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BACKGROUND: Health-related quality of life (HRQoL) assessment in patients with acne is recommended by several national guidelines. There are several acne-specific HRQoL instruments. OBJECTIVES: Participants of the European Academy of Dermatology and Venereology (EADV) Task Forces (TFs) on QoL and Patient Oriented Outcomes (PO) and Acne, Rosacea, and Hidradenitis Suppurativa (ARHS) agreed to scrutinize aspects of existing acne-specific HRQoL instruments for their relevance in international study. METHODS: Consensus agreement on items related to QoL was reached after an independent assessment by seven experts from the EADV TFs on QoL and PO, and a list of 97 items was prepared and proposed to a group of acne patients. In order to have data from patients to check if any important topics were overseen, another group of acne patients from participating countries was asked to list how acne influenced different aspects of their lives. RESULTS: Based on results obtained from 601 acne patients from nine countries, most of the items and topics showed low relevance for acne patients especially during the previous month or shorter time periods. Based on percentage of relevance and factor analysis, short (6 items) and long (45 items) lists of the most relevant topics were formed. CONCLUSION: Most of the items and topics from the initial list showed low relevance for acne patients. None of the identified acne-specific HRQoL instruments contain all the items that were deemed most relevant to acne patients. For this reason, participating members of the EADV TFs on QoL and PO, and ARHs are in the process of developing a new acne-specific HRQoL instrument.

Highlights • Squamous cell carcinoma in hidradenitis suppurativa is difficult to diagnose. • Early excision to diagnose occult malignancy is recommended. • Vulvar cancer in hidradenitis suppurativa has a high frequency of metastases. • Appropriate imaging to establish the extent of the disease is required. • It has an aggressive course with rapid progression., Background Hidradenitis suppurativa (HS) is a debilitating disorder characterized by chronic inflammation in intertriginous areas. Malignant transformation to squamous cell carcinoma (SCC) is rare and is mostly diagnosed in the perianal area in men. The clinical behavior of SCC in HS can be aggressive, with local invasion and distant metastases. Case descriptions. We describe two cases of vulvar SCC in HS. The first demonstrates a 75 year old woman with a severe undertreated HS for over 30 years, who presented with a widespread vulvar cancer with lymphangitis carcinomatosa and inguinal and pelvic lymphadenopathy within several weeks after first suspicion of a malignancy. She died shortly after diagnosis. The second case describes a 61 year old woman diagnosed with HS 7 years ago, who presented with a rapidly progressive vulvar cancer with suspicion for ingrowth in the anal sphincter, vagina and levator ani muscle with inguinal and pelvic lymphadenopathy. She received radical chemoradiation with a complete response on imaging, but had a local recurrence within 2 months after finishing treatment. A posterior exenteration was performed but 5 months after surgery she had a second recurrence in the vulvar scar and pelvic floor muscles with possible bone metastases. She received palliative chemotherapy. Conclusion Vulvar SCC in an area of HS is a rare condition which is difficult to diagnose. It can have an aggressive course with rapid progression and a high frequency of metastases at presentation. Early surgical excision of HS to diagnose occult malignant transformation, appropriate imaging to establish the extent of the disease and an aggressive treatment plan without any delays are recommended.

Contains fulltext : 200471.pdf (Publisher’s version ) (Closed access) Clinical diagnosis of inflammatory skin disorders (ISD), including hair and nail disorders, is not always straightforward. Not uncommonly, a punch biopsy may be required. Dermoscopy and videodermoscopy (VD) are non-invasive techniques that are used for in vivo examination of the skin, hair, and nails. Both techniques can contribute to determining the accurate diagnosis of common ISD and can be useful for assessing treatment effects. However, the value of VD over conventional dermoscopy for ISD is undetermined. We systematically searched and reviewed the current published literature on ISD evaluated by VD and dermoscopy in the electronic databases, PubMed, Embase, the Cochrane Library, and Web of Science. All studies were assessed for quality using the Strengthening the Reporting of Observational studies in Epidemiology and Cochrane checklist. Finally, 82 studies were eligible for inclusion. An overview is presented of the (video)dermoscopic features for common ISD diagnoses, with details regarding the level of accuracy and features that should be monitored during treatment. Although both techniques are promising, studies of high methodological quality are necessary to determine the value of VD over conventional dermoscopy for common ISD.

