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A new study published in the Journal of Rheumatology unveiled that intravenous golimumab for juvenile idiopathic arthritis in a long-term extension trial had an acceptable risk-benefit profile.

Juvenile idiopathic arthritis (JIA) is the most prevalent rheumatologic disorder in children and is classified into three subtypes, namely, polyarticular, oligoarticular, and systemic onset. The patients with polyarticular JIA have a variety of etiologic risk factors, distinct disease courses, and treatment obstacles. The children with polyarticular JIA often have a more refractory course when compared to children whose joints are not as damaged. They have a longer course of active illness, which puts them at higher risk of joint injury and worse functional results as well as a lower quality of life.

This study by Hermine Brunner and the team evaluated the pharmacokinetics (PK), clinical effect, immunogenicity, and safety of intravenous (IV) golimumab in children with active polyarticular-course juvenile idiopathic arthritis (pcJIA) who took part in the open-label, long-term extension (LTE) of GO-VIVA (a medication to treat active polyarticular-course juvenile idiopathic arthritis) through week 252.

The participants in GO-VIVA who kept receiving IV golimumab (80 mg/m2 every 8 weeks) following week 52 were included in this trial. Clinical response was evaluated through week 116, while PK and safety were evaluated through weeks 244 (final dosage) and 252, respectively. Clinical outcomes measured were the clinical juvenile arthritis disease activity score in 10 joints (cJADAS10) and JIA–American College of Rheumatology (ACR) responses. Non-responder imputation was employed for binary outcomes, whereas observed data was utilized for other descriptive analyses.

69 individuals who entered the LTE and finished the week 252 visit comprised 112/127 (88.2%). From week 52 to week 244, golimumab concentrations at the median steady-state trough were mostly maintained. Also, the frequencies of antigolimumab antibodies were stable between weeks 52 and 244.

Up to week 116, when the median cJADAS10 was 1.6 and 56.7% (72/127) of individuals attained cJADAS10 < 5 (low disease activity), week 52 JIA-ACR 30/50/70/90 response rates were mostly sustained. Through week 252, the rates of major adverse events and severe infections were 7.7 and 3.9, per 100 patient-years, respectively. Overall, the data of this study demonstrate that IV golimumab therapy gives a long-term clinical outcome through week 116, with a satisfactory risk-benefit profile.

Source:

Brunner, H. I., Pacheco-Tena, C., Louw, I., Vega-Cornejo, G., Alexeeva, E., Appenzeller, S., Chasnyk, V., Griffin, T., Navarrete Suarez, C., Knupp-Oliveira, S., Zeft, A., Butbul Aviel, Y., De Ranieri, D., Gottlieb, B. S., Levy, D. M., Rabinovich, C. E., Artur Silva, C., Spivakovsky, Y., Uziel, Y., … Ruperto, N. (2024). Intravenous Golimumab in Children With Polyarticular-Course Juvenile Idiopathic Arthritis: Long-Term Extension of an Open-Label, Phase III Study. In The Journal of Rheumatology (p. jrheum.2024-0298). The Journal of Rheumatology. https://doi.org/10.3899/jrheum.2024-0298

A recent study found that Reduced port laparoscopic posterior mesh rectopexy may serve as an effective therapeutic option for full-thickness rectal prolapse. Compared to the conventional multiport surgery (MPS), reduced port surgery was found to have smaller wound sizes and better cosmetic outcomes. The study results were published in the journal BMC Surgery. 

Laparoscopic rectopexy has long been considered a reliable treatment for full-thickness rectal prolapse. More recently, reduced port surgery (RPS) has gained attention as a new approach that potentially offers benefits over the traditional multiport surgery (MPS) technique. The primary advantages proposed for RPS include reduced postoperative pain and improved cosmetic outcomes. Hence researchers from Osaka National Hospital, Japan conducted a study to assess the practicality and safety of RPS when used for treating full-thickness rectal prolapse.

Also Read: Transrectal Prostate Biopsy: Nitrous oxide may significantly reduce patient-rated pain

A retrospective study was carried out to analyze 37 patients who underwent laparoscopic rectopexy for full-thickness rectal prolapse between October 2012 and December 2018. Out of these, 10 patients underwent traditional multiport surgery (MPS), while 27 patients were treated using the reduced port surgery (RPS) technique. Where laparoscopic posterior mesh rectopexy, also known as the Wells procedure, is the standard surgical method for addressing full-thickness rectal prolapse, the authors also conducted an RPS. In RPS, surgeons utilized a multi-channel access device combined with an additional 12-mm right-hand port to complete the procedure. The primary outcome of the study was to evaluate short-term outcomes for both RPS and MPS by examining several metrics, including operative time, blood loss, postoperative complication rates, and the duration of hospital stay after surgery.

Findings:

• Upon comparing the two groups, the results showed no statistically significant differences in median operative times, blood loss volumes, postoperative complication rates, or the length of hospital stays between patients undergoing MPS and those treated with RPS.
• Both techniques appeared to be equally effective and safe in managing full-thickness rectal prolapse.
• However, RPS was found to have significantly smaller wound size suggesting better cosmetic outcomes.

Also Read: Low-Dose Ketamine, Lignocaine, and Dexmedetomidine Combo effectively controls hemodynamics and pain for laparoscopic nephrectomies: Study

Despite these promising findings for RPS, the study highlights that further research is necessary to establish its superiority over MPS. The retrospective nature of the study and the small sample size limit the ability to draw definitive conclusions. The authors suggest that a prospective, randomized, controlled trial is needed to rigorously assess whether RPS offers any distinct advantages in terms of clinical outcomes, patient recovery, and overall efficacy when compared to traditional multiport approaches. In conclusion, while reduced port laparoscopic posterior mesh rectopexy shows potential as a viable therapeutic option for full-thickness rectal prolapse, the current evidence does not demonstrate significant differences between RPS and MPS in key perioperative outcomes. Future research with a more robust study design is essential to determine if RPS could eventually replace or become preferred over MPS in clinical practice.

