Efficacy of long-term risankizumab treatment for moderate-to-severe plaque psoriasis: Subgroup analyses by baseline characteristics and psoriatic disease manifestations through 256 weeks (LIMMitless trial).

BACKGROUND: Psoriasis is an inflammatory skin disease that impacts a heterogeneous group of patients and can have multiple clinical manifestations. Risankizumab is approved for the treatment of moderate-to-severe plaque psoriasis. OBJECTIVES: To evaluate the long-term efficacy of risankizumab according to baseline patient characteristics, and for the treatment of high-impact disease manifestations (nail, scalp and palmoplantar psoriasis), through 256 weeks of continuous treatment in the phase 3 LIMMitless study. METHODS: This subgroup analysis evaluated pooled data from patients with moderate-to-severe plaque psoriasis who were randomized to risankizumab 150 mg during two double-blind, phase 3, 52-week base studies (UltIMMa-1/2; NCT02684370/NCT02684357) and were enrolled in the phase 3 LIMMitless open-label extension study (NCT03047395). Subgroup assessments included the proportion of patients who achieved ≥90%/100% improvement in Psoriasis Area and Severity Index (PASI 90/100). Among patients with nail, scalp and/or palmoplantar psoriasis in addition to skin psoriasis, assessments included changes from baseline in and resolution of these three psoriatic manifestations. RESULTS: Overall, a numerically similar proportion of patients (N = 525) achieved PASI 90/100 through Week 256, regardless of their baseline age, sex, body mass index, weight, PASI or psoriatic arthritis status. Patients with nail, scalp and/or palmoplantar psoriasis experienced substantial improvements in manifestation-specific indices (mean improvement from baseline to Week 256 of >81%, >94% and >97%, respectively); in patients with all three manifestations (N = 121), 44.6% achieved complete clearance of these manifestations at Week 256. CONCLUSIONS: Risankizumab demonstrated generally consistent efficacy through 256 weeks across patient subgroups and showed durable long-term efficacy for psoriatic disease manifestations.

Management of hard-to-heal leg ulcers with an acid-oxidising solution versus standard of care: the MACAN study.

OBJECTIVE: The efficacy of available wound dressings in the treatment of hard-to-heal wounds is limited. A new therapeutic approach using an acid-oxidising solution (AOS) was developed. Its effect on healing progress, tolerability and safety properties were investigated in a clinical study, and compared with standard of care (SOC) wound dressings. The study aimed to demonstrate the non-inferiority of AOS to SOC in terms of wound healing progress. METHOD: This open-label, randomised controlled trial was conducted at two study centres in Austria with patients with either infected or non-infected hard-to-heal leg ulcers of different aetiology. Patients were treated for six weeks either with AOS or SOC wound dressings. Outcome assessments included the percentage of granulation and re-epithelialisation tissue, wound size reduction, changes in wound pH, infection control and wound pain, local tolerability and adverse events (AEs). Healing time and rate were also assessed. RESULTS: A total of 50 patients took part. In the AOS group, wounds exhibited higher amounts of granulation and re-epithelialisation tissue, and a faster and more pronounced wound size reduction compared with wounds in the SOC group. In the AOS-treated versus SOC-treated patients, a greater percentage of complete healing of hard-to-heal ulcers was achieved by the end of the study period (32% versus 8%, respectively). Furthermore, the wound pH decreased significantly faster in these wounds (p<0.0001). In all patients with infected leg ulcers, local infection was overcome more rapidly under AOS treatment. In the AOS group, one AE and no serious adverse events (SAEs) were detected versus 24 AEs and two SAEs in the SOC group. CONCLUSION: In this study, AOS proved to be a highly effective treatment to support wound healing in infected or non-infected hard-to-heal leg ulcers of different aetiology. Efficacy was found to be not only non-inferior but superior to SOC wound dressings. Furthermore, tolerability and safety profiles were favourable for AOS.

Moisture-associated skin damage (MASD): A best practice recommendation from Wund-D.A.CH.

