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  1. Article ; Online: Re: Toremifene to reduce fracture risk in men receiving androgen deprivation therapy for prostate cancer. M. R. Smith, R. A. Morton, K. G. Barnette, P. R. Sieber, S. B. Malkowicz, D. Rodriguez, M. L. Hancock and M. S. Steiner. J Urol 2010;184:1316-1321.

    Langley, Ruth E / Cafferty, Fay H / Pollock, Philip A / Price, Patricia / Abel, Paul D

    The Journal of urology

    2011  Volume 185, Issue 6, Page(s) 2430–1; author reply 2431–2

    MeSH term(s) Bone Density Conservation Agents/therapeutic use ; Fractures, Bone/chemically induced ; Fractures, Bone/prevention & control ; Gonadotropin-Releasing Hormone/agonists ; Humans ; Male ; Prostatic Neoplasms/drug therapy ; Risk Factors ; Toremifene/therapeutic use
    Chemical Substances Bone Density Conservation Agents ; Gonadotropin-Releasing Hormone (33515-09-2) ; Toremifene (7NFE54O27T)
    Language English
    Publishing date 2011-04-22
    Publishing country United States
    Document type Comment ; Letter
    ZDB-ID 3176-8
    ISSN 1527-3792 ; 0022-5347
    ISSN (online) 1527-3792
    ISSN 0022-5347
    DOI 10.1016/j.juro.2011.02.036
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  2. Article ; Online: Increase in invasive

    Beres, Stephen B / Olsen, Randall J / Long, S Wesley / Langley, Ross / Williams, Thomas / Erlendsdottir, Helga / Smith, Andrew / Kristinsson, Karl G / Musser, James M

    Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin

    2024  Volume 29, Issue 13

    Abstract: ... Group ... ...

    Abstract Group A
    MeSH term(s) Humans ; Streptococcus pyogenes/genetics ; Phylogeny ; Iceland/epidemiology ; Streptococcal Infections/epidemiology ; Scotland/epidemiology
    Language English
    Publishing date 2024-03-29
    Publishing country Sweden
    Document type Journal Article
    ZDB-ID 1338803-4
    ISSN 1560-7917 ; 1025-496X
    ISSN (online) 1560-7917
    ISSN 1025-496X
    DOI 10.2807/1560-7917.ES.2024.29.13.2400129
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Effect of very long-term storage and multiple freeze and thaw cycles on 11-dehydro-thromboxane-B

    Petrucci, Giovanna / Hatem, Duaa / Langley, Ruth / Cleary, Siobhan / Gentry-Maharaj, Aleksandra / Pitocco, Dario / Rizzi, Alessandro / Ranalli, Paola / Zaccardi, Francesco / Habib, Aida / Rocca, Bianca

    Scientific reports

    2024  Volume 14, Issue 1, Page(s) 5546

    Abstract: ... of arachidonic acid, i.e. urinary 11-dehydro-thromboxane-(Tx) B ...

    Abstract Biological samples are often frozen and stored for years and/or thawed multiple times, thus assessing their stability on long-term storage and repeated freeze-thaw cycles is crucial. The study aims were to assess:-the long-term stability of two major enzymatic and non-enzymatic metabolites of arachidonic acid, i.e. urinary 11-dehydro-thromboxane-(Tx) B
    MeSH term(s) Humans ; Antioxidants ; Arachidonic Acid ; Creatinine ; Freezing ; Immunoenzyme Techniques ; Prostaglandins F ; Thromboxanes
    Chemical Substances Antioxidants ; Arachidonic Acid (27YG812J1I) ; Creatinine (AYI8EX34EU) ; Prostaglandins F ; Thromboxanes
    Language English
    Publishing date 2024-03-06
    Publishing country England
    Document type Journal Article
    ZDB-ID 2615211-3
    ISSN 2045-2322 ; 2045-2322
    ISSN (online) 2045-2322
    ISSN 2045-2322
    DOI 10.1038/s41598-024-55720-3
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  4. Article ; Online: Super-response to guselkumab treatment in patients with moderate-to-severe psoriasis: age, body weight, baseline Psoriasis Area and Severity Index, and baseline Investigator's Global Assessment scores predict complete skin clearance.

