Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

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Taltz® ▼ (ixekizumab): Effekt vid psoriasisartrit vid tidigare inadekvat respons på biologiska medel

Ixekizumab förbättrade symptom och tecken på psoriasisartrit jämfört med placebo hos patienter med tidigare otillräckligt respons på biologiska läkemedel.

Results from Clinical Studies

SPIRIT-P2 was a multicenter, randomized clinical trial which compared the safety and efficacy of ixekizumab with that of placebo in adult patients with active PsA and prior inadequate response or intolerance to 1 or 2 TNF inhibitors.1

After the 24-week double-blind placebo-controlled clinical trial period, there was an open-label extension period from weeks 24 to 156 in which efficacy and safety analyses were conducted. 1   

Patients failing to demonstrate at least 20% improvement from baseline in both TJC and SJC at week 32 or any subsequent visit were required to discontinue from the study.  1

The primary study outcome was the proportion of patients who achieved at least 20% improvement from baseline in ACR at week 24.1

Over 90% of patients had previously discontinued TNF inhibitor therapy due to inadequate response, including

  • approximately 56% with a prior inadequate response to 1 TNF inhibitor, and

  • approximately 35% with a prior inadequate response to 2 TNF inhibitors.1,2

The remainder (<10%) were intolerant to a TNF inhibitor.1

24-Week results

Compared with placebo, a significantly greater proportion of patients in the IXEQ4W (following 160-mg starting dose) and IXEQ2W (following 160-mg starting dose) groups achieved ACR20, ACR50, and ACR70 (p≤0.0001 for all) (see Table 1).1

Note: The dosing schedule IXEQ2W is not consistent with the approved dosing schedule for psoriatic arthritis in the Taltz summary of product characteristics.

Table 1. SPIRIT-P2 Efficacy Results: Percent ACR Response at 24 Weeks (Double-Blind Treatment Period, ITT Population) for Ixekizumab vs Placebo, NRI1

Efficacy Measure

PBO (n=118)

IXE 80 mg Q4W (n=122)

IXE 80 mg Q2W (n=123)

ACR20, n (%)

23 (19.0)

65 (53.0)a

59 (48.0)a

ACR50, n (%)

6 (5.0)

43 (35.0)a

41 (33.0)a

ACR70, n (%)

0

27 (22.0)ab

15 (12.0)ab

Abbreviations: ACR = American College of Rheumatology (Index); ITT = intent-to-treat; IXE = ixekizumab; n = number of patients in the analysis population; NRI = non-responder imputation; PBO = placebo; Q2W = every 2 weeks; Q4W = every 4 weeks.

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

a p≤.001.

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

These results were sustained at 52 and 108 weeks as described below.3,4

Compared with placebo, a significantly greater proportion of patients in the IXE 80 mg Q4W (following 160-mg starting dose) and IXE 80 mg Q2W (following 160-mg starting dose) groups achieved ACR20 regardless of previous inadequate response to either 1 or 2 TNF inhibitors (see Figure 1). 1  

Figure 1. ACR20 Response at Week 24 by TNFi-Use Subgroup (Inadequate Response to 1 TNFi, Inadequate Response to 2 TNFi, Intolerance to TNFi), NRI1

Abbreviations: ACR20 = at least 20% improvement in American College of Rheumatology Response criteria; IR = inadequate responder; ITT = intent-to-treat; IXE Q2W = 80 mg of ixekizumab every 2 weeks; IXE Q4W = 80 mg of ixekizumab every 4 weeks; NRI = nonresponder imputation; PBO = placebo; TNFi = tumor necrosis factor inhibitor.
*p<.001 vs. PBO; †p<.01 vs. PBO.
NRI, Double-blind Treatment Period, ITT Population. Note: Primary outcome of trial was ACR20 at week 24.

52-Week results

By 52 weeks, in the ITT population, ACR20 was achieved by

  • 61.5% of patients in the IXEQ4W treatment arm, and

  • 51.2% of patients in the IXEQ2W treatment arm (see Figure 2).3

By week 52, improvements from baseline were also observed in all ixekizumab-treated groups in measures of ACR50 and ACR70 (missing data imputed using NRI). 3  

Figure 2. ACR20 Results in SPIRIT-P2 Through 52 Weeks, NRI, ITT Population3

Abbreviations: ACR20 = 20% improvement in American College of Rheumatology criteria; ITT = intent-to-treat; IXE = ixekizumab 80mg; NRI = non-responder imputation; PBO = placebo; Q2W = every 2 weeks; Q4W = every 4 weeks.  ‡ =  p ≤.001 vs placebo   

Week 108 results

Responses in ACR20, ACR50, and ACR70 at 108 weeks in the ITT population are available in Table 2.

Table 2. SPIRIT-P2 Efficacy Results: Percent Response at 108 Weeks (ITT Population; mNRI)4

Efficacy Measure

IXE Q4W (n = 122)

IXE Q2W (n = 123) 

ACR20, n (%) 

73 (59.6) 

59 (47.9) 

ACR50, n (%) 

56 (46.2) 

40 (32.5)

ACR70, n (%) 

28 (23.2) 

27 (22.6) 

Abbreviations: ACR20/50/70 = American College of Rheumatology 20/50/70 index; BSA = body surface area; ITT = intent-to-treat; IXE = ixekizumab; LDI-B = Leeds dactylitis index-basic; LEI = Leeds enthesitis index; mNRI = modified NRI;  n, number of patients who met criteria; Nx, number of patients in the specified analysis population; PASI75/90/100 = Psoriasis Area and Severity 75/90/100 response; PBO = placebo; Q2W = every 2 weeks; Q4W = every 4 weeks.

PASI Results

In those patients with psoriatic lesions on at least 3% of their BSA at baseline, a significantly greater percentage of patients in either IXE dosing group achieved PASI 75 than did patients in the placebo group (p< 0.0001 for IXEQ4W and IXEQ2W) at week 24. A greater proportion of patients in the ixekizumab dosing groups had sustained PASI 75 results at weeks 52 and 108 than did patients in the placebo group, although the differences were not statistically significant. 1,3,4 

Therapeutic Indication and Posology

Ixekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies.2

The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg (one injection) every 4 weeks thereafter.2

References

1. 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 randomized, 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

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

3. Genovese MC, Combe B, Kremer JM, Tsai TF, Behrens F, Adams DH, Lee C, Kerr L, Nash P. Safety and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2. Rheumatology (Oxford). 2018;57(11):2001-2011. http://dx.doi.org/10.1093/rheumatology/key182.

4. Orbai AM, Gellett AM, Kerr L, Constantin A. Efficacy and safety of ixekizumab in patients with active psoriatic arthritis and previous inadequate response to TNF inhibitors: two-year follow-up from a phase 3 study [abstract]. Arthritis Rheumatol.2018; 70 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-ixekizumab-in-patients-with-active-psoriatic-arthritis-and-previous-inadequate-response-to-tnf-inhibitors-two-year-follow-up-from-a-phase-3-study/

Glossary

ACR = American College of Rheumatology

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

BSA = body surface area

IXEQ2W = ixekizumab 80 mg every 2 weeks

IXEQ4W = ixekizumab 80 mg every 4 weeks

ITT = intent-to-treat

NRI = nonresponder imputation

PASI 75 = 75% improvement from baseline in Psoriasis Area and Severity Index

PsA = psoriatic arthritis

SJC = swollen joint count

TJC = tender joint count

TNF = tumor necrosis factor

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2019 M03 05

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