This study was conducted to investigate the mechanisms of anaphylaxis in patients with osteoarthritis of the knee and hip after diclofenac etalhyaluronate [product name: JOYCLU® (JCL)] intra-articular injection and to determine the utility of tests to investigate the mechanism involved.

Methods:

In this observational study in Japan, patients aged ≥20 years with knee or hip osteoarthritis who received JCL intra-articular injection experienced anaphylactic symptoms considered related to JCL (‘experienced patients’) or did not experience allergic symptoms considered related to JCL (‘non-experienced patients’). Basophil activation tests (BATs), specific immunoglobulin E (IgE) antibody testing by enzyme-linked immunosorbent assays (ELISAs) or immunochromatographic kit, and genome-wide association studies (GWASs) were conducted using patient blood and saliva.

Results:

Thirteen experienced patients and 14 non-experienced patients were tested. Seven experienced patients tested positive by BAT using diclofenac etalhyaluronate-containing test substances. Diclofenac-specific IgE antibodies were detected in four of seven BAT-positive patients but not in the non-experienced patients. Specific IgE antibody testing by immunochromatographic kit and genome-wide association study showed no clear results.

Conclusions:

These findings suggest that anaphylaxis occurs after JCL administration via an IgE-mediated mechanism and that diclofenac etalhyaluronate may be involved in this mechanism. BAT and diclofenac -specific IgE enzyme-linked immunosorbent assay may be useful tests for investigating the mechanisms of anaphylactic reactions after JCL administration.

2023-01-01·Acute medicine & surgery

Anaphylactic shock due to intra‐articular injection of diclofenac etalhyaluronate sodium: A case report

作者: Uchiyama, Sohta ; Mizutani, Akihito ; Watanabe, Maasa ; Ono Ricart, Yukika ; Yatabe, Tomoaki ; Ito, Takashi

Abstract:

Background:

Anaphylactic shock of diclofenac etalhyaluronate agent can be prolonged and recurrent. However, its reports are rare, and consequently, its method of management remains to be established.

Case Presentation:

A 65‐year‐old woman received an intra‐articular injection of diclofenac and hyaluronate. After 20 min, systemic urticaria and severe hypotension developed after walking. After an intramuscular adrenaline injection, she was transferred to our hospital. Despite administration of continuous noradrenaline and adrenaline, hypotension persisted. Seven hours after the joint injection, 25 mL of knee joint fluid was aspirated under ultrasound guidance. Mobilization was performed 24 h after joint injection. However, urticaria rapidly spread after standing. At 45 and 46 h after joint injection, we confirmed that no symptoms, including urticaria, recurred after walking.

Conclusion:

Anaphylactic shock due to intra‐articular injection of diclofenac etalhyaluronate is prolonged and requires extended observation. Aspiration of joint fluid may be one of the treatment options.

2022-12-01·BMC musculoskeletal disorders3区 · 医学

Diclofenac–hyaluronate conjugate (diclofenac etalhyaluronate) intra-articular injection for hip, ankle, shoulder, and elbow osteoarthritis: a randomized controlled trial

3区 · 医学

ArticleOA

作者: Kano, Kazuyuki ; Ikegami, Hiroyasu ; Nishii, Megumi ; Kumai, Tsukasa ; Seo, Takayuki ; Kubo, Toshikazu

Abstract:

Background:

To evaluate the efficacy and safety of intra-articular injection of diclofenac etalhyaluronate (DF-HA) in patients with osteoarthritis (OA) of the hip, ankle, shoulder, or elbow.

Methods:

In this randomized, placebo-controlled, double-blind study in Japan, Japanese patients aged ≥20 years diagnosed with OA of the hip, ankle, shoulder, or elbow were randomly assigned 1:1 to DF-HA 30 mg or placebo (citric acid-sodium citrate buffered solution). Subjects received three injections of the study drug in each joint cavity every 4 weeks and were assessed for 12 weeks after the first injection. The primary endpoint was the mean change from baseline in a diary-based 11-point numerical rating scale (NRS) for pain over 12 weeks, analyzed for each joint. Treatment-emergent adverse events were recorded, and morphological changes in each joint were evaluated radiographically.