    Reich, K / Gordon, K B / Strober, B / Langley, R G / Miller, M / Yang, Y-W / Shen, Y-K / You, Y / Zhu, Y / Foley, P / Blauvelt, A

    Journal of the European Academy of Dermatology and Venereology : JEADV

    2022  Volume 36, Issue 12, Page(s) 2393–2400

    Abstract: Background: Psoriasis is a chronic immune-mediated inflammatory skin disease that often leads to a diminished quality of life. Goals of treating patients with psoriasis have shifted with more focus on achieving near or complete clearance of the skin. ... ...

    Abstract Background: Psoriasis is a chronic immune-mediated inflammatory skin disease that often leads to a diminished quality of life. Goals of treating patients with psoriasis have shifted with more focus on achieving near or complete clearance of the skin. Guselkumab, a fully human monoclonal antibody targeting interleukin-23, is effective in treating moderate-to-severe psoriasis.
    Objective: To describe the baseline characteristics of patients with moderate-to-severe psoriasis achieving super-response (Psoriasis Area and Severity Index [PASI] 100 response at Weeks 20 and 28) after commencing guselkumab treatment.
    Methods: Pooled data from VOYAGE 1 and VOYAGE 2 studies identified super-response; baseline demographic, disease and pharmacokinetic characteristics were compared with non-super-response. A stepwise logistic regression analysis identified which factors were potentially predictive of super-response status, with significance level of 0.1.
    Results: A subset of patients randomized to guselkumab comprised this post hoc analysis (n = 664); 271 patients achieved super-response vs. 393 with non-super-response. Patient age at study entry and baseline body weight (≤90 kg vs. >90 kg), PASI, and Investigator's Global Assessment (IGA) score were significant predictors of super-response status, with odds ratios (95% confidence intervals) of 0.98 (0.967-0.993; P = 0.003), 1.42 (1.026-1.977; P = 0.034), 0.97 (0.955-0.993; P = 0.007) and 0.66 (0.433-0.997; P = 0.048), respectively. More patients with super-response achieved an early response: Week 2 PASI 75 (5.5% vs. 1.8%) and Week 8 PASI 100 (22.5% vs. 3.3%) vs. non-super-response. Median serum guselkumab concentrations through Week 28 were slightly greater in patients with super-response vs. non-super-response.
    Conclusion: Guselkumab was more likely to achieve early clinical responses (complete skin clearance) in younger patients, less obese patients and patients with less severe psoriasis.
    MeSH term(s) Humans ; Adalimumab/therapeutic use ; Body Weight ; Double-Blind Method ; Psoriasis ; Quality of Life ; Severity of Illness Index ; Treatment Outcome ; Randomized Controlled Trials as Topic
    Chemical Substances Adalimumab (FYS6T7F842) ; guselkumab (089658A12D)
    Language English
    Publishing date 2022-08-22
    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.18474
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Vaccination recommendations for adults receiving biologics and oral therapies for psoriasis and psoriatic arthritis: Delphi consensus from the medical board of the National Psoriasis Foundation.

    Chat, Vipawee S / Ellebrecht, Christoph T / Kingston, Paige / Gondo, George / Bell, Stacie / Cordoro, Kelly M / Desai, Seemal R / Duffin, Kristina C / Feldman, Steven R / Garg, Amit / Gelfand, Joel M / Gladman, Dafna / Green, Lawrence J / Gudjonsson, Johann / Han, George / Hawkes, Jason E / Kircik, Leon / Koo, John / Langley, Richard /
    Lebwohl, Mark / Michael Lewitt, G / Liao, Wilson / Martin, George / Orbai, Ana-Maria / Reddy, Soumya M / Richardson, Veronica / Ritchlin, Christopher T / Schwartzman, Sergio / Siegel, Evan L / Van Voorhees, Abby S / Wallace, Elizabeth B / Weinberg, Jeffrey M / Winthrop, Kevin L / Yamauchi, Paul / Armstrong, April W

    Journal of the American Academy of Dermatology

    2024  

    Abstract: Background: For psoriatic patients who need to receive nonlive or live vaccines, evidence-based recommendations are needed regarding whether to pause or continue systemic therapies for psoriasis and/or psoriatic arthritis.: Objective: To evaluate ... ...

