Expert opinion: defining response to omalizumab in patients with chronic spontaneous urticaria

Omalizumab (a recombinant, humanized anti-immunoglobulin-E anti-body) has been shown in three pivotal Phase III trials (ASTERIA I, II and GLACIAL) and real-world studies to be effective and well-tolerated for the treatment of chronic spontaneous urticaria (CSU), and is the only licensed third-line treatment for CSU. However, the definition of response to omalizumab treatment often differs between clinical trials, real-world studies, and daily practice of individual physicians globally. As such, a consensus definition of “complete”, “partial” and “non-response” to omalizumab is required in order to harmonize treatment management and compare data. Here, it is proposed that a disease measurement tool, for example, the 7-Day Urticaria Activity Score (UAS7) or Urticaria Control Test (UCT) is required for defining response. The addition of quality of life measurements is helpful to gain insight into a patient’s disease burden and its changes during treatment. A potential omalizumab treatment approach based on speed and pattern of response at 1-3 and 3-6 months is suggested. In cases where there is no response during the first 1-3 months, physicians should consider reassessing the original CSU diagnosis. Moreover, in patients showing partial response at 12 weeks, treatment with omalizumab should be continued in order to maximize the possibility of achieving symptom control. If patients have a UAS7>6 and/or UCT<12, then continued treatment is advised, dependent on physician judgement and patient expectations. In treatment responders, omalizumab treatment can be resumed at a later stage after discontinuation with the same degree of symptom control.     

Verhandlungen ärztlicher Gesellschaften

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Emerging Technologies and Family: A Cross-National Study of Family Clinicians’ Views

Emerging technology adoption poses new challenges and opportunities to families and clinicians. Research that explores clinicians’ understanding and use of information-communication technologies; however, is still scarce. Our study, a replication of a cross-national study in four countries (Canada, Mexico, Spain, and the United States), investigated the relationship among clinicians’ use of and attitudes toward emerging technologies and their beliefs about technology’s impact on families in Turkey. We further inquired the relationship of two factors: the impact of emerging technology on the clinicians’ own families and the impact of cultural values on the attitudes toward technology use. The Turkish version of the modified Emerging Technologies and Families Survey was administered to family clinicians. The analytical strategy included a comparison of the data we collected in Turkey (n = 97) and the raw data from the original study (n = 258). We found significant cross-national differences in clinicians’ use of and attitudes toward information-communication technologies, and their assessments of families’ struggles with emerging technology. We analyzed the data vis-a-vis cultural differences and gave a special emphasis on implications for enhancing clinical practice.

1. Emerging technologies challenge families’ and family therapists’ assumptions about healthy family processes; attention to the self of the therapist at the intersection of cultural values is core in a sound assessment of families adopting emerging technologies.

2. Cultural humility and a curious stance may counteract the pervasive negative discourse about emerging technology adoption.

3. Empowering parents and couples to put technology in “its place” may ease the negative impact and enhance the positive influence of these technologies on families.

     

Blood Pressure Changes in Migraine Patients before,during and after Migraine Attacks

Migraine attacks are characterized by headaches associated with neurological, gastrointestinal, and autonomic symptoms. A relationship between migraine and hypertension or hypotension is controversial. In this study, we aimed to determine if blood pressure changes were related to migraine attacks. From the outpatient clinic of our neurology department, 62 normotensive migraine patients with and without aura were chosen for study in accordance with the International Headache Society 2004 criteria. A questionnaire including general and specific questions was given to the patients to be filled out during 6 consequent migraine attacks. The patients received a fully automatic digital brachial upper arm sphygmomanometer (Omron M 4‐1) to measure the changes in their blood pressure during attacks. The patients were asked to record their blood pressure changes 3 times: (1) just before or very early, (2) during (when headache peaks), and (3) 1 hour after the attack. Twenty‐three of the 62 patients (57 women, 5 men) had migraine with aura (22 women and 1 man), and 39 of them did not have aura (35 women and 4 men). There was no statistically significant difference between systolic and diastolic values obtained before or very early, during the peak level, and 1 hour after the end of the attacks (P > 0.05). Although diastolic hypotensive values were not different statistically between groups, when all the patients were considered, diastolic hypotensive values were detected in a considerable number of patients (a total of 115 measurements). In this normotensive migrainous population, we observed that diastolic hypotension before or very early, during, and after migraine attack was the most significant result (5.1%). Although it was not statistically significant, the total number of hypotensive values was remarkable.     

