Taltz ® (ixekizumab) injektion

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Taltz® ▼ (ixekizumab): Utsättning och återinsättning hos patienter med psoriasisartrit

De flesta patienter som återfallit efter utsättning av ixekizumab återfick MDA (minimal sjukdomsaktivitet) efter återinsättning av ixekizumab.

Summary

  • In the SPIRIT-P3 study, patients who achieved sustained MDA while receiving ixekizumab were randomized to either continue receiving ixekizumab or switch to placebo (withdrawal). Significantly more patients who continued treatment with ixekizumab maintained MDA than did patients who switched to placebo (p<.001).1,2

  • The time to relapse was significantly shorter in the placebo group than in the ixekizumab group for the MDA components TJC, SJC, PASI/BSA, and pain VAS (p≤.01).1

  • Most patients who relapsed following ixekizumab withdrawal regained MDA following retreatment with ixekizumab.2

 Please note that the mentioned dosing schedule IXEQ2W in this statement is not consistent with the approved dosing schedule for psoriatic arthritis in the Taltz summary of product characteristics. Please refer to the Taltz summary of product characteristics for approved dosing.3

SPIRIT-P3 Trial Design

SPIRIT-P3 is a phase 3b study in which patients with active PsA who were naive to bDMARDs and had previously had an inadequate response to at least one cDMARD received open-label treatment with ixekizumab 80 mg Q2W following a 160 mg starting dose. Patients who achieved MDA for 3 months between weeks 36 to 64 were randomized to either continue receiving ixekizumab Q2W or switch to placebo through week 104 or until relapse. During this double-blind withdrawal period, patients who relapsed by no longer meeting MDA criteria were switched back to ixekizumab Q2W through week 104.1,2

Minimal disease activity was defined as meeting at least 5 of the following 7 criteria:1,2

  • TJC ≤1

  • SJC ≤1

  • PASI total score ≤1 or BSA ≤3%

  • Patient pain VAS score ≤15

  • Patient global disease activity VAS score ≤20

  • HAQ-DI ≤0.5, or

  • Tender entheseal points ≤1.

Achievement of MDA

Of the 394 patients who participated in the open-label treatment period of SPIRIT-P3, 158 (40%) met the MDA criteria for 3 consecutive months between weeks 36 to 64 and were randomized to double-blind treatment with ixekizumab Q2W (n=79) or placebo (n=79). Of those 158 patients who met the MDA criteria, 77 (ixekizumab, n=40; placebo, n=37) achieved VLDA, defined as meeting all 7 MDA components.1,2

Time and Rate of Relapse

Loss of Minimal Disease Activity

During the randomized withdrawal period, the cumulative relapse rate was 73% for placebo and 34% for ixekizumab (p<.001). The median time to relapse for the group of patients who received placebo was significantly shorter than that of the group of patients who continued receiving ixekizumab (p<.001) (see Figure 1).1,2

Figure 1. Time To Loss of Minimal Disease Activity After Treatment Withdrawal in SPIRIT-P32

Abbreviations: IXE = ixekizumab; MDA = minimal disease activity; NA = not available; Q2W = every 2 weeks.

Of the 77 patients who achieved VLDA, 30/37 (81%) patients in the placebo group and 10/40 (25%) patients in the ixekizumab group relapsed.1

Loss of Tender Joint Count Response

The median time to loss of TJC response for the group of patients who received placebo was significantly shorter than that of the group of patients who continued receiving ixekizumab (p≤.01) (see Figure 2).1

Figure 2. Time To Loss of Tender Joint Count Response1

Abbreviations: IXE = ixekizumab; NE = not estimable; Q2W = every 2 weeks; TJC = tender joint count.

Note: Data from the randomized double-blind withdrawal period in the intent-to-treat population with TJC ≤1 at randomization.

p≤.01 vs IXE Q2W.

Loss of Swollen Joint Count Response

The median time to loss of SJC response for the group of patients who received placebo was significantly shorter than that of the group of patients who continued receiving ixekizumab (p≤.001) (see Figure 3).1

Figure 3. Time To Loss of Swollen Joint Count Response1

Abbreviations: IXE = ixekizumab; NE = not estimable; Q2W = every 2 weeks; SJC = swollen joint count.

Note: Data from the randomized double-blind withdrawal period in the intent-to-treat population with SJC ≤1 at randomization.

p≤.001 vs IXE Q2W.

