Taltz ® (ixekizumab) injektion

För fullständig produktresumé för Taltz® se FASS.

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

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

Detailed Information

No head-to-head trials have been conducted comparing the efficacy and safety of ixekizumab to that of risankizumab 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

Risankizumab-rzaa is a humanized IgG1 mAb that selectively binds to the p19 subunit of the human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses. Risankizumab-rzaa 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 Risankizumab in Plaque Psoriasis

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

  • AIC using the Bucher method, and

  • MAIC using the Signorovitch method, which is an extension of AIC taking into account differences in baseline characteristics and/or treatment effect modifiers matched to the means of the characteristics available in the literature.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, ustekinumab and placebo were used as the common comparators for the indirect comparison of ixekizumab and risankizumab.3

Figure 1. Study Design for Indirect Comparison of Ixekizumab and Risankizumab3

Abbreviations: AIC = adjusted indirect comparison; IXE = ixekizumab; MAIC = matching adjusted indirect comparison; PLA = placebo; RIS = risankizumab; UST = ustekinumab.

The risk difference for PASI responses are available in

The authors concluded that indirect comparison across multiple analysis methods using a placebo comparator bridge indicated that ixekizumab provides clinical benefits over risankizumab in terms of PASI 75 and PASI 90 response and with regard to speed of action up to week 12 in patients with moderate-to-severe psoriasis.3

In the ustekinumab bridge, efficacy analysis was performed on a smaller sample size (256 unmatched ixekizumab-treated patients compared to 1952 unmatched ixekizumab-treated patients in the placebo bridge) which may have led to less precise results.3

Figure 2. Ixekizumab vs Risankizumab Indirect Comparison of PASI 75 Responses at Week 12 Via Comparator Bridges3

Abbreviations: AIC = adjusted indirect comparison; IXE = ixekizumab; MAIC = matching adjusted indirect comparison; PASI 75 = 75% improvement from baseline in Psoriasis Area and Severity Index; PLA = placebo; RIS = risankizumab; UST = ustekinumab.

Figure 3. Ixekizumab vs Risankizumab Indirect Comparison of PASI 90 Responses at Week 4 Via Comparator Bridges3

Abbreviations: AIC = adjusted indirect comparison; IXE = ixekizumab; MAIC = matching adjusted indirect comparison; PASI 90 = 90% improvement from baseline in Psoriasis Area and Severity Index; PLA = placebo; RIS = risankizumab; UST = ustekinumab.

Figure 4. Ixekizumab vs Risankizumab Indirect Comparison of PASI 90 Responses at Week 8 Via Comparator Bridges3

Abbreviations: AIC = adjusted indirect comparison; IXE = ixekizumab; MAIC = matching adjusted indirect comparison; PASI 90 = 90% improvement from baseline in Psoriasis Area and Severity Index; PLA = placebo; RIS = risankizumab; UST = ustekinumab.

Figure 5. Ixekizumab vs Risankizumab Indirect Comparison of PASI 90 Responses at Week 12 Via Comparator Bridges3

Abbreviations: AIC = adjusted indirect comparison; IXE = ixekizumab; MAIC = matching adjusted indirect comparison; PASI 90 = 90% improvement from baseline in Psoriasis Area and Severity Index; PLA = placebo; RIS = risankizumab; UST = ustekinumab.

References

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

2. SKYRIZI [package insert]. North Chicago, IL: AbbVie Inc; 2019.

3. Gottlieb A, Ramot Y, Smith S, et al. Indirect comparison of ixekizumab versus risankizumab 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, DC. https://www.aad.org/eposters/Submissions/getFile.aspx?id=9775&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

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

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 13


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