Human Clinical Research and Therapeutics

2014 Journal of Investigative Dermatology  
The TNF-α antagonist adalimumab (ADA) has been used to treat patients (pts) with moderate to severe plaque psoriasis (Ps) and psoriatic arthritis (PsA) in Japan. This analysis assessed efficacy and safety of ADA treatment in pts with PsA from post-marketing surveillance. This 24-week (wk), open-label, post-marketing, observational trial was conducted at 634 sites in Japan (NCT01155570) in pts with Ps and with or without PsA. In PsA pts, efficacy evaluations included the proportion of pts
more » ... ng ≥75% reduction in Psoriasis Area Severity Index (PASI) from baseline (PASI75; LOCF), Disease Activity Score 28 (DAS28; observed cases), and European League Against Rheumatism (EULAR; LOCF) response (moderate, good); safety was also assessed. Of registered Ps pts (n=749; excluding 3 from 1 site), 217 and 213 pts with PsA were evaluated for safety and efficacy, respectively, of which 146 (67.3%) were men. Pts mean age was 47.9±12.0 years and mean disease (Ps or PsA) duration 13.3±9.8 years; 97.2% had previous Ps or PsA treatment. PASI75, evaluated in 156 PsA pts, was achieved by 45.2% and 51.3% at wks16 and 24, respectively. Mean DAS28-erythrocyte sedimentation rate, evaluated in 94 pts, improved from 4.4±1.7 at baseline to 2.4±1.3 (n=60) at wk16 and 2.3±1.3 (n=62) at wk24 (p<0.0001, both). Mean DAS28-C-reactive protein, evaluated in 131 pts, improved from 3.5±1.3 at baseline to 2.0±1.0 (n=81) at wk16 and 1.8±0.9 (n=85) at wk24 (p<0.0001, both). EULAR response (good/moderate), evaluated in 113 pts, was 7.1%/65.5% at wk16 and 8.9%/68.1% at wk24. Adverse events (AEs) were reported by 82 (37.8%) pts; serious AEs by 9 (4.1%). Following ADA treatment in Japanese pts with PsA, no new AEs or new incidences of AEs were observed; PASI, DAS28 and EULAR response improved significantly from baseline to wks 16 and 24. Similarity in survival in stage 4 basosquamous carcinoma and stage 4 squamous cell carcinoma: Results of a single-site retrospective cohort study Basosquamous carcinoma (BSC) is a rare histological subtype of basal cell carcinoma (BCC) thought to have a clinical course more similar to squamous cell carcinoma (SCC). However, no estimates of overall survival (OS) or progression-free survival (PFS) are currently available for BSC of any stage, making direct comparison impossible. The objective of this single-institution retrospective cohort study was to estimate and compare OS and PFS of Stage 4 BSC and Stage 4 SCC, as well as to relate these values to published estimates of OS and PFS of Stage 4 BCC. Biopsy-proven cases were identified by querying an institutional cancer registry, yielding 18 Stage 4 BSC and 36 Stage 4 SCC cases. The median OS (95% confidence interval (CI)) was 6.5 (3.9-∞) years for BSC and 3.5 (1.8-5.7) years for SCC. The five-year OS rate (95% CI) was 53% (19-79%) for BSC and 30% (14-49%) for SCC. The median PFS (95% CI) was 1.2 (0.5-3.0) years for BSC and 0.7 (0.5-1.0) years for SCC. Cox models adjusting for age at Stage 4 diagnosis and nodal status revealed a hazard ratio (95% CI) of 0.77 (0.32-1.85) for OS and 0.86 (0.43-1.73) for PFS of BSC compared to SCC. Log-rank tests for differences in OS (p=0.15) and PFS (p=0.53) between BSC and SCC were not statistically significant. Our study is the first to report survival data for BSC. While the OS and PFS of BSC and SCC are not significantly different in this study, the survival curves do show that BSC carries an intermediate prognosis compared to BCC and SCC. This suggests that larger studies may reveal statistically significant differences in OS and PFS between BSC and SCC. 515 Free dermatoplasty combining with vacuum sealing drainage with or without Pelnac used for the treatment of extensive follicular occulusion triad in the gluteal and perianal regions
doi:10.1038/jid.2014.109 fatcat:l7trfnds45ghdgytzj65t5xgza