The March 2023 rheumatology month in review highlights recent data regarding nipocalimab as a treatment option for hemolytic disease of the fetus and newborn and myasthenia gravis, trends in fibromyalgia, the recent US Food and Drug Administration (FDA) approval of the high-concentration formulation of the adalimumab-adaz biosimilar, and the differences among specialties in biosimilar uptake.

Hyperbaric Oxygen Therapy for Treating Patients With Fibromyalgia and Traumatic Brain Injury

Fibromyalgia, a central sensitization syndrome caused by an issue in the brain's interpretation of signals from the body, can be triggered by brain injury, viral infections, such as COVID-19, and severe emotional stress. In their pilot study, conducted 10 years ago, Shai Efrati, MD, PhD, and his team discovered that treatment with hyperbaric oxygen therapy could successfully eliminate fibromyalgia symptoms.

Hyperbaric Oxygen Therapy Improves Pain, Quality of Life in Patients With Fibromyalgia Triggered by Traumatic Brain Injury

A total of 58 patients were included in the analysis, with no significant differences in baseline symptoms or characteristics reported. A significant group-by-time interaction in pain intensity post hyperbaric oxygen therapy (HBOT) treatment compared with the pharmacological group (d = -0.95, P = 0.001) was observed with a large net effect size in reduction in pain intensity following HBOT compared with those receiving medications. After HBOT, 37.9% of patients no longer met the diagnostic criteria for fibromyalgia compared with 0% in the medication group.

Quality of life improvements and an increase in pain thresholds and were also observed in patients receiving HBOT. Fibromyalgia Impact Questionnaire (FIQ) and Global Pain Scale (GPS) scores improved with a significant group-by-time interaction in the HOBT group.

Shai Efrati, MD, PhD: Hyperbaric Oxygen Therapy for Fibromyalgia Treatment

Efrati’s team explored how to regenerate and repair damaged brain tissue in this patient population. They began with classical indications, like stroke and multi-brain injuries, and found that a certain protocol of hyperbaric oxygen therapy triggers stem cell replication in the brain, generated new blood vessels, and triggered repair mechanisms in the brain.

The current study aimed to evaluate the efficacy of this therapy in patients with fibromyalgia induced by brain injuries. Investigators randomized patients into 2 treatment groups: those who received traditional medications like pregabalin (Lyrica) and duloxetine (Cymbalta) or those who received a dedicated protocol of hyperbaric oxygen therapy. Efrati and his team analyzed the patients' pain, quality of life, physical performance, and other symptoms related to fibromyalgia before and after hyperbaric oxygen therapy treatment.

Nipocalimab as a Viable Treatment Option for Autoimmune, Alloimmune Diseases

Janssen’s novel pathway approach may be used to treat a variety of autoantibody-driven diseases categorized into 3 segments: maternal fetal (hemolytic disease of the fetus and newborn [HDFN]), rare autoantibody diseases, and prevalent rheumatic diseases.

HDFN occurs when a pregnant person forms alloantibodies against the developing fetus during pregnancy. These circulating alloantibodies, which are the mother's immune reaction to the developing fetus, can cross the placenta through the fetal neonatal receptor (FcRn), causing harm to the fetus's red blood cells. This can result in anemia and, in severe cases, fetal death, which can occur in up to a quarter of cases of severe HDFN.

The impact of HDFN on patients and their families is significant and underscores the need for continued research and development in this area. Nipocalimab may be a possible candidate to kickstart the pipeline.

The drug, which is also currently being studied as a potential treatment option for myasthenia gravis, has the potential to be a safe, effective, and approved targeted therapy for patients with unmet needs.

Breaking the Blood Barrier: Understanding Hemolytic Disease of the Fetus and Newborn

Janssen is currently studying nipocalimab for the treatment of HDFN, reflecting the significant impact of the disease on patients and families. Results of the phase 2 UNITY trial, recently announced by Janssen via press release, reported positive topline results that demonstrated that the majority of available nipocalimab-treated pregnancies met the primary endpoint, meaning they achieved a live birth at or after gestational age of 32 weeks without requiring an intrauterine transfusion (IUT) throughout their pregnancy.

Sindhu Ramchandren, MD: Nipocalimab may be a Promising New Treatment Option for Myasthenia Gravis

In an interview with HCPLive, Sindhu Ramchandren, MD, Director of Clinical Development and Clinical Leader, Neuroscience, Janssen, discussed the clinical significance of the results of a recent phase 2 trial and the therapeutic impact nipocalimab could make on patients living with myasthenia gravis.

The trial underscored the hypothesis that reducing autoantibody levels would improve symptoms in these patients. It also reported comparable adverse events between patients receiving nipocalimab and the placebo cohort, indicating that it is a safe and well-tolerated drug. The ongoing larger, phase 3 study, which is currently enrolling patients, will hopefully reinforce these results.

FDA Approval of a Biosimilar, Perspectives Among Specialties Regarding Biosimilar Uptake

Cardinal Health surveyed over 350 providers spanning rheumatology, dermatology, gastroenterology, and ophthalmology to better understand the changing landscape of the industry and the market shifts that are continuing to occur given the expansion of biosimilars. Results were compiled in the Cardinal Health 2023 Biosimilars Report, published earlier this year.

In an interview with HCPLive Rheumatology, Bruce Feinberg, DO, Vice President and Chief Medical Officer at Cardinal Health, explained the how Cardinal Health is focusing on understanding and engaging with all sectors of the healthcare economy, including providers, payers, patients, and biopharma manufacturers.

The month also saw the FDA approval of a high-concentration formulation of the biosimilar adalimimab-adaz. The approval was based on positive results from a phase I pharmacokinetics bridging study, which showed comparable PK and similar safety and immunogenicity of adalimumab 50 mg/mL and adalimumab high-concentration formulation.

Bruce Feinberg, DO: Differences Among Specialties in Biosimilar Uptake

Results of the survey indicated that physicians who have more experience with biosimilars and a greater variety of reference brands with biosimilars available tend to have higher levels of acceptance and adoption. For instance, in oncology, where there are many biosimilars and policies like the Oncology Care Model that encourage their use, there has been a much higher adoption rate. Rheumatology is following a similar trajectory as oncology, while gastroenterology and dermatology, which have had less exposure to biosimilars, reported lower adoption rates.

Cardinal Health is also seeing the impact of policy on prescribing patterns, which adds another layer of complexity to the analysis. By looking at factors, including exposure and patient complexity, they can start to identify patterns and gain insights into the different levels of adoption across specialties.

FDA Approves High-Concentration Formulation Biosimilar Adalimumab-Adaz

“As one of the first adalimumab high-concentration formulation biosimilars approved in the US, Hyrimoz HCF has the potential to expand access for millions of people who face the realities of living with a serious inflammatory disease and to enhance the patient experience,” Keren Haruvi, President, Sandoz Inc, Head of North America, said in a statement.

The HCF biosimilar, which will be launched in Q3 2023, will allow for patients to receive a reduced injection volume in a citrate-free formulation. The drug marks the first Sandoz biosimilar introduced to the US market for these specific conditions.