Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Hur byter man från en annan biologisk behandling till Taltz® (ixekizumab) vid psoriasisartrit?

Särskilda rekommendationer vid byte från en annen biologisk behandling till Ixekizumab är inte tillgängliga. I kliniska prövningar krävdes en washout period.

How to Switch from A Different Biologic Therapy to Taltz® (ixekizumab) in Psoriatic Arthritis?

Specific recommendations on switching from another biologic therapy to ixekizumab for the treatment of PsA are not available.

Clinical Trial Overview

SPIRIT-P2 (N=363) is a phase 3, 24-week, double-blind, placebo-controlled trial in patients with active PsA and an inadequate response or intolerance to 1 or 2 TNF inhibitors. This study enrolled patients who were previously treated with an anti-TNF agent and discontinued the anti-TNF agent for either lack of efficacy or intolerance (anti-TNF-IR patients).1 The discontinuation of the TNF inhibitor was followed by a washout period, if applicable, prior to randomization (see Table 1).2 The study design of SPIRIT-P2 is shown in Figure 2.

Please note that the dosing schedule IXE Q2W mentioned in this statement is not cosistent with the approved dosing schedule for psoriatic arthritis. Please refer to the Taltz Summary of Product Characteristics for approved dosing.1

Table 1. SPIRIT-P2 Washout Periods for Patients who Received Another Biologic Therapy Prior to Initiating Ixekizumab Therapy2

Biologic

Washout Period

Etanercept (Enbrel®)

Minimum of 28 days

Infliximab (Remicade®)

Minimum of 60 days

Adalimumab (Humira®)

Minimum of 60 days

Certolizumab pegol (Cymzia®)

Minimum of 60 days

Alefacept (Amevive®)

Minimum of 60 days

Golimumab (Simponi®; Simponi Aria®)

Minimum of 90 days

Rituximab (Rituxan®)

Minimum of 12 months

Other biologic agent or small molecule

Minimum of 5 half-lives prior to baseline (week 0; visit 2)

Efficacy in Patients With Inadequate Response or Intolerance to Tumor Necrosis Factor Inhibitors

At week 24, significantly more patients who received ixekizumab Q2W or Q4W achieved ACR20, ACR50, and ACR70 response at week 24 compared with placebo (p<.0001) (see Table 2).2

Table 2. SPIRIT-P2 Efficacy Results: Percent Response at 24 Weeks (Double-Blind Treatment Period, ITT Population) for Ixekizumab vs Placebo, NRI2

Efficacy Result

PBO (n=118)

IXE 80 mg Q4W (n=122)

IXE 80 mg Q2W (n=123)


N=118

N=122

N=123

ACR20, n (%)

23 (19)

65 (53)a

59 (48)a

ACR50, n (%)

6 (5)

43 (35)a

41 (33)a

ACR70, n (%)

0

27 (22)ab

15 (12)ab

Abbreviations: ACR20 = 20% improvement from baseline in American College of Rheumatology Index; ACR50 = 50% improvement from baseline in American College of Rheumatology Index; ACR70 = 70% improvement from baseline in American College of Rheumatology Index; ITT = intent-to-treat; IXE = ixekizumab; NRI = nonresponder imputation; PBO = placebo; Q2W = every 2 weeks; Q4W = every 4 weeks. 

NOTE: p values derived using logistic regression analysis except where noted. 

a p<.0001.

b P value derived with the Fisher's exact test.

Similar percentages of patients attained ACR20 at week 24 whether they had an inadequate response to 1 or 2 TNF inhibitors or an intolerance to a TNF inhibitor (see Table 3).2

Table 3. Percentage of Patients who Attained ACR20 Response at Week 24 Following Inadequate Response or Intolerance to TNF Inhibitors in the SPIRIT-P2 Clinical Trial2

Previous Exposure to TNF Inhibitor, n/N (%)

IXE Q2W

IXE Q4W

Inadequate responder to 1 TNF inhibitor

28/65 (43)a

39/71 (55)b

Inadequate responder to 2 TNF inhibitors

24/46 (52)b

21/41 (51)a

Intolerance to TNF inhibitor

7/12 (58)

5/10 (50)

Abbreviations: ACR20 = 20% improvement from baseline in American College of Rheumatology Index; IXE Q2W = ixekizumab 80 mg every 2 weeks; IXE Q4W = ixekizumab 80 mg every 4 weeks; PBO = placebo; TNF = tumor necrosis factor. 

a p<.01 vs PBO.

b p<.001 vs PBO.

