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  1. Article ; Online: Editorial: fixed-dose combination calcipotriol/betamethasone dipropionate foam in the treatment of patients with psoriasis.

    Lebwohl, M / Warren, R B

    Journal of the European Academy of Dermatology and Venereology : JEADV

    2021  Volume 35 Suppl 1, Page(s) 3–4

    MeSH term(s) Betamethasone/analogs & derivatives ; Calcitriol/analogs & derivatives ; Dermatologic Agents/therapeutic use ; Drug Combinations ; Humans ; Ointments ; Psoriasis/drug therapy ; Treatment Outcome
    Chemical Substances Dermatologic Agents ; Drug Combinations ; Ointments ; calcipotriene (143NQ3779B) ; betamethasone-17,21-dipropionate (826Y60901U) ; Betamethasone (9842X06Q6M) ; Calcitriol (FXC9231JVH)
    Language English
    Publishing date 2021-02-23
    Publishing country England
    Document type Editorial
    ZDB-ID 1128828-0
    ISSN 1468-3083 ; 0926-9959
    ISSN (online) 1468-3083
    ISSN 0926-9959
    DOI 10.1111/jdv.17026
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  2. Article ; Online: Addressing challenges associated with long-term topical treatment and benefits of proactive management in patients with psoriasis.

    Lebwohl, M / Thaçi, D / Warren, R B

    Journal of the European Academy of Dermatology and Venereology : JEADV

    2021  Volume 35 Suppl 1, Page(s) 35–41

    Abstract: The majority of patients with psoriasis vulgaris (chronic plaque psoriasis) can be treated successfully with short-term topical therapies. However, long-term management of psoriasis with topicals is challenging and tends to take a reactive approach to ... ...

    Abstract The majority of patients with psoriasis vulgaris (chronic plaque psoriasis) can be treated successfully with short-term topical therapies. However, long-term management of psoriasis with topicals is challenging and tends to take a reactive approach to disease relapse, rather than a proactive approach aimed at maintaining disease remission. Patients are often dissatisfied with the delay in treatment response and inconvenience of applying topical treatments, and therefore frequently discontinue treatment leading to poor outcomes. Relapse is common, particularly with reactive management, as underlying residual disease can remain following initial skin clearance; some patients find that their disease at relapse may be worse than their initial symptoms. This can have a detrimental effect on patient quality of life (QoL) and increase the risk of psoriasis-associated depression. A long-term proactive management approach, with maintenance treatment following initial treatment success, could help sustain disease remission and improve clinical and QoL outcomes for patients. Treatment with fixed-dose calcipotriol 50 µg/g betamethasone dipropionate 0.5 mg/g cutaneous foam (Cal/BD foam) is effective in the short term, providing a fast onset of action and improvements in disease at 4 weeks. Results from the Phase III PSO-LONG study demonstrated that long-term proactive management was superior to reactive management in prolonging time to first relapse, reducing number of relapses and increasing days in remission in adults with psoriasis vulgaris. Furthermore, Cal/BD foam was well tolerated in PSO-LONG. No new safety concerns were identified over 52 weeks; the safety profile was consistent with that described previously. Given this, Cal/BD foam should be considered when prescribing topicals for the long-term proactive management for patients with psoriasis.
    MeSH term(s) Adult ; Betamethasone ; Dermatologic Agents/therapeutic use ; Drug Combinations ; Humans ; Neoplasm Recurrence, Local/drug therapy ; Psoriasis/drug therapy ; Quality of Life
    Chemical Substances Dermatologic Agents ; Drug Combinations ; Betamethasone (9842X06Q6M)
    Language English
    Publishing date 2021-03-05
    Publishing country England
    Document type Journal Article
    ZDB-ID 1128828-0
    ISSN 1468-3083 ; 0926-9959
    ISSN (online) 1468-3083
    ISSN 0926-9959
    DOI 10.1111/jdv.17053
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  3. Article ; Online: Update on risankizumab for the treatment of moderate to severe psoriasis.

    Al-Janabi, A / Warren, R B

    Expert opinion on biological therapy

    2020  Volume 20, Issue 11, Page(s) 1245–1251

    Abstract: Introduction: The therapeutic landscape for psoriasis is ever-changing. Risankizumab is the newest approved biologic and one of three currently licensed that targets the p19 subunit of interleukin-23 (IL-23). It is increasingly clear that different ... ...

