Publications by authors named "A Wollenberg"

311 Publications

Patient preferences for atopic dermatitis medications in the UK, France and Spain: a discrete choice experiment.

BMJ Open 2022 Aug 2;12(8):e058799. Epub 2022 Aug 2.

Evidera, London, UK

Objectives: We aimed to quantify patient preferences for efficacy, safety and convenience features of atopic dermatitis (AD) treatments.

Design And Setting: Online discrete choice experiment survey.

Participants: Adults in the UK, France and Spain who had used AD treatments during the past 2 years.

Primary And Secondary Outcome Measures: Preferences for attributes were analysed using a multinomial logit model. Willingness to make trade-offs was expressed as the maximum acceptable decrease (MAD) in the probability of achieving clear/almost clear skin at week 16.

Results: The survey was completed by 404 patients (44.1±12.0 years; 65% women; 64% moderate/severe eczema). Most patients (68%) had no prior experience of using self-injectable treatments for AD or any other illness. Participants most valued increasing the chance of achieving a meaningful reduction in itch at week 16 from 20% to 50%, followed by reducing the risks of serious infections from 6% to 0% and of eye inflammation from 20% to 0%. Participants were willing to accept a decrease in the possibility of achieving clear/almost clear skin to obtain a treatment that can be paused (MAD=24.1%), requires occasional check-ups (MAD=16.1%) or no check-ups (MAD=20.9%) over frequent check-ups, is administered as a one time per day or two times per day oral pill versus a subcutaneous injection every 2 weeks (MAD=16.6%), has a 2-day over 2-week onset of action (MAD=11.3%), and can be used for flare management (MAD=5.8%).

Conclusions: Although patients with AD most valued treatment benefits and risks, they were willing to tolerate reduced efficacy to obtain a rapid onset, oral administration, less frequent monitoring and a treatment that can be paused. Understanding patients' preferences for AD therapies, including new targeted therapies, can aid shared decision-making between clinicians and patients and support health technology assessments.
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August 2022

Long-term 2-Year Safety and Efficacy of Tralokinumab in Adults with Moderate-to-severe Atopic Dermatitis: Interim Analysis of the ECZTEND Open-label Extension Trial.

J Am Acad Dermatol 2022 Jul 18. Epub 2022 Jul 18.

Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Background: Additional long-term treatments are needed for moderate-to-severe atopic dermatitis (AD). An ongoing, open-label, 5-year extension trial, ECZTEND (NCT03587805), assesses tralokinumab plus optional topical corticosteroids in participants from previous tralokinumab parent trials (PTs) with moderate-to-severe AD.

Objective: To evaluate safety and efficacy of up to 2 years tralokinumab treatment in a post hoc interim analysis.

Methods: Safety analyses included adults from completed PTs enrolled in ECZTEND, regardless of tralokinumab exposure duration. Efficacy analyses included adult participants treated with tralokinumab in ECZTEND for ≥1 year, and subgroup analyses of those on tralokinumab for 2 years (1 year from PT, 1 year in ECZTEND). Primary endpoint was number of adverse events (AEs) with additional efficacy endpoints.

Results: Participants on tralokinumab had an exposure-adjusted rate of 237.8 AEs/100 patient-years exposure (N=1174) in the safety analysis set. Exposure-adjusted incidence rates of common AEs were comparable to PTs, although at lower rates. With 2 years of tralokinumab, improvements in extent and severity of AD were sustained, with EASI-75 in 82.5% of participants (N=345).

Limitations: Possible selection bias; no placebo arm; some participants experienced treatment gaps between PTs and ECZTEND.

Conclusion: Over 2 years, tralokinumab was well-tolerated and maintained long-term control of AD signs and symptoms.
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July 2022

Patient-oriented measures for phase 3 studies of tralokinumab for treatment of atopic dermatitis (ECZTRA 1, 2 and 3).

Ann Allergy Asthma Immunol 2022 Jul 14. Epub 2022 Jul 14.

Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA.

Background: Tralokinumab, as monotherapy or in combination with topical corticosteroids (TCS), has demonstrated significant efficacy through 52 weeks in phase 3 trials of adults with moderate-to-severe atopic dermatitis (AD) and additional efficacy in a long-term extension trial. Early changes in patient-reported symptoms have not been communicated.

Objective: To examine early changes in patient-reported outcomes (PROs) across the ECZTRA 1, 2, and 3 tralokinumab trials.

Methods: Monotherapy data (ECZTRA 1+2) was pooled; ECZTRA 3 examined tralokinumab + optional TCS. PROs were assessed through the trials.

Results: 1596 and 380 patients were randomized in ECZTRA 1+2 and ECZTRA 3, respectively. Baseline demographics and clinical characteristics were similar between groups. Early separation from placebo was observed in percentage improvement in worst average daily pruritus numerical rating score (NRS) [week 1, ECZTRA 1+2; week 2, ECZTRA 3] and from day 2 in ECZTRA 1+2 daily data. More tralokinumab-treated patients achieved clinically meaningful improvements (≥4 points) in NRS by week 2 (ECZTRA 1+2) or week 3 (ECZTRA 3) versus placebo. Improvements in eczema-related sleep NRS were seen within 2 weeks (week 1, ECZTRA 1+2; week 2, ECZTRA 3), supported by similar improvements in other sleep measures. Meaningful changes in Dermatology Life Quality Index were observed from week 2 (ECZTRA 1+2). Results were supported by numerical differences from placebo in Patient-Orientated Eczema Measure total score (week 2, both datasets).

Conclusion: Tralokinumab +/- TCS demonstrated early and clinically meaningful improvements versus placebo in several PROs, which may be beneficial to patients because AD symptom relief is a key treatment concern for patients.
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July 2022

2-Phosphonobutane-1,2,4,-Tricarboxylic Acid (PBTC): pH-Dependent Behavior Studied by Means of Multinuclear NMR Spectroscopy.

Molecules 2022 Jun 24;27(13). Epub 2022 Jun 24.

Central Radionuclide Laboratory and Radiation Protection, Technical University Dresden, 01062 Dresden, Germany.

Although 2-phosphonobutane-1,2,4,-tricarboxylic acid, PBTC, has manifold industrial applications, relevant and reliable data on the protonation of PBTC are poor. However, these data are critical parameters for ascertaining PBTC speciation, especially with regard to a sound structural and thermodynamic characterization of its metal ion complexes. A rigorous evaluation of pH-dependent H, C, and P chemical shifts along with accessible scalar spin-spin coupling constants () was performed in order to determine the p values of PBTC in 0.5 molal NaCl aqueous solution by means of nuclear magnetic resonance (NMR) spectroscopy. The phosphonate group revealed p values of 0.90 ± 0.02 and 9.79 ± 0.02, and the p values associated with the carboxylic groups are 3.92 ± 0.02, 4.76 ± 0.03, and 6.13 ± 0.03. Supported by DFT-calculated structures revealing strong intramolecular hydrogen bonding, the sequence of deprotonation could be unambiguously determined.
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June 2022