Wund-D.A.CH., as the umbrella organization of German-speaking wound treatment societies, has currently developed a best practice recommendation for skin damage caused by body fluids, which is known as moisture-associated skin damage (MASD) in English-speaking countries. In this expert consensus, the diseases incontinence-associated dermatitis (IAD), intertriginous dermatitis, including intertrigo, gram-negative bacterial toe web infection and toxic contact dermatitis, including periwound and peristomal dermatitis are presented in a differentiated manner. A common feature of these clinical diseases is a deterioration of skin integrity due to prolonged exposure to body fluids such as urine, stool, sweat or wound exudate with associated physical-irritative and/or chemical irritation. In addition, other comorbidities and cofactors play an important role. The diagnosis of these interdisciplinary and interprofessionally relevant MASD is difficult in everyday clinical practice because there are currently no uniform definitions and many relevant differential diagnoses. Effective strategies for the prevention and therapy of these skin diseases are, for example, continence management, use of efficient, absorbent aids with good retention as well as consistent skin protection and adequate skin care. Another important aspect is the education of patients and relatives about the origin, treatment and prevention of MASD.

Therapeutic index for local infections score (TILI): a new diagnostic tool.

OBJECTIVE: Local wound infections are a major challenge for patients and health professionals. Various diagnostic and therapeutic options are available. However, a generally accepted standard is still lacking in Europe. The aim was to develop an easy-to-use clinical score for the early detection of local wound infections, as a basis for decision-making on antiseptic therapy or decolonisation. METHOD: An interdisciplinary and interprofessional panel of experts from seven European countries was brought together to discuss the various aspects of diagnosing local wound infections. RESULTS: The result was the adoption of the Therapeutic Index for Local Infections (TILI) score, developed in Germany by Initiative Chronische Wunden e.V., specifically for health professionals not specialised in wound care. Available in six European languages, the TILI score could also be adapted for different European countries, depending on their specific national healthcare requirements. The six clinical criteria for local wound infection are erythema to surrounding skin; heat; oedema, induration or swelling; spontaneous pain or pressure pain; stalled wound healing; and increase and/or change in colour or smell of exudate. Meeting all criteria indicates that antiseptic wound therapy could be started. Regardless of these unspecific clinical signs, there are also health conditions for the clinical situation which are a direct indication for antimicrobial wound therapy. These include the presence of wound pathogens, such as meticillin-resistant Staphylococcus aureus, septic surgical wound or the presence of free pus. CONCLUSION: The development of the new internationally adapted TILI score, which could also be used by any caregiver in daily practice to diagnose local infections in acute and hard-to-heal wounds, is the result of expert consensus. However, the score system has to be validated through a clinical evaluation. This is to be performed in expert centres throughout Europe.

Therapeutic Index for Local Infections score validity: a retrospective European analysis.

OBJECTIVE: A score to identify local wound infections was developed by a panel of experts from seven European countries. The Therapeutic Index for Local Infections (TILI) score was designed for health professionals who are not specialised in wound care. This study was carried out to test the validity of the TILI score in everyday practice. METHOD: Content validity was analysed by means of evaluation by a panel of experts, individually and face-to-face, followed by a European multicentred, retrospective, observational study. Participating clinicians sent anonymised copies of completed TILI scores for patients with leg ulcers along with a photograph of the wound for analysis by two blinded reviewers. Concordance (Kappa index) and convergent criterion validity (sensitivity, specificity, accuracy, Youden's J Index and receiver operator characteristic (ROC) or area under the curve (AUC) curve) were calculated to construct validity and reliability. RESULTS: A total of 307 patients with leg ulcers from seven institutions in five European countries were included in this retrospective analysis. It was shown that the diagnosis of local wound infection could be documented well with five of the six clinical criteria included in the TILI score. By summing up these facultative criteria in comparison with any direct criteria that may be present, there would have been an indication for local antiseptic wound therapy in 22% of patients examined. CONCLUSIONS: The results show that the TILI score is concordant with the expert assessment of patients and with good diagnostic characteristics. Thus, the easy-to-use TILI score can now be used in the daily routine practice of health professionals to diagnose local wound infections.

Efficacy of MMP-inhibiting wound dressings in the treatment of chronic wounds: a systematic review.

