Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

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Taltz® ▼ (ixekizumab): Användning med konventionella DMARD vid psoriasisartrit

I en jämförande studie visade sig ixekizumab vara effektivare än ustekinumab för att nå det primära effektmåttet för PASI 90 i vecka 12.

Background

This summary contains information on the ixekizumab dosing schedule IXE Q2W and the combination of ixekizumab with other cDMARDs than MTX that are not consistent with the information contained within the Summary of Product Characteristics (SmPC). Please refer to the SmPC for full prescribing information.

SPIRIT-P1 (N=417) is a phase 3, 24-week double-blind, placebo-controlled trial with an active reference arm 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 TNF inhibitor, with an extension period of up to 3 years.2

The cDMARDs permitted during the trials were MTX, leflunomide, sulfasalazine, or hydroxychloroquine. Patients must have been treated for at least 12 weeks prior to baseline and on a stable dose for at least 8 weeks prior to baseline, with

  • oral or parenteral MTX (10-25 mg/week)

  • leflunomide (20 mg/day)

  • sulfasalazine (up to 3 g/day), or

  • hydroxychloroquine (up to 400 mg/day).1,2

SPIRIT-P1 included patients who were cDMARD naïve, had received past treatment with a cDMARD, or were receiving no more than one cDMARD at study entry. SPIRIT-P2 included patients who had been previously treated with one or more cDMARDs or were receiving treatment with no more than one cDMARD at study entry.1,2

Concomitant cDMARD Use in SPIRIT-P1

Table 1 lists the distribution of patients with concomitant cDMARD use across treatment arms in SPIRIT-P1. As demonstrated in the table, MTX constituted the largest percentage of patients with concomitant use of cDMARDs.3

Table 1. Concomitant cDMARD Therapy in SPIRIT-P13

 

IXE Q2W
N=103

IXE Q4W
N=107

PBO
N=106

cDMARD current use, n (%)

63 (61.2%)

68 (63.6%)

69 (65.1%)

Methotrexate use, n (%)

53 (51.5%)

57 (53.3%)

59 (55.7%)

Abbreviations: cDMARD = conventional disease-modifying antirheumatic drug; IXE Q2W = ixekizumab 80 mg every 2 weeks following 160 mg starting dose; IXE Q4W = ixekizumab 80 mg every 4 weeks following 160 mg starting dose; PBO = placebo.

In SPIRIT-P1, ixekizumab demonstrated efficacy in improvement of PsA signs and symptoms and slowed structure progression in bDMARD-naïve patients relative to placebo, regardless of concomitant cDMARD use. The incidence of TEAEs, SAEs and AEs leading to discontinuations was similar vs placebo across all treatment groups, with or without concomitant cDMARD or MTX use.3 

Concomitant cDMARD Use in Spirit-P2

The primary objective of the trial was to assess whether IXE Q2W or IXE Q4W was superior to PBO in the treatment of PsA in patients who had inadequate response, loss of efficacy, or intolerance to TNF inhibitors as measured by ACR20 score at week 24.2

At baseline, 185 (51%) patients received background cDMARDs, 149 of which were receiving MTX. Patients in this trial were not stratified by cDMARD use within treatment arms.4 

In SPIRIT-P2, response rates for ACR20, ACR50, and MDA were significantly higher in patients treated with ixekizumab vs PBO, regardless of background cDMARD use. Treatment-emergent adverse events, SAEs, or discontinuations due to AEs were comparable to the overall trial population.5

Integrated SPIRIT-P1 and SPIRIT-P2 Analysis at Week 156

A post hoc analysis of data from SPIRIT-P1 and SPIRIT-P2 evaluated the safety and efficacy of treatment with ixekizumab up to 3 years in subgroups of patients with

  • no cDMARD use for 3 years (ixekizumab monotherapy)

  • MTX use without interruption of 14 days or more, and

  • concomitant use of a cDMARD, including methotrexate, sulfasalazine, leflunomide, cyclosporine, or hydroxychloroquine, without interruption of 14 days or more.6

Overall, patients who received ixekizumab in SPIRIT-P1 and SPIRIT-P2 had improvements in all evaluated efficacy outcomes (ACR20/50/70, PASI 75/90/100, and HAQ-DI response rates) over 156 weeks, and response rates were similar regardless of background methotrexate or other cDMARD use.6

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.7

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. Coates LC, Kishimoto M, Gottlieb A, et al. Ixekizumab efficacy and safety with and without concomitant conventional disease-modifying antirheumatic drugs (cDMARDs) in biologic DMARD (bDMARD)-naïve patients with active psoriatic arthritis (PsA): results from SPIRIT-P1. RMD Open. 2017;3(2):e000567. http://dx.doi.org/10.1136/rmdopen-2017-000567

4. Nash P, Behrens F, Orbai AM, et al. AB0944 Efficacy and safety of ixekizumab when used alone or in combination with conventional disease-modifying antirheumatic drugs (CDMARDS) in tnf-experienced patients with psoriatic arthritis. Ann Rheum Dis. 2018;77(suppl 2):1596-1597. https://ard.bmj.com/content/77/Suppl_2/1596.2

5. Nash P, Behrens F, Orbai AM, et al. Ixekizumab is efficacious when used alone or when added to conventional synthetic disease-modifying antirheumatic drugs (cDMARDs) in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor inhibitors. RMD Open. 2018;4(2):e000692. http://dx.doi.org/10.1136/rmdopen-2018-000692

6. Coates LC, Kronbergs A, Sprabery AT, et al. Efficacy and safety of ixekizumab in patients with active psoriatic arthritis based on concomitant conventional disease-modifying antirheumatic drugs (cDMARD) use: results from SPIRIT-P1 and SPIRIT-P2. Poster presented at: European League Against Rheumatism (Virtual); June 3-6, 2020.

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

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

AE = adverse event

bDMARD = biologic disease-modifying antirheumatic drug

cDMARD = conventional disease-modifying antirheumatic drug

HAQ-DI = Health Assessment Questionnaire-Disability Index

IXE = ixekizumab

MDA = minimal disease activity

MTX = methotrexate

PASI 100 = 100% improvement from baseline in Psoriasis Area and Severity Index

PASI 90 = 90% improvement from baseline in Psoriasis Area and Severity Index

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

PBO = placebo

PsA = psoriatic arthritis

Q2W = every 2 weeks

Q4W = every 4 weeks

SAE = serious adverse event

TEAE = treatment-emergent adverse event

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 2020 M06 03


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