Further reading: Kusunoki, C., Uemura, M., Osaki, M. et al. Reduced port laparoscopic rectopexy for full-thickness rectal prolapse. BMC Surg 24, 246 (2024). https://doi.org/10.1186/s12893-024-02545-6

Severe autoimmune conditions such Type I diabetes, Addison’s disease, lupus and inflammatory bowel disease, are between two to three times more common in women who have been diagnosed with premature ovarian insufficiency (POI) compared to the general population.

The research, published in Human Reproduction, one of the world’s leading reproductive medicine journals, is the largest to investigate the link between autoimmune conditions and POI, has followed nearly 20,000 women for longer than any other study and is the only one to match women with POI with women of similar ages in the general population for comparison.

The researchers say their findings significantly strengthen the hypothesis that autoimmune processes play a “pivotal role” in the onset of POI.

POI occurs when ovaries no longer work properly and have stopped producing eggs in women younger than 40 years. Periods become irregular and then stop, and some women experience menopause symptoms.

Dr Susanna Savukoski, a gynaecology and obstetrics doctor at Oulu University Hospital and University of Oulu, Finland, led the study. She said: “Estimates of the prevalence of premature ovarian insufficiency of autoimmune origin have ranged from 4% to 50%. Our study has found that autoimmune diseases were two-to-three-fold more common in women diagnosed with POI at the time they were diagnosed, and incidence of these diseases was two-to-three-fold higher during the first years after being diagnosed with POI, compared to a control group of similarly aged women from the general population. The incidence was higher than in the control group even more than a decade after being diagnosed with POI.”

Dr Savukoski and her colleagues analysed health data from Finland’s comprehensive registries. From the medicine reimbursement registry maintained by the Social Insurance Institution of Finland, they identified 3972 women who had been granted the right to full reimbursement for hormone replacement therapy (HRT) because of POI diagnosis under the age of 40 years, between the years 1988 and 2017. Each woman with POI was matched with four women of similar ages, forming a control group of 15708 women. In both groups of women, they analysed data on severe autoimmune conditions – diseases that were diagnosed and treated in specialist health centres – between 1970 and 2017.

They found that among women who were diagnosed with POI, 223 women (5.6%) had been diagnosed with at least one autoimmune disorder before the date when reimbursement for HRT because of POI was granted, and 503 women (12.7%) were diagnosed with at least one autoimmune disorder after the date of HRT during the follow-up period.

Women were 2.6 times more likely to have an autoimmune disorder before a POI diagnosis when compared to the control group. Among women with POI, the risk of autoimmune conditions ranged from nearly double for over-active thyroid glands, to nearly 26 times for polyglandular autoimmune diseases – rare diseases of the hormone (or endocrine) system.

Women without existing autoimmune diseases at the time they were diagnosed with POI were nearly three times as likely to be diagnosed with an autoimmune disease in the following three years, with the risk decreasing but still significantly higher than in the control group during the follow-up period of at least 12 years.

Dr Savukoski said: “These findings reflect the fact that the association between POI and severe autoimmune diseases is strong and that the women with POI have long-term risk for autoimmune conditions. As with POI, severe autoimmune diseases typically manifest with significant symptoms and can have very unfavourable effects on general health, functional ability and quality of life. Luckily, there are good medication options available for many of these conditions.

“It’s important to stress that most women with POI do not develop severe autoimmune conditions and most women with severe autoimmune diseases do not develop POI. However, medical professionals should be aware of the increased risk, and patients should be informed about it as well.

“It should be noted that the risk is not the same for all autoimmune conditions: the association between POI and some autoimmune conditions, such as polyglandular autoimmune syndrome, Addison’s disease and vasculitis was very strong – a ten to 26-fold risk of having these diseases among women with POI preceding their POI diagnosis compared to the controls – while the risk of having rheumatoid arthritis or hyperthyroidism was about two-fold.

“As POI threatens fertility at a young age, this indicates that women with an increased risk of the condition should be encouraged to try to conceive when they are young. However, some autoimmune diseases can significantly increase the risk of pregnancy complications, especially if therapeutic control is not good enough, and this should be considered in discussions with patients. Unfortunately, so far, there are no treatments available to prevent the development of POI or autoimmune diseases.”

The biological mechanisms underlying the association between POI and autoimmune diseases are not fully understood, especially as the mechanisms may be different depending on the disease.

“In the future, the research should focus on finding detailed mechanisms of how POI develops in different autoimmune conditions. That would enhance development of preventive treatments against POI of autoimmune origin and other autoimmune conditions as well,” said Dr Savukoski. “We are investigating whether long-term use of HRT can prevent other conditions developing among women with POI.”

Strengths of the study include the large numbers of women and the high quality of data from the Finnish registries. A limitation is that the study only included autoimmune disorders diagnosed in specialist health centres; less severe conditions such as coeliac disease and underactive thyroid glands are often diagnosed and treated in primary healthcare, so the overall prevalence of autoimmune disorders in women with POI is higher.

Reference:

S M Savukoski, H Silvén, P Pesonen, E Pukkala, M Gissler, E Suvanto, M -M Ollila, M Niinimäki, Excess of severe autoimmune diseases in women with premature ovarian insufficiency: a population-based study, Human Reproduction, 2024;, deae213, https://doi.org/10.1093/humrep/deae213.