Safety profile of intravenous and subcutaneous siplizumab,an anti‐CD2 monoclonal antibody,for the treatment of plaque psoriasis: results of two randomized,double‐blind,placebo‐controlled studies

Several biologics targeting different cytokines and receptors, including T‐cell receptors, have been approved for psoriasis treatment. Siplizumab, a humanized anti‐CD2 monoclonal antibody, may potentially provide an alternative therapy for psoriasis. Its safety profile and immunogenicity was examined in adults with plaque psoriasis. Two multicenter phase II randomized, double‐blind, placebo‐controlled studies: one tested two intravenous (I.V.) doses (0.012 and 0.04 mg/kg) of siplizumab every 2 weeks × 8 doses (124 patients); the second study tested three subcutaneous (S.C.) dose regimens of siplizumab (5 mg × 12 weeks, 5 mg × 6 weeks + placebo × 6 weeks, 7 mg × 4 weeks + placebo × 8 weeks), and placebo × 12 weeks (420 patients). Adverse events (AEs) and laboratory values were monitored. Immunogenicity was determined by anti‐siplizumab antibodies quantification. In both studies, siplizumab exhibited an acceptable safety profile; most common AEs judged to be siplizumab related were lymphopenia, chills, and headache, reported at a higher frequency in the siplizumab‐treated vs. placebo group. Siplizumab‐related reductions in absolute lymphocyte count did not result in clinical evidence of immune suppression. Anti‐siplizumab antibodies were detected after exposure to siplizumab; however, there was no evidence of an association between antibody development and AEs. Siplizumab exhibited an acceptable safety profile in adult patients with plaque psoriasis when administered as multiple I.V. or S.C. doses. Higher, clinically relevant doses of siplizumab would need to be tested to fully assess its safety.     

Behavioral therapies trials: a case example

BACKGROUND: Behavior change is integral to the prevention and treatment of many disorders associated with deleterious lifestyles. Rigorous scientific testing of behavior change interventions is an important goal for nursing research. APPROACH: The stage model for behavioral therapy development is recommended as a useful framework for evaluating behavior change strategies. The NIH model specifies three stages from initial testing of novel behavioral therapies to their dissemination in community settings. Definitions of each step in a Stage I trial and a case example of Mindfulness-Based Stress Reduction (MBSR) in therapeutic community treatment are provided. RESULTS: It is feasible to adapt a behavioral therapy such as MBSR using the stage model framework. Steps in the process include: (a) determining pilot study design and describing the population; (b) modifying the intervention and developing the manual; (c) training the teachers; (d) implementing a pilot study; and (e) monitoring treatment integrity. DISCUSSION: The development of behavior therapies requires the same scientific rigor used in pharmacotherapy research. Stage I of the model enables consideration of the "dose" of a behavioral intervention necessary to achieve behavior change in a defined population. The stage model offers an excellent approach to achieving rigor in a variety of potentially useful therapies of interest to nurse researchers.     

Glycemic index of American-grown jasmine rice classified as high

The primary objective was to determine the glycemic index (GI) of jasmine rice grown in the United States (US). Secondary objective was to compare the GI of US grown jasmine rice to those grown in Thailand. Twelve healthy subjects were served all four brands of jasmine rice and a reference food (glucose), each containing 50?g of available carbohydrate. Fingerstick blood glucose was measured at 0, 15, 30, 45, 60, 90, and 120?min after consumption following a fasting state. The GI was calculated using the standard equation. The GI values for test foods ranged from 96 to 116 and were all classified as high GI foods. No difference in GI was found between American-grown and Thailand-grown jasmine rice. Although not statistically significant, observations show glycemic response among Asian American participants may be different. GI should be considered when planning meals with jasmine rice as the main source carbohydrate.     

Comparative immunogenicities of frozen and refrigerated formulations of live attenuated influenza vaccine in healthy subjects

The frozen version of live attenuated influenza vaccine (LAIV; FluMist) was compared with a newly licensed, refrigerated formulation, the cold-adapted influenza vaccine, trivalent (CAIV-T), for their immunogenicity, safety, and tolerability in healthy subjects 5 to 49 years of age. Eligible subjects were randomized 1:1 to receive CAIV-T or frozen LAIV. Subjects 5 to 8 years of age received two doses of vaccine 46 to 60 days apart; subjects 9 to 49 years of age received one dose of vaccine. Equivalent immunogenicities were defined as serum hemagglutination inhibition (HAI) geometric mean titer (GMT) ratios >0.5 and <2.0 for each of the three vaccine-specific strains. A total of 376 subjects 5 to 8 years of age and 566 subjects 9 to 49 years of age were evaluable. Postvaccination HAI GMT ratios were equivalent for CAIV-T and LAIV. The GMT ratios of CAIV-T/LAIV for the H1N1, H3N2, and B strains were 1.24, 1.02, and 1.00, respectively, for the 5- to 8-year-old age group and 1.14, 1.12, and 0.96, respectively, for the 9- to 49-year-old age group. Seroresponse/seroconversion rates (fourfold or greater rise) were similar in both age groups for each of the three vaccine strains. Within 28 days, the most frequent reactogenicity event in the CAIV-T and LAIV groups was runny nose/nasal congestion, which occurred at higher rates after dose 1 (44% and 42%, respectively) than after dose 2 (41% and 29%, respectively) in the 5- to 8-year-old group. Otherwise, the rates of adverse events (AEs) were similar between the treatment groups and the two age cohorts, with no serious AEs related to the study vaccines. The immunogenicities, reactogenicity events, and AEs were comparable for refrigerated CAIV-T and frozen LAIV.     