Results:

The study drug (DF-HA vs placebo) was injected into 90, 60, 90, or 50 subjects with OA of the hip, ankle, shoulder, or elbow (46 vs 44, 30 vs 30, 45 vs 45, and 25 vs 25, respectively). The group differences in the mean change from baseline in the pain NRS over 12 weeks were − 0.81 (95% confidence interval: − 1.48 to − 0.13), − 0.07 (− 1.03 to 0.89), 0.15 (− 0.48 to 0.78), and 0.61 (− 0.41 to 1.62) for the hip, ankle, shoulder, and elbow joints, respectively, with statistically significant differences observed only in the hip joint. The change from baseline in the hip joint was greater with DF-HA than placebo at all time points from Weeks 1–12. No clinically significant adverse events or radiographic changes were observed.

Conclusions:

Intra-articularly administered DF-HA for hip OA produced a rapid response and was safe, with analgesia maintained for 12 weeks when administered every 4 weeks.

Trial registration:

JapicCTI-173,678 (First registered date: 21 August 2017).

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2022-03-30

·Pharmaceutical Technology

Pipeline therapies promising better disease management for osteoarthritis

Osteoarthritis (OA) is a degenerative joint disease that affects millions of people worldwide and is the most common form of arthritis. It is caused by deterioration of the protective cartilage layer that connects the ends of the bones, and most commonly impacts the hands, hips and knees. OA is more frequently seen in people older than 50 years of age, but younger people can also develop it due to injuries, abnormal joint structure or genetic background. Despite Zilretta’s (triamcinolone acetonide extended-release) and Joycle’s (diclofenac etalhyaluronate) launches in 2017 and last year, respectively, their addition has not provided a novel approach to the management of OA. GlobalData has identified candidates in the late-stage pipeline that have the potential to shift the competitive landscape and treatment paradigm by addressing important unmet needs over the following decade. There are currently 120 pipeline products within the seven major markets (7MM: the US, France, Germany, Italy, Spain, UK and Japan). Of these, eight are expected to launch over the next decade (Phases IIb–III). Therapies targeting OA treatment are distinguished into two categories: pain management medications and disease-modifying osteoarthritis drugs (DMOADs). To date, treatments approved or recommended for OA treatment only include pain management regimens that aim to relieve symptoms without stopping disease progression. Drugs currently in the pipeline, however, are targeting both strategies, with a quarter of the late-stage products being DMOADs. Even though OA is among the most prevalent diseases worldwide, basic unmet needs such as lack of early diagnosis and inability to halt disease progression have yet to be addressed. According to key opinion leaders (KOLs), a significant number of OA patients seek treatment after experiencing pain for months or even years. Lack of knowledge prevents patients from recognising OA-specific symptoms early, which eventually leads to chronic pain and compromises quality of life. In addition, as current OA treatments only target pain and do not prevent disease progression, DMOADs are medications highly anticipated both by physicians and patients. Related Two DMOADs currently in the third phase of clinical studies, namely Kolon TissueGene’s Invossa (NCT03203330, NCT03291470) and Biosplice Therapeutics’ lorecivivint (NCT03928184, NCT04385303), are being studied in moderate-to-severe patients and are competing for first-to-market advantage. KOLs interviewed by GlobalData expect that should they make it to market, physicians will swiftly adopt DMOADs in their treatment paradigm and patients will more actively seek treatment for OA, being hopeful that these treatments will effectively prevent disease progression. OA impacts a large percentage of the population, meaning there is ample opportunity for developers to enter the OA space to address the lack of DMOADs in the market. Developers are striving to be first to market to treat this debilitating joint disease, which has a significant impact on patient quality of life. The first DMOAD to market is likely to grasp a significant market share from current pain management treatments. GlobalData expects the launch of these therapies to shape the OA market and mark a new chapter in the management of OA.

