Sustained response to guselkumab regardless of baseline characteristics in patients with active psoriatic arthritis and inadequate response to TNF inhibitors: results from the phase 3b COSMOS clinical trial.

Objectives: To prospectively evaluate the effect of guselkumab through 48 weeks across various clinical outcomes in subgroups of patients with psoriatic arthritis (PsA) and inadequate response to tumour necrosis factor inhibitors (TNFi-IR) from the phase 3b COSMOS trial. Subgroups were defined by baseline demographics, disease characteristics and prior/ongoing therapies.

Methods: Patients with active PsA (tender joint count (TJC) and swollen joint count (SJC) both ≥3) and TNFi-IR were randomised 2:1 to receive guselkumab 100 mg at week 0, week 4, then every 8 weeks through week 44 or to placebo with cross-over to guselkumab 100 mg at week 16 (early escape) or week 24 (planned).

Guselkumab in Biologic-Naïve Patients with Active Psoriatic Arthritis in Russia: A Post Hoc Analysis of the DISCOVER-1 and -2 Randomized Clinical Trials.

Introduction: There are limited data on the use of advanced therapies to treat psoriatic arthritis (PsA) in Russia. Guselkumab, an interleukin (IL)-23p19-subunit inhibitor, demonstrated efficacy in patients with PsA in the phase 3 DISCOVER-1 and -2, and COSMOS trials. This analysis evaluated the efficacy and safety of guselkumab in patients with PsA in Russia.

Hurdles in new drug development in rheumatic diseases.

Introduction: Rheumatic diseases are heterogenous conditions with multifactorial underlying physiologic pathogeneses. Despite recent progress in the identification and development of advanced therapies primarily focusing on disrupting the immunological abnormalities that cause these conditions, rheumatic disease management remains challenging in a notable proportion of patients, with many exhibiting uncontrolled or refractory disease activity. New and improved therapies are needed to respond to this treatment gap.

Clinical trial: Clinical and endoscopic outcomes with ustekinumab in patients with Crohn's disease: Results from the long-term extension period of STARDUST.

Background: STARDUST, a phase 3b randomised trial, compared ustekinumab therapeutic strategies in patients with Crohn's disease (CD) using early endoscopic assessment and treat-to-target (T2T) versus standard of care (SoC).

Aim: To assess the efficacy of ustekinumab extended treatment in a long-term extension (LTE) of up to 104 weeks with dosing adapted according to clinical, biomarker and endoscopy outcomes.

Methods: Adults with moderately-to-severely active CD received intravenous ustekinumab approximating 6 mg/kg at Week 0 and subcutaneous ustekinumab 90 mg at Week 8.

Improvement in patient-reported outcomes and work productivity following 3-year ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: results from the PsABio real-world study.

Background: To evaluate the real-world effect of the IL-12/23 inhibitor ustekinumab or of a tumour necrosis factor inhibitor (TNFi) on patient-reported outcomes (PRO) and their association with effectiveness endpoints in psoriatic arthritis (PsA) patients over 3 years.

Methods: In PsABio (NCT02627768), a prospective, observational study, patients with PsA that were prescribed first- to third-line ustekinumab or a TNFi, and remained on that drug for 3 years, were analysed for change in baseline in PROs (EuroQol-5 dimensions health state VAS [EQ-5D VAS], 12-item Psoriatic Arthritis Impact of Disease questionnaire [PsAID-12; range 0-10], Work Productivity and Activity Impairment for Psoriatic Arthritis questionnaire [WPAI; results expressed as a percentage for each domain]), and the association between PROs and WPAI with effectiveness endpoints, clinical disease activity index for psoriatic arthritis (cDAPSA), low disease activity (LDA)/remission, minimal disease activity (MDA) and very low disease activity (VLDA).

Results: In 437 patients (mean age 49.

Long-term effectiveness and persistence of ustekinumab and TNF inhibitors in patients with psoriatic arthritis: final 3-year results from the PsABio real-world study.

Objectives: To evaluate real-world persistence and effectiveness of the IL-12/23 inhibitor, ustekinumab or a tumour necrosis factor inhibitor (TNFi) for psoriatic arthritis over 3 years.

Methods: PsABio (NCT02627768), a prospective, observational study, followed patients with PsA prescribed first-line to third-line ustekinumab or a TNFi. Persistence and effectiveness (achievement of clinical Disease Activity for PSA (cDAPSA) low disease activity (LDA)/remission and minimal disease activity/very LDA (MDA/VLDA)) were assessed every 6 months.

Persistence and effectiveness of the IL-12/23 pathway inhibitor ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: 1-year results from the real-world PsABio Study.

Objective: We evaluated real-world treatment persistence and effectiveness at 1 year following initiation of IL-12/23 inhibitor ustekinumab or a tumour necrosis factor inhibitor (TNFi) for psoriatic arthritis (PsA).

