13 research outputs found
Rapidly Growing Eroded Nodule On The Ear Lobe [schnell Wachsender, Erodierter Knoten Am Ohrläppchen]
[No abstract available]616364Megahed, M., Polypoid basal cell carcinoma: A new clinicopathological variant (1999) Br J Dermatol, 140, pp. 701-703Kirkup, M.E., De Berker, D.A., Clinical measurement of dimensions of basal cell carcinoma: Effect of waiting for elective surgery (1999) Br J Dermatol, 141, pp. 876-879Gordon, P.M., Cox, N.H., Paterson, W.D., Lawrence, C.M., Basal cell carcinoma: Are early appointments justifiable? (2000) Br J Dermatol, 142, pp. 446-448Fisher, G.H., Bangash, S.J., Mones, J., Geronemus, R.G., Rapid growth of basal cell carcinoma in a multigestational pregnancy (2006) Derm Surg, 32, pp. 1418-142
Secukinumab Sustains Early Patient-Reported Outcome Benefits Through 1 Year: Results from 2 Phase III Randomized Placebo-Controlled Clinical Trials Comparing Secukinumab with Etanercept
BACKGROUND: Psoriasis is a chronic condition with negative impact on patients\u27 quality of life that most often requires lifelong effective and safe treatment. OBJECTIVE: This analysis focused on the effect of secukinumab treatment on patient-reported health-related quality of life as assessed by the Dermatology Life Quality Index (DLQI) in patients with moderate to severe psoriasis. METHODS: The proportion of subjects achieving DLQI score 0/1 response at week 24, time to DLQI score 0/1 response, and sustained DLQI score 0/1 response up to week 52 were compared between secukinumab and etanercept. RESULTS: Of 1470 subjects, 1144 received secukinumab and 326 received etanercept. DLQI score 0/1 response rates were significantly higher for secukinumab than for etanercept at week 24. The median time to DLQI score 0/1 response was significantly shorter for secukinumab versus etanercept (12 vs 24 weeks; P \u3c .01). The majority of secukinumab-treated subjects achieved DLQI score 0/1 response at week 24 and sustained it through week 52 along with a 90% to 100% reduction in the Psoriasis Area and Severity Index total score response. LIMITATIONS: Placebo comparisons are limited during the maintenance period because of rerandomization at week 12. CONCLUSION: Secukinumab treatment provided faster and greater sustained improvements in quality of life than etanercept over 52 weeks, consistent with greater clinical response
Secukinumab retreatment-as-needed versus fixed-interval maintenance regimen for moderate to severe plaque psoriasis: A randomized, double-blind, noninferiority trial (SCULPTURE)
BackgroundSecukinumab has demonstrated high, sustained efficacy in psoriasis to 52 weeks on a fixed-interval regimen.ObjectiveWe sought to compare a retreatment-as-needed versus a fixed-interval regimen.MethodsIn this double-blind study, adults with moderate to severe plaque psoriasis were randomized 1:1 to subcutaneous secukinumab at 300 mg (n = 484) or 150 mg (n = 482) weekly from baseline until week 4, and at week 8. At week 12, patients achieving 75% or more improvement from baseline Psoriasis Area and Severity Index score (PASI 75) were rerandomized to 2 dose levels of secukinumab retreatment as needed (n = 217, 300 mg; n = 206, 150 mg) or fixed interval (n = 217; n = 203). Primary end point was noninferiority of retreatment as needed versus fixed interval for maintaining PASI 75 to week 52.ResultsSecukinumab induced high responses by week 12 (84.4%-91.1% PASI 75 responders). From week 12 to week 52, more patients on fixed interval (78.2%, 300 mg; 62.1%, 150 mg) maintained PASI 75 versus retreatment as needed (67.7%; 52.4%); statistical noninferiority of retreatment as needed was not established. Overall safety, including very low incidences of treatment-emergent anti-drug antibodies (<0.5%), was similar between regimens.LimitationsThe primary end point was developed without any known precedent.ConclusionSecukinumab fixed interval showed clear benefit versus the study-specified retreatment-as-needed regimen for maintaining efficacy. Both regimens exhibited safety consistent with previous trials. The potential of retreatment as needed with secukinumab warrants further investigation
Secukinumab long-term safety experience:A pooled analysis of 10 phase II and III clinical studies in patients with moderate to severe plaque psoriasis
Item does not contain fulltextBACKGROUND: Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, has demonstrated efficacy and safety in patients with moderate to severe plaque psoriasis. OBJECTIVE: We reviewed safety data from the secukinumab psoriasis phase II/III program. METHODS: Data were pooled from 10 phase II/III secukinumab psoriasis studies. RESULTS: Analysis included 3993 subjects; 3430 received secukinumab, representing 2725 subject-years (SYs) of exposure. Over 52 weeks, for secukinumab 300 mg, 150 mg, and etanercept, respectively, exposure-adjusted incidence rates (IRs) per 100 SYs were comparable across treatments for total adverse events (AEs; 236.1, 239.9, and 243.4, respectively); infections (91.1, 85.3, and 93.7, respectively); serious AEs (7.4, 6.8, and 7.0, respectively); serious infections (1.4, 1.1, and 1.4, respectively); malignant or unspecified tumors (0.77, 0.97, and 0.68, respectively); and adjudicated major adverse cardiovascular events (0.42, 0.35, and 0.34, respectively). AEs were not dose-related except for nonserious, mild/moderate, skin/mucosal candidiasis (IRs 3.55, 1.85, and 1.37 for secukinumab 300 mg, 150 mg, and etanercept, respectively). LIMITATIONS: There was a limited number of patients in comparator groups and the exposure to placebo was short. CONCLUSION: Secukinumab had a favorable safety profile, had no meaningful difference between the 300- and 150-mg doses and, in terms of safety, was comparable to etanercept over 52 weeks in patients with moderate to severe plaque psoriasis