Superior Effectiveness of Tofacitinib Compared to Vedolizumab in Anti-TNF-experienced Ulcerative Colitis Patients: A Nationwide Dutch Registry Study.

BACKGROUND & AIMS: Clinicians face difficulty in when and in what order to position biologics and Janus kinase inhibitors in patients with anti-tumor necrosis factor-alpha (TNF) refractory ulcerative colitis (UC). We aimed to compare the effectiveness and safety of vedolizumab and tofacitinib in anti-TNF-exposed patients with UC in our prospective nationwide Initiative on Crohn and Colitis Registry. METHODS: Patients with UC who failed anti-TNF treatment and initiated vedolizumab or tofacitinib treatment were identified in the Initiative on Crohn and Colitis Registry in the Netherlands. We selected patients with both clinical as well as biochemical or endoscopic disease activity at initiation of therapy. Patients previously treated with vedolizumab or tofacitinib were excluded. Corticosteroid-free clinical remission (Simple Clinical Colitis Activity Index ≤2), biochemical remission (C-reactive protein ≤5 mg/L or fecal calprotectin ≤250 µg/g), and safety outcomes were compared after 52 weeks of treatment. Inverse propensity score-weighted comparison was used to adjust for confounding and selection bias. RESULTS: Overall, 83 vedolizumab- and 65 tofacitinib-treated patients were included. Propensity score-weighted analysis showed that tofacitinib-treated patients were more likely to achieve corticosteroid-free clinical remission and biochemical remission at weeks 12, 24, and 52 compared with vedolizumab-treated patients (odds ratio [OR], 6.33; 95% confidence interval [CI], 3.81-10.50; P < .01; OR, 3.02; 95% CI, 1.89-4.84; P < .01; and OR, 1.86; 95% CI, 1.15-2.99; P = .01; and OR, 3.27; 95% CI, 1.96-5.45; P < .01; OR, 1.87; 95% CI, 1.14-3.07; P = .01; and OR, 1.81; 95% CI, 1.06-3.09; P = .03, respectively). There was no difference in infection rate or severe adverse events. CONCLUSIONS: Tofacitinib was associated with superior effectiveness outcomes compared with vedolizumab in anti-TNF-experienced patients with UC along with comparable safety outcomes.

What web-based intervention for chronic cancer-related fatigue works best for whom? Explorative moderation analyses of a randomized controlled trial.

PURPOSE: Approximately 25% of cancer patients suffer from chronic cancer-related fatigue (CCRF), which is a complex, multifactorial condition. While there are evidence-based interventions, it remains unclear what treatment works best for the individual patient. This study explored whether baseline characteristics moderated the effect of web-based mindfulness-based cognitive therapy (eMBCT) versus ambulant activity feedback (AAF) and a psycho-education control group (PE) on fatigue in patients suffering from CCRF. METHODS: In a randomized controlled trial, participant suffering from CCRF participated in either eMBCT, AAF, or PE. Complete data of the treatment-adherent sample (≥ 6 sessions) was used to explore whether sociodemographic, clinical, and psychological characteristics at baseline moderated the intervention effect on fatigue severity at 6 months. RESULTS: A trend showed that baseline fatigue severity and fatigue catastrophizing moderated the intervention effect. That is, at low levels of fatigue severity and catastrophizing, patients benefited more from AAF than from eMBCT and at high levels of fatigue severity and catastrophizing, patients benefited more from eMBCT than from PE. CONCLUSIONS: This study found some preliminary evidence on what treatment works best for the individual suffering from CCRF. These findings emphasize the potential gain in effectiveness of personalizing treatment. An alternative approach that might help us further in answering the question "what treatment works best for whom?" is discussed.

Exploring the interconnectedness of fatigue, depression, anxiety and potential risk and protective factors in cancer patients: a network approach.

Researchers have extensively studied fatigue, depression and anxiety in cancer patients. Several risk and protective factors have been identified for these symptoms. As most studies address these constructs, independently from other symptoms and potential risk and protective factors, more insight into the complex relationships among these constructs is needed. This study used the multivariate network approach to gain a better understanding of how patients' symptoms and risk and protective factors (i.e. physical symptoms, social withdrawal, illness cognitions, goal adjustment and partner support) are interconnected. We used cross-sectional data from a sample of cancer patients seeking psychological care (n = 342). Using network modelling, the relationships among symptoms of fatigue, depression and anxiety, and potential risk and protective factors were explored. Additionally, centrality (i.e. the number and strength of connections of a construct) and stability of the network were explored. Among risk factors, the relationship of helplessness and physical symptoms with fatigue stood out as they were stronger than most other connections in the network. Among protective factors, illness acceptance was most centrally embedded within the network, indicating it had more and stronger connections than most other variables in the network. The network identified key connections with risk factors (helplessness, physical symptoms) and a key protective factor (acceptance) at the group level. Longitudinal studies should explore these risk and protective factors in individual dynamic networks to further investigate their causal role and the extent to which such networks can inform us on what treatment would be most suitable for the individual cancer patient.