    Abstract Introduction: The therapeutic landscape for psoriasis is ever-changing. Risankizumab is the newest approved biologic and one of three currently licensed that targets the p19 subunit of interleukin-23 (IL-23). It is increasingly clear that different biologics vary in their efficacy, effectiveness, and safety profiles, highlighting that there is a need to understand for which patients and in which circumstances to use each drug.
    Areas covered: This article summarizes original clinical trial data, and reviews in more detail recent post-marketing studies and meta-analyses that differentiate risankizumab from other biologics. It also briefly explores the evidence for risankizumab in the treatment of other immune-mediated inflammatory diseases.
    Expert opinion: Risankizumab is a highly effective biologic for the treatment of moderate-to-severe plaque psoriasis. Recent open-label extension data for risankizumab shows sustained treatment responses to week 136. Indirect comparisons suggest IL-17 inhibitors have a faster onset, though head-to-head comparison with secukinumab shows non-inferiority at week 16 and superiority of risankizumab at week 52. Risankizumab is very well tolerated and data from the IMMhance trial suggests that risankizumab can be used in patients with latent tuberculosis without risk of reactivation.
    MeSH term(s) Antibodies, Monoclonal/therapeutic use ; Antibodies, Monoclonal, Humanized/therapeutic use ; Clinical Trials as Topic/statistics & numerical data ; Humans ; Interleukin-17/immunology ; Interleukin-23 Subunit p19/immunology ; Meta-Analysis as Topic ; Product Surveillance, Postmarketing/statistics & numerical data ; Psoriasis/drug therapy ; Psoriasis/epidemiology ; Psoriasis/pathology ; Severity of Illness Index
    Chemical Substances Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; IL17A protein, human ; IL23A protein, human ; Interleukin-17 ; Interleukin-23 Subunit p19 ; risankizumab (90ZX3Q3FR7) ; secukinumab (DLG4EML025)
    Language English
    Publishing date 2020-09-25
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 2052501-1
    ISSN 1744-7682 ; 1471-2598
    ISSN (online) 1744-7682
    ISSN 1471-2598
    DOI 10.1080/14712598.2020.1822813
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  4. Article ; Online: Risankizumab vs. adalimumab for moderate-to-severe plaque psoriasis: a critical appraisal.

    Al-Janabi, A / Warren, R B

    The British journal of dermatology

    2020  Volume 183, Issue 2, Page(s) 220–221

    MeSH term(s) Adalimumab/therapeutic use ; Antibodies, Monoclonal ; Humans ; Psoriasis/drug therapy ; Severity of Illness Index ; Treatment Outcome
    Chemical Substances Antibodies, Monoclonal ; risankizumab (90ZX3Q3FR7) ; Adalimumab (FYS6T7F842)
    Language English
    Publishing date 2020-02-13
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 80076-4
    ISSN 1365-2133 ; 0007-0963
    ISSN (online) 1365-2133
    ISSN 0007-0963
    DOI 10.1111/bjd.18856
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  5. Article ; Online: Risk of tuberculosis reactivation with interleukin (IL)-17 and IL-23 inhibitors in psoriasis - time for a paradigm change.

    Nogueira, M / Warren, R B / Torres, T

    Journal of the European Academy of Dermatology and Venereology : JEADV

    2020  Volume 35, Issue 4, Page(s) 824–834

    Abstract: Tuberculosis is an infectious disease with a major global impact, ranked in the top 10 mortality causes worldwide. In an immunocompetent individual, the host defence mechanisms control Mycobacterium tuberculosis infection and induce the latent form of ... ...