OBJECTIVE: Matrix metalloproteinases (MMPs) substantially contribute to the development of chronicity in wounds. Thus, MMP-inhibiting dressings may support healing. A systematic review was performed to determine the existing evidence base for the treatment of hard-to-heal wounds with these dressings. METHODS: A systematic literature search in databases and clinical trial registers was conducted to identify randomised controlled trials (RCTs) investigating the efficacy of MMP-inhibiting dressings. Studies were analysed regarding their quality and clinical evidence. RESULTS: Of 721 hits, 16 relevant studies were assessed. There were 13 studies performed with collagen and three with technology lipido-colloid nano oligosaccharide factor (TLC-NOSF) dressings. Indications included diabetic foot ulcers, venous leg ulcers, pressure ulcers or wounds of mixed origin. Patient-relevant endpoints comprised wound size reduction, complete wound closure, healing time and rate. Considerable differences in the quality and subsequent clinical evidence exist between the studies identified. Substantial evidence for significant improvement in healing was identified only for some dressings. CONCLUSION: Evidence for the superiority of some MMP-inhibiting wound dressings exists regarding wound closure, wound size reduction, healing time and healing rate. More research is required to substantiate the existing evidence for different types of hard-to-heal wounds and to generate evidence for some of the different types of MMP-inhibiting wound dressings.

[Sucrose octasulfate-evidence in the treatment of chronic wounds]. / Sucrose Octasulfat ­ Evidenz in der Behandlung chronischer Wunden.

Patients with chronic wounds should receive wound treatment in addition to causative therapy. In this context, the lack of adequate evidence for wound healing products has been repeatedly discussed. Using the example of TLC-sucrose octasulfate (TLC: technology lipido-colloid), the present review shows that there is significant data with good evidence and comparability in this area. One therapeutic approach to promote wound healing is the inhibition of matrix-metalloproteinases, for example by sucrose octasulfate. For wound products containing TLC-sucrose octasulfate, several sequential clinical studies have been conducted in recent years. The WHAT study was an open randomized controlled trial (RCT) with 117 patients with venous leg ulcers (VLU). The CHALLENGE study was a double-blind RCT with 187 patients with VLU. The SPID study was a pilot study with 33 patients with diabetic foot ulcers (DFU). The two prospective, multicenter clinical pilot studies NEREIDES and CASSIOPEE examined a total of 88 patients with VLU in different phases of healing. In the REALITY study, a pooled data analysis was performed on eight observational studies with 10,220 patients with chronic wounds of different genesis. In the double-blind, two-armed EXPLORER RCT, 240 patients with neuro-ischemic DFU were followed from first presentation until complete healing. In all studies, a significant promotion of wound healing could be shown by the use of wound healing products with TLC-sucrose octasulfate.

Knowledge and Influence of Predatory Journals in Dermatology: A Pan-Austrian Survey.

The aim of this study was to assess the knowledge and influence of predatory journals in the field of dermatology in Austria. A total of 286 physicians (50.5% men) completed a questionnaire. The vast majority of subjects read scientific articles (n = 281, 98.3%) and took them into consideration in their clinical decision-making (n = 271, 98.5% of participants that regularly read scientific literature). Open access was known by 161 (56.3%), predatory journals by 84 (29.4%), and the Beall's list by 19 physicians (6.7%). A total of 117 participants (40.9%) had been challenged by patients with results from the scientific literature, including 9 predatory papers. Participants who knew of predatory journals had a higher level of education as well as scientific experience, and were more familiar with the open-access system (p < 0.001). These results indicate that the majority of dermatologists are not familiar with predatory journals. This is particularly the case for physicians in training and in the early stages of their career.

The Management of Critically Colonized and Locally Infected Leg Ulcers with an Acid-Oxidizing Solution: A Pilot Study.

