Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

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Taltz® ▼ (ixekizumab): Jämförelse med Tildrakizumab i psoriasis

Det finns inga uppgifter från direkt jämförande studier som jämför ixekizumab med tildrakizumab. Indirekta jämförelseanalyser ges nedan.

Detailed Information

No head-to-head trials have been conducted comparing the efficacy and safety of ixekizumab to that of tildrakizumab in the treatment of psoriasis.

Ixekizumab is an IgG4 monoclonal antibody that binds with high affinity (< 3 pM) and specificity to interleukin 17A (both IL‑17A and IL‑17A/F). Elevated concentrations of IL‑17A have been implicated in the pathogenesis of psoriasis by promoting keratinocyte proliferation and activation, as well as in the pathogenesis of psoriatic arthritis and axial spondyloarthritis by driving inflammation leading to erosive bone damage and pathological new bone formation. Neutralisation of IL‑17A by ixekizumab inhibits these actions. Ixekizumab does not bind to ligands IL‑17B, IL‑17C, IL‑17D, IL‑17E or IL‑17F.1 

In vitro binding assays confirmed that ixekizumab does not bind to human Fcγ receptors I, IIa, and IIIa or to complement component C1q.1

Tildrakizumab-asmn is a humanized IgG1/k mAb that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Tildrakizumab inhibits the release of proinflammatory cytokines and chemokines.2

Since clinical trials are conducted under widely varying and controlled conditions, efficacy outcomes and adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adjusted Indirect Comparison of Ixekizumab and Tildrakizumab in Plaque Psoriasis

The methodology used to indirectly compare the efficacy outcomes (PASI 75, PASI 90, and PASI 100) of ixekizumab and tildrakizumab in patients with moderate-to-severe psoriasis were

  • AIC using the Bucher method, and

  • MAIC using the Signorovitch method in which reweighting was performed matching the following baseline characteristics in terms of means or percentages: patient age, sex, previous biologic treatment, PASI score, and BSA affected.3

Both methods of indirect comparisons used are subject to limitations including the potential for bias due to differences between trial populations and imbalances in unobserved factors between trials. These limitations can only be avoided with head-to-head randomized trials.4,5

As shown in Figure 1, etanercept and placebo were used as the common comparators for the indirect comparison of ixekizumab and tildrakizumab.3

Figure 1. Study Design for Indirect Comparison of Ixekizumab and Tildrakizumab3

Abbreviations: ETN = etanercept; IXE = ixekizumab; PASI 75/90/100 = 75%/90%/100% improvement from baseline in Psoriasis Area and Severity Index; PBO = placebo; TIL = tildrakizumab.

Dashed line represents indirect comparison and solid line represents direct comparison.

The risk differences for PASI responses up to week 12 are available in Figure 2.

The authors concluded the results of this indirect comparison suggest that ixekizumab might provide clinical benefits over tildrakizumab in terms of faster onset of action and higher levels of skin clearance up to week 12 in patients with moderate-to-severe psoriasis.3

Figure 2. Ixekizumab vs Tildrakizumab Indirect Comparison of PASI Responses Via Comparator Bridges3

Abbreviations: AIC = adjusted indirect comparison; ETN = etanercept; IXE = ixekizumab; MAIC = matching adjusted indirect comparison; PASI = Psoriasis Area Severity Index; PASI 75/90/100 = 75%/90%/100% improvement from baseline in Psoriasis Area and Severity Index; PBO = placebo; TIL = tildrakizumab.

References

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

2. ILUMYA [package insert]. Sharjah, U.A.E.: Sun Pharma Global FZE, Inc; 2018.

3. Gottlieb A, Saure D, Wilhelm S, et al. Indirect comparison of ixekizumab versus tildrakizumab for up to 12 weeks of treatment in patients with moderate-to-severe psoriasis. Poster presented at: 77th Annual Meeting of the American Academy of Dermatology; March 1-5, 2019; Washington, D.C. https://www.aad.org/eposters/Submissions/getFile.aspx?id=8051&type=sub

4. Bucher HC, Guyatt GH, Griffith LE, et al. The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J Clin Epidemiol 1997;50(6):683-691. https://doi.org/10.1016/S0895-4356(97)00049-8

5. Signorovitch JE, Wu EQ, Yu AP, et al. Comparative effectiveness without head-to-head trials: a method for matching-adjusted indirect comparisons applied to psoriasis treatment with adalimumab or etanercept. Pharmacoeconomics. 2010;28(10):935-945. http://dx.doi.org/10.2165/11538370-000000000-00000

Glossary

AIC = adjusted indirect comparison

BSA = body surface area

IgG1 = immunoglobulin G subclass 1

IgG4 = immunoglobulin G subclass 4

IL = interleukin

mAb(s) = monoclonal antibody

MAIC = matched-adjusted indirect comparison

PASI = Psoriasis Area and Severity Index

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

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

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

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 M08 19


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