Adalimumab Effective after Resolution of Intra-Abdominal Abscess in Crohn Disease
Crohn disease, a type of inflammatory bowel disease, is marked by acute flare-ups and periods of remission, and can be complicated by bowel perforation or obstruction, or intra-abdominal abscesses. Intra-abdominal abscesses occur in 10% to 30% of patients with Crohn disease; management of this complication is challenging; surgery is often necessary. A French study, GETAID, examined the role of anti-tumor necrosis factor (TNF) antibodies, such as adalimumab, in the management of those patients.
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GETAID was a prospective, multicenter, open-label observational study that enrolled 117 patients age 18 or older with a diagnosis of Crohn disease complicated by intra-abdominal or pelvic abscess. Before initiation of adalimumab, all patients had achieved complete resolution of sepsis and the abscess through administration of systemic antibiotics (median treatment length, 22 days) or percutaneous abscess drainage (median treatment length, 13 days). The study estimated the success rate of adalimumab in these patients at 24 weeks, defined as no need for steroids after week 12 and no need for intestinal resection, and no recurrence of abscess or clinical relapse. The study also sought to determine long-term success, defined as survival without abscess, relapse, or need for intestinal resection at week 104.
At week 24, 87 patients (74%) achieved successful remission with the adalimumab treatment; of the 30 patients who failed to control their Crohn disease with adalimumab, 15 ultimately underwent surgery. At week 104, 72.9% of patients continued to have a successful response to adalimumab treatment, not experiencing any abscess recurrence or need for intestinal surgery. Of the 31 patients with treatment failure, 27 underwent surgical resection.
In patients in whom abscesses were carefully managed before initiating treatment, the study showed the high efficacy of adalimumab in the short and long term. Researchers note that carefully preparing patients through administration of antibiotics, percutaneous drainage when feasible, and assessment of complete resolution of the abscess is mandatory to choosing the most suitable intervention (intestinal resection or anti-TNF treatment). (Bouhnik, Y, et al. (2023). Adalimumab in biologic-naïve patients with Crohn's disease after resolution of an intra-abdominal abscess: A prospective study from the GETAID. Clin Gastroenterol Hepatol, 21(13), 3365–3378.E5. Retrieved December 2023 from https://www.cghjournal.org/article/S1542-3565(23)00072-1/fulltext)
Released: January 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer
Incidence of Post-COVID Conditions Reduced in Vaccinated Adults
The scale of the COVID-19 pandemic revealed the prevalence of postviral conditions. The syndrome associated with COVID-19 infection, known as long COVID or post-COVID-19 condition, is estimated to affect as many as 200 million individuals, with persistent symptoms that include fatigue, dyspnea, cognitive impairment, headache, muscle pains, and cardiac symptoms such as chest pain and palpitations.
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Studies demonstrate that receiving multiple doses of the COVID vaccine before an initial infection can dramatically reduce the risk of long COVID. A large population-based cohort study published in BMJ examined data from all adults in two regions of Sweden with a first COVID-19 infection between 27 December 2020 (start of vaccination in Sweden) and 9 February 2022 (end of full-population PCR testing). The study, which included 589,722 individuals, was part of the SCIFI-PEARL project (Swedish COVID-19 Investigation for Future Insights—A Population Epidemiology Approach using Register Linkage), a nationwide linked multiregister observational study of the pandemic. Individuals were followed from their first COVID infection until death, emigration, subsequent vaccination, reinfection, diagnosis of long COVID, or end of follow-up.
Those who had received one or more COVID-19 vaccines before acute infection were 58% less likely to develop long COVID than unvaccinated individuals. Of 299,692 vaccinated individuals who were infected with COVID-19, 1,201 (0.4%) had a diagnosis of long COVID during follow-up, compared with 4,118 of 290,030 unvaccinated individuals (1.4%). Further analysis showed a dose-response relationship between vaccine exposure and the risk of long COVID:
- One dose decreased risk by 21%
- Two doses decreased risk by 59%
- Three or more doses decreased risk by 73%
These results are similar to the cumulative protective effect of the COVID vaccines against outcomes of acute infection, such as severe illness or death.