2021-06-22

·GlobeNewswire

New Therapeutic Drugs for Tendinitis Treatment Coming Down

Los Angeles, USA, June 21, 2021 (GLOBE NEWSWIRE) -- New Therapeutic Drugs for Tendinitis Treatment Coming Down the Pipeline There are around 4+ key companies that are developing therapies for Tendinitis. MiMedx has its drug candidate in the most advanced stage. However, the Tendinitis pipeline consists of fewer drugs, so there is an opportunity for different companies to work in this arena and dominate the market. DelveInsight’s “Tendinitis Pipeline Insight” report provides comprehensive insights about 4+ companies and 4+ pipeline drugs in the Tendinitis pipeline landscapes. It comprises Tendinitis pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Tendinitis therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Tendinitis pipeline products. Some of the key takeaways from the Tendinitis Pipeline Report Get an overview of pipeline landscape @ Tendinitis Clinical Trials Analysis Tendinitis (also called tendonitis) is an inflammation or irritation of a tendon, a thick cord, which attaches bone to muscle. Tendinitis can occur in almost any area of the body. The most common places are the base of the thumb, elbow, shoulder, hip, knee, Achilles tendon. Tendinitis Emerging Drugs SI-613 is a formulation in which hyaluronic acid and a non-steroidal anti-inflammatory drug (NSAID) are chemically bound utilizing Seikagaku’s proprietary technology. SI-613 was developed to offer pain relief and anti-inflammatory effect by sustained release of NSAID, and the joint function was enhanced by the effect of hyaluronic acid. It is anticipated to offer prompt and sustained relief from severe pain and inflammation associated with osteoarthritis and enthesopathy. The drug is currently in phase II of clinical trials for Tendinitis treatment. MP1032’s mode of action is to accelerate the healing process that allows for MP1032 as a therapeutic for tendinitis before tendinosis develops. In addition, MP1032 could speed up the repair of already damaged tendons and hence also decrease the duration of tendinosis treatments. The drug is currently in phase I of clinical trials for the treatment of tendinitis. dHACM is a micronized dehydrated Human Amnion Chorion Membrane developed by MiMedx for Tendinitis and is currently in the phase III stage of development. AmnioFix is processed using Purion, a unique patented method for placental-based allografts according to the American Association of Tissue Banks (AATB) standards. The product is derived from donated C-sections of live births in the US. The product faces active preservation of the extracellular matrix (ECM), regulatory proteins, and elimination of blood contaminants through a proprietary cleansing process. For an additional level of safety, the product is terminally sterilized. For further information, refer to the detailed report @ Tendinitis Pipeline Therapeutics Scope of Tendinitis Pipeline Drug Insight · Tendinitis Therapies Late-stage (Phase III) · Tendinitis Therapies Mid-stage (Phase II)· Tendinitis Therapies Early-stage (Phase I) · Tendinitis Pre-clinical stage and Discovery candidates · Discontinued and Inactive candidates · Cyclooxygenase inhibitors· Cell replacements, Tissue replacements· Collagen modulators; MicroRNA modulators · Peptides· Monoclonal Antibody· Polymer· Small molecule· Gene therapy · Oral· Parenteral· Intravitreal· Subretinal· Topical · Monotherapy· Combination· Mono/Combination Key Questions regarding Current Tendinitis Treatment Landscape and Emerging Therapies Answered in the Pipeline Report Table of Contents Get a customized pipeline report @ Tendinitis Drugs Pipeline Report Related Reports DelveInsight’s Krabbe Disease Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. DelveInsight’s Laryngeal Cancer Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. DelveInsight’s Nosocomial Pneumonia Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. DelveInsight’s Ornithine Transcarbamylase Deficiency (OTC Deficiency) Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease. About DelveInsightDelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also provides Healthcare Consulting services comprising credible market analysis that will help accelerate the business growth and overcome challenges with a practical approach.

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