Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

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Taltz® ▼ (ixekizumab): Inverkan på naglar i psoriasisartrit

I SPIRIT-P1 och SPIRIT-P2 resulterade behandling med Taltz (ixekizumab) i signifikant förbättring av nagelpsoriasis.

Detailed Information

In SPIRIT-P1 and SPIRIT-P2  clinical trials performed in patients with active PsA, ixekizumab treatment resulted in significant improvement in fingernail psoriasis compared to PBO by week 12, with additional improvement continuing through week 24 and week 52.1-3

Approximately 70% of patient in SPIRIT-P1 and approximately 65% of patients in SPIRIT-P2 had fingernail psoriasis at baseline.1,2

The NAPSI scale was used in both clinical trials to evaluate the severity of fingernail bed psoriasis and fingernail matrix psoriasis by area of involvement. Score ranges from 0 to 80.1

Both trials assessed change from baseline in NAPSI score compared to placebo in those patients who had fingernail involvement at baseline (baseline NAPSI > 0).

NAPSI assessment in patients with baseline fingernail involvement was a pre-specified secondary objective in SPIRIT-P1 and a pre-specified exploratory objective in SPIRIT-P2.1,2

SPIRIT-P1 (N=417) is a phase 3, 24-week double-blind, placebo and active-controlled trial in patients with active PsA who are naïve to bDMARDs, with an extension period of up to 3 years.1

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 TNFi, with an extension period of up to 3 years.2

There was a greater reduction in mean NAPSI score compared to PBO at weeks 12 and 24 in both SPIRIT-P1 and -P2, as illustrated in Figure 1 and Figure 2.1,2,4

As illustrated in Figure 3, there was a numerically greater difference in the number of patients achieving NAPSI=0 (clear nails) for all ixekizumab-treated patients compared to PBO through week 24 in SPIRIT-P1. These differences were statistically significant compared to PBO for both treatment arms at week 12, and for the Q2W treatment arm at week 24.1

As illustrated in Figure 4, there was a statistically significant difference in the number of patients achieving NAPSI=0 at week 24 in SPIRIT-P2.4

  • Week 12 had an 8.4 point reduction in NAPSI in Q4W and 7.7 point reduction in Q2W.

  • Week 24 had a 14.0 point reduction in NAPSI in Q4W and 15.5 point reduction in Q2W.

Data at week 52 show persistent high clinical response both for NAPSI reduction from baseline and achievement of NAPSI=0. See  

Figure 1. Mean Improvement in Fingernail Psoriasis (NAPSI) from SPIRIT-P1 (Biologic-Naïve) Clinical Trial1

Abbreviations: IXE = ixekizumab; NAPSI = Nail Psoriasis Severity Index; PBO = placebo; Q2W = every 2 weeks; Q4W = every 4 weeks.
Notes: NAPSI scores range from 0 (no nail psoriasis) to 80 (severe nail psoriasis).
Analyses were conducted in patients with fingernail psoriasis (NAPSI > 0) at baseline.
Baseline NAPSI Mean Scores ranged from 20 to 25 across treatment arms.
All comparisons between IXE and PBO were statistically significant (p<.05) by week 12 and all subsequent timepoints.

Continuous endpoints were analyzed using mixed effect model repeat measurement.

*p<0.05.

Figure 2. Mean Improvement in Fingernail Psoriasis (NAPSI) from SPIRIT-P2 (TNFi-Experienced) Clinical Trial4

Abbreviations: IXE = ixekizumab; LSM = least squares mean; NAPSI = Nail Psoriasis Severity Index; PBO = placebo; Q2W = every 2 weeks; Q4W = every 4 weeks; TNFi = tumor necrosis factor inhibitor.

Notes: All patients in SPIRIT-P2 had been previously treated with TNFi and had an inadequate response to one or two TNFi or were intolerant to TNFi.
NAPSI scores range from 0 (no nail psoriasis) to 80 (severe nail psoriasis).
Analyses were conducted in patients with fingernail psoriasis (NAPSI > 0) at baseline.
Baseline NAPSI Mean Scores ranged from 24 to 30 across treatment arms.
All comparisons between IXE and PBO were statistically significant (p<.05) by week 12 and all subsequent timepoints.

