Dual targeted therapy in patients with psoriatic arthritis and spondyloarthritis: a real-world multicenter experience from Spain.

Dual targeted therapy (DTT) has emerged as a promising approach in patients with refractory spondyloarthritis (SpA) or psoriatic arthritis (PsA) and extra-musculoskeletal manifestations of both diseases, but its effectiveness/safety ratio still remains unclear. This is a retrospective, real-world multicenter study in refractory SpA and PsA patients with simultaneous use of two biological or synthetic targeted agents. Effectiveness was assessed using Ankylosing Spondylitis Disease Activity Score with C-reactive protein (ASDAS-CRP) and Disease Activity in Psoriatic Arthritis (DAPSA) Score. We identified 39 different DTT combinations in 36 patients (22 SpA; 14 PsA), 25 of them with concomitant inflammatory bowel disease. The most commonly used combinations were TNF inhibitor plus antagonist of the IL12/23 pathway, followed by TNF inhibitor plus IL-17 antagonist. During a median exposure of 14.86 months (IQR 8-20.2), DTT retention rate was 69.4% (n=25/36; 19 SpA, 6 PsA). Major clinical improvement (change in ASDAS-CRP > 2 or improvement > 85% in DAPSA) was achieved in 69.4% of patients (n=25/36 therapeutical combinations; 17/21 SpA, 8/15 PsA), with a 58.3% (n=21/36 combinations; 15/20 SpA, 6/13 PsA) low-activity/remission rate. Of the patients who were receiving glucocorticoids, 55% managed to withdraw them during follow-up. Interestingly, only four serious adverse events in three patients were observed, leading to DTT discontinuation.

Guselkumab effectiveness and survival in patients with psoriasis and psoriatic arthritis: Multicenter analysis in daily clinical practice by the Spanish Psoriasis Group.

Guselkumab is a monoclonal antibody that selectively blocks the p19 subunit of interleukin 23 and has been approved for the treatment of moderate to severe psoriasis and active psoriatic arthritis in adult patients due to its efficacy in different clinical trials. Therefore, itis important to know the performance of guselkumab in this setting of patients in clinical practice given that a high percentage of them are not represented in these clinical trials. Our objective was to evaluate the effectiveness and tolerability of guselkumab in clinical practice in the first patients with psoriasis and psoriatic arthritis treated since the date of its approval for psoriasis in Spain, in joint dermatology-rheumatology clinics. A multicenter retrospective data collection was carried out, in which 14 hospitals participated, including a total of 90 patients with psoriatic arthritis confirmed by a rheumatologist. Data collection was recorded at baseline and at weeks 12, 24, and 52 for both the articular and cutaneous domains. Ninety PsA patients started treatment with guselkumab and therefore were included in this study. The vast majority had already failed to at least to one biologic therapyprior guselkumab prescription. The median age was 55 years, 61% were female and 46% had a BMI ≥ 30 kg/m2 . Sixty-nine percent suffered from peripheral arthritis, and in 34% an axial involvement was also detected; dactylitis or enthesitis was present in 24% and 29% of patients, respectively. Guselkumab was effective in controlling both articular and skin manifestations of PsA patients. Absolute PASI significantly decreased from 10.5 to 4.8, 1.9 and 1.3 at weeks 12, 24, and 52, respectively. In 29 out of 61 (48%) of cases, DAPSA was moderate or high, and patients showed a significant reduction in DAPSA at 12, 24, and 52 weeks of treatment (mean DAPSA values at baseline and follow up were 29, 20, 16, and 14, respectively). Patients with DAPSA in low activity or in remission at the time of initiation of guselkumab maintained response at the end of the study period. No new safety concerns were detected. Seventy-eight out of 90 patients (84.4%) persisted on treatment after 2 years follow-up. Our experience suggests that guselkumab isan effective drug for PsA and PsO patients in clinical practice with good tolerability and no additional safety signals, making it a new therapeutic alternative for the treatment of PsA and PsO patients.

[Major epidemiological changes and clinical variables in patients undergoing a program of heart rehabilitation after cardiac surgery - MEPHISTOPHELES]. / Major epidemiological changes and clinical variables in patients undergoing a program of heart rehabilitation after cardiac surgery - MEPHISTOPHELES.