OBJECTIVE: Critical colonization or local infection is very common in chronic wounds, but clinically problematic. Because therapeutic options for these conditions are limited in number and efficacy, the study authors tested a new acid-oxidizing solution (AOS [Nexodyn]; APR Applied Pharma Research S.A., Balerna, Switzerland) to determine its ancillary antimicrobial properties and potential support for wound healing. DESIGN AND SETTING: This open-label clinical case series was conducted with a prospective, single-arm design at the Federal County Hospital in Bregenz, Austria. PATIENTS: In the study, 30 patients with critically colonized or locally infected chronic leg ulcers of any origin were included. INTERVENTIONS: The AOS was applied on each leg ulcer at every dressing change for 35 days. MAIN OUTCOME MEASURES: The tolerability and performance of the AOS were assessed by evaluating the ulcer characteristics and comparing them with those at baseline. The clinical course of wounds was analyzed using standard measures for bioburden, local infection, pain, pH, and wound healing. MAIN RESULTS: Application of the solution was well tolerated, and no adverse events were recorded. In all patients, local infection was overcome, and wound bed pH and wound area decreased significantly. In addition, patient pain levels decreased to a level where interventions were not required after study day 7. In 37% of all patients, a complete resolution of chronic ulcers was achieved by the end of the study period. CONCLUSION: According to these results, the AOS seems to be a valid and highly tolerable treatment to support wound healing in locally infected ulcers. Nevertheless, larger controlled cohort studies are needed to substantiate these findings.

Lebensqualität und Behandlungsziele bei Psoriasis aus Patientensicht: Ergebnisse eines österreichweiten Querschnitt-Survey.

HINTERGRUND: Patienten mit Psoriasis sind mit einer krankheitsbedingten Einschränkung ihrer Lebensqualität konfrontiert, weshalb einer hochqualitativen dermatologischen Versorgung ein besonderer Stellenwert zukommt. PATIENTEN UND METHODIK: Wir führten einen bundesweiten Querschnitt-Survey in Österreich (BQSAustria Psoriasis 2014/2015) mit dem Schwerpunkt auf Lebensqualität und Therapiezufriedenheit bei Patienten mit Psoriasis in dermatologischer Behandlung vorwiegend an Zentren mit überwiegend tertiären Versorgungsaufgaben durch. ERGEBNISSE: 70,2 % der 1184 befragten Patienten berichtete über eine eingeschränkte Lebensqualität (DLQI 2-5: 29,4 %; 6-10: 19,3 %; 11-15: 11,5 %; 16-20: 5,2 % und > 20: 4,9 %) trotz Behandlung innerhalb der letzten vier Wochen (mit lokaler Therapie in 88,2 % und/oder systemischer Therapie in 38,7 % der Fälle). Mit den verabreichten Therapien konnte im Durchschnitt kein einziges von 25 definierten subjektiven Behandlungszielen im gewünschten Ausmaß erreicht werden. So litten 82,2 % der Patienten trotz Behandlung weiter unter Juckreiz, wobei statistisch hochsignifikante Assoziationen mit einem schlechten Gesundheitszustand in der letzten Woche (Spear-man-Rangkorrelation; p = 1.1e-45), dem Ausmaß des psoriatischen Körperoberflächenbefalls (p = 3.2e-11) und Kopfhautbefalls (p = 3.2e-11) sowie Schmerzen (p = 2.3e-22) vorlagen. Die Behandlung mit einem Biologikum war mit einer signifikant höheren Patientenzufriedenheit verbunden (Wilcoxon-Test, p = 2.0e-16). SCHLUSSFOLGERUNGEN: Die Lebensqualität der meisten österreichischen Patienten mit Psoriasis in dermatologischer Versorgung ist krankheitsbedingt beeinträchtigt, und es besteht ein Verbesserungspotenzial bei der Umsetzung von Behandlungszielen.

Quality of life and treatment goals in psoriasis from the patient perspective: results of an Austrian cross-sectional survey.

