IMPORTANCE Surgery is a mainstay in the management of hidradenitis suppurativa (HS). Adalimumab is the first drug approved for HS.OBJECTIVE To investigate the efficacy and safety of adalimumab in combination with wide-excision surgery followed by secondary intention healing. DESIGN, SETTING, AND PARTICIPANTSThe Safety and Efficacy of Adalimumab for Hidradenitis Suppurativa Peri-Surgically (SHARPS) trial was a phase 4, randomized, double-blind, placebo-controlled study of adalimumab in conjunction with surgery. Patients were enrolled in 45 sites across 20 countries from July 18, 2016, to February 2, 2019, with the last patient visit on October 16, 2019. Eligible patients (aged 18-65 years) had moderate to severe HS that required radical surgery in an axillary or inguinal region and had 2 other anatomical regions affected, with 1 or more regions at Hurley stage II or III. Analysis was conducted in November 2019.INTERVENTIONS Patients were randomized 1:1 to receive continuous adalimumab, 40 mg, or placebo during presurgery (12 weeks), perioperative (2 weeks), and postoperative (10 weeks) periods. MAIN OUTCOMES AND MEASURESThe primary end point was the proportion of patients achieving HS clinical response across all body regions at week 12.RESULTS Overall, 103 patients were randomized to adalimumab and 103 to matching placebo. Among all patients, 51% (n = 106) were women, 94% (n = 193) were White, and the mean (SD) age was 37.6 (11.3) years. At week 12, significantly more patients receiving adalimumab (49 of 103 [48%]) vs placebo (35 of 103 [34%]; P = .049) achieved HS clinical response across all body regions (treatment difference, 14% [95% CI, 0%-27%]). Treatment-emergent adverse events were reported in 74 of 103 patients (72%) and 69 of 103 patients (67%) in the adalimumab and placebo groups, respectively. No increased risk of postoperative wound infection, complication, or hemorrhage was observed with adalimumab vs placebo. Two deaths occurred in the adalimumab group; neither was considered as having a reasonable possibility of relationship to study drug. CONCLUSIONS AND RELEVANCEAdalimumab was efficacious in conjunction with wide-excision surgery followed by secondary intention healing, with no need to interrupt treatment prior to surgery. These data support further investigation of adalimumab as an adjuvant therapy to surgery in patients with moderate to severe HS.
mouth cancer have traditionally been higher in men than in women, this gap is narrowing over time.There is an urgent need for action against mouth cancer. Although patients' quality of life during and after treatment has steadily improved, survival rates from the disease have barely increased. 2 The stage at which mouth cancer is diagnosed has a significant effect on overall survival. When the cancer is still confined to the primary site and small (stage I, less than 2 cm), nearly 90% of people survive for at least two years. But six out of ten mouth cancers are found at a late stage (stages III and IV, greater than 4 cm or with spread), and this means a much lower survival rate (at stage IV, around 45% of people survive for at least two years) and high treatmentrelated morbidity in those who survive.Delays in diagnosis of oral cancer can lead to patients having more advanced stages of cancer, especially when the delay is more than a month. Delays in referral from primary to secondary care are associated with a threefold increase in mortality.
Introduction: Hidradenitis suppurativa (HS) is a chronic, inflammatory and painful cutaneous disease which often has a negative influence on patients' quality of life. Dermatology-specific instruments, such as Dermatology Life Quality Index and Skindex, are commonly used to evaluate HS patients' quality of life. However, due to the lack of specific questions, these scales may not be adequate and may not reflect the real problem. Aim: To translate and validate the Polish version of a newly created HS-specific questionnaire-Hidradenitis Suppurativa Quality of Life (HiSQOL). Material and methods: A forward and backward translation was conducted from the original English version of the questionnaire to Polish language according to international standards. The validation was performed on a group of 30 patients suffering from HS, who completed the questionnaire twice with a 4-5 days' interval. Results: The Polish version of HiSQOL questionnaire showed a very good internal consistency (Cronbach α coefficient was 0.96 for total score). Excellent reproducibility with the intraclass correlation coefficient (ICC) of 0.97 was demonstrated. Conclusions: The Polish version of HiSQOL questionnaire has high internal reliability, validity and reproducibility. It can be used as a tool to assess health-related quality of life in the patients suffering from hidradenitis suppurativa.
Background: Medical conditions with high variability in clinical costs and outcomes, such as psoriasis, represent a critical area for health-care value improvement. Thus, the prescription pattern variability of psoriasis biologics merits further study. Objective: The purpose of our study was to determine whether there is variation in psoriasis biologic prescribing patterns. Methods: This study analyzed data from the Truven MarketScan Commercial Claims and Encounters database. Patients with International Classification of Diseases, Ninth Revision psoriasis diagnoses from January 1, 2008, to December 31, 2013, and continuously enrolled for at least 12 months were included. Patient sex, geographic location by census region, and new pharmacy claims for etanercept, adalimumab, and ustekinumab were included. Descriptive and multivariable analyses using logistic regression were performed. Results: Twenty nine thousand seven hundred thirty patients with psoriasis had 36 366 new prescription claims. Statistically significant differences in biologic pharmacy claims existed across US census region and year of claim. The South census region had the most prescriptions (per million population) of each biologic and the greatest increase in new prescriptions for adalimumab and ustekinumab, while the Northeast had the fewest. Etanercept pharmacy claims steadily decreased across all regions over time, while ustekinumab experienced an 8-fold increase. Conclusion: Prescription pattern variability for psoriasis biologics is associated with US census region and year of pharmacy claim.
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