Continuous endpoints were analyzed using mixed effect model repeat measurement.

*p<0.05

Figure 3. Complete Resolution of Fingernail Psoriasis (NAPSI=0) at Weeks 12 and 24 from SPIRIT-P1 (Biologic-Naïve) Clinical Trial1

Abbreviations: IXE = ixekizumab; NAPSI = Nails Psoriasis Severity Index; PBO = placebo; Q4W = every 4 weeks.
Notes: Analyses were conducted in patients with baseline fingernail psoriasis (NAPSI > 0).

Continuous endpoints were analyzed using mixed effect model repeat measurement. 
*p≤.01 vs. PBO; p<.01 vs. PBO; p<.025 vs. PBO.

Figure 4. Complete Resolution of Fingernail Psoriasis (NAPSI=0) at Week 24 from SPIRIT-P2 (TNFi-Experienced) Clinical Trial4

Abbreviations: CI = confidence interval; IXE = ixekizumab; NAPSI = Nails Psoriasis Severity Index; PBO = placebo; Q4W = every 4 weeks; TNFi = tumor necrosis factor inhibitor.
Notes: All patients in SPIRIT-P2 had been previously treated with TNFi and had an inadequate response to one or two TNFi or were intolerant to TNFi.
Analyses were conducted in patients with baseline fingernail psoriasis (NAPSI > 0).

Missing data were imputed using nonresponder imputation. 
*p<.05 vs. PBO; †p<.0001 vs. PBO based on Fisher’s exact test.

Table 1. Rates of NAPSI Reduction and Achievement of NAPSI=0 at 52 Weeksa3





 


SPIRIT-P1 (bDMARD Naive) 

SPIRIT-P2 (TNFi Inadequate Response or Intolerance)

 

IXE Q4W 

N=107

IXE Q2W

N=103

IXE Q4W 

N=122

IXE Q2W 

N=123

NAPSI mean (SD) change from baseline 

-15.9 (18.3) 

-20.0 (20.8)

-15.2 (19.7)

-14.4 (19.0)

NAPSI=0 

n/Nx (%)

30/69 (43.5)

28/74 (37.8)

41/89 (46.1)

24/74 (32.4)

Abbreviations: bDMARD = biologic disease modifying antirheumatic drugs; IXE = ixekizumab; NAPSI = nail psoriasis severity index; N (Nx) = number in treatment arm; Q2W = every two weeks; Q4W = every 4 weeks; SD = standard deviation; TNFi-IR = tumor necrosis factor inhibitor.

a Missing data were imputed using nonresponder imputation for categorical variables and modified baseline observation carried forward for continuous variables

References

1. Mease PJ, van der Heijde D, Ritchlin CT, et al. 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

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 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

3. Merola JF, Kishimoto M, Adams D, et al. Ixekizumab improves nail and skin psoriasis through 52 weeks of treatment in patients with active psoriatic arthritis: Results from two randomized, double-blind, phase 3 clinical trials (SPIRIT-P1 and SPIRIT-P2). Abstract presented at: 5th World Psoriasis and Psoriatic Arthritis Conference, June 27-30, 2018; Stockholm, Sweden.

4. Kristensen L, Merola JF, Dutz J, et al. Ixekizumab improves nail and skin lesions in patients with active psoriatic arthritis and prior TNF inadequate response. Poster presented at: European League Against Rheumatism; June 14-17, 2017; Madrid, Spain.

Glossary

bDMARD = biologic disease-modifying antirheumatic drug

EMA = European Medicines Agency

LSM = least squares mean

NAPSI = Nail Psoriasis Severity Index

PBO = placebo

PsA = psoriatic arthritis

Q2W = every 2 weeks

Q4W = every 4 weeks

SD = standard deviation

TNFi = tumor necrosis factor inhibitor

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 2017 M12 01

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