Lana Pine is the editor of HCPLive Rheumatology. She is an experienced editor and technical writer with a demonstrated history of working in the banking and publishing industries. In her free time, she enjoys cooking, yoga, listening to podcasts, and drawing. She can be reached via email at LPine@mjhlifesciences.com.

Lana Pine

The rheumatology month in review highlights a program developed by Janssen to support health equity in patients with psoriatic disease, the increased risks pregnant women with rheumatic diseases face, and trends in fibromyalgia management.

Fibromyalgia impacts patients in a variety of ways, including an increased risk of comorbidities, such as celiac disease and irritable bowel syndrome (IBS), as well as an increased likelihood of developing anxiety and depression. Results of a recent study showed patients with fibromyalgia tended to have lower physical activity levels when compared with healthy controls, in part due to pain. However, programs, such as the telerehabilitation intervention highlighted below, have been proven to improve quality of life in this patient population.

Fibromyalgia Significantly Linked to Benign Gastrointestinal Disorders

Investigators performed a study using data from the largest health maintenance organization in Israel. The link between fibromyalgia and benign gastrointestinal disorders, including IBS, peptic ulcer disease (PUD), celiac disease, gastroesophageal reflux disease (GERD), ulcerative colitis, and Crohn’s disease, as well as gastrointestinal malignancies such as stomach, liver, pancreatic, colorectal, and bile duct cancers, was evaluated.

 diagnosis was significantly associated with GERD, PUD, IBS, Crohn’s disease, ulcerative colitis, and celiac disease. Compared with controls, patients with fibromyalgia had a higher prevalence of IBS (4.8% vs 1.1%, respectively), celiac disease (.7 vs .4%, respectively), Crohn’s disease (.8% vs .4%, respectively), and ulcerative colitis (.6% vs .4%, respectively).

However, no significant differences were observed regarding gastrointestinal malignancies between patients with fibromyalgia compared with the controls.

Reduced Physical Activity Levels Observed in Patients With Fibromyalgia

While exercise has been deemed beneficial in the management of fibromyalgia, the symptoms of the condition can create barriers that discourage exercise, including the belief that exercise may intensify symptoms. Other anecdotal data also showed that most patients with fibromyalgia lead a sedentary lifestyle.

The case-control study included 70 patients with fibromyalgia and 50 age- and gender-matched controls. Patients with fibromyalgia reported significantly less recreational, transportation-related, and total physical activity levels when compared with controls., They also reported significantly less time spent walking and in vigorous activities when compared with healthy individuals.

Telerehabilitation Improves Quality of Life in Patients With Fibromyalgia

Pooled results of a systematic review of randomized controlled trials proved that telerehabilitation improved the Fibromyalgia Impact Questionnaire (FIQ) score and quality of life in patients with fibromyalgia when compared with controls. The intervention also improved depression levels, pain intensity, and pain catastrophizing in this patient population.

“Telerehabilitation can provide accessible and continuous rehabilitation medical services for patients with fibromyalgia who cannot attend traditional face-to-face services or are geographically remote, and it could enable patients to manage their disease at any time and place in a timely and appropriate manner,” wrote Mao-Yuan Wang, PhD, Department of Rehabilitation Medicine, The First Affiliated Hospital of Gannan Medical University, China, and colleagues.

Janssen Develops Programs to Support Health Equity in Psoriatic Disease

Soumya Chakravarty, MD, PhD, FACP, FACR, Senior Director, Strategic Lead, Janssen Rheumatology, and Daphne Chan, PhD, Head of Dermatology Medical Affairs, Janssen, highlighted Janssen’s recent programs designed to reduce health inequity in patients living with psoriatic disease.

The team developed 2 potential solutions collaboratively with the community. The first is a patient navigation program and the second is a concept called "Beyond the Textbook," which provides healthcare providers with culturally inclusive resources to navigate conversations around psoriatic disease in patients of color.

Chan and Chakravarty discovered a lack of information and representation regarding simple images of psoriatic disease, including plaques and psoriatic arthritis in patients of color.

Pregnancy Outcomes in Women With Rheumatic Disease

Pregnant women with rheumatic disease are at an increased risk of a multitude of adverse events, including preeclampsia and placental disorders. These risks may also extend to the fetus and child, including new research that maternal rheumatoid arthritis is linked to an increased risk of Autism Spectrum Disorder (ASD).

However, recent data demonstrated that monitoring 25-hydropxy vitamin D levels can lower the risk of miscarriage and premature delivery in pregnant women with lupus.

CCR East: Study Offers Overview of Pregnancy Outcomes in Takayasu Arteritis

Described by the American College of Rheumatology as a rare form of vasculitis disease characterized by inflammation of the aorta and main branches, Takayasu arteritis poses a significant threat to quality of life for patients.

Raksadawan and Sabahat Usmani, MD, of Louis A. Weiss Memorial Hospital, launched the current study with the intent of exploring the effect of Takayasu arteritis on delivery outcomes as a follow-up to a previous research examining effects on other outcomes.

“While [Takayasu arteritis] patients had a significantly higher rate of comorbidities: gestational hypertension, thyroid disorders, and increased incidence of genitourinary infections, [the condition] does not seem to cause adverse outcomes during the delivery period,” wrote investigators.

