Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease:an integrated analysis of Phase II/III Clinical Development Programs

IntroductionTheoretical risks of biologic agents remain under study.ObjectiveThe aim of this study was to integrate 1-year safety data from 12 ustekinumab registrational trials.MethodsPatients had moderate-to-severe plaque psoriasis, active psoriatic arthritis (PsA) (± methotrexate), or moderate-to-severe Crohn's disease (CD; failed/intolerant of immunomodulators/corticosteroids). Psoriatic patients received subcutaneous ustekinumab 45/90 mg or placebo, generally at week 0, week 4, then every 12 weeks thereafter, while those with CD received a single intravenous ustekinumab dose (130 mg or weight range-based dosing of approximately 6 mg/kg) or placebo induction dose at week 0, followed by subcutaneous ustekinumab 90 mg at week 8 and every 8/12 weeks thereafter. The incidence rates of a priori-defined safety events were integrated post hoc (adjusted for duration of follow-up, reported per 100 patient-years [PYs]).ResultsAmong 6280 enrolled patients, 5884 ustekinumab-treated patients (psoriasis: 3117; PsA: 1018; CD: 1749) contributed 4521 PYs versus 674 PYs in placebo-treated patients through year 1 (829 PYs and 385 PYs during 8- to 16-week controlled periods). Combined across diseases among ustekinumab- versus placebo-treated patients, respective incidences/100 PYs (95% confidence intervals) of infections were 125.4 (122.2-128.7) versus 129.4 (120.9-138.3) through year 1, and not meaningfully increased in patients who did versus those who did not receive methotrexate (92.5 [84.2-101.5] vs. 115.3 [109.9-121.0]), or significantly increased in patients who did versus those who did not receive corticosteroids (116.3 [107.3-125.9] vs. 107.3 [102.0-112.8]) at baseline. Major adverse cardiovascular events (0.5 [0.3-0.7] vs. 0.3 [0.0-1.1]), malignancies (0.4 [0.2-0.6] vs. 0.2 [0.0-0.8]), and deaths (0.1 [0.0-0.3] vs. 0.0 [0.0-0.4]) were rare across indications.ConclusionsUstekinumab demonstrated a favorable and consistent safety profile across registrational trials in approved indications.Trial registrationsClinicalTrials.gov identifier: NCT00320216, NCT00267969, NCT00307437, NCT00454584, NCT00267956, NCT01009086, NCT01077362, NCT00265122, NCT00771667, NCT01369329, NCT01369342, and NCT01369355

A study on alkali pretreatment conditions of sorghum stem for maximum sugar recovery using statistical approach

Bioethanol production from lignocellulosic biomass provides an alternative energy-production system. Sorghum bicolor stem is a cheap agro-waste for bioethanol production. In this study, response surface methodology (RSM) was used to optimize alkali pretreatment conditions for sorghum bicolor stem with respect to substrate concentration, NaOH concentration and pretreatment time based on a central composite rotary design. The main goal was to achieve the highest glucose and xylose yields after enzymatic hydrolysis. Under optimum conditions of pretreatment i.e. time 60.4 min, solid loading 4.2%, and NaOH concentration 1.7%, yields of 98.94% g glucose/g cellulose and 65.14% g xylose/g hemicelluloses were obtained. The results of a confirmation experiment under the optimal conditions agreed well with model predictions. Pretreatment of sorghum bicolor stem at the optimum condition increased the glucose and xylose yields by 7.14 and 3.02 fold, respectively. Alkali pretreatment showed to be a great choice for the pretreatment of sorghum bicolor stem

Correction to: Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs.

In the original publication of this article, the following correction should be noted in Table 5

Correction to:Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs

In the original publication of this article, the following correction should be noted in Table 5

A multicenter, non-interventional study to evaluate patient-reported experiences of living with psoriasis

<p><i>Background</i>: Moderate to severe plaque psoriasis (with or without psoriatic arthritis) places significant burden on patients’ lives. <i>Objective</i>: Explore and document patients’ experiences of living with psoriasis, including symptoms, treatments, impact on daily lives and patient-reported functioning. <i>Methods</i>: In a US-based, non-interventional study, narrative interviews were conducted at baseline and again within 16 weeks. In interviews, patients with moderate to severe psoriasis indicated symptoms, ranked symptoms according to level of bother and indicated areas of their lives affected by psoriasis. Transcripts of interviews were coded for themes. Measurements of psoriasis severity including BSA, PGA and PASI were recorded. <i>Results</i>: Symptoms reported most frequently included flaking/scaling (non-scalp areas), itching/scratching and rash, while the most bothersome symptoms were itching/scratching, flaking/scaling (non-scalp areas) and skin pain. Frequently reported impact areas were social and emotional. <i>Conclusion</i>: Broad-reaching interviews with patients with psoriasis show that these patients suffer in many aspects of their lives and in ways not indicated by typical psoriasis severity measures. Patients with psoriatic arthritis reported symptoms and disease-related complications at higher rates than those without arthritis. Physicians’ explorations of the effect of psoriasis on patients’ life events could aid in managing these patients.</p