Real-world data from a single Greek centre on the use of secukinumab in plaque psoriasis: effectiveness, safety, drug survival, and identification of patients that sustain optimal response.

BACKGROUND: Few studies have investigated the long-term outcomes of secukinumab in real-life psoriasis treatment where diverse patient profiles require a personalized approach. OBJECTIVES: To determine long-term performance of secukinumab in moderate-to-severe plaque psoriasis, and identify potential clinical factors predictive of sustained optimal response under real-world conditions. METHODS: In this 78-week, single-centre, retrospective study, effectiveness, safety and drug survival of secukinumab were evaluated. Effectiveness data are reported as observed. Co-primary endpoints were absolute Psoriasis Area and Severity Index (PASI) ≤3 at week 4, 16, 52, 78, and clinical predictors of PASI ≤3 and PASI100 responses at week 52 and 78. RESULTS: A total of 85 patients (75.3% male; mean age 48.6 years) were included. Absolute PASI ≤3 was achieved in 73% and 83% of patients at week 52 and 78, respectively. PASI 75/90/100 responses at week 52 (71.6%, 50.8%, and 40.3%, respectively) were sustained at week 78 (73.6%, 64.2%, and 45.3%, respectively). Median absolute PASI remained low at week 52/78 (0.9/0.6, respectively), while mean absolute PGA also sustained low (0-1) values after 16-78 weeks. Investigator's Global Assessment 0/1 response rate was maintained by week 52/78 (72/83%, respectively). The drug survival rate of secukinumab at week 78 was 79.1%. Treatment was discontinued in 17.9% of patients after an average of 41.7 weeks, mainly due to loss of effectiveness (10.4%). A total of 27% experienced adverse events, without critical safety concerns. Based on multivariate analysis, advanced body mass index (BMI) and presence of ≥3 comorbidities decreased the chance of achieving PASI ≤3 at week 78 [OR (95% CI) 0.78 (0.64-0.97); P = 0.024, and OR (95% CI) 0.045 (0.002-0.83); P = 0.037, respectively]. CONCLUSIONS: Secukinumab showed consistently high effectiveness in this real-life cohort, with an acceptable safety profile. Over time, persistence of PASI ≤3 response appears to be lower in patients with high BMI or multiple comorbidities.

[Insufficient tetanus vaccination protection in psoriasis and systemic immunosuppression : Results of a retrospective investigation of 101 patients]. / Unzureichender Tetanusimpfschutz bei Psoriasis und systemischer Immunsuppression : Ergebnisse einer retrospektiven Untersuchung an 101 Patienten.

BACKGROUND: With a prevalence of approximately 3 % worldwide, psoriasis is one of the most frequent chronic inflammatory skin diseases. Patients with moderate to severe psoriasis are treated guideline-conform with immunomodulatory or immunosuppressive agents. According to current guidelines physicians should be vigilant about the vaccination status of immunosuppressed patients. OBJECTIVE: The aim of the study was to serologically objectify the tetanus vaccination status in systemically treated patients with moderate to severe psoriasis in Germany. MATERIAL AND METHODS: Within the context of this retrospective study the concentration of immunoglobulin G antibodies against Clostridium tetani was determined in 101 patients with systemic immunosuppression suffering from psoriasis. RESULTS: In a total of 27.7% (n = 28; 11 male, 17 female) of the patients, insufficient immunoglobulin G antibody concentrations were detected, corresponding to a higher risk of an infection with C. tetani. Group subanalyses indicated an insufficient tetanus protection especially in patients ≥65 years old (50%). CONCLUSION: The tetanus immune status of psoriasis patients was shown to be comparable with the general population. The results of our investigation underline that people suffering from psoriasis have to be tested for tetanus protection and if necessary, vaccinations have to be renewed.

Real-world data on the efficacy and safety of apremilast in patients with moderate-to-severe plaque psoriasis.