BACKGROUND: Patients with psoriasis experience impairment in quality of life. Thus, high-quality dermatological care is of particular importance. PATIENTS AND METHODS: We performed a nationwide cross-sectional survey in Austria (BQSAustria Psoriasis 2014/2015) with a special focus on quality of life and satisfaction with treatment among psoriasis patients predominantly treated at tertiary care centers. RESULTS: Overall, 70.2 % of 1,184 patients reported impaired quality of life (DLQI 2-5: 29.4 %; 6-10: 19.3 %; 11-15: 11.5 %; 16-20: 5.2 % and > 20: 4.9 %) despite treatment over the preceding four weeks (topical treatment in 88.2 % of cases and/or systemic treatment in 38.7 %). On average, none of the 25 defined subjective treatment goals was achieved to a sufficient degree. In particular, 82.2 % of patients continued to have pruritus despite treatment, which was highly significantly associated with a poor general health status over the preceding week (Spearman's rank correlation; p  =  1.1e-45), the extent of body surface area (p  =  3.2e-11) and scalp area (p  =  3.2e-11) affected, as well as pain (p  =  2.3e-22). Treatment with a biologic was significantly correlated with higher patient satisfaction (Wilcoxon-Test, p  =  2.0e-16). CONCLUSIONS: Despite dermatological care, the majority of Austrian psoriasis patients continues to experience impaired quality of life; there is potential for improvement in the achievement of treatment goals.

Wound Curriculum for Nurses.

The European Wound Management Association (EWMA) has just finalised the first curriculum in a series of several curricula intended for use in levels 5-7 of the European Qualifications Framework (EQF)1. The aim of these is to support a common approach to post-registration qualification in wound management for nurses across Europe. EWMA hopes and will work towards a close collaboration with European nurse organisations as well as educational institutions to implement these common curricula.

Tofacitinib versus etanercept or placebo in moderate-to-severe chronic plaque psoriasis: a phase 3 randomised non-inferiority trial.

BACKGROUND: New therapeutic options are needed for patients with psoriasis. Tofacitinib, an oral Janus kinase inhibitor, is being investigated as a treatment for moderate-to-severe chronic plaque psoriasis. In this study, we aimed to compare two tofacitinib doses with high-dose etanercept or placebo in this patient population. METHODS: In this phase 3, randomised, multicentre, double-dummy, placebo-controlled, 12-week, non-inferiority trial, adult patients with chronic stable plaque psoriasis (for ≥12 months) who were candidates for systemic or phototherapy and had a Psoriasis Area and Severity Index (PASI) score of 12 or higher and a Physician's Global Assessment (PGA) of moderate or severe, and had failed to respond to, had a contraindication to, or were intolerant to at least one conventional systemic therapy, were enrolled from 122 investigational dermatology centres worldwide. Eligible patients were randomly assigned in a 3:3:3:1 ratio to receive tofacitinib 5 mg or 10 mg twice daily at about 12 h intervals, etanercept 50 mg subcutaneously twice weekly at about 3-4 day intervals, or placebo. Randomisation was done by a computer-generated randomisation schedule, and all patients and study personnel were masked to treatment assignment. The co-primary endpoints were the proportion of patients at week 12 with at least a 75% reduction in the PASI score from baseline (PASI75 response) and the proportion of patients achieving a PGA score of "clear" or "almost clear" (PGA response), analysed in the full analysis set (all patients who were randomised and received at least one dose of study drug). This study is registered with ClinicalTrials.gov, number NCT01241591. FINDINGS: Between Nov 29, 2010, and Sept 13, 2012, we enrolled 1106 eligible adult patients with chronic plaque psoriasis and randomly assigned them to the four treatment groups (330 to tofacitinib 5 mg twice daily, 332 to tofacitinib 10 mg twice daily, 336 to etanercept 50 mg twice weekly, and 108 to placebo). Of these patients, 1101 actually received their assigned study medication (329 in the tofactinib 5 mg group, 330 in the tofacitinib 10 mg group, 335 in the etanercept group, and 107 in the placebo group). At week 12, PASI75 responses were recorded in 130 (39·5%) of 329 patients in the tofacitinib 5 mg group, 210 (63·6%) of 330 in the tofacitinib 10 mg group, 197 (58·8%) of 335 in the etanercept group, and six (5·6%) of 107 in the placebo group. A PGA response was achieved by 155 (47·1%) of 329 patients in the tofacitinib 5 mg group, 225 (68·2%) of 330 in the tofacitinib 10 mg group, 222 (66·3%) of 335 in the etanercept group, and 16 (15·0%) of 107 in the placebo group. The rate of adverse events was similar across the four groups, with serious adverse events occurring in seven (2%) of 329 patients in the tofacitinib 5 mg group, five (2%) of 330 in the tofacitinib 10 mg group, seven (2%) of 335 in the etanercept group, and two (2%) of 107 in the placebo group. Three (1%) of 329 patients in the tofacitinib 5 mg group, ten (3%) of 330 in the tofacitinib 10 mg group, 11 (3%) of 335 in the etanercept group, and four (4%) of 107 patients in the placebo group discontinued their assigned treatment because of adverse events. INTERPRETATION: In patients with moderate-to-severe plaque psoriasis, the 10 mg twice daily dose of tofacitinib was non-inferior to etanercept 50 mg twice weekly and was superior to placebo, but the 5 mg twice daily dose did not show non-inferiority to etanercept 50 mg twice weekly. The adverse event rates over 12 weeks were similar for tofacitinib and etanercept. This study indicates that in the future tofacitinib could provide a convenient and well-tolerated therapeutic option for patients with moderate-to-severe plaque psoriasis. FUNDING: Pfizer Inc.

