis
  • failed to adequately respond to secukinumab and consecutively switched to ixekizumab (subset of patients in the study)

26 (subset of patients in the study)

76.9% (20/26) achieved a PASI 75 response at weeks 12-16

26 patients (26%) experienced an AE in all enrolled patients (not specific to the secukinumab switching to ixekizumab subset of patients)

Multicenter, retrospective study10

  • adult patients with plaque psoriasis
  • received ixekizumab for ≥24 weeks after prior treatment with secukinumab

22

11/21 patients (52.4%) with available data achieved PASI 75 or PASI <3 at week 12


8/19 patients (42.1%) achieved PASI 75 or PASI <3 at week 24

16/22 patients were still receiving ixekizumab treatment and 10 of 16 patients (62.5%) achieved PASI 75 or PASI <3 at the final observation

AEs included

  • injection site reactions (n=3)
  • abscess (n=1)
  • common cold (n=1)
  • herpes zoster (n=1), and
  • subtotal coronary artery stenosis following stent implantation (n=1)

Abbreviations: AE = adverse event; BSA = body surface area; DLQI = Dermatology Life Quality Index; PASI = Psoriasis Area and Severity Index; PASI 75 = 75% improvement from baseline in Psoriasis Area and Severity Index; PASI 90 = 90% improvement from baseline in Psoriasis Area and Severity Index; PASI 100 = 100% improvement from baseline in Psoriasis Area and Severity Index; PGA = Physician Global Assessment.

Ixekizumab Clinical Trial Exclusion Criteria Regarding IL-17 Antagonists

Psoriasis

Secukinumab was not yet marketed when the ixekizumab pivotal clinical trials were initiated (UNCOVER-1, -2, and -3). In these 3 pivotal trials, previous participation in any study investigating other IL-17 antagonists was a criterion for exclusion.11

Patients with previous exposure to IL-17 inhibitors were allowed to enroll in IXORA-P, a study of continuous ixekizumab Q2W dosing in patients with moderate-to-severe plaque psoriasis. Patients were excluded if they had inadequate response to an IL-17 inhibitor.12

Note: The continuous dosing schedule IXE Q2W is not consistent with the approved dosing schedule for plaque pasoriasis. Please refer to the Taltz Summary of Product Characteristics for approved dosing.13

Psoriasis Clinical Trial Information

Previous Biologics Users: Brief Results from Psoriasis Clinical Trials

Examination of the presence or absence of previous treatment with a biologic did not identify a difference in response at week 12 of the pivotal phase 3 UNCOVER clinical trials (UNCOVER-1, -2, and -3).14

Previous Secukinumab Exposures in Trial of Ixekizumab Dosed Every 2 Weeks for Plaque Psoriasis

Of patients enrolled in IXORA-P (N=1227), 13 reported previous treatment with secukinumab.15 Patients who received secukinumab within a washout period of <5 months were excluded from the trial. Patients were excluded if they had an inadequate response to secukinumab or any IL-17 inhibitor.12

Note: The continuous dosing schedule IXE Q2W is not consistent with the approved dosing schedule for plaque psoriasis. Please refer to the Taltz Summary of Product Characteristics for approved dosing.13

Secukinumab and Other Biologic Users Switched to Ixekizumab in the Corrona Psoriasis Registry

The National Psoriasis Foundation and Corrona, LLC have collaborated to create the largest independent North American psoriasis registry.16

This prospective, multicenter, observational, disease-based registry is designed to study the long-term comparative safety of biologic medications that are used to treat psoriasis and to analyze the epidemiology and natural history of the disease, current treatment practices, psoriasis comorbidities, and comparative effectiveness in a real-world population of psoriasis patients.17

Demographic and clinical data are collected from patients with psoriasis who have started on or switched to a systemic psoriasis treatment (biologic or select nonbiologic) within the previous 12 months. Questionnaires are completed by the investigator and patient at routine outpatient visits. All treatment decisions are the sole responsibility of the treating clinician(s).17

Proportion of Patients Achieving Efficacy Outcomes After 6 Months of Ixekizumab Treatment Following a Switch From Secukinumab or Another Biologic Treatment in the Corrona Psoriasis Registry shows the proportion of patients achieving efficacy outcomes after 6 months of ixekizumab treatment following a switch from secukinumab or other biologics. The study population in this analysis included psoriasis patients in the Corrona registry who had immediate prior exposure to 

  • secukinumab and discontinued due to secukinumab failure (inadequate initial response or failure to maintain initial response; N=108)
  • secukinumab and discontinued for any reason besides failure (secukinumab non-failure; N=28)
  • other biologics (TNF inhibitors, IL-12/23 inhibitor, or IL-23 inhibitors) and discontinued that biologic due to failure (inadequate initial response or failure to maintain initial response; N=200), and
  • other biologics (TNF inhibitors, IL-12/23 inhibitor, or IL-23 inhibitors) and discontinued for any reason besides failure (other biologic non-failure; N=83).18

At the 6-month follow-up vs baseline, both secukinumab and other biologic failure patients who switched to ixekizumab achieved improvements in disease severity (for all, 95% CIs did not include 0).18

Corrona, LLC changed their name to CorEvitas, LLC in March 2021.19

Proportion of Patients Achieving Efficacy Outcomes After 6 Months of Ixekizumab Treatment Following a Switch From Secukinumab or Another Biologic Treatment in the Corrona Psoriasis Registry18

Abbreviations: BIO = biologics; BSA = body surface area; IGA = Investigator Global Assessment; PASI = Psoriasis Area and Severity Index; PASI 75 = 75% improvement from baseline in Psoriasis Area and Severity Index; PASI 90 = 90% improvement from baseline in Psoriasis Area and Severity Index; PASI 100 = 100% improvement from baseline in Psoriasis Area and Severity Index; SEC = secukinumab.

