Safety and tolerability of adalimumab for the treatment of psoriasis: a review summarizing 15 years of real-life experience

Sator, Paul

doi:10.1177/2040622318772705

Cited by 44 publications

(35 citation statements)

References 84 publications

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“…The switch from reference biologic medicinal product to a biosimilar was also evaluated in this study and results are consistent with the findings from the study in patients with moderate-to-severe chronic plaque-type psoriasis, which also showed that switching between ref-ADL and SDZ-ADL does not have an impact on efficacy, safety, or immunogenicity of ref-ADL [13]. The safety profile of SDZ-ADL was consistent with the known safety profile of ref-ADL [38,39]. Over 48 weeks, incidence of TEAEs was comparable between the two treatment groups.…”

Section: Immunogenicitysupporting

confidence: 88%

Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study

et al. 2020

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Background Sandoz adalimumab SDZ-ADL (GP-2017) is an approved adalimumab biosimilar with similar efficacy and comparable safety and immunogenicity to reference adalimumab (ref-ADL) as confirmed by analytical, pharmacokinetic and confirmatory studies. ADMYRA, a phase III double-blind study, was conducted with an aim to generate efficacy, safety and immunogenicity comparability data in patients with moderate-to-severe rheumatoid arthritis (RA) having inadequate response to disease-modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX). The study also evaluated an aspect of 'switching' reference product to the biosimilar in terms of efficacy, safety and immunogenicity up to Week 48. Methods Eligible patients (N = 353) were randomized 1:1 to receive subcutaneous (sc) SDZ-ADL 40 mg (n = 177) or ref-ADL (n = 176) every other week from Week 0 to Week 24. At Week 24, all patients with at least a moderate response by Disease Activity Score-28 including high-sensitivity C-reactive protein (DAS28-CRP) in the SDZ-ADL group continued SDZ-ADL (n = 159), and in the ref-ADL group were switched to SDZ-ADL (n = 166), treated for up to 46 weeks. The primary endpoint was change in DAS28-CRP from baseline at Week 12. Other efficacy endpoints included proportion of patients with European League Against Rheumatism (EULAR) response, EULAR remission, Boolean remission, safety and immunogenicity. Results The DAS28-CRP score changes from baseline at Week 12 were similar between SDZ-ADL (− 2.16) and ref-ADL (− 2.18) with a mean difference (95% CI) of 0.02 (− 0.24 to 0.27), which was within the pre-specified equivalence margin of ± 0.6. After switching treatment from ref-ADL to SDZ-ADL, the mean DAS28-CRP change was similar between the SDZ-ADL and 'ref-ADL/switched SDZ-ADL' group (− 3.09 vs − 3.05). The proportion of patients with good/moderate EULAR response was 69.2%/29.0% in the SDZ-ADL group and 68.0%/29.6% in the 'ref-ADL/switched SDZ-ADL' group. The proportion of patients in EULAR remission was 51.4% and 54.4% and in Boolean remission was 16.8% and 21.6% for SDZ-ADL and 'ref-ADL/switched SDZ-ADL' groups, respectively. The secondary endpoints were similar across the treatment groups. The incidence of adverse events (AEs) and injection-site reactions were low and similar between SDZ-ADL and 'ref-ADL/switched SDZ-ADL' groups (AEs 70.6% vs 68.8%, injection-site reactions 4.0% vs 6.3%), and most of these patients experienced AEs of mild or moderate severity. Antidrug antibodies were detected in 24.2% and 25.6% of patients treated with SDZ-ADL and 'ref-ADL/switched SDZ-ADL', respectively, from baseline to Week 48, of which 72.5% in SDZ-ADL and 79.1% in 'ref-ADL/switched SDZ-ADL' groups were neutralizing. Conclusions In patients with moderate-to-severe RA who had an inadequate response to DMARDs, SDZ-ADL demonstrated a similar efficacy and a comparable safety and immunogenicity profile to ref-ADL. Efficacy was sustained after switching from ref-ADL to SDZ-ADL with no impact on safety (NCT02744755).