Efficacy in Patients With Inadequate Response or Intolerance to Tumor Necrosis Factor Inhibitors With and Without Conventional Disease-Modifying Antirheumatic Drug Therapy

In addition to having had an inadequate response or intolerance to treatment with 1 or 2 TNF inhibitors, patients enrolled in SPIRIT-P2 were required to have received treatment with 1 or more cDMARDs (MTX, sulfasalazine, leflunomide, or hydroxychloroquine).2

Table 4 shows the numbers of patients in each treatment arm with current and past cDMARD use.

Table 4. Current and Past Use of Conventional Disease-Modifying Antirheumatic Drugs at Baseline in SPIRIT-P22,3

 

IXE Q4W (n=122)

IXE Q2W (n=123)

PBO (n=118)

Current use of ≥1 cDMARD, n (%)

60 (49)

73 (59)

52 (44)

Past use of cDMARD, n (%)

62 (51)

50 (41)

66 (56)

Abbreviations: cDMARD = conventional disease-modifying antirheumatic drug; IXEQ2W = ixekizumab 80 mg every 2 weeks; IXEQ4W = ixekizumab 80 mg every 4 weeks; PBO = placebo.

The ACR20 response was similar across ixekizumab treatment groups regardless of current or past cDMARD use at baseline (Figure 1).2

Figure 1. SPIRIT-P2: ACR20 Response at Week 24 by Baseline Conventional Disease-Modifying Antirheumatic Drug Use, NRI2

Abbreviations: ACR20 = 20% improvement from baseline in American College of Rheumatology Index; IXEQ2W = ixekizumab 80 mg every 2 weeks; IXEQ4W = ixekizumab 80 mg every 4 weeks; NRI = nonresponder imputation; PBO = placebo.

* p<.01 vs PBO.
p<.001 vs PBO.

Safety in Patients With Inadequate Response or Intolerance to TNF Inhibitors

The safety profile for SPIRIT-P2 was consistent with other ixekizumab studies of patients with psoriatic arthritis.2

References

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

2. Nash P, Kirkham B, Okada M, et al. 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

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

4. Genovese MC, Combe B, Kremer JM, et al. Safety and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2. Rheumatology. 2018;57(11):2001-2011. http://dx.doi.org/10.1093/rheumatology/key182

Glossary

ACR20 = 20% improvement from baseline in American College of Rheumatology Index

ACR50 = 50% improvement from baseline in American College of Rheumatology Index

ACR70 = 70% improvement from baseline in American College of Rheumatology Index

cDMARD = conventional disease-modifying antirheumatic drug

MTX = methotrexate

PsA = psoriatic arthritis

Q2W = every 2 weeks

Q4W = every 4 weeks

TNF = tumor necrosis factor

Appendix: SPIRIT-P2 Study Design

Figure 2. SPIRIT-P2 Study Design: Double-Blind Treatment and Extension Periods2,4

Abbreviations: IR = inadequate responder; IXE = ixekizumab; Q2W = every 2 weeks; Q4W = every 4 weeks; SJC = swollen joint count; TJC = tender joint count.

a All IRs (as determined by prespecified, blinded TJC and SJC criteria) at week 16 received rescue therapy and were analyzed as nonresponders at week 24. Placebo-IRs received their first dose of IXE at week 16.
b
Patients were discontinued from the study if they did not demonstrate a ≥20% improvement from baseline in both TJC and SJC at week 32 or at any subsequent visit during the study.

Notes: Among patients initially randomized to IXE Q2W (N=123), 107 entered the extension period on IXE Q2W. Among patients initially randomized to IXE Q4W (N=122), 111 entered the extension period on IXE Q4W.

Datum fӧr senaste ӧversyn 2020 M07 28


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