Biologics in the management of psoriasis

Bahner, Jennifer D.; Cao, Lauren; Korman, Neil J.

doi:10.2147/ccid.s3629

CCID

2009

DOI: 10.2147/ccid.s3629

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Biologics in the management of psoriasis

Jennifer D. Bahner

Lauren Cao

Neil J. Korman

Abstract: Psoriasis is a chronic inflammatory systemic disease for which there exist topical, ultraviolet, systemic, and biologic treatments. Biologic agents selectively interfere with the immune mechanisms responsible for psoriasis. Etanercept, infliximab, and adalimumab target tumor necrosis factor-alpha and have demonstrated efficacy in the treatment of psoriasis and psoriatic arthritis. Alefacept and efalizumab target T lymphocytes, are effective in the treatment of psoriasis, but are not approved for psoriatic arth… Show more

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2015

2024

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Cited by 3 publications

References 122 publications

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Post‐Marketing Safety of Ustekinumab Based on 14‐Year Follow‐Up in Danish National Patient Data

Kim,

Jensen,

Egeberg

et al. 2024

Pharmacoepidemiology and Drug

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PurposePsoriasis (PsO), a chronic inflammatory skin disorder affecting a substantial proportion of populations globally, often necessitates systemic treatment including biologics. This 14‐year cohort study, based on Danish national register data, aimed to investigate the enduring safety profile of ustekinumab compared to other systemic psoriasis treatments.MethodsUsing comprehensive Danish national register data, this study scrutinized patients diagnosed with psoriasis or psoriatic arthritis (PsA) who received ustekinumab. The treatment group comparators were non‐biological systemic treatment (non‐biologic), tumor necrosis factor α inhibitor medicine groups (TNF‐α), interleukin (IL)‐17 inhibitors (IL‐17), and IL‐23 inhibitors (IL‐23). The study periods for comparisons were 2009–2022 for non‐biologic and TNF‐α, 2015–2022 for IL‐17, and 2018–2022 for IL‐23. Outcomes were malignancies, cardiovascular events, serious infections, and serious hypersensitivity reactions. Cox proportional hazards regression models were employed to analyze two estimands: a standard intention‐to‐treat (ITT) estimand and a continuous‐index‐treatment (CIT) estimand, which considered switch and re‐initiation of treatments within individuals.ResultsUsers of ustekinumab were found to be younger on average, with an average age of 45.1 years compared to 51.6, 47.2, 49.0, and 48.4 years in the non‐biologic, TNF‐α, IL‐17, and IL‐23 groups, respectively. Also, 57.3% of the ustekinumab users were male, compared to 46.7%, 48.9%, 50.9%, and 58.3% for the non‐biologic, TNF‐α, IL‐17, and IL‐23 groups, respectively. Although the hazard ratio estimates varied across comparators, ustekinumab was found to be safe: regardless of PsA status, no discernible safety signals in terms of malignancy, MACE, severe infections, or severe hypersensitivity reactions were observed for ustekinumab when compared to the treatment comparators.ConclusionsThe present study corroborated the enduring safety of ustekinumab in the context of PsO treatment.

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Post‐Marketing Safety of Ustekinumab Based on 14‐Year Follow‐Up in Danish National Patient Data

Kim,

Jensen,

Egeberg

et al. 2024

Pharmacoepidemiology and Drug

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Chimeric Fusion Proteins Used for Therapy: Indications, Mechanisms, and Safety

Baldo¹

2015

Drug Saf

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Chimeric fusion proteins, produced by genetic engineering, are currently made up of effector peptides, for example, a ligand-binding portion of a cytokine or growth factor, extracellular domains of lymphocyte antigens, or a toxin linked to a suitable fusion partner. This review covers eight fusion proteins that have received regulatory approval for human therapy: etanercept, belatacept, abatacept, alefacept, rilonacept, romiplostim, aflibercept, and denileukin-diftitox. Important requirements for an effective fusion protein are effective targeting and binding, cytotoxicity, and a stable molecule with an extended half-life. The Fc region of human IgG1 is generally chosen as the fusion partner for the effector molecule(s) because it extends the fusion protein half-life by recycling via the salvage neonatal FcRn receptor and protects the molecule from lysosomal degradation. Each of the fusion proteins has IgG1 Fc as a fusion partner except denileukin-diftitox, which employs a modified diphtheria toxin effector peptide linked to interleukin-2. For six of the Fc fusion proteins, the effector peptide(s) is linked to the N-terminus of the Fc piece but for the thrombopoietin-mimetic romiplostim, linkage is through the C-terminus. Although some clear type I and IV hypersensitivities are known to be induced by fusion protein therapy, the pathomechanisms underlying many adverse hematologic, respiratory, renal, and cutaneous events have generally not been investigated. Assessment of immunogenicity risk is important because a number of immune-based, or influenced, adverse reactions such as anaphylaxis, cutaneous manifestations, infusion, and injection-site reactions, and cytokine release syndrome can occur. Features of many reactions, some autoimmune in nature, suggest type II, III, or IV hypersensitivities. Clinical findings with the anti-arthritis anti-psoriasis biologic etanercept provide the largest body of current knowledge of fusion protein-induced adverse events. For most fusion proteins, little information is available on appropriate diagnostic and desensitization procedures for hypersensitivity and other adverse responses, although skin test concentrations and some successful desensitization protocols have been published for etanercept.

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Uncovering the unmet needs among psoriasis patients in the Asia‐Pacific region

Tada

Huang

et al. 2021

The Journal of Dermatology

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Studies on the psychosocial and emotional burden of psoriasis have been extensive; however, there is limited knowledge and awareness of patients’ attitude and behavior towards psoriasis treatment. To understand psoriasis patients’ attitude and behavior towards treatment of psoriasis, especially those treated with biologics, a multi‐stage study qualitative and quantitative methodology was conducted among psoriasis patients. An online survey was conducted with 45 moderate‐to‐severe psoriasis patients each in Australia, Japan, South Korea, and Taiwan for 20 min. This was followed by qualitative in‐depth interviews conducted among psoriasis patients in Australia (n = 3) and Japan (n = 2) for 60 min. All of the findings were workshopped with key opinion leaders and patient advisory groups to identify potential solutions addressing patients’ unmet needs. Five common insights were identified across the region, highlighting patients’ attitude and behavior towards psoriasis treatment, especially for those treated with biologics. These insights comprised the following: (i) one of the key factors driving patients’ treatment choice included their ability to enjoy clear skin for longer period (68%); (ii) bio‐maintenance patients had a higher expectation (4.9 months) of how long their skin could stay clear, compared to their pre‐biologics initiation days (2.9 months); (iii) once a good response is achieved, bio‐maintenance patients were more concerned about symptoms returning (44%) than development of side‐effects (19%); (iv) bio‐maintenance patients felt psychologically and physically affected during flare‐ups despite being on more efficacious treatment; and (v) bio‐maintenance patients still felt they were at risk of flare‐ups (4.5/7), almost similar risk perception as non‐biologics patients (4.9/7). Findings from this study showed that psoriasis patients look for treatment with the least risk of flare‐ups so that they were able to enjoy clear skin for a long time.

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Biologics in the management of psoriasis

Cited by 3 publications

References 122 publications

Post‐Marketing Safety of Ustekinumab Based on 14‐Year Follow‐Up in Danish National Patient Data

Post‐Marketing Safety of Ustekinumab Based on 14‐Year Follow‐Up in Danish National Patient Data

Chimeric Fusion Proteins Used for Therapy: Indications, Mechanisms, and Safety

Uncovering the unmet needs among psoriasis patients in the Asia‐Pacific region

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