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190 results on '"Cork, M. J."'

1. Randomized controlled pilot trial with ion‐exchange water softeners to prevent eczema (SOFTER trial)

Author

Jabbar‐Lopez, Z. K., primary, Ezzamouri, B., additional, Briley, A., additional, Greenblatt, D., additional, Gurung, N., additional, Chalmers, J. R., additional, Thomas, K. S., additional, Frost, T., additional, Kezic, S., additional, Common, J. E. A., additional, Danby, S., additional, Cork, M. J., additional, Peacock, J. L., additional, and Flohr, C., additional

Published
2021
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6. Tralokinumab for moderate-to-severe atopic dermatitis: results from two 52-week, randomized, double-blind, multicentre, placebo-controlled phase III trials (ECZTRA 1 and ECZTRA 2)

Author

Wollenberg, A., Blauvelt, A., Guttman-Yassky, E., Worm, M., Lynde, C., Lacour, J. -P., Spelman, L., Katoh, N., Saeki, H., Poulin, Y., Lesiak, A., Kircik, L., Cho, S. H., Herranz, P., Cork, M. J., Peris, K., Steffensen, L. A., Bang, B., Kuznetsova, A., Jensen, T. N., Osterdal, M. L., Simpson, E. L., Peris K. (ORCID:0000-0002-5237-0463), Wollenberg, A., Blauvelt, A., Guttman-Yassky, E., Worm, M., Lynde, C., Lacour, J. -P., Spelman, L., Katoh, N., Saeki, H., Poulin, Y., Lesiak, A., Kircik, L., Cho, S. H., Herranz, P., Cork, M. J., Peris, K., Steffensen, L. A., Bang, B., Kuznetsova, A., Jensen, T. N., Osterdal, M. L., Simpson, E. L., and Peris K. (ORCID:0000-0002-5237-0463)

Abstract

Background: Tralokinumab, a fully human monoclonal antibody, specifically neutralizes interleukin-13, a key cytokine driving peripheral inflammation in atopic dermatitis (AD). In phase II studies, tralokinumab combined with topical corticosteroids provided early and sustained improvements in AD signs and symptoms. Objectives: To evaluate the efficacy and safety of tralokinumab monotherapy in adults with moderate-to-severe AD who had an inadequate response to topical treatments. Methods: In two 52-week, randomized, double-blind, placebo-controlled, phase III trials, ECZTRA 1 and ECZTRA 2, adults with moderate-to-severe AD were randomized (3 : 1) to subcutaneous tralokinumab 300 mg every 2 weeks (Q2W) or placebo. Primary endpoints were Investigator’s Global Assessment (IGA) score of 0 or 1 at week 16 and ≥ 75% improvement in Eczema Area and Severity Index (EASI 75) at week 16. Patients achieving an IGA score of 0 or 1 and/or EASI 75 with tralokinumab at week 16 were rerandomized to tralokinumab Q2W or every 4 weeks or placebo, for 36 weeks. The trials were registered with ClinicalTrials.gov: NCT03131648 and NCT03160885. Results: At week 16, more patients who received tralokinumab vs. placebo achieved an IGA score of 0 or 1: 15·8% vs. 7·1% in ECZTRA 1 [difference 8·6%, 95% confidence interval (CI) 4·1–13·1; P = 0·002] and 22·2% vs. 10·9% in ECZTRA 2 (11·1%, 95% CI 5·8–16·4; P < 0·001) and EASI 75: 25·0% vs. 12·7% (12·1%, 95% CI 6·5–17·7; P < 0·001) and 33·2% vs. 11·4% (21·6%, 95% CI 15·8–27·3; P < 0·001). Early improvements in pruritus, sleep interference, Dermatology Life Quality Index, SCORing Atopic Dermatitis and Patient-Oriented Eczema Measure were observed from the first postbaseline measurements. The majority of week 16 tralokinumab responders maintained response at week 52 with continued tralokinumab treatment without any rescue medication (including topical corticosteroids). Adverse

Published
2021

7. European Task Force on Atopic Dermatitis: position on vaccination of adult patients with atopic dermatitis against COVID-19 (SARS-CoV-2) being treated with systemic medication and biologics

Author

MS Dermatologie/Allergologie, Infection & Immunity, Thyssen, J P, Vestergaard, C, Barbarot, S, de Bruin-Weller, M S, Bieber, T, Taieb, A, Seneschal, J, Cork, M J, Paul, C, Flohr, C, Weidinger, S, Trzeciak, M, Werfel, T, Heratizadeh, A, Darsow, U, Simon, D, Torrelo, A, Chernyshov, P V, Stalder, J-F, Gelmetti, C, Szalai, Z, Svensson, Å, von Kobyletzki, L B, De Raeve, L, Fölster-Holst, R, Christen-Zaech, S, Hijnen, D J, Gieler, U, Gutermuth, J, Bangert, C, Spuls, P I, Kunz, B, Ring, J, Wollenberg, A, Deleuran, M, MS Dermatologie/Allergologie, Infection & Immunity, Thyssen, J P, Vestergaard, C, Barbarot, S, de Bruin-Weller, M S, Bieber, T, Taieb, A, Seneschal, J, Cork, M J, Paul, C, Flohr, C, Weidinger, S, Trzeciak, M, Werfel, T, Heratizadeh, A, Darsow, U, Simon, D, Torrelo, A, Chernyshov, P V, Stalder, J-F, Gelmetti, C, Szalai, Z, Svensson, Å, von Kobyletzki, L B, De Raeve, L, Fölster-Holst, R, Christen-Zaech, S, Hijnen, D J, Gieler, U, Gutermuth, J, Bangert, C, Spuls, P I, Kunz, B, Ring, J, Wollenberg, A, and Deleuran, M

Published
2021

16. Randomized controlled pilot trial with ion‐exchange water softeners to prevent eczema (SOFTER trial).

Author

Jabbar‐Lopez, Z. K., Ezzamouri, B., Briley, A., Greenblatt, D., Gurung, N., Chalmers, J. R., Thomas, K. S., Frost, T., Kezic, S., Common, J. E. A., Danby, S., Cork, M. J., Peacock, J. L., and Flohr, C.