Survival and Effectiveness of Tumour Necrosis Factor-alpha Inhibitors in the Treatment of Plaque Psoriasis under Daily Life Conditions: Report from the Psoriasis Registry Austria.

This retrospective multicentre analysis from the Psoriasis Registry Austria (PsoRA) was conducted to determine drug effectiveness and survival of anti-tumour necrosis factor alpha (anti-TNF-α) agents in patients with moderate-to-severe chronic plaque psoriasis over a 9-year period. Data on 1,019 treatment cycles with adalimumab (n = 460), etanercept (n = 501), and/or infliximab (n = 58) administered to 827 patients (272 women, 555 men) were available for analysis. Compared with etanercept, adalimumab and infliximab showed superior short-term effectiveness. Intention-to-treat-calculated median drug survivals for adalimumab (1,264 days) and etanercept (1,438 days) were similar to each other (p = 0.74), but significantly superior to that of infliximab (477 days) (p = 7.0e-07 vs. adalimumab and p=2.2e-07 vs. etanercept, respectively). Their drug survival rates at 36 months were 51.6%, 56.0%, and 22.6%, respectively. Survival rates correlated significantly with effectiveness for adalimumab and etanercept, but not for infliximab.

Compression therapy in patients with venous leg ulcers.

Wund-D.A.CH. is the umbrella organization of the various wound care societies in German-speaking countries. The present consensus paper on practical aspects pertinent to compression therapy in patients with venous leg ulcers was developed by experts from Germany, Austria, and Switzerland. In Europe, venous leg ulcers rank among the most common causes of chronic wounds. Apart from conservative and interventional wound and vein treatment, compression therapy represents the basis of all other therapeutic strategies. To that end, there are currently a wide variety of materials and systems available. While especially short-stretch bandages or multicomponent systems should be used in the initial decongestion phase, ulcer stocking systems are recommended for the subsequent maintenance phase. Another - to date, far less common - alternative are adaptive Velcro bandage systems. Medical compression stockings have proven particularly beneficial in the prevention of ulcer recurrence. The large number of treatment options currently available enables therapists to develop therapeutic concepts geared towards their patients' individual needs and abilities, thus resulting in good acceptance and adherence. Compression therapy plays a crucial role in the treatment of patients with venous leg ulcers. In recent years, a number of different treatment options have become available, their use and application differing among German-speaking countries. The present expert consensus is therefore meant to outline concrete recommendations for routine implementation of compression therapy in patients with venous leg ulcers.

Kompressionstherapie bei Patienten mit Ulcus cruris venosum.