Loss of Pain Visual Analog Scale Response

The median time to loss of pain VAS response for the group of patients who received placebo was significantly shorter than that of the group of patients who continued receiving ixekizumab (p≤.001).1

Figure 4. Time To Loss of Pain Visual Analog Scale Response1

Abbreviations: IXE = ixekizumab; NE = not estimable; Q2W = every 2 weeks; VAS = Visual Analog Scale.

Note: Data from the randomized double-blind withdrawal period in the intent-to-treat population with pain VAS score ≤15 at randomization.

p≤.001 vs IXE Q2W.

Loss of Tender Entheseal Point Response

The median time to loss of tender entheseal point response was not significantly different between the placebo group and the ixekizumab group (see Figure 5).1

Figure 5. Time To Loss of Tender Entheseal Point Response1

Abbreviations: IXE = ixekizumab; NE = not estimable; Q2W = every 2 weeks; TEP = tender entheseal point.

Note: Data from the randomized double-blind withdrawal period in the intent-to-treat population with TEPs ≤1 at randomization.

Loss of Psoriasis Area and Severity Index Response

The median time to loss of PASI response for the group of patients who received placebo was significantly shorter than that of the group of patients who continued receiving ixekizumab (p≤.001) (see Figure 6).1

Figure 6. Time To Loss of Psoriasis Area and Severity Index Response1

Abbreviations: IXE = ixekizumab; NE = not estimable; PASI = Psoriasis Area and Severity Index; Q2W = every 2 weeks.

Note: Data from the randomized double-blind withdrawal period in the intent-to-treat population with PASI total score ≤1 at randomization.

p≤.001 vs IXE Q2W.

Loss of Health Assessment Questionnaire Disability Index Response

The median time to loss of HAQ-DI response was not significantly different between the placebo group and the ixekizumab group (see Figure 7).1

Figure 7. Time to Loss of Health Assessment Questionnaire Disability Index Response1

Abbreviations: HAQ-DI = Health Assessment Questionnaire Disability Index; IXE = ixekizumab; NE = not estimable; Q2W = every 2 weeks.

Note: Data from the randomized double-blind withdrawal period in the intent-to-treat population with HAQ-DI ≤0.5 at randomization.

Loss of Body Surface Area Response

The median time to loss of BSA response for the group of patients who received placebo was significantly shorter than that of the group of patients who continued receiving ixekizumab (p≤.001) (see Figure 8).1

Figure 8. Time To Loss of Body Surface Area Response1

Abbreviations: BSA = body surface area; IXE = ixekizumab; NE = not estimable; Q2W = every 2 weeks.

Note: Data from the randomized double-blind withdrawal period in the intent-to-treat population with BSA ≤3% at randomization.

p≤.001 vs IXE Q2W.

Achievement of Minimal Disease Activity Following Relapse

Most patients who relapsed during the randomized withdrawal period regained MDA after restarting treatment with ixekizumab. The median time to regain MDA was 4.1 weeks for the placebo group and 4.7 weeks for the ixekizumab group (see Figure 9).2 

Figure 9. Time To Regain Minimal Disease Activity After Relapse2

Abbreviations: IXE = ixekizumab; MDA = minimal disease activity; Q2W = every 2 weeks.

Therapeutic Indication

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.3

References

1. Coates L, Pillai S, Hufford M, et al. Withdrawal of ixekizumab results in loss of efficacy in multiple clinical domains in patients with psoriatic arthritis who had achieved minimal disease activity: results from the SPIRIT-P3 study. Poster presented at: Annual Meeting of the American College of Rheumatology; November 8-13, 2019; Atlanta, Georgia.

2. Coates LC, Pillai SG, Zhang L, et al. Continuing versus withdrawing ixekizumab in patients with psoriatic arthritis who achieved sustained minimal disease activity: results from the SPIRIT-P3 study. Poster presented at: Annual Meeting of the American College of Rheumatology; November 8-13, 2019; Atlanta, Georgia.

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

Glossary

bDMARD = biologic disease-modifying antirheumatic drug

BSA = body surface area

cDMARD = conventional disease-modifying antirheumatic drug

HAQ-DI = Health Assessment Questionnaire-Disability Index

MDA = minimal disease activity

PASI = Psoriasis Area and Severity Index

PsA = psoriatic arthritis

Q2W = every 2 weeks

SJC = swollen joint count

TJC = tender joint count

VAS = Visual Analog Scale

VLDA = Very Low Disease Activity 

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 M11 07


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