A novel, fixed-dose calcipotriol and betamethasone dipropionate cream for the topical treatment of plaque psoriasis: Direct and indirect evidence from phase 3 trials discussed at the 30th EADV Congress 2021.

Four posters about the novel, fixed-dose calcipotriol and betamethasone dipropionate cream (CAL/BDP cream) based on Poly-Aphron Dispersion (PAD) Technology were presented at the 30th European Academy of Dermatology and Venereology (EADV) Congress 2021 and are summarized here. CAL/BDP cream was compared in two randomized, phase 3 trials to vehicle and active comparator (CAL/BDP gel/topical suspension [TS]) in adults with plaque psoriasis (NCT03802344 and NCT03308799). Pooled data from both trials demonstrated significant greater efficacy in favour of CAL/BDP cream for all efficacy endpoints, including PGA treatment success, mPASI, and mPASI75 compared to CAL/BDP gel/TS. CAL/BDP cream was well tolerated and comparable to CAL/BDP gel/TS with no adverse drug reactions with a frequency >1%. In the NCT03308799 study, CAL/BDP cream demonstrated a substantial improvement in the proportion of participants achieving a minimum 4-point improvement on the peak pruritus numeric rating scale (NRS) score compared with vehicle at Weeks 1, 4 and 8. CAL/BDP cream also improved quality of life (QoL), as assessed through the Dermatology Life Quality Index (DLQI), and the EQ-VAS at Week 8 compared with active comparator. Treatment convenience of CAL/BDP cream, as measured by the Psoriasis Treatment Convenience Scale, was superior to CAL/BDP gel/TS at all studied timepoints, including questions addressing formulation's greasiness and overall treatment satisfaction. Finally, an indirect comparison following the Bucher's method of adjusted indirect comparison and the difference-in-differences method was conducted to compare CAL/BDP cream and CAL/BDP foam, as both therapies have been compared to CAL/BDP gel/TS. Indirect evidence showed that treatment with CAL/BDP cream was associated with a trend for greater QoL improvement than CAL/BDP foam when DLQI improvement was assessed at the recommended treatment duration of 8 weeks for CAL/BDP cream and 4 weeks for CAL/BDP foam. CAL/BDP cream was statistically superior versus CAL/BDP foam in four out of five treatment satisfaction domains.

Navicular bone position determined by positional MRI: a reproducibility study.

OBJECTIVE: To examine intraobserver, interobserver and between-day reproducibility of positional MRI for evaluation of navicular bone height (NVH) and medial navicular position (MNP). MATERIALS AND METHODS: Positional MRI (pMRI) of the foot was performed on ten healthy participants (0.25 T G-scanner). Scanning was performed in supine and standing position, respectively. Two radiologists evaluated the images in a blinded manner. Reliability and agreement were assessed by calculation of intraclass correlation coefficient (ICC) and 95 % limits of agreement as a percentage of the mean (LOA%). RESULTS: Intraobserver and interobserver reliability was "substantial" in both supine and standing position (ICC 0.86-0.98) and showed good agreement (LOA% 4.9-14.7 %). Between-day reliability of navicular height and medial navicular position in standing position remained substantial (ICC 0.85-0.92) with adequate agreement (LOA% 8.3-19.8 %). In supine position between-day reliability was "moderate" for NVH (ICC 0.72) and "slight" for MNP (ICC 0.39). Agreement remained adequate between-days for MNP in supine position (LOA% 17.7 %), but it was less than adequate for NVH in supine position (LOA% 24.2 %). CONCLUSION: Navicular height and medial navicular position can be measured by pMRI in a very reproducible manner within and between observers. Increased measurement variation is observed between-days in supine position, which may be due to small positional differences or other unknown biomechanical factors.

Sonographic measurements of the achilles tendon, plantar fascia, and heel fat pad are reliable: A test-retest intra- and intertester study.

PURPOSE: To determine intra- and interobserver reliability and precision of sonographic (US) scanning in measuring thickness of the Achilles tendon, plantar fascia, and heel fat pad in patients with heel pain. METHODS: Seventeen consecutive patients referred with heel pain were included. Two evaluators blinded to the diagnosis performed independently US scanning of both feet without any dialogue with the patient. The examiner left the room, and the next examiner entered. All patients had two US scans performed by each examiner. Two months later, the US images were randomly presented to the evaluators for measurements. Reliability and agreement were assessed by calculation of intraclass correlation coefficient (ICC), 95% limits of agreement (LOA), and typical error (TE). LOA was calculated as a percentage of the mean thickness of each structure to obtain a unitless parameter. RESULTS: We found excellent intratester reliability (ICC 0.78-0.98) and good intertester reliability using one measurement (ICC 0.72-0.91) and excellent (ICC 0.85-0.95) when using average of two measurements. The intratester agreements were good with LOA: 9.5-23.4% and TE: 3.4-8.4%. The intertester agreements were acceptable using one measurement with LOA: 16.1-36.4%, and better using two measurements with LOA: 14.4-33.2%. CONCLUSIONS: US is a reliable technique of measurement in the daily clinic, and one single measurement is sufficient. In research, we recommend that the same observer performs the US measurements, if one single scanning is preferred; if more researchers are involved, the average measurement of two US scans is recommended. © 2016 Wiley Periodicals, Inc. J Clin Ultrasound 44:480-486, 2016.