    Abstract Background: For psoriatic patients who need to receive nonlive or live vaccines, evidence-based recommendations are needed regarding whether to pause or continue systemic therapies for psoriasis and/or psoriatic arthritis.
    Objective: To evaluate literature regarding vaccine efficacy and safety and to generate consensus-based recommendations for adults receiving systemic therapies for psoriasis and/or psoriatic arthritis receiving nonlive or live vaccines.
    Methods: Using a modified Delphi process, 22 consensus statements were developed by the National Psoriasis Foundation Medical Board and COVID-19 Task Force, and infectious disease experts.
    Results: Key recommendations include continuing most oral and biologic therapies without modification for patients receiving nonlive vaccines; consider interruption of methotrexate for nonlive vaccines. For patients receiving live vaccines, discontinue most oral and biologic medications before and after administration of live vaccine. Specific recommendations include discontinuing most biologic therapies, except for abatacept, for 2-3 half-lives before live vaccine administration and deferring next dose 2-4 weeks after live vaccination.
    Limitations: Studies regarding infection rates after vaccination are lacking.
    Conclusion: Interruption of antipsoriatic oral and biologic therapies is generally not necessary for patients receiving nonlive vaccines. Temporary interruption of oral and biologic therapies before and after administration of live vaccines is recommended in most cases.
    Language English
    Publishing date 2024-02-07
    Publishing country United States
    Document type Journal Article
    ZDB-ID 603641-7
    ISSN 1097-6787 ; 0190-9622
    ISSN (online) 1097-6787
    ISSN 0190-9622
    DOI 10.1016/j.jaad.2023.12.070
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article: DRAGON-Data: a platform and protocol for integrating genomic and phenotypic data across large psychiatric cohorts.

    Lynham, Amy J / Knott, Sarah / Underwood, Jack F G / Hubbard, Leon / Agha, Sharifah S / Bisson, Jonathan I / van den Bree, Marianne B M / Chawner, Samuel J R A / Craddock, Nicholas / O'Donovan, Michael / Jones, Ian R / Kirov, George / Langley, Kate / Martin, Joanna / Rice, Frances / Roberts, Neil P / Thapar, Anita / Anney, Richard / Owen, Michael J /
    Hall, Jeremy / Pardiñas, Antonio F / Walters, James T R

    BJPsych open

    2023  Volume 9, Issue 2, Page(s) e32

    Abstract: Background: Current psychiatric diagnoses, although heritable, have not been clearly mapped onto distinct underlying pathogenic processes. The same symptoms often occur in multiple disorders, and a substantial proportion of both genetic and ... ...

    Abstract Background: Current psychiatric diagnoses, although heritable, have not been clearly mapped onto distinct underlying pathogenic processes. The same symptoms often occur in multiple disorders, and a substantial proportion of both genetic and environmental risk factors are shared across disorders. However, the relationship between shared symptoms and shared genetic liability is still poorly understood.
    Aims: Well-characterised, cross-disorder samples are needed to investigate this matter, but few currently exist. Our aim is to develop procedures to purposely curate and aggregate genotypic and phenotypic data in psychiatric research.
    Method: As part of the Cardiff MRC Mental Health Data Pathfinder initiative, we have curated and harmonised phenotypic and genetic information from 15 studies to create a new data repository, DRAGON-Data. To date, DRAGON-Data includes over 45 000 individuals: adults and children with neurodevelopmental or psychiatric diagnoses, affected probands within collected families and individuals who carry a known neurodevelopmental risk copy number variant.
    Results: We have processed the available phenotype information to derive core variables that can be reliably analysed across groups. In addition, all data-sets with genotype information have undergone rigorous quality control, imputation, copy number variant calling and polygenic score generation.
    Conclusions: DRAGON-Data combines genetic and non-genetic information, and is available as a resource for research across traditional psychiatric diagnostic categories. Algorithms and pipelines used for data harmonisation are currently publicly available for the scientific community, and an appropriate data-sharing protocol will be developed as part of ongoing projects (DATAMIND) in partnership with Health Data Research UK.
    Language English
    Publishing date 2023-02-08
    Publishing country England
    Document type Journal Article
    ZDB-ID 2829557-2
    ISSN 2056-4724
    ISSN 2056-4724
    DOI 10.1192/bjo.2022.636
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  7. Article ; Online: Long-term safety of risankizumab from 17 clinical trials in patients with moderate-to-severe plaque psoriasis.

    Gordon, K B / Lebwohl, M / Papp, K A / Bachelez, H / Wu, J J / Langley, R G / Blauvelt, A / Kaplan, B / Shah, M / Zhao, Y / Sinvhal, R / Reich, K

    The British journal of dermatology

    2021  Volume 186, Issue 3, Page(s) 466–475

    Abstract: Background: Risankizumab has demonstrated efficacy and safety in patients with moderate-to-severe plaque psoriasis in randomized clinical trials.: Objectives: To evaluate safety data from risankizumab psoriasis phase I-III clinical trials.: Methods! ...

