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It is a common practice in modern obstetrics in view of
various obstetrical or medical indications. Usually, the decision to induce
labor is made after considering the risk and benefits of prolonging the
pregnancy. Successful induction results in vaginal delivery. However, the
process is not completely seamless. Failure of induction can lead to cesarean
section and the associated risks. It is
therefore important to predict the chances of success of induction.

Efforts have been made to predict the rate of success of
induction. Currently the most popular and widely used method is the Bishop’s
score. It is a quantifiable but subjective method. Hence assessment is likely
to vary from observer to observer. So the search for better predictors
continues.

Trans-vaginal sonography (TVS) is an alternative but
objective method emerging for assessing the cervix to predict the success of
induction of labor by reducing interobserver variations. TVS measurements are
quantitative and easy to reproduce, with minimal discomfort to the patient. It
also allows a better evaluation of cervical length, since the supra-vaginal
part of cervix is difficult to measure digitally. It also provides access to
internal os, which cannot be reached in a closed cervix and where the
effacement begins. Various parameters that can be used for cervical evaluation
using TVS are cervical length, cervical funneling, cervical position, posterior
cervical angle, distance of presenting part from external os, uterocervical
angle, etc. Although many studies have been conducted to compare the Bishop’s
score with TVS cervical evaluation, the superiority of one method over the
other has not been clearly defined. In addition, there is a lack of definite
and established cut offs to use TVS assessment in defining the success of
induction. Some researchers have attempted to develop cut offs and scores to
use the TVS assessment. However, these scores are not widely used at present.
This might be because they used the parameters that are not easy to measure.

The aim of this study by Srivastava and Coumary A was to
compare the two methods: Bishop’s score and MGM pre induction cervical scoring
system (MGPICSS), and to develop an easy to use system for using TVS assessment
to predict the successful induction of labor. This was an observational study
conducted in a tertiary care center. 120 patients who met the selection
criteria were included. Prior to the induction of labor the Bishop’s score and
the sonographic scoring was assigned. Successful induction was defined as the patient
entering the active phase of labor.

84% of participating women entered the active phase of
labor. While 72.6% women had a normal vaginal delivery, 67.8% women delivered
vaginally within 24 hours of induction. The TVS score (MGPICSS) of ≥2 predicted
the successful induction with a specificity of 100% and sensitivity of 39.3%
and AUC 0.74. In comparison, the Bishop score of ≥4 had a specificity of 75%
and sensitivity of 44% and AUC 0.56. The prediction of delivery within 24 hours
at the MGPICSS of ≥2 had a specificity of 100% and sensitivity of 42.9% and AUC
0.76. For the same, the Bishop’s score of ≥4 had specificity of 83.3% and
sensitivity of 45.5% and AUC 0.71.

This study compared the Bishop’s score with the TVS
assessment of cervix to predict the success of induction. It was concluded that
the MGPICSS better predicted the successful induction of labor and also the
delivery within 24 hours of the induction. TVS examination also causes less
discomfort to the patients than digital examination.

TVS assessment of cervix is a better predictor of success of
induction in comparison to Bishop’s score. According to the present study,
MGPICSS of ≥2 can predict the successful outcome with specificity of 100% and
sensitivity of 39.3%. Also a score of ≥2 can predict the chances of delivery
within 24 hours with a specificity of 100% and sensitivity of 42.9%. MGPICSS is
doable even by the beginners and has reduced interobserver variations.

Source: Srivastava and Coumary A / Indian Journal of
Obstetrics and Gynecology Research 2024;11(2):276–280

https://doi.org/10.18231/j.ijogr.2024.053

This e-Delphi study offers significant clinical treatment recommendations regarding key aspects of intralesional corticosteroid administration (ICA) in keloids. The researchers note that implementing these guidelines is expected to enhance consistency in keloid treatment and improve overall outcomes. The findings were published online in the American Journal of Clinical Dermatology. 

Keloids are raised scars that result from an overproduction of collagen during the healing process. They can cause discomfort and distress for patients, making effective treatment crucial. ICA is the primary treatment for keloids. However, there is considerable variability in its application across clinical and scientific practices, making it difficult to compare treatment outcomes effectively.

To address this issue, Qi Yin, Department of Dermatology, Amsterdam UMC location University of Amsterdam, Amsterdam, The Netherlands, and colleagues sought to reach a consensus on key aspects of intralesional corticosteroid administration using hypodermic needles for keloid treatment. They convened a global panel of dermatologists and plastic surgeons who specialize in this field, to develop consensus-based clinical recommendations for all physicians involved in managing keloids.