Item does not contain fulltext Background Patients and the course of treatment in daily practice are different from randomized controlled trials (RCTs). Objectives Primary objective: to analyse the percentage of patients achieving PASI 75. Secondary objectives: PASI 50, PASI 90, PASI 100 responses, the percentage of patients experiencing at least one serious adverse event (SAE) and the response in biologic-naive vs. non-naive patients. Methods Prospectively collected efficacy and safety data of a cohort of psoriasis patients treated with adalimumab in daily practice between May 2007 and July 2011 were analyzed. Efficacy was determined using an intention-to-treat analysis and an as treated analysis, in comparison with the course baseline PASI before the start of adalimumab and the original baseline PASI before the start of any biologic therapy. Results Eighty-five patients received adalimumab therapy with a mean treatment duration of 1.4 (range 0.02-3.1) years. Compared with the original baseline PASI, PASI 75 response rates at week 12 and 24 were 34% and 38% (ITT). PASI 75 responses were well maintained until week 132. Only the PASI 75 response rate at week 12 differed significantly between biologic-naive (56%) and non-naive patients (29%). Sixteen patients (19%) experienced 28 SAEs. Seven patients (8%) experienced SAEs considered possibly or probably related to adalimumab. Conclusions In this cohort, PASI75 responses were substantial but lower than in RCTs and other daily practice studies. Efficacy was well maintained during more than 2 years of follow-up and differed only between biologic-naive and non-naive patients at week 12. The incidence of SAEs was low but seems higher than observed in RCTs.

Item does not contain fulltext 01 februari 2012

Contains fulltext : 109446.pdf (Publisher’s version ) (Closed access) BACKGROUND: The cumulative exposition to biologics is increasing with prolonged treatment with a certain biologic or consecutive biological treatment. However, long-term safety data are limited available. OBJECTIVES: The aim of this study was to prospectively evaluate the 5-year safety of biological treatment for psoriasis in daily practice. METHODS: A cohort of 173 psoriasis patients on biologics was prospectively followed for 5 years. All adverse events reported were documented and analysed. Primary endpoint was the percentage of patients reporting at least one serious adverse event. The rate of malignancies, serious infections and serious cardiovascular events was compared with the general population incidence rate. The nature and rate of dermatological adverse events was compared with a group of prospectively followed rheumatoid arthritis patients on TNF-alpha blocking therapy. RESULTS: Between February 2005 and April 2010, 173 patients were enrolled in the registry and went through a total number of 263 treatment episodes. The total number of patient-years of follow-up in the registry was 409. The number of patient-years was the highest for etanercept. Forty-nine patients (28%) reported 88 serious adverse events. Only one serious adverse event was certainly causally related to the biologic and 21 events (24% of SAEs) were considered possibly related. The incidence of malignancies, serious infections and serious cardiovascular events was comparable with the population incidence rate, except for skin malignancies. The incidence of skin malignancies was significantly higher than the general population incidence rate. The nature and rate of dermatological adverse events differed from the rheumatoid arthritis cohort. CONCLUSIONS: In this cohort, the safety of biological therapies for psoriasis was favourable with a low incidence of therapy-related serious adverse events. 01 maart 2012

Contains fulltext : 97308.pdf (Publisher’s version ) (Closed access) BACKGROUND: Guidelines concerning biological treatment of patients with psoriasis recommend different pretreatment and monitoring laboratory panels in variable frequencies to monitor treatment. OBJECTIVES: To investigate the relevance of laboratory investigations in monitoring patients with psoriasis on etanercept or adalimumab. METHODS: A prospective cohort study over 5 years was conducted in all consecutive patients with psoriasis on etanercept or adalimumab. All laboratory investigations performed for monitoring treatment were analysed. Laboratory abnormalities were graded according to the Common Terminology Criteria for Adverse Events v4.03. The primary endpoint was the percentage of patients with a grade 3 or grade 4 laboratory abnormality. The secondary endpoints were defined as: (i) significant changes in laboratory parameters during etanercept or adalimumab treatment and (ii) the percentage of patients having a laboratory abnormality requiring discontinuation of etanercept or adalimumab treatment. RESULTS: Laboratory parameters were available for 162 patients treated with etanercept and/or adalimumab. The number of treatment episodes was 155 for etanercept and 58 for adalimumab. Follow-up was 316 patient-years for etanercept and 54 patient-years for adalimumab. Thirty-eight of 146 patients treated with etanercept (26%) had one or more grade 3 and/or grade 4 laboratory abnormalities. For adalimumab, this was eight of 58 (14%). These were predominantly considered unrelated to biologic therapy. For both biologics, significant changes were observed in mean laboratory parameters during treatment compared with pretreatment as well as significant trends. However, mean values during treatment remained within normal ranges. Laboratory abnormalities did not lead to permanent discontinuation of biologic treatment in any patient. CONCLUSIONS: In this cohort, the incidence of biologic therapy-related serious laboratory abnormalities was low. Our findings do not support a need for routine laboratory testing in patients with psoriasis on etanercept or adalimumab beyond the laboratory testing required for concomitant therapies or comorbidities.