Subjects
RANDOMIZED controlled trials, ION exchange (Chemistry), WATER softening, WATER hardness, ECZEMA
Abstract

Background: Observational studies suggest an increased risk of eczema in children living in hard versus soft water areas, and there is, therefore, an interest in knowing whether softening water may prevent eczema. We evaluated the feasibility of a parallel‐group assessor‐blinded pilot randomized controlled trial to test whether installing a domestic ion‐exchange water softener before birth in hard water areas reduces the risk of eczema in infants with a family history of atopy. Methods: Pregnant women living in hard water areas (>250 mg/L calcium carbonate) in and around London UK, were randomized 1:1 antenatally to either have an ion‐exchange water softener installed in their home or not (ie to continue to receive usual domestic hard water). Infants were assessed at birth and followed up for 6 months. The main end‐points were around feasibility, the primary end‐point being the proportion of eligible families screened who were willing and able to be randomized. Clinical end‐points were evaluated including frequency of parent‐reported doctor‐diagnosed eczema and visible eczema on skin examination. Descriptive analyses were conducted, and no statistical testing was performed as this was a pilot study. Results: One hundred and forty‐nine families screened were eligible antenatally and 28% (41/149) could not have a water softener installed due to technical reasons or lack of landlord approval. Eighty of 149 (54%) were randomized, the primary end‐point. Two participants withdrew immediately after randomization, leaving 39 participants in each arm (78 total). Attrition was 15% (12/78) by 6 months postpartum. All respondents (n = 69) to the study acceptability questionnaire reported that the study was acceptable. Fifty‐six of 708 (7.9%) water samples in the water softener arm were above the hard water threshold of 20 mg/L CaCO3. At 6 months of age 27/67 infants (40%) developed visible eczema, 12/36 (33%) vs. 15/31 (48%) in the water softener and control groups, respectively, difference −15% (95% CI −38, 8.3%), with most assessments (≥96%) remaining blinded. Similarly, a lower proportion of infants in the water softener arm had parent‐reported, doctor‐diagnosed eczema by 6 months compared to the control arm, 6/17 (35%) versus 9/19 (47%), difference −12% (95% CI −44, 20%). Conclusion: A randomized controlled trial of water softeners for the prevention of atopic eczema in high‐risk infants is feasible and acceptable. Trial registration: NCT03270566 (clinicaltrials.gov) [ABSTRACT FROM AUTHOR]

Published
2022
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46. Conjunctivitis in atopic dermatitis patients with and without dupilumab therapy – international eczema council survey and opinion

Author

Thyssen, J. P., de Bruin-Weller, M. S., Paller, A. S., Leshem, Y. A., Vestergaard, C., Deleuran, M., Drucker, A. M., Foelster-Holst, R., Traidl-Hoffmann, C., Eyerich, K., Taieb, A., Su, J. C., Bieber, T., Cork, M. J., Eichenfield, L. F., Guttman-Yassky, E., Wollenberg, A., Thyssen, J. P., de Bruin-Weller, M. S., Paller, A. S., Leshem, Y. A., Vestergaard, C., Deleuran, M., Drucker, A. M., Foelster-Holst, R., Traidl-Hoffmann, C., Eyerich, K., Taieb, A., Su, J. C., Bieber, T., Cork, M. J., Eichenfield, L. F., Guttman-Yassky, E., and Wollenberg, A.

Abstract

Background: Conjunctivitis is common in patients with atopic dermatitis (AD) in general and a commonly reported adverse event in AD clinical trials with dupilumab. Objective: To survey opinions and experience about conjunctivitis occurring in AD, including those during dupilumab treatment in a group of AD experts from the International Eczema Council (IEC). Methods: Electronic survey and in-person discussion of management strategies. Results: Forty-six (53.5%) IEC members from 19 countries responded to the survey. Consensus was reached for several statements regarding diagnostic workup, referral and treatment. IEC members suggest that patients with AD should (i) routinely be asked about ocular complaints or symptoms, (ii) obtain information about the potential for conjunctivitis before starting dupilumab therapy and (iii) if indicated, be treated with dupilumab despite previous or current conjunctivitis. In cases of new-onset conjunctivitis, there was consensus that dupilumab treatment should be continued when possible, with appropriate referral to an ophthalmologist. Limitations: The study relies on expert opinion from dermatologists. Responses from few dermatologists without dupilumab access were not excluded from the survey. Conclusion: The IEC recommends that dermatologists address conjunctivitis in patients with AD, especially during treatment with dupilumab.

Published
2019

47. Pyoderma Gangrenosum

Author

McDonagh, A. J. G., Cork, M. J., and Harrington, C. I.

Published
1991

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