Employees Diagnosed with Cancer: Current Perspectives and Future Directions from an Employer's Point of View.

Purpose and methods Cancer survivors have a higher risk of adverse work outcomes such as not being able to return to work (RTW). The process of returning to work is complex as a result of the diverse stakeholders and numerous factors involved related to the employee diagnosed with cancer, the work environment, health care system, and the legal system. One of the key stakeholders is the employer, as the employer is in the position to facilitate work accommodations. Therefore, the purpose of this brief review is to consider opportunities regarding the role of the employer to enhance the work participation of employees with cancer. Results and conclusions We currently know little about which aspects of employer support have a positive impact on the ability of employees diagnosed with cancer to retain at work or RTW. In addition, there is a lack of interventions and tools which support employers in their management of employees diagnosed with cancer. The inclusion of employer support into the workplace can help employees diagnosed with cancer with their work retention and RTW, which is an important aspect of their quality of life and benefits the society at large.

Prevalence of chronic rhinosinusitis in the general population based on sinus radiology and symptomatology.

BACKGROUND: The prevalence of chronic rhinosinusitis (CRS) measured in epidemiologic studies is 5% to 12%. This might be an overestimation because of overlap with other diseases, such as allergic rhinitis. OBJECTIVE: We aimed to calculate the prevalence of CRS using a combination of epidemiologically based CRS according to the European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS) together with sinonasal opacification on imaging. METHODS: Subjects who underwent a computed tomographic or magnetic resonance imaging scan of the head for any nonrhinologic indication were asked to fill in the Global Allergy and Asthma European Network survey containing EPOS symptom criteria. The scans were evaluated according to the Lund-Mackay (LM) scoring system. Epidemiologically based CRS is based on nasal symptoms according to EPOS; clinically based CRS also encompasses endoscopy and/or CT scanning. RESULTS: Eight hundred thirty-four subjects were included. One hundred seven (12.8%) had epidemiologically based CRS according to EPOS. Of these subjects, 50% had an LM score of 0, 26% had an LM score of 1 to 3, and 23% had an LM score of 4 or greater. Twenty-five (3.0%) subjects had clinically based CRS (based on LM score ≥4), and 53 (6.4%) subjects had clinically based CRS (based on LM score >0). Allergic rhinitis was reported by 167 (20%) subjects. In subjects who did not report upper airway symptoms, 57% had an LM score of 0, 30% had an LM score of 1 to 3, and 12% had an LM score of 4 or greater. CONCLUSION: We found a prevalence of 3.0% to 6.4% of clinically based CRS (depending on an LM cutoff point; ie, LM ≥ 4 or LM > 0, respectively) in a relatively randomly selected group of subjects.

Effectiveness of Two Web-Based Interventions for Chronic Cancer-Related Fatigue Compared to an Active Control Condition: Results of the "Fitter na kanker" Randomized Controlled Trial.

BACKGROUND: Approximately one third of all patients who have been successfully treated for cancer suffer from chronic cancer-related fatigue (CCRF). Effective and easily accessible interventions are needed for these patients. OBJECTIVE: The current paper reports on the results of a 3-armed randomized controlled trial investigating the clinical effectiveness of two different guided Web-based interventions for reducing CCRF compared to an active control condition. METHODS: Severely fatigued cancer survivors were recruited via online and offline channels, and self-registered on an open-access website. After eligibility checks, 167 participants were randomized via an embedded automated randomization function into: (1) physiotherapist-guided Ambulant Activity Feedback (AAF) therapy encompassing the use of an accelerometer (n=62); (2) psychologist-guided Web-based mindfulness-based cognitive therapy (eMBCT; n=55); or (3) an unguided active control condition receiving psycho-educational emails (n=50). All interventions lasted nine weeks. Fatigue severity was self-assessed using the Checklist Individual Strength - Fatigue Severity subscale (primary outcome) six times from baseline (T0b) to six months (T2). Mental health was self-assessed three times using the Hospital Anxiety and Depression Scale and Positive and Negative Affect Schedule (secondary outcome). Treatment dropout was investigated. RESULTS: Multiple group latent growth curve analysis, corrected for individual time between assessments, showed that fatigue severity decreased significantly more in the AAF and eMBCT groups compared to the psycho-educational group. The analyses were checked by a researcher who was blind to allocation. Clinically relevant changes in fatigue severity were observed in 66% (41/62) of patients in AAF, 49% (27/55) of patients in eMBCT, and 12% (6/50) of patients in psycho-education. Dropout was 18% (11/62) in AAF, mainly due to technical problems and poor usability of the accelerometer, and 38% (21/55) in eMBCT, mainly due to the perceived high intensity of the program. CONCLUSIONS: Both the AAF and eMBCT interventions are effective for managing fatigue severity compared to receiving psycho-educational emails. TRIAL REGISTRATION: Trialregister.nl NTR3483; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3483 (Archived by WebCite at http://www.webcitation.org/6NWZqon3o).