Methods: PsABio (NCT02627768), a prospective, observational study, followed patients with PsA prescribed first-line to third-line ustekinumab or TNFi. Drug persistence, effectiveness (achievement of clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) low disease activity (LDA)/remission and minimal disease activity/very low disease activity (MDA/VLDA)), and safety were assessed every 6 months.

Treat to target versus standard of care for patients with Crohn's disease treated with ustekinumab (STARDUST): an open-label, multicentre, randomised phase 3b trial.

Background: A treat-to-target strategy, in which strictly defined treatment targets facilitate decision making in clinical practice, is advocated as an optimised management approach for some chronic disorders. The aim of the STARDUST trial was to assess whether a treat-to-target strategy with early endoscopy, regular biomarker and clinical symptom monitoring, and dose intensification for persistent inflammatory activity, was more successful in achieving endoscopic improvement at week 48 than a clinically driven maintenance strategy in patients with moderate-to-severe active Crohn's disease receiving ustekinumab.

Methods: This open-label, multicentre, randomised phase 3b trial included adults with active, moderate-to-severe Crohn's disease (Crohn's Disease Activity Index [CDAI] 220-450 and Simple Endoscopic Score in Crohn's Disease [SES-CD] ≥3) for whom conventional therapy or one biologic therapy, or both, had failed.

Physicians in the pharmaceutical industry: their roles, motivations, and perspectives.

Although physicians occupy a significant number of key positions in the pharmaceutical industry, practicing clinicians are often unaware of the variety of career paths within this industry, or of the structure of a pharmaceutical company. Here, we address questions that practicing clinicians frequently ask their colleagues in the pharmaceutical industry. In addition to providing an overview of the common roles occupied by physicians in pharma, we also describe the various motivations for transitioning into the industry and discuss different scenarios regarding the timing of the career change.

Early response to adalimumab predicts long-term remission through 5 years of treatment in patients with ankylosing spondylitis.

Objectives: To describe the efficacy and safety through 5 years of adalimumab treatment in patients with ankylosing spondylitis (AS), and to identify predictors of remission.

Methods: Patients with active AS were followed up to 5 years during a 24-week randomised, controlled period, followed by an open-label extension. Disease activity and clinical improvement were evaluated by Assessment in Spondyloarthritis International Society (ASAS) responses, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Ankylosing Spondylitis Disease Activity Score (ASDAS).

Comparative study of MRI and power Doppler ultrasonography of the heel in patients with spondyloarthritis with and without heel pain and in controls.

Introduction: Imaging of heel enthesopathy in spondyloarthritis (SpA) could potentially be useful for diagnosis and monitoring. The aim of this study was to assess the diagnostic capacities of MRI and power Doppler ultrasonography (PDUS) of the heel to distinguish patients with SpA from controls and to distinguish between patients with SpA with and without enthesopathy.

Methods: A cross-sectional single-centre study was performed in 51 patients (102 heels) with definite SpA according to Amor's criteria.

Diagnosis of peripheral psoriatic arthritis: recommendations for clinical practice based on data from the literature and experts opinion.

Objective: To propose French recommendations for the clinical, biological and radiological diagnosis of peripheral psoriatic arthritis (PsA) in daily practice based on data from the literature and expert opinion.

Method: The strategy was the following: the choice of four questions, concerning this topic by the scientific committee according to the Delphi method, forming the basis of the recommendations. The Systematic literature research based on Medline, Cochrane and abstracts from the annual meetings of the French society of rheumatology (SFR), American college of rheumatology (ACR) and European ligue against rheumatism (EULAR).

Prognosis and follow-up of psoriatic arthritis with peripheral joint involvement: development of recommendations for clinical practice based on published evidence and expert opinion.

Objectives: To develop recommendations about prognosis and follow-up of psoriatic arthritis (PsA) with peripheral joint involvement in everyday clinical practice.

Methods: The strategy was as following: (a) The choice of five questions, by the scientific committee according to the Delphi method, considered as a basis for the recommendations; (b) the Systematic Literature Research based on Medline, Cochrane and abstracts from the annual meetings of SFR, EULAR and ACR. An expert committee composed with 68 rheumatologists elaborated and validated the recommendations, specifying the strength and the degree of agreement for each of them.

Pharmacological treatment (biotherapy excluded) of peripheral psoriatic arthritis: development of recommendations for clinical practice based on data from the literature and experts opinion.

Objectives: To develop recommendations about treatment (except anti-TNF agents) of psoriatic arthritis with peripheral joint involvement (PsA) seen in everyday practice, using evidence from the literature, supplemented with expert opinion when needed.

Methods: The recommendations were based on evidence from the literature. First, a scientific committee used a Delphi procedure to select five focal points of interest.