    Abstract Tuberculosis is an infectious disease with a major global impact, ranked in the top 10 mortality causes worldwide. In an immunocompetent individual, the host defence mechanisms control Mycobacterium tuberculosis infection and induce the latent form of the disease. However, in the presence of diseases or therapies, which exert an immunosuppressive effect, latent tuberculosis can be re-activated. Psoriasis is an immune-mediated, inflammatory disease, and its treatment has rapidly evolved over the last few years. It has long been recognized that the tumour necrosis factor (TNF)-α inhibitors are associated with increased risk of reactivation of latent tuberculosis infection. Thus, international guidelines have been suggesting tuberculosis screening before starting the treatment with all biological agents since then. In addition, the institution of chemoprophylaxis in the presence of latent tuberculosis and the annual screening for tuberculosis thereafter have also been indicated. However, anti-tuberculosis treatments can have significant side-effects and there are currently several contraindications to their use. The risk benefit of starting anti-tuberculous treatment should be carefully weighed up. The emergence of new biological drugs for the treatment of psoriasis, such as interleukin (IL)-17 and IL-23 inhibitors, has reignited the subject of tuberculosis reactivation as it is possible that IL-17 and 23 blockade do not carry the same risk of TB reactivation as TNF-α inhibitors. Although preclinical studies have shown that cytokines IL-17 and IL-23 have a possible role against infection with M. tuberculosis, data from clinical trials and post-marketing surveillance with drugs that inhibit these cytokines appear to suggest that they are not crucial to this response. In this article, we review the available data on tuberculosis reactivation after the treatment of psoriasis with IL-17 and IL-23 inhibitors, and its possible impact on the way we currently manage latent tuberculosis infection before or after starting treatment with these new drugs.
    MeSH term(s) Humans ; Interleukin-17 ; Interleukin-23 ; Latent Tuberculosis/chemically induced ; Mycobacterium tuberculosis ; Psoriasis/drug therapy ; Tuberculosis ; Tumor Necrosis Factor-alpha
    Chemical Substances Interleukin-17 ; Interleukin-23 ; Tumor Necrosis Factor-alpha
    Language English
    Publishing date 2020-09-01
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 1128828-0
    ISSN 1468-3083 ; 0926-9959
    ISSN (online) 1468-3083
    ISSN 0926-9959
    DOI 10.1111/jdv.16866
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  6. Article ; Online: Safety of selective IL-23p19 inhibitors for the treatment of psoriasis.

    Crowley, J J / Warren, R B / Cather, J C

    Journal of the European Academy of Dermatology and Venereology : JEADV

    2019  Volume 33, Issue 9, Page(s) 1676–1684

    Abstract: Psoriasis is a chronic disease that requires long-term treatment. Consequently, understanding the safety and tolerability of any potential treatment over time is critical to effective prescribing. The biologic agents currently available for the treatment ...

    Abstract Psoriasis is a chronic disease that requires long-term treatment. Consequently, understanding the safety and tolerability of any potential treatment over time is critical to effective prescribing. The biologic agents currently available for the treatment of psoriasis target a number of different inflammatory cytokines involved in psoriasis disease pathogenesis. The monoclonal antibodies tildrakizumab, guselkumab and risankizumab target the p19 subunit that is specific to interleukin (IL)-23. This article reviews published data on the safety of these IL-23p19 inhibitors in patients with psoriasis compared with other currently available biologic therapies. Data from randomized, placebo- and active-controlled phase 3 clinical trials show tildrakizumab, guselkumab and risankizumab to have a favourable risk-benefit profile in patients with moderate to severe psoriasis. No significant safety concerns have been observed for any of these IL-23p19 inhibitors in the data published to date. The most commonly reported adverse events (AEs) associated with these agents in phase 3 studies were upper respiratory tract infections. No increase was seen in rates of serious infections, malignancies or major adverse cardiovascular events, with no signals suggestive of an elevated risk of opportunistic infections, active tuberculosis or reactivation of latent tuberculosis infection, mucocutaneous Candida infections, triggering or worsening of inflammatory bowel disease, demyelinating disorders or suicidal ideation. Selectively targeting IL-23p19 may help avoid AEs that have been associated with biologic agents with other mechanisms of action. Data from long-term extension studies and patient registries will further establish the safety profile of IL-23p19 inhibitors for the treatment of moderate to severe psoriasis in routine practice.
    MeSH term(s) Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized/adverse effects ; Antibodies, Monoclonal, Humanized/therapeutic use ; Biological Products/adverse effects ; Biological Products/therapeutic use ; Humans ; Interleukin-23 Subunit p19/antagonists & inhibitors ; Psoriasis/drug therapy
    Chemical Substances Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Biological Products ; Interleukin-23 Subunit p19 ; guselkumab (089658A12D) ; risankizumab (90ZX3Q3FR7) ; tildrakizumab (DEW6X41BEK)
    Language English
    Publishing date 2019-06-27
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 1128828-0
    ISSN 1468-3083 ; 0926-9959
    ISSN (online) 1468-3083
    ISSN 0926-9959
    DOI 10.1111/jdv.15653
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  7. Article ; Online: Long-term efficacy and safety of secukinumab in the treatment of the multiple manifestations of psoriatic disease.