For this purpose, a panel of 12 dermatologists and 11 plastic surgeons specializing in keloids rated 30 statements over two online e-Delphi rounds, achieving a 100% response rate in both sessions. A total of 15 keloid experts took part in the final consensus meetings. Consensus was established when at least 75% of participants selected “agree” or “strongly agree” on a 7-point Likert scale.

The following were the key findings:

• Consensus was achieved on several key treatment aspects, including treatment goals, the indication for intralesional corticosteroid administration, and the preference for triamcinolone acetonide (TAC) at a concentration of 40 mg/mL, with a maximum dosage of 80 mg per month administered at 4-week intervals.
• Strategies to minimize pain during the procedure, the use of 1 mL syringes with 25 or 27-gauge needles, and blanching as an endpoint for successful infiltration were agreed upon. Participants also noted the importance of avoiding subcutaneous injections and the possibility of making multiple passes in very firm keloids before infiltration.
• Consensus was not reached on TAC dosing, methods of prior local anesthesia, or the specific location of injection.

To conclude, this e-Delphi consensus study offers evidence-based clinical treatment recommendations for intralesional corticosteroid administration in keloids, targeting all physicians involved in keloid management. Key aspects covered include treatment goals, indications for ICA, choice of corticosteroid, dosing guidelines, treatment intervals, syringe and needle specifications, local anesthesia use, and manual injection techniques.

“Implementing these recommendations is expected to enhance consistency in ICA practices for keloid treatment, making outcomes more comparable and potentially improving overall treatment results,” the researchers concluded.

Reference:

Yin, Q., Wolkerstorfer, A., Lapid, O. et al. KECORT Study: An International e-Delphi Study on the Treatment of KEloids Using Intralesional CORTicosteroids in Clinical Practice. Am J Clin Dermatol (2024). https://doi.org/10.1007/s40257-024-00888-7

The Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. announced promising interim results from their ongoing Phase 3 trial of sibeprenlimab, an investigational treatment for immunoglobulin A nephropathy (IgA nephropathy) in adults. This announcement comes as a significant milestone in the search for effective therapies for this progressive kidney disease, which can lead to end-stage kidney disease (ESKD).

Sibeprenlimab is a monoclonal antibody that targets APRIL (A PRoliferation-Inducing Ligand), playing a crucial role in regulating the immune response that contributes to IgA nephropathy. By inhibiting the production of Gd-IgA1 and the formation of harmful immune complexes, sibeprenlimab aims to mitigate the disease’s progression. The treatment has already gained Breakthrough Therapy designation following encouraging results from the Phase 2 ENVISION clinical trial.

The interim analysis, conducted by an independent data monitoring committee, revealed that the Phase 3 VISIONARY study met its primary endpoint. Results showed that sibeprenlimab led to a statistically significant reduction in the 24-hour urine protein-to-creatine ratio compared to placebo after nine months of treatment. This multicenter, randomized, double-blind, placebo-controlled trial involved approximately 530 adult patients receiving standard care, making it the largest study in this patient population.

Dr. John Kraus, executive vice president and chief medical officer of Otsuka Pharmaceutical Development & Commercialization, remarked on the findings in a press release: “The positive interim data from this trial suggest that by targeting APRIL, we could provide a new therapeutic strategy for people living with this progressive kidney disease.” He expressed gratitude to the participants, caregivers, and investigators involved in the study.

Brian Pereira, CEO of Visterra, Inc., an Otsuka U.S. affiliate, also commented on the significance of the results, noting sibeprenlimab’s potential to offer a much-needed, disease-modifying treatment option for IgA nephropathy patients.

The ongoing Phase 3 study continues to assess kidney function changes over 24 months, using an estimated glomerular filtration rate (eGFR). The study is expected to conclude in early 2026, with further analyses planned to fully understand sibeprenlimab’s therapeutic potential. Otsuka aims to review these interim results with the FDA to facilitate a possible regulatory submission for accelerated approval.

About Sibeprenlimab

Sibeprenlimab (formerly VIS649) is an investigational monoclonal antibody developed by Visterra, Inc., a subsidiary of Otsuka. It targets APRIL (A PRoliferation-Inducing Ligand), a key player in the pathogenic cascade of IgA nephropathy. By blocking APRIL, sibeprenlimab aims to reduce levels of immunoglobulin A (IgA) and Gd-IgA1, potentially lowering auto-antibody production and immune complexes. This reduction may lead to fewer immune complex deposits in the kidneys, decreasing proteinuria and inflammation.

The drug’s mechanism could slow kidney damage and progression toward ESKD by addressing a specific driver of nephron loss in IgA nephropathy. Early-stage trials have shown promise, highlighting sibeprenlimab’s potential to provide a new therapeutic option for patients with this challenging condition.