Wund-D.A.CH. ist der Dachverband deutschsprachiger Fachgesellschaften, die sich mit den Thematiken der Wundbehandlung beschäftigen. Experten verschiedener Fachgesellschaften aus Deutschland, Österreich und der Schweiz haben nun einen aktuellen Konsens der Kompressionstherapie für Patienten mit Ulcus cruris venosum erstellt. In Europa ist das Ulcus cruris venosum eine der häufigsten Ursachen für chronische Wunden. Neben der konservativen und interventionellen Wund- und Venentherapie, ist die Kompressionstherapie die Basis der Behandlungsstrategien. Die Kompressionstherapie kann heute mit sehr unterschiedlichen Materialien und Systemen durchgeführt werden. Während in der Entstauungsphase insbesondere Verbände mit Kurzzugbinden oder Mehrkomponentensysteme zur Anwendung kommen, sind es anschließend überwiegend Ulkus-Strumpfsysteme. Eine weitere, bislang wenig verbreitete Alternative sind adaptive Kompressionsbandagen. Insbesondere für die Rezidivprophylaxe werden medizinische Kompressionsstrümpfe empfohlen. Durch die Vielzahl der heute zur Verfügung stehenden Behandlungsoptionen, kann für nahezu alle Patienten ein Konzept entwickelt werden, dass sich an den individuellen Bedürfnissen und Fähigkeiten orientiert und daher auch akzeptiert und durchgeführt wird. Die Kompressionstherapie ist für die Behandlung von Patienten mit Ulcus cruris venosum essentiell. In den letzten Jahren sind viele verschiedene Therapieoptionen verfügbar, die in den deutschsprachigen Ländern unterschiedlich angewendet oder durchgeführt werden. Daher soll dieser Expertenkonsens dazu beitragen, konkrete Empfehlungen für die praktische Durchführung der Kompressionstherapie von Patienten mit Ulcus cruris venosum darzustellen.

Efficacy and cost-effectiveness of octenidine wound gel in the treatment of chronic venous leg ulcers in comparison to modern wound dressings.

The aim of this study was to determine the efficacy, safety and cost-effectiveness of an octenidine-based wound gel in the treatment of chronic venous leg ulcers. For this purpose, 49 wounds were treated with either modern wound-phase-adapted dressings alone (treatment arm 1; n = 17), octenidine wound gel plus modern wound-phase-adapted dressings (treatment arm 2; n = 17) or octenidine wound gel alone (treatment arm 3; n = 15). During the study period of 42 days with dressing changes every 3-5 days, wound healing characteristics and treatment costs of different dressings were analysed. Wound size reduction was significantly better (P = 0·028) in both octenidine wound gel treatment arms compared to modern dressings alone with total reductions of 14·6%, 64·1% and 96·2% in treatment arms 1-3. Early wound healing was merely observed under octenidine wound gel treatment (n = 9), whereby lowest treatment costs were generated by octenidine wound gel alone (€20·34/dressing change). As a result, the octenidine wound gel is cost-effective and well suitable for the treatment of chronic venous leg ulcers, considering both safety and promotion of wound healing.

Tumoricidal activity of TLR7/8-activated inflammatory dendritic cells.

Imiquimod (IMQ), a synthetic agonist to Toll-like receptor (TLR) 7, is being successfully used for the treatment of certain skin neoplasms, but the exact mechanisms by which this compound induces tumor regression are not yet understood. While treating basal cell carcinoma (BCC) patients with topical IMQ, we detected, by immunohistochemistry, sizable numbers of both myeloid dendritic cells (mDCs) and plasmacytoid DCs (pDCs) within the inflammatory infiltrate. Surprisingly, peritumoral mDCs stained positive for perforin and granzyme B, whereas infiltrating pDCs expressed tumor necrosis factor-related apoptosis-inducing ligand (TRAIL). The biological relevance of this observation can be deduced from our further findings that peripheral blood-derived CD11c(+) mDCs acquired antiperforin and anti-granzyme B reactivity upon TLR7/8 stimulation and could use these molecules to effectively lyse major histocompatibility complex (MHC) class I(lo) cancer cell lines. The same activation protocol led pDCs to kill MHC class I-bearing Jurkat cells in a TRAIL-dependent fashion. While suggesting that mDCs and pDCs are directly involved in the IMQ-induced destruction of BCC lesions, our data also add a new facet to the functional spectrum of DCs, ascribing to them a major role not only in the initiation but also in the effector phase of the immune response.