    Abstract Background: Risankizumab has demonstrated efficacy and safety in patients with moderate-to-severe plaque psoriasis in randomized clinical trials.
    Objectives: To evaluate safety data from risankizumab psoriasis phase I-III clinical trials.
    Methods: Short-term safety (through week 16) was analysed using integrated data from five phase II and III clinical trials. Long-term safety was evaluated using integrated data from 17 phase I-III completed and ongoing trials.
    Results: Short-term safety analyses included 1306 patients receiving risankizumab 150 mg and 300 patients receiving placebo [402·2 and 92·0 patient-years (PY) of exposure, respectively]. Long-term analyses included 3072 risankizumab-treated patients (exposure: 7927 PY). The median (excluding four outliers) treatment duration was 2·9 years (range 2 days to 5·9 years). Exposure-adjusted adverse event rates did not increase with long-term treatment (318 vs. 171 events per 100 PY for short- and long-term analyses). With long-term risankizumab treatment, rates of serious adverse events were 7·8 per 100 PY, serious infections 1·2 per 100 PY, nonmelanoma skin cancer (NMSC) 0·7 per 100 PY, malignant tumours excluding NMSC 0·5 per 100 PY, and adjudicated major adverse cardiovascular events 0·3 per 100 PY, with no important identified risks. Limitations include that the study inclusion and exclusion criteria varied and that three studies enrolled ≤ 50 patients.
    Conclusions: Risankizumab demonstrated a favourable safety profile over short- and long-term treatment in patients with moderate-to-severe psoriasis.
    MeSH term(s) Antibodies, Monoclonal/adverse effects ; Clinical Trials as Topic ; Humans ; Psoriasis/drug therapy ; Severity of Illness Index ; Treatment Outcome
    Chemical Substances Antibodies, Monoclonal ; risankizumab (90ZX3Q3FR7)
    Language English
    Publishing date 2021-11-24
    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.20818
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  8. Article ; Online: Secukinumab long-term efficacy and safety in psoriasis through to year 5 of treatment: results of a randomized extension of the phase III ERASURE and FIXTURE trials.

    Langley, Richard G / Sofen, Howard / Dei-Cas, Ignacio / Reich, Kristian / Sigurgeirsson, Bardur / Warren, Richard B / Paul, Carle / Szepietowski, Jacek C / Tsai, Tsen-Fang / Hampele, Isabelle / You, Ruquan / Charef, Pascal / Papavassilis, Charis

    The British journal of dermatology

    2023  Volume 188, Issue 2, Page(s) 198–207

    Abstract: Background: In the long-term extension study of the ERASURE and FIXTURE trials, the efficacy of secukinumab (a fully human anti-interleukin-17A monoclonal antibody) was demonstrated to have been maintained through to year 3 of treatment in moderate-to- ... ...

