Extension of ustekinumab maintenance dosing interval in moderate-to-severe psoriasis: results of a phase IIIb, randomized, double-blinded, active-controlled, multicentre study (PSTELLAR).

BACKGROUND: Phase III studies showed that some patients maintained response for ≥ 6 months following ustekinumab discontinuation. OBJECTIVES: To assess clinical responses with extended ustekinumab maintenance dosing intervals. METHODS: Adults with moderate-to-severe plaque psoriasis received ustekinumab at weeks 0, 4 and 16 during open-label treatment. Patients achieving a week-28 Physician's Global Assessment (PGA) score of cleared/minimal (PGA = 0/1) were randomized 1 : 4 to group 1 [approved every 12 weeks (q12 wk) maintenance] or group 2 (q12-24 wk; response-based dosing determined by time to loss of PGA = 0/1). Key end points included the number of visits with PGA = 0/1 (primary end point) and ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) between weeks 88 and 112, and PGA/PASI responses between weeks 28 and 112. RESULTS: Overall, 378 patients achieved PGA = 0/1 at week 28 and were randomized to group 1 (n = 76) or group 2 (n = 302). Patients in group 1 had numerically greater mean numbers of visits with PGA = 0/1 than group 2 and also with PASI 75 from week 88 to 112. A higher proportion of patients in group 1 (55%) than group 2 (39%) had PGA = 0/1 at all seven visits from week 88 to 112. Maintenance of response was observed with dose-interval extension beyond q12 wk in a subset of patients. Extending the dosing interval did not affect antibody development or safety. CONCLUSIONS: Efficacy was better maintained among week-28 PGA responders randomized to continue q12 wk ustekinumab vs. extending maintenance dosing based on clinical response, although some patients maintained high levels of efficacy with up to q24 wk dosing.

Estimation of influenza and severe acute respiratory illness incidence (burden) in three provinces of the Islamic Republic of Iran, 2012 and 2013.

There are few estimates of influenza burden in the WHO Region for the Eastern Mediterranean. In this study we estimated the burden of severe acute respiratory infection (SARI) and influenza-associated SARI (F-SARI) in selected provinces of Islamic Republic of Iran, the trends of SARI and confirmed cases of influenza (F-SARI) over 12 months (seasonality), and the age groups most at risk. Using the electronic Iranian influenza surveillance system and data of cases in sentinel hospitals of 3 selected provinces, we estimated the monthly trend (seasonality) of incidence for SARI and F-SARI, overall incidence of SARI and F-SARI and their disaggregation by age with the aid using the Monte Carlo technique. The age groups most at-risk were children aged under 2 years and adults older than 50 years.

Estimation of influenza and severe acute respiratory illness incidence [burden] in three provinces of the Islamic Republic of Iran, 2012 and 2013

There are few estimates of influenza burden in the WHO Region for the Eastern Mediterranean. In this study we estimated the burden of severe acute respiratory infection [SARI] and influenza-associated SARI [F-SARI] in selected provinces of Islamic Republic of Iran, the trends of SARI and confirmed cases of influenza [F-SARI] over 12 months [seasonality], and the age groups most at risk. Using the electronic Iranian influenza surveillance system and data of cases in sentinel hospitals of 3 selected provinces, we estimated the monthly trend [seasonality] of incidence for SARI and F-SARI, overall incidence of SARI and F-SARI and their disaggregation by age with the aid using the Monte Carlo technique. The age groups most at-risk were children aged under 2 years and adults older than 50 years

Peu d'estimations sont disponibles sur la charge de la grippe dans la Région OMS de la Méditerranée orientale. Dans la présente étude, nous avons estimé la charge de morbidité due aux infections respiratoires aiguës sévères [IRAS] et aux IRAS associés à la grippe dans certaines provinces de la République islamique d'Iran, ainsi que les tendances des IRAS et des cas de grippe confirmés sur 12 mois [saisonnalité], et les groupes d'âge les plus exposés. En utilisant le système électronique iranien de surveillance de la grippe et les données relatives aux cas des hôpitaux sentinelles de trois provinces sélectionnées, nous avons estimé la tendance mensuelle [saisonnalité] de l'incidence des IRAS et des IRAS dus à la grippe, l'incidence globale des IRAS et des IRAS dues à la grippe et leur ventilation par âge grâce à la méthode de Monte Carlo. Les groupes d'âge les plus exposés au risque étaient les enfants de moins de 2 ans et les adultes de plus de 50 ans