    Reich, K / Warren, R B / Coates, L C / Di Comite, G

    Journal of the European Academy of Dermatology and Venereology : JEADV

    2020  Volume 34, Issue 6, Page(s) 1161–1173

    Abstract: Psoriatic disease is a multifaceted disorder, which develops in the skin, its appendages and joints. Though characterized by different pathogenic background and clinical manifestations, skin plaque psoriasis (PsO), psoriatic arthritis (PsA) and ... ...

    Abstract Psoriatic disease is a multifaceted disorder, which develops in the skin, its appendages and joints. Though characterized by different pathogenic background and clinical manifestations, skin plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) are related, sharing key inflammatory mechanisms and hence mode of management. Secukinumab is a fully human monoclonal antibody that selectively binds and neutralizes interleukin-17A. It has been approved for use as a subcutaneous injection for the treatment of moderate-to-severe PsO, PsA and AS. The current review highlights the long-term efficacy and safety profile of secukinumab in the treatment of plaque psoriasis and its multiple manifestations from its phase 3 clinical trial programme. The long-term extension of pivotal trials has shown sustainable efficacy and safety of secukinumab up to 5 years in PsO, PsA and AS and up to 2.5 years in moderate-to-severe nail and palmoplantar PsO through dedicated randomized controlled trials. The effect of secukinumab therapy in all these indications has corresponding effects on improvement in quality-of-life and daily activities. Overall, secukinumab is an effective and safe treatment choice for patients suffering from psoriatic disease in its multiple clinical variants.
    MeSH term(s) Antibodies, Monoclonal/adverse effects ; Antibodies, Monoclonal, Humanized ; Arthritis, Psoriatic/drug therapy ; Humans ; Psoriasis/drug therapy
    Chemical Substances Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; secukinumab (DLG4EML025)
    Language English
    Publishing date 2020-01-07
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 1128828-0
    ISSN 1468-3083 ; 0926-9959
    ISSN (online) 1468-3083
    ISSN 0926-9959
    DOI 10.1111/jdv.16124
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  8. Article ; Online: Psoriasis comorbidities: a worldwide problem?

    Warren, R B

    The British journal of dermatology

    2011  Volume 165, Issue 5, Page(s) 929

    MeSH term(s) Female ; Humans ; Male ; Psoriasis/epidemiology
    Language English
    Publishing date 2011-10-24
    Publishing country England
    Document type Journal Article ; Comment
    ZDB-ID 80076-4
    ISSN 1365-2133 ; 0007-0963
    ISSN (online) 1365-2133
    ISSN 0007-0963
    DOI 10.1111/j.1365-2133.2011.10678.x
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  9. Article ; Online: Complete clearance and Psoriasis Area and Severity Index response for brodalumab and ustekinumab by previous treatment history in AMAGINE-2 and AMAGINE-3.

    Reich, K / Hansen, J B / Puig, L / Konstantinou, M P / Warren, R B

    Journal of the European Academy of Dermatology and Venereology : JEADV

    2021  Volume 35, Issue 10, Page(s) 2034–2044

    Abstract: Background: The pathway for treatment of psoriasis is partly dependent upon disease severity, and patients may experience inadequate response at any point along the treatment pathway. Patients who repeatedly fail therapy represent a population in whom ... ...