These findings underline the importance of timely vaccinations during pandemics. Future pandemic preparedness plans should continue to prioritize prompt manufacture, evaluation, and distribution of vaccines. (Lundberg-Morris, L., et al. (2023). Covid-19 vaccine effectiveness against post-covid-19 condition among 589 722 individuals in Sweden: Population based cohort study. BMJ, 383, Article e076990. Retrieved December 2023 from https://www.bmj.com/content/383/bmj-2023-076990; Sivan, M., et al. (2023). Does timely vaccination help prevent post-viral conditions? BMJ, 383, 2633. Retrieved December 2023 from https://www.bmj.com/content/383/bmj.p2633)
Released: January 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer
Once-Weekly Somapacitan Is Effective Replacement for Growth Hormone in Children with GH Deficiency
Somapacitan, a long-acting growth hormone (GH) derivative, has demonstrated sustained efficacy and tolerability over 2 years of treatment of GH deficiency in prepubertal children. GH deficiency is characterized by inadequate production or secretion of GH, resulting in reduced growth velocity and ultimately in reductions in adult height. The disorder can be treated by daily subcutaneous injections of recombinant GH, which can restore normal growth. But the daily injections can present a treatment burden, disrupting daily lives and family routines.
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In REAL4, a randomized, multinational, open-label, controlled parallel group phase 3 trial, consisting of a 52-week main phase and a 3-year safety extension, 200 treatment-naïve prepubertal patients in 85 sites in 20 countries were randomized 2:1 to somapacitan (0.16 mg/kg weekly; n = 132) or GH (0.034 mg/kg daily; n = 68). After 1 year, all patients were switched to somapacitan. The main outcome measured was height velocity (HV) in cm/yr at week 104; change in HV was calculated from week 0 in the first year and from week 52 in the second year.
Height velocity was sustained in both groups between week 52 and week 104. Mean HV in the second year for those continuing to receive somapacitan treatment was 8.4 cm/yr; mean HV in the second year for those who switched from daily GH to somapacitan was 8.7 cm/yr. Other assessments, including changes in HV standard deviation score (SDS), changes in height SDS, bone age versus chronological age, and mean insulin-like growth factor-1 (IGF-I) SDS, were similar between the two groups and within the normal range. IGF-I release is stimulated by GH, and IGF-I SDS is commonly used as a surrogate marker for efficacy, adherence, and safety in long-term GH treatment. Mean IGF-I SDS during year 2, from baseline to week 104, in the continuous somapacitan group was 1.8, and in the group that switched from GH to somapacitan was 2.1.
On a patient preference questionnaire, most parents or caregivers of patients who switched treatment preferred once-weekly somapacitan over daily GH treatment (45/50, 90%), with the vast majority (38/45) reporting a strong or very strong preference for somapacitan. The most common reasons given for this preference were:
- Decrease in the number of injections given: 27/45, 60%
- Parents less worried about remembering to give injections: 21/45, 46.7%
- Children less worried or annoyed about injections: 15/45, 33.3% each.
Most respondents (35/45, 77.8%) said they would be more adherent to once-weekly somapacitan compared with daily GH treatment. These findings are encouraging because they indicate that somapacitan can overcome the poor treatment adherence associated with daily GH injections. (Miller, B. S., et al. (2023). Effective GH replacement with somapacitan in children with GHD: REAL4 2-year results and after switch from daily GH. J Clin Endocrinol Metab, 108(12), 3090–3099. Retrieved December 2023 from https://academic.oup.com/jcem/article/108/12/3090/7219888)
Released: January 2024
Nursing Drug Handbook
© 2024 Wolters Kluwer