Contains fulltext : 97645.pdf (Publisher’s version ) (Closed access) WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: Infliximab is an effective treatment for rheumatoid arthritis, ankylosing spondylitis, Crohn's disease (both adult and paediatric), ulcerative colitis, psoriatic arthritis and plaque psoriasis and national and international guidelines have been developed for each indication. WHAT THIS STUDY ADDS: This study is the first study which compared current international, national and local guidelines from the medical specialties involved in the treatment with infliximab on the following topics: indication, dosage, synergy and monitoring of vital signs. AIMS: Infliximab, an anti-TNF biologic agent, is currently indicated and reimbursed for rheumatoid arthritis, ankylosing spondylitis, Crohn's disease (both adult and paediatric), ulcerative colitis, psoriatic arthritis and plaque psoriasis. Development of national and international guidelines for rheumatology, gastroenterology and dermatology, was mostly based on clinical studies and expert opinion. The aim of this study was to compare available guidelines and local protocols for rheumatology, dermatology and gastroenterology, regarding dosage of infliximab, synergy of infliximab with concomitant medication and monitoring of vital signs during infliximab administration, for achieving optimal care. METHODS: Current international, national and local guidelines on the use of infliximab were reviewed and compared, differences and shortcomings were identified, and optimal treatment schedules discussed during a meeting (July 2008) of clinical experts and researchers from three departments of a Dutch university hospital. RESULTS: Recommended dosages of infliximab are not equal for different indications. Loss of response to infliximab is a common problem encountered within the three medical specialties, but indications for adjustments in treatment schedules are lacking in all of the guidelines. Monitoring of vital signs (blood pressure, pulse, temperature) during infusion with infliximab is common practice and recommended by some guidelines. Routine measurement of vital signs is not of any value in predicting or recognizing acute infusion reactions, in our experience, and this is confirmed by literature on inflammatory bowel disease. CONCLUSION: Different indications encompass different dosing schedules. National and internal guidelines do not provide advice regarding loss of response. Routine measurement of vital signs during infusion is not valuable in detecting acute infusion reactions and should only be performed in case of an acute infusion reaction. These topics need to be studied in future studies and covered in future guidelines.

Contains fulltext : 88057.pdf (Publisher’s version ) (Closed access) 01 januari 2010

Contains fulltext : 82616.pdf (Publisher’s version ) (Open Access) Radboud Universiteit Nijmegen, 25 oktober 2010 Promotor : Kerkhof, P.C.M. van de Co-promotor : Jong, E.M.G.J. de 223 p.

Contains fulltext : 88933.pdf (Publisher’s version ) (Closed access) Background Although costs of biologics are high, effective treatment of patients with psoriasis may reduce the total health care costs, as it may limit the need for hospitalization. Objectives To investigate the economic impact of psoriasis, including direct costs, before and after the introduction of biologics, with special focus on hospitalized patients, treatment effectiveness and patient satisfaction with medication. Patients and methods A descriptive retrospective cohort study including 67 patients with high-need psoriasis was done. Direct costs were investigated for the biologic and pre-biologic period. Direct costs for a subgroup of hospitalized patients were analysed separately. Patient satisfaction with biologic treatment was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM) version II. Effectiveness of biologic therapy was investigated by means of the Psoriasis Area and Severity Index (PASI). Results Mean total direct costs were euro10 146 per patient per year (PPPY) in the pre-biologic treatment period, compared with euro17 712 PPPY in the biologic treatment period. For six patients in the cohort, introduction of biologics led to a reduction of direct costs, as these patients did not need long hospitalizations. Treatment with biologics led to a decrease in PASI from 19.0 at the start of biologic therapy to 6.4 at analysis (66.4%). Patient satisfaction with biologics was high, indicated by a mean TSQM score of 77.8. Conclusions Introduction of biologic therapies may have cost-neutral or cost-saving effects for patients who otherwise require long hospitalization periods. Treatment with biologics proved effective and was accompanied by high satisfaction for the patients. 01 juni 2010

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Contains fulltext : 252871.pdf (Publisher’s version ) (Open Access) Radboud University, 01 september 2022 Promotor : Kerkhof, P.C.M. van de Co-promotores : Driessen, R.J.B., Tijn, E.P.M. 182 p.

Contains fulltext : 233906.pdf (Publisher’s version ) (Open Access) Radboud University, 28 juni 2021 Promotor : Jong, E.M.G.J. de Co-promotores : Driessen, R.J.B., Erp, P.E.J. van 220 p.