References

1Georgakopoulos JR, Phung M, Ighani A, et al. Biologic switching between interleukin 17A antagonists secukinumab and ixekizumab: a 12-week multicenter, retrospective study. J Eur Acad Dermatol Venereol. 2019:33(1):e7-e8. https://dx.doi.org/10.1111/jdv.15100

2Bokor-Billmann T, Schäkel K. No need to change the drug class: ixekizumab-following secukinumab-therapy in psoriasis. J Dermatolog Treat. 2019;30(3):216-220. http://dx.doi.org/10.1080/09546634.2018.1506081

3Conti A, Peccerillo F, Amerio P, et al. Efficacy and safety of switching to ixekizumab in secukinumab nonresponder patients with psoriasis: results from a multicentre experience. Br J Dermatol. 2019;180(6):1547-1548. http://dx.doi.org/10.1111/bjd.17580

4Sherman S, Cohen ES, Amitay-Laish I, et al. IL-17A inhibitor switching - efficacy of ixekizumab following secukinumab failure. A single-center experience. Acta Derm Venereol. 2019;99(9):769-773. http://dx.doi.org/10.2340/00015555-3200

5Hegazy S, Konstantinou MP, Bulai Livideanu C, et al. Efficacy of ixekizumab in patients with resistance or incomplete response to secukinumab. J Eur Acad Dermatol Venereol. 2019;33(9):e338-e341. http://dx.doi.org/10.1111/jdv.15630

6Chiricozzi A, Burlando M, Caldarola G, et al. Ixekizumab effectiveness and safety in the treatment of moderate-to-severe plaque psoriasis: a multicenter, retrospective observational study. Am J Clin Dermatol. 2020;21(3):441-447. http://dx.doi.org/10.1007/s40257-019-00490-2

7Fougerousse AC, Boulard C, Reguiai Z, et al; GEM Resopso. Switch between interleukin-17A antagonists for psoriasis: a French multicentric retrospective experience. Accessed November 9, 2020. https://www.resopso.fr/wp-content/uploads/2019/06/P383.pdf

8Gasslitter I, Kirsten N, Augustin M, et al. Successful intra-class switching among IL-17 antagonists: a multicentre, multinational, retrospective study. Arch Dermatol Res. 2019;311(5):421-424. http://dx.doi.org/10.1007/s00403-019-01907-y

9Deza G, Notario J, Lopez-Ferrer A, et al. Initial results of ixekizumab efficacy and safety in real-world plaque psoriasis patients: a multicentre retrospective study. J Eur Acad Dermatol Venereol. 2019;33(3):553-559. http://dx.doi.org/10.1111/jdv.15288

10Amschler K, Phillip S, Mohr J, et al. Long-term follow-up of 22 psoriatic patients treated with ixekizumab after failure of secukinumab. Dermatol Online J. 2020;26(1):2. https://escholarship.org/uc/item/235408bf

11Gordon KB, Blauvelt A, Papp KA, et al; UNCOVER-1, UNCOVER-2, and UNCOVER-3 Study Groups. Phase 3 trials of ixekizumab in moderate-to-severe plaque psoriasis. N Engl J Med. 2016;375(4):345-356. http://dx.doi.org/10.1056/NEJMoa1512711

12Langley RG, Papp K, Gooderham M, et al; IXORA-P Investigators. Efficacy and safety of continuous every-2-week dosing of ixekizumab over 52 weeks in patients with moderate-to-severe plaque psoriasis in a randomized phase III trial (IXORA-P). Br J Dermatol. 2018;178(6):1315-1323. http://dx.doi.org/10.1111/bjd.16426

13Taltz [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands

14Data on file, Eli Lilly and Company and/or one of its subsidiaries.

15Papp KA, Blauvelt A, Sullivan J, et al. Efficacy of ixekizumab in patients previously treated with IL-17 inhibitors. Poster presented at: 26th Meeting of the European Academy of Dermatology and Venereology (EADV); September 13-17, 2017; Geneva, Switzerland.

16More than 5,000 patients enrolled in Corrona Psoriasis Registry. Press release. National Psoriasis Foundation; June 5, 2018.

17The Corrona Psoriasis (PSO) Registry. ClinicalTrials.gov. Updated June 5, 2020. Accessed February 23, 2021. https://clinicaltrials.gov/ct2/show/NCT02707341.

18Lockshin B, Harrison R, McLean R, et al. Outcomes in ixekizumab patients following exposure to secukinumab and other biologics in the Corrona Psoriasis Registry. Poster presented at: Innovations in Dermatology Virtual Spring Conference; March 16-20, 2021.

19Corrona announces name change to CorEvitas and expanded strategic direction. Press release. CorEvitas, LLC; March 9, 2021. Accessed April 8, 2021. https://www.corevitas.com/node/425

Glossary

IL-12/23 = interleukin-12/23

IL-17 = interleukin-17

IL-23 = interleukin-23

Lilly = Eli Lilly and Company

mAb = monoclonal antibody

Q2W = every 2 weeks

TNF = tumor necrosis factor

Datum fӧr senaste ӧversyn April 08, 2021


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