Vitamin D Levels Can Influence Risk of Miscarriage, Premature Delivery in Women with Lupus

Congress of Clinical Rheumatology (CCR) East 2023 annual meeting

, which examined the role of 25-hydroxy vitamin D insufficiency and BMI on adverse pregnancy outcomes in 

, describe the presence of a U-shaped curve association between maternal serum 25-hydropxy vitamin D level and adverse pregnancy outcomes. The lowest prevalence of adverse pregnancy outcomes observed among those with a maternal vitamin D level of 40-59 ng/dL.

Further analysis suggested the same trend was present when miscarriage and premature deliveries were examined separately but this 

 value failed to reach statistical significance, which investigators attribute to smaller numbers.

Maternal RA Linked to Increased Risk of Autism Spectrum Disorder in Children

 diagnosis before delivery was linked to an increased risk of offspring ASD. The association between maternal arthralgia and ASD indicated other pathways of risk than autoimmunity and inflammation, acting jointly or independently of RA.

The prospective, population-based cohort study included all children born alive in Sweden between 1995 and 2015, with a follow-up period through 2017. Of the 3629 children born to mothers with an RA diagnosis, 1.94% (n = 70) were ultimately diagnoses with ASD, compared with 1.92% (n = 28,892) of 1,503,908 children born to mothers without RA.

A maternal RA diagnosis before delivery was linked to an increased risk of offspring with ASD (HR = 1.43, 95% CI 1.11–1.84), particularly for those with seronegative RA (HR = 1.61, 95% CI 1.12–2.30).

Articles

The rheumatology month in review highlights a program developed by Janssen to support health equity, the increased risks pregnant women with rheumatic diseases face, and trends in fibromyalgia management.

Rheumatology Month in Review: May 2023

 month in review highlights infliximab biosimilars data presented at 

, California’s proposed plan to produce and market biosimilar insulin which could result in $100 million in annual savings, and new US Food and Drug Administration (FDA) approvals.

In May, the adalimumab-adbm autoinjector pen and the high-concentration, citrate-free formulation of the biosimilar adalimumab-aaty, were approved by the FDA. These approvals highlight the continued growth of the biosimilars market and further expand the treatment options for patients living with inflammatory, autoimmune diseases.

FDA Approves Biosimilar Adalimumab-adbm Autoinjector Pen

The adalimumab-adbm (Cyltezo) autoinjector pen was approved by the FDA ahead of the July 1 commercial launch, according to a 

 from Boehringer Ingelheim. The drug is an FDA-approved interchangeable biosimilar to adalimumab (Humira) and is used to treat a variety of chronic inflammatory diseases, including rheumatoid arthritis, juvenile idiopathic arthritis, and psoriatic arthritis. The pre-filled pen will be available in 2-, 4-, and 6-pack options.

"The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector," said Stephen Pagnotta, executive director and biosimilar commercial lead at Boehringer Ingelheim. "We're excited to be able to offer the Cyltezo Pen as an additional option to patients.”

FDA Approves High-Concentration, Citrate-Free Biosimilar Adalimumab-aaty

The FDA approved adalimumab-aaty (Yuflyma), a high-concentration (100 mg/mL) and citrate-free biosimilar version of adalimumab (Humira), according to a 

The approval was based on a comprehensive assortment of preclinical, clinical, and analytical studies which showed the biosimilar was comparable to the reference drug regarding safety, efficacy, immunogenicity, and pharmacokinetics following treatment initiation.

The drug, which is the first high-concentration and citrate-free adalimumab biosimilar to receive European Commission approval in Europe, will be available via a pre-filled syringe as well as an autoinjector to meet patients’ different preferences and needs.

Data on infliximab biosimilars data included a study presented at Digestive Disease Week (DDW) 2023 in which investigators enrolled adolescent and young adult patients to assess a one-time non-medical shift to an infliximab biosimilar. Other data at the conference included a study demonstrating a switch to an infliximab biosimilar was not linked to adverse events when compared with the originator, and an evaluation of switch back rates among patients receiving ABP 710 (infliximab-axxq).

Non-Medical Switch to Infliximab Biosimilar Did Not Impact Remission in Young Patients

“Studies in adults with inflammatory bowel disease (IBD) have demonstrated that a one-time switch from the originator to a biosimilar has not resulted in loss of response, increased side effects, or antibody development,” wrote Ross Maltz, MD, associate professor and pediatric gastroenterologist in the Department of Pediatrics at the Ohio State Wexner Medical Center. “Data describing non-medical switching is limited in adolescents and young adults.”

A retrospective review was conducted to evaluate the clinical outcomes of one-time non-medical switches from the infliximab originator to a biosimilar in young patients with IBD.

Of those who had a full 12 months of follow-up data (n = 33), 91% remained on the biosimilar (n = 30/33). No statically significant differences in erythrocyte sedimentation rate(ESR), C-reactive protein (CRP), tumor necrosis factor inhibitor (TNF) levels, and albumin were observed pre- and post-switch.

Infliximab Biosimilar Not Associated With Adverse Events in IBD

Investigators evaluated the safety of biosimilar switching in a US cohort