BACKGROUND: Psoriasis is a chronic inflammatory skin disease, which requires long-term, safe and effective treatment. Apremilast, a small-molecule PDE4 inhibitor, has been introduced as psoriasis (and psoriatic arthritis) treatment in Europe in 2015. OBJECTIVE: We analysed and report the efficacy and safety of apremilast in the first 51 patients with psoriasis that have undergone treatment with this novel small molecule in our outpatient clinic. METHOD: Our primary endpoint was the evaluation of clinical response to apremilast according to the percentage of Psoriasis Area Severity Index (PASI) reduction (ΔPASI) at 16 weeks after treatment initiation. Secondary endpoints were the evaluation at week 16 of (i) PASI; (ii) Dermatology Life Quality Index (DLQI); (iii) Physician Global Assessment (PGA); (iv) Psoriasis Scalp Severity Index (PSSI); and (v) the percentage of patients who achieved ΔPASI50, ΔPASI75, ΔPASI90 and ΔPASI100; (vi) adverse events (AE); (vii) reasons for drug discontinuation; and (viii) drug survival. RESULTS: About 59.3% of the patients who remained on apremilast achieved at least ΔPASI75 at week 16, while 11.1% achieved combined 50% ≤ PASI < 75% and DLQI ≤ 5 (satisfactory response) adequate enough to maintain treatment. Five patients (18.5%) also achieved ΔPASI100. Patients discontinued apremilast (28%), mostly during the first 4 weeks due to adverse events (12%) with gastrointestinal symptoms being the most common, and later due to lack of efficacy (16%). A statistically significant improvement of PASI, DLQI, PGA and PSSI scores was observed after 4 and 16 weeks of treatment relative to pretreatment measurements. CONCLUSION: Apremilast is a safe and efficacious treatment for psoriasis patients as it produces ΔPASI75 and ΔPASI50 responses combined with DLQI ≤ 5 in 16 weeks in 70.4% of the patients. These results, from a real-world setting, confirm the efficacy and safety of apremilast which has been demonstrated in large phase III clinical trials.

[A new topically applied morphine gel for the pain treatment in patients with chronic leg ulcers: first results of a clinical investigation]. / Schmerzreduktion bei Patienten mit chronischem Ulcus cruris durch ein neu entwickeltes Morphingel : Erste Resultate einer klinischen Untersuchung.

BACKGROUND: The approach to patients with chronic leg ulcers should include not only an accurate diagnosis with appropriate therapy fort he underlying disease, but also the development of effective analgesia. To assess the analgesic effect of topical morphine, we developed a new morphine gel with polihexanide as a preservative for the local pain treatment. PATIENTS AND METHODS: We have studied 30 patients with painful chronic leg ulcers with an average age of 66 years. The respective pain intensity was assessed 24 hours after application of the morphine hydrogel and objectified with a visual analogue scale (VAS) ranged from 0 to 10. RESULTS: All investigated patients had a pain intensity of at least 4 points before the topical application of the morphine gel; the average pain intensity was 7.8. After application of the morphine gel, a significant reduction of the average pain intensity was observed, with an average pain intensity of 4.5. CONCLUSION: These first clinical results with the new morphine gel suggest that at least fort he first 24 hours it combines the advantages of a moist wound healing and a local pain treatment. This new development is certainly a promising therapeutic alternative for pain treatment in patients with chronic leg ulcers.

Abdominal compartment syndrome: effects on organ function.

Abdominal compartment syndrome (ACS) constitutes a critical clinical situation presenting a remarkable incidence being the causal factor of variable abdominal and extra-abdominal pathology, thus a rising issue of interest in intensive medical care over the past decade. Moreover, ACS as a condition potentially leading to Multiple Organ Failure (MOF), its better understanding could provide more effective management resulting to limitation of MOF incidence and mortality.

Diagnostic and therapeutic aspects in medullary thyroid carcinoma.

Medullary thyroid carcinoma (MTC) is a rare and particularly aggressive type of thyroid cancer with several distinctive features that distinguish its management from other thyroid cancers. Since MTC was first recognised as a distinct tumour in 1959, it became clear that MTC is more difficult to cure than differentiated thyroid cancer and has higher rates of recurrence and mortality, but it is usually a slow growing tumor compared with other malignancies. In addition, unlike differentiated thyroid cancer, there is no known effective systemic therapy for MTC.

Complications of thyroid surgery.

Thyroid surgery has a history of significant changes in the technique and the incidence of complications. Since then continuous developments in surgical techniques and better understanding of thyroid anatomy and pathology have increased the safety of thyroid surgery and reduced the incidence of complications. Nowadays, the rate of postoperative mortality is extremely low. Nevertheless, the incidence of postoperative complications varies in literature from 7.4% to 53% of the operations performed. The most common and potentially life-threatening complications in thyroid gland surgery are vocal cord palsy and hypocalcemia. Herein we discuss the common complications in thyroid gland surgery and their proper management.