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Section: Immunogenicitysupporting

confidence: 88%

Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study

et al. 2020

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“…4,5 In a recent review of 15 years of realworld data, ADA was highlighted for its superior shortterm effectiveness and drug survival compared with etanercept. 9 Although IXE has demonstrated superior efficacy over etanercept and ustekinumab in clinical trials, 5,10,11 there is a paucity of real-world studies comparing the effectiveness and drug survival of IXE to those of other biologics, and there has been no direct comparison between IXE and ADA in psoriasis patients. 12 To fill this gap, this retrospective analysis aimed to evaluate and compare real-world treatment patterns, including treatment persistence (drug survival), adherence, discontinuation, switching, and restart, among psoriasis patients treated with either IXE or ADA in the United States (U.S.).…”

Section: Plain Language Summarymentioning

confidence: 99%

<p>Comparison of Real-World Treatment Patterns Among Psoriasis Patients Treated with Ixekizumab or Adalimumab</p>

Blauvelt¹,

Shi²,

Burge³

et al. 2020

PPA

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Background: There is lack of real-world treatment pattern comparison data between ixekizumab and adalimumab which are approved for the treatment of moderate-to-severe plaque psoriasis. Objective: To compare real-world treatment patterns among psoriasis patients initiating ixekizumab or adalimumab in the United States. Methods: Psoriasis patients with ≥1 claim for ixekizumab or adalimumab between March 1, 2016, and May 31, 2018, were identified (index date = date of first ixekizumab or adalimumab claim) from the IBM Watson Health MarketScan ® databases. Patients were required to be continuously enrolled for ≥12 months before the index date and followed for a minimum of 6 months until inpatient death, enrollment end, or study end, whichever occurred first. Treatment persistence, adherence, discontinuation, restart, and switching were analyzed. Inverse probability of treatment weighting and multivariable regression modeling were employed to address cohort imbalances and estimate the adjusted risk of non-persistence, discontinuation, and switching, and the odds of adherence. Results: A total of 646 ixekizumab and 3668 adalimumab users were included and followed for a mean of 14.0 and 16.5 months, respectively. Compared to adalimumab, ixekizumab was associated with 19% lower risk of non-persistence (hazard ratio [HR]=0.81, 95% confidence interval [CI]: 0.69-0.95), 26% lower risk of discontinuation (HR=0.74, 95% CI: 0.62-0.88), and 28% lower risk of switching (HR=0.72, 95% CI: 0.57-0.91). Ixekizumab users had higher odds of medication possession ratio ≥80% (odds ratio [OR]=1.36, 95% CI: 1.10-1.69) but similar odds by proportion of days covered ≥80% (OR=1.22, 95% CI: 0.98-1.53). Conclusion: Psoriasis patients treated with ixekizumab demonstrated longer persistency, higher adherence and were less likely to discontinue or switch treatment compared to adalimumab users. However, while patients achieving highly adherent threshold significantly differed by MPR ≥80%, it did not by PDC ≥80%; hence, further analysis using fixed-length follow-up is required.

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“…Various factors contribute to NIEs. The chemical and physical properties of biologics that may contribute to NIEs are summarized in Table 3 (Abbvie, 2018;Eshtiaghi & Gooderham, 2018;European Medicines Agency, 2005Ferris et al, 2019;Immunex Corporation, 2016;Kavanaugh et al, 2012;Lacour et al, 2017;Nakamura et al, 2017;Papp et al, 2016;Sator, 2018;Savage, Wittmann, Mcgonagle, & Helliwell, 2015;US Food and Drug Administration, 2008, 2011, 2017a, 2017c, 2017d, 2018a, 2018b, 2018c, 2019a, 2019bvan der Heijde et al, 2018).…”

Section: Types Of Negative Injection Experiencesmentioning

confidence: 99%

Classification and mitigation of negative injection experiences with biologic medications

Fernandez

Madsen

Krase

et al. 2020

Dermatologic Therapy

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Injection site reactions with biologic medications are encountered with variable frequency. Although there is no clear definition, they commonly manifest with pain and irritation at the injection site. Previously proposed reaction classification systems may be impractical or insufficient, and more intuitive nomenclature may benefit clinical dermatologists and patients. Negative injection experiences (NIE) are common reasons for biologic medication nonadherence. Here we provide clinical classifications and recommendations for mitigating these reactions. We categorized NIEs into the following: (a) physical, due to the needle and injection process, (b) irritant, related to properties of the injected solution, and (c) allergic, both immediate and delayed.

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Safety and tolerability of adalimumab for the treatment of psoriasis: a review summarizing 15 years of real-life experience

Cited by 44 publications

References 84 publications

Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study

Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study

<p>Comparison of Real-World Treatment Patterns Among Psoriasis Patients Treated with Ixekizumab or Adalimumab</p>

Classification and mitigation of negative injection experiences with biologic medications

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