Expression and distribution of phosphodiesterase isoenzymes in the human seminal vesicles

IntroductionPhosphodiesterase (PDE) isoenzymes have been shown to play a role in the control of human male genital tissues. There are hints from basic research and clinical studies that PDE5 inhibitors may have the ability to retard the male ejaculatory response. While the expression of PDE isoenzymes in the human seminal vesicles (SVs) has been described, the distribution of cyclic adenosine monophosphate (AMP)‐ and cyclic guanosine monophosphate (GMP)‐PDEs has not yet been investigated.AimThe aim of this study was to elucidate the expression and distribution of PDE isoenzymes PDE3A, PDE4 (isoforms A and B), PDE5A, and PDE11A in human SV tissue.MethodsUsing immunohistochemistry (double‐labeling techniques, laser fluorescence microscopy), the occurrence of PDE3A, PDE4A, PDE4B, PDE5A, and PDE11A, the vasoactive intestinal polypeptide (VIP), calcitonin gene‐related peptide (CGRP), and protein gene product 9.5 (PGP 9.5) was examined in sections of SV. Cytosolic supernatants prepared from isolated human SV tissue were subjected to Western blot analysis using specific anti‐PDE antibodies.Main Outcome MeasureThe expression and distribution by of PDE3A, PDE4A, PDE4B, PDE5A, and PDE11A in the human SV were investigated by means of immunohistochemistry and Western blot analysis.ResultsImmunosignals specific for PDE3A were seen in both the smooth muscle and the glandular epithelium, whereas staining for PDE4A, PDE5A, and PDE11A was mainly limited to epithelial cells. Varicose nerve fibers transversing the sections also presented staining for PDE3A. In nerve fibers and nerve endings, PDE4A and PDE4B were found co‐localized with VIP; PDE5A‐positive nerves also presented immunosignals specific for CGRP. The expression of said PDE isoenzymes was confirmed by Western blotting.ConclusionsThe results indicate that cyclic AMP‐ and cyclic GMP‐PDE isoenzymes are involved in the control of secretory activity and efferent neurotransmission in the SV. These findings might be of importance with regard to the identification of new therapeutic avenues to treat premature ejaculation. Ückert S, Waldkirch ES, Sonnenberg JE, Sandner P, Kuczyk MA, and Hedlund P. Expression and distribution of phosphodiesterase (PDE) isoenzymes in the human seminal vesicles. J Sex Med 2011;8:3058–3065.     

Effects of yoga on the quality of life in cancer patients

ObjectiveThis study sought to investigate the effects of yoga on the quality of life in patients with breast cancer.DesignTwenty patients between 30 and 50 years of age presently under treatment for breast cancer were included in the study. The physical characteristics of the patients were recorded and general physiotherapy assessments performed. Eight sessions of a yoga program including warming and breathing exercises, asanas, relaxation in supine position, and meditation were applied to participants.Main outcome measuresThe pre- and post-yoga quality of life assessments for the patients were conducted using the Nottingham Health Profile (NHP). Patients' stress levels were assessed using the STAI-I and STAI-II anxiety inventory. Their satisfaction levels about the yoga program was evaluated using the visual analog scale (VAS).ResultsIt was found that patients' quality of life scores after the yoga program were better than scores obtained before the yoga program (p < 0.05). After sessions, there was a statistically significant decrease in their STAI-I (measuring the reactions of anxiety) scores and STAI-II (measuring the permanence of anxiety) scores (p < 0.05). It was found out that the satisfaction score concerning the yoga program was considerably increased after the yoga program (p < 0.05).ConclusionsIt can be concluded that yoga is valuable in helping to achieve relaxation and diminish stress, helps cancer patients perform daily and routine activities, and increases the quality of life in cancer patients. This result was positively reflected in patients satisfaction with the yoga program.     

Alpha interferon and lamivudine combination therapy for chronic hepatitis B in children

BACKGROUND: Lamivudine is a new alternative therapeutic agent for chronic hepatitis B, in which alpha interferon (IFN-alpha) monotherapy is not successful enough. Published reports have revealed no satisfactory data on IFN-alpha and lamivudine combination therapy in children. The aim of this study is to investigate the efficacy and safety of this combination therapy in children with chronic hepatitis B. METHODS: Children with chronic hepatitis B were given either IFN-alpha and lamuvidine (group 1, n = 47) or IFN-alpha alone (group 2, n = 30). Alpha interferon was administered as 5 million U/m2 s.c., thrice a week for 6 months and lamivudine 4 mg/kg per day p.o., maximum 100 mg, for 1 year. Clinical examination was performed; blood cell counts and serum alanine aminotransferase (ALT) and amylase were studied at each visit. At the third, sixth and twelfth month, serological markers were determined. RESULTS: End of therapy response was achieved in 19 (40.4%) patients in group 1 and in 14 (46.7%) children in group 2 (P > 0.05). In group 1, pretreatment serum ALT and hepatic activity index (HAI) were statistically higher in children who responded to therapy (P < 0.005). In group 2, mean serum ALT was higher and hepatitis B virus (HBV) DNA was lower in responders. Sustained response rate was 40.4 versus 43.3% in two groups. CONCLUSION: The response rate of IFN-alpha and lamivudine combination therapy in children with chronic hepatitis B was similar to that of IFN-alpha monotherapy. High ALT level and HAI, rather than low HBV-DNA level were found to be important predictors of response.