BACKGROUND: Recent observational studies show an increase of more complex and critically ill patients referred to Italian cardiac rehabilitation (CR) departments; the exact mechanisms underlying this phenomenon, however, have not been clearly identified. The aim of our study was to evaluate the epidemiological and clinical changes that occurred over the last decade in patients hospitalized in CR departments with high admittance rates. METHODS: We have retrospectively evaluated all patients admitted between 2002 and 2009 to our division of CR (n = 3340, 1155 female, mean age 66.4 ± 11 years) after recent cardiac surgery. The study population was divided into two homogeneous groups: the four-year period 2002-2005, group A (n = 1614, 540 female, mean age 66.1 ± 10 years) and the four-year period 2006-2009, group B (n = 1726, 615 female, mean age 67.4 ± 11 years). Data were compared using specific indicators of clinical complexity. RESULTS: Patients aged >75 years were more in group B compared to A (26.3 vs 19.8%, p<0.0001), as well as patients with recent complex surgical interventions, such as combined coronary artery bypass grafting and heart valve surgery (16.4 vs 10.2%, p<0.0001). An increased incidence of cardiovascular death (1.4 vs 0.6%, p=0.02), acute coronary syndrome (1.5 vs 0.7%, p=0.02) and persistent atrial fibrillation/flutter (13.5 vs 7.1%, p<0.0001) was observed in group B, as well as an increased prevalence of systolic heart failure (18.3 vs 9.0%, p<0.0001). Similarly, the incidence of acute respiratory failure episodes (1.0 vs 0.4%, p=0.05), the prevalence of patients admitted with a tracheostomy tube (2.6 vs 0.2%, p<0.0001) and the incidence of acute renal failure (1.1 vs 0.5%, p=0.05) were significantly increased in group B. Postoperative infections and surgical wound complications were 4-fold higher in group B (13.9 vs 3.1%, p<0.0001, and 12.8 vs 2.3%, p<0.0001, respectively). Compared to group A, patients of group B showed a significantly lower physical performance, as expressed by the Rivermead motility index (3.8 ± 1.1 vs 5.2 ± 0.8, p<0.001); moreover, the number of subjects able to perform an incremental training program was significantly lower in group B than group A (14.8 vs 60.6%, p<0.0001). Mean hospital stay was longer in group B than group A (25.4 ± 13 vs 22.1 ± 9 days, p<0.001). CONCLUSIONS: Our study, by collecting data from a CR division in northern Italy with high admittance rates, demonstrates a dramatic increase in clinical complexity over the last few years. This points to the need for new expertise and major resources to be allocated to CR departments.

[Diagnosis and management of dysphagia in patients with tracheostomy tube after cardiac surgery: an early screening protocol]. / Come riconoscere e gestire la disfagia nel cardioperato tracheostomizzato: proposta di un protocollo di screening.

SCOPE: Patients with tracheostomy tube after major cardiac surgery undergoing Cardiac Rehabilitation Program often present swallowing disorders that need a specific evaluation. This study aimed at validating the usefulness of a swallowing screen protocol in order to obtain an early assessment of dysphagia and to prevent aspiration, malnutrition and dehydration risks. MATERIALS AND METHODS: The protocol has been applied to 38 consecutive patients with tracheostomy tube after cardiac surgery between September 2007 and December 2009. The average age of patients was 73 +/- 6 years; the average value of left ventricular ejection fraction was 41 +/- 4%. The protocol included a water swallowing test and a specific swallowing test with blue dye. During tests, the presence of signs of swallowing dysfunction was evaluated and oxygen saturation levels were monitored. RESULTS: Out of 38 patients, 2 did not show any swallowing deficits; 18 showed deficits in the water swallowing test even though they presented a preserved swallowing function during specific swallowing test. All these 20 patients (53%), before discharge, restarted an oral feeding and obtained an adequate body mass index and effective coughing, so they were soon decannulated. Twelve patients (31%) showed deficits during the water swallowing test, confirmed by the specific swallowing test with blue dye: the tracheostomy tube was not removed and a specific program of swallowing rehabilitation was performed. Before discharge all patients restarted an oral feeding, recovered an effective coughing and were decannulated. Six patients (16%), because of persistent dysphagia, underwent percutaneous endoscopic gastrostomy. None of these 38 patients developed ab ingestis pneumonia, dehydration or malnutrition. CONCLUSIONS: An early assessment of swallowing in patients with tracheostomy tube after cardiac surgery allows the selection of patients with higher aspiration risk, preventing possible severe complications.