    Abstract Background: In the long-term extension study of the ERASURE and FIXTURE trials, the efficacy of secukinumab (a fully human anti-interleukin-17A monoclonal antibody) was demonstrated to have been maintained through to year 3 of treatment in moderate-to-severe plaque psoriasis.
    Objectives: To assess the efficacy and safety of secukinumab through to year 5 of treatment in moderate-to-severe plaque psoriasis.
    Methods: Responders with ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) from two core trials - ERASURE and FIXTURE - were randomized 2 : 1 at year 1 (end of core trials) to either the same dose (300 or 150 mg, continuous treatment) or placebo (treatment withdrawal) every 4 weeks, until year 3 or relapse (> 50% reduction in maximal PASI from core study baseline). Partial responders (achieving PASI 50 but not PASI 75) at year 1 continued at the same dose as in the core trials. At year 3, all patients received open-label secukinumab treatment, with those on secukinumab 300 mg continuing on their dose, while those on secukinumab 150 mg or placebo received secukinumab 150 or 300 mg based on the physician's discretion. The study is registered on ClinicalTrials.gov with the identifier NCT01544595.
    Results: Most patients randomized to placebo at year 1 relapsed, but the response was rapidly recaptured upon reinitiation of treatment. PASI responses were sustained with secukinumab through to year 5. The PASI responses for the 300 mg responders + partial responders group at year 1 (PASI 75/90/100: 86.8%/72.8%/45.9%) trended downwards until year 3 (PASI 75/90/100: 82.3%/58.4%/32.7%) and then remained stable through year 4 (PASI 75/90/100: 83.3%/60.1%/32.2%) until year 5 (PASI 75/90/100: 81.1%/62.8%/35.1%). Dermatology Life Quality Index showed sustained benefit up to year 5. Absolute PASI responses were maintained throughout the study. The most common adverse events (AEs) were infections and infestations, nasopharyngitis, and upper respiratory tract infections (URTIs). The overall exposure-adjusted incidence rate (EAIR; with 95% confidence interval) for all AEs was 139.9 (130.3-149.9). EAIRs for Crohn's disease and neutropenia were 0.1 (0.0-0.3) and 0.5 (0.3-0.8), respectively.
    Conclusions: The 4-year extension of two pivotal phase III trials demonstrated that secukinumab treatment was effective through to year 5 and improved quality of life in patients with moderate-to-severe plaque psoriasis. The most common AEs were infections and infestations, nasopharyngitis, and URTIs. The safety profile was consistent with that in the secukinumab phase II/III clinical development programme.
    MeSH term(s) Humans ; Quality of Life ; Nasopharyngitis/chemically induced ; Antibodies, Monoclonal, Humanized/adverse effects ; Psoriasis/drug therapy ; Respiratory Tract Infections ; Treatment Outcome ; Severity of Illness Index ; Double-Blind Method
    Chemical Substances secukinumab (DLG4EML025) ; Antibodies, Monoclonal, Humanized
    Language English
    Publishing date 2023-02-09
    Publishing country England
    Document type Randomized Controlled Trial ; Journal Article
    ZDB-ID 80076-4
    ISSN 1365-2133 ; 0007-0963
    ISSN (online) 1365-2133
    ISSN 0007-0963
    DOI 10.1093/bjd/ljac040
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  9. Article ; Online: A head-to-head comparison of ixekizumab vs. guselkumab in patients with moderate-to-severe plaque psoriasis: 24-week efficacy and safety results from a randomized, double-blinded trial.

    Blauvelt, A / Leonardi, C / Elewski, B / Crowley, J J / Guenther, L C / Gooderham, M / Langley, R G / Vender, R / Pinter, A / Griffiths, C E M / Tada, Y / Elmaraghy, H / Lima, R G / Gallo, G / Renda, L / Burge, R / Park, S Y / Zhu, B / Papp, K

    The British journal of dermatology

    2020  Volume 184, Issue 6, Page(s) 1047–1058

    Abstract: ... with the interleukin (IL)-17A inhibitor ixekizumab vs. the IL-23p19 inhibitor guselkumab in the IXORA-R head-to-head ... up to week 24.: Methods: IXORA-R enrolled adults with moderate-to-severe plaque psoriasis, defined ...

    Abstract Background: Significantly more patients with moderate-to-severe plaque psoriasis treated with the interleukin (IL)-17A inhibitor ixekizumab vs. the IL-23p19 inhibitor guselkumab in the IXORA-R head-to-head trial achieved 100% improvement in Psoriasis Area and Severity Index (PASI 100) at week 12.
    Objectives: To compare skin and nail clearance and patient-reported outcomes for ixekizumab vs. guselkumab, up to week 24.
    Methods: IXORA-R enrolled adults with moderate-to-severe plaque psoriasis, defined as static Physician's Global Assessment ≥ 3, PASI ≥ 12 and involved body surface area ≥ 10%. Statistical comparisons were performed using the Cochran-Mantel-Haenszel test stratified by pooled site. Time-to-first-event comparisons were performed using Kaplan-Meier analysis, and P-values were generated using adjusted log-rank tests stratified by treatment group. Cumulative days at clinical and patient-reported responses were compared by ancova. The trial was registered with ClinicalTrials.gov (NCT03573323).
    Results: Of the 1027 patients randomly assigned, 90% completed the trial (465 of 520 ixekizumab and 459 of 507 guselkumab). As early as week 2 and through week 16, more patients on ixekizumab achieved PASI 100 (P < 0·01). At week 24, ixekizumab was noninferior to guselkumab (50% vs. 52%, difference -2·3%), with no statistically significant difference in PASI 100 (P = 0·41). More patients receiving ixekizumab showed completely clear nails at week 24 (52% vs. 31%, P = 0·007). The median time to first PASI 50/75/90 and PASI 100 were 2 and 7·5 weeks shorter, respectively, for patients on ixekizumab vs. guselkumab (P < 0·001). Patients on ixekizumab also had a greater cumulative benefit, with more days at PASI 90 and 100, with Dermatology Life Quality Index of 0 or 1, and itch free (P < 0·05). The frequency of serious adverse events was 3% for each group, with no new safety signals.
    Conclusions: Ixekizumab was noninferior to guselkumab in complete skin clearance and superior in clearing nails at week 24. Ixekizumab cleared skin more rapidly in patients with moderate-to-severe plaque psoriasis, with a greater cumulative benefit, than guselkumab. Overall, the safety findings were consistent with the known safety profile for ixekizumab.
    MeSH term(s) Adult ; Antibodies, Monoclonal, Humanized ; Double-Blind Method ; Humans ; Psoriasis/drug therapy ; Severity of Illness Index ; Treatment Outcome
    Chemical Substances Antibodies, Monoclonal, Humanized ; guselkumab (089658A12D) ; ixekizumab (BTY153760O)
    Language English
    Publishing date 2020-10-25
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial ; 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.19509
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  10. Article ; Online: Impact of previous biologic use on the efficacy and safety of brodalumab and ustekinumab in patients with moderate-to-severe plaque psoriasis: integrated analysis of the randomized controlled trials AMAGINE-2 and AMAGINE-3.