    Abstract Background: The pathway for treatment of psoriasis is partly dependent upon disease severity, and patients may experience inadequate response at any point along the treatment pathway. Patients who repeatedly fail therapy represent a population in whom effective and well-tolerated treatment options are limited.
    Objectives: To investigate and describe patients achieving Psoriasis Area and Severity Index (PASI) 100 and cumulative treatment benefit over time in patients with moderate-to-severe psoriasis receiving brodalumab or ustekinumab by prior treatment.
    Methods: We conducted a post hoc analysis of data from two phase 3, randomized, controlled, 52-week AMAGINE trials of brodalumab to describe patients who achieved complete clearance as measured by PASI 100 by prior treatment subgroup (naïve to systemic and biologic treatment, systemic-treated but biologic-naïve, biologic-treated without failure, and biologic-treated with failure). A competing risk model was used to assess cumulative incidence over a 52-week period with outcomes of PASI 100 or inadequate response. Cumulative clinical benefit of treatment was determined with an area under the curve analysis.
    Results: The 52-week cumulative incidence of patients achieving PASI 100 was consistently higher for brodalumab vs. ustekinumab across treatment pathway subgroups (76% vs. 58% in systemic/biologic-naïve patients, 78% vs. 55% in systemic-treated/biologic-naïve patients, 75% vs. 41% in biologic-treated patients without failure, and 70% vs. 30% in biologic-treated patients with failure). Rates of inadequate response were lower with brodalumab compared with ustekinumab across all subgroups. Cumulative treatment benefit was also higher for all subgroups treated with brodalumab compared with those treated with ustekinumab.
    Conclusion: Treatment with brodalumab was associated with higher levels of complete clearance and greater cumulative benefit over time compared with ustekinumab, in patients with moderate-to-severe psoriasis, regardless of prior treatment experience.
    MeSH term(s) Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; Humans ; Psoriasis/drug therapy ; Severity of Illness Index ; Treatment Outcome ; Ustekinumab
    Chemical Substances Antibodies, Monoclonal ; Antibodies, Monoclonal, Humanized ; brodalumab (6ZA31Y954Z) ; Ustekinumab (FU77B4U5Z0)
    Language English
    Publishing date 2021-07-24
    Publishing country England
    Document type Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial
    ZDB-ID 1128828-0
    ISSN 1468-3083 ; 0926-9959
    ISSN (online) 1468-3083
    ISSN 0926-9959
    DOI 10.1111/jdv.17433
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  10. Article ; Online: Long-term efficacy and safety of brodalumab in moderate-to-severe plaque psoriasis: a post hoc pooled analysis of AMAGINE-2 and -3.

    Reich, K / Iversen, L / Puig, L / Lambert, J / Mrowietz, U / Kaplan Saday, K / Warren, R B

    Journal of the European Academy of Dermatology and Venereology : JEADV

    2022  Volume 36, Issue 8, Page(s) 1275–1283

    Abstract: Background: Brodalumab is a monoclonal antibody that blocks multiple interleukin (IL)-17 family cytokines by binding to the shared A subunit of the IL-17 receptor. In Phase 3 trials, brodalumab provided high levels of skin clearance through 52 weeks in ... ...

    Abstract Background: Brodalumab is a monoclonal antibody that blocks multiple interleukin (IL)-17 family cytokines by binding to the shared A subunit of the IL-17 receptor. In Phase 3 trials, brodalumab provided high levels of skin clearance through 52 weeks in patients with moderate-to-severe psoriasis and was generally well tolerated.
    Objectives: To assess efficacy response rates and safety outcomes through 120 weeks for patients with moderate-to-severe psoriasis who received brodalumab.
    Methods: Safety and efficacy data were pooled for patients from AMAGINE-2 and -3 who received continuous brodalumab 210 mg every 2 weeks, or brodalumab 210 mg every 2 weeks after receiving either brodalumab 140 mg or placebo through Week 12. Efficacy data are presented using observed data, non-responder imputation (NRI) and a combination of NRI and missing at random assumption to account for missing data. Absolute PASI scores are presented using mixed-effect model repeated measure modelling and multiple imputation.
    Results: Based on observed data at Week 120, 86% of the continuous brodalumab 210 mg group achieved PASI 90 and 74% achieved PASI 100. At Week 12, 58% of this group achieved absolute PASI ≤1; this proportion increased to approximately 80% at Week 52 and persisted through Week 120. Among patients receiving continuous brodalumab 210 mg, median duration of brodalumab exposure was 747 days and the overall exposure-adjusted event rate of treatment emergent adverse events per 100 patient-years was 329. Safety through 120 weeks was comparable to the results of the primary AMAGINE-2 and -3 studies. Patients who switched to brodalumab 210 mg after receiving either brodalumab 140 mg or placebo through Week 12 showed similar skin clearance and safety profiles.
    Conclusions: Brodalumab treatment was well tolerated and resulted in high levels of skin clearance that were rapidly achieved and maintained through Week 120, supporting its long-term efficacy and safety profile.
    MeSH term(s) Antibodies, Monoclonal, Humanized/therapeutic use ; Double-Blind Method ; Humans ; Psoriasis ; Severity of Illness Index ; Treatment Outcome
    Chemical Substances Antibodies, Monoclonal, Humanized ; brodalumab (6ZA31Y954Z)
    Language English
    Publishing date 2022-04-01
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 1128828-0
    ISSN 1468-3083 ; 0926-9959
    ISSN (online) 1468-3083
    ISSN 0926-9959
    DOI 10.1111/jdv.18068
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