A problem-solving approach to effective insulin injection for patients at either end of the body mass index

People with diabetes require skills and knowledge to adhere to medication regimens and self-manage this complex disease. Effective self-management is contingent upon effective problem solving and decision making. Gaps existed regarding useful approaches to problem solving by individuals with very low and very high body mass index (BMI) who self-administer insulin injections. This article addresses those gaps by presenting findings from a patient survey, a symposium on the topic of problem solving, and recent interviews with diabetes educators to facilitate problem-solving approaches for people with diabetes with high and low BMI who inject insulin and/or other medications. In practice, problem solving involves problem identification, definition, and specification; goal and barrier identification are a prelude to generating a set of potential strategies for problem resolution and applying these strategies to implement a solution. Teaching techniques, such as site rotation and ensuring that people with diabetes use the appropriate equipment, increase confidence with medication adherence. Medication taking is more effective when people with diabetes are equipped with the knowledge, skills, and problem-solving behaviors to effectively self-manage their injections.     

Nerve growth factor receptors: analysis of the interaction of ßNGF with membranes of chick embryo dorsal root ganglia

The binding of the β subunit of Nerve Growth Factor (ßNGF) to membrane preparations of 8-day chick embryo dorsal root ganglia (DRG) has been investigated under conditions similar to those used to study the binding of ßNGF to intact single cell dissociates of DRG²³.The equilibrium binding data reveal heterogeneity of binding that is more complex than that seen with intact cells. Binding is not saturable up to¹²⁵IßNGF concentrations of 10⁻⁸ M. Steady-state and kinetic binding data show two sites with dissociation constants similar to those found on DRG cells. In addition, displacement data reveal a binding component with lower affinity (K_d = 10⁻⁶M) which is not found on intact cells.As with intact cells, the difference in the affinities of the two high affinity sites has been shown to be due to different rate constants of dissociation. The kinetics of dissociation of NGF are slower with membranes than with cells, and dissociation characteristics of¹²⁵IßNGF change with increasing time of exposure to membranes. Degradation of¹²⁵IßNGF during incubation with membranes is minimal and does not complicate the analysis of steady-state binding. Insulin does not to either of the two high affinity sites.Heterogeneity of the¹²⁵IßNGF preparation and cooperativity of binding as a cause for the heterogeneity of the binding of NGF has been ruled out. Although there was an apparent increase in the rate of dissociation of¹²⁵IßNGF in the presence of unlabelled NGF, a finding previously interpreted as evidence for negative cooperativity⁷, this was shown to be independent of receptor site occupancy by NGF, and in part due to isotopic dilution within a diffusion barrier around the membranes.     

Molluscum contagiosum involving an epidermoid cyst with xanthogranuloma‐like reaction in an HIV‐infected patient

Background: Molluscum contagiosum (MC) causes characteristic cutaneous lesions that occur mainly in children, sexually active adults, and immunocompromised individuals, especially those with human immunodeficiency virus (HIV) infection. Patients infected with HIV, particularly those with advanced disease, have an increased incidence, up to 33.3%, of MC in non‐anogenital areas. MC has been rarely found to be associated with epidermoid cysts. Case report: A 44‐year‐old male with HIV infection presented with the complaint of a‐3‐month history of a tender nodule on the left neck. H&E stained sections showed a ruptured cyst, lined with squamous epithelium showing cytopathic changes of MC, and a xanthogranuloma‐like inflammatory reaction with characteristic Touton‐type giant cells. Conclusion: MC infections are common, however MC associated with epidermoid cysts is infrequent. A few cases of MC occurring in epidermoid cysts have previously been reported. We are presenting a case of MC involving an epidermoid cyst in an AIDS patient, with a unique xanthogranuloma‐like reaction. Xanthogranulomatous (XG) reactions have been infrequently reported in association with other viral infections, however, poxvirus‐associated XG reaction has only been observed in animals. This is the first reported case of MC‐associated XG reaction in humans. Aldabagh B, Ly MN, Hessel AB, Usmani AS. Molluscum contagiosum involving an epidermoid cyst with xanthogranuloma‐like reaction in an HIV‐infected patient.