    Papp, K A / Gordon, K B / Langley, R G / Lebwohl, M G / Gottlieb, A B / Rastogi, S / Pillai, R / Israel, R J

    The British journal of dermatology

    2018  Volume 179, Issue 2, Page(s) 320–328

    Abstract: Background: Biologics are being used increasingly to treat moderate-to-severe psoriasis. Efficacy may differ in patients with previous exposure to biologics.: Objectives: To investigate the impact of previous biologic exposure on the efficacy and ... ...

    Abstract Background: Biologics are being used increasingly to treat moderate-to-severe psoriasis. Efficacy may differ in patients with previous exposure to biologics.
    Objectives: To investigate the impact of previous biologic exposure on the efficacy and safety of brodalumab and ustekinumab in patients with moderate-to-severe plaque psoriasis.
    Methods: Two placebo- and ustekinumab-controlled phase III clinical trials. There was an initial 12-week induction phase where patients were treated with brodalumab [210 mg or 140 mg every 2 weeks (Q2W)], ustekinumab or placebo. Efficacy end points included ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) and static Physician's Global Assessment (score of 0 or 1) vs. placebo, PASI 100 vs. ustekinumab, Dermatology Life Quality Index and Psoriasis Symptom Inventory. Adverse events were monitored throughout.
    Results: In total, 493 patients [334 (27%) brodalumab 210 mg Q2W and 159 (26%) ustekinumab] had received prior biologics; 150 (12%) and 62 (10%), respectively, reported previously failed treatment with a biologic. Brodalumab efficacy in patients with or without previous exposure to biologics was statistically equivalent: 40·9% and 39·5% of biologic-naive and -experienced patients achieved PASI 100 at week 12, compared with 21·1% and 17·0% with ustekinumab (both P < 0·001). In patients where prior biologics had been successful or failed, 41·7% and 32·0% achieved PASI 100, compared with 21·1% and 11·3% with ustekinumab. Tolerability was similar, and did not appear to be influenced by previous treatment with biologics.
    Conclusions: The efficacy of brodalumab 210 mg Q2W was similar regardless of prior biological therapy (P = 0·31, 0·32 and 0·64 for PASI 75, 90 and 100, respectively). Almost twice as many patients achieved PASI 100 or complete clearance with brodalumab at week 12 compared with ustekinumab; the differences were most noticeable where previous biologics had failed. Both treatments were well tolerated.
    MeSH term(s) Adult ; Aged ; Antibodies, Monoclonal/administration & dosage ; Antibodies, Monoclonal/adverse effects ; Biological Products/administration & dosage ; Biological Products/adverse effects ; Drug Substitution ; Female ; Humans ; Male ; Middle Aged ; Psoriasis/diagnosis ; Psoriasis/drug therapy ; Severity of Illness Index ; Treatment Outcome ; Ustekinumab/administration & dosage ; Ustekinumab/adverse effects
    Chemical Substances Antibodies, Monoclonal ; Biological Products ; brodalumab (6ZA31Y954Z) ; Ustekinumab (FU77B4U5Z0)
    Language English
    Publishing date 2018-05-23
    Publishing country England
    Document type Clinical Trial, Phase III ; Journal Article ; Randomized Controlled Trial
    ZDB-ID 80076-4
    ISSN 1365-2133 ; 0007-0963
    ISSN (online) 1365-2133
    ISSN 0007-0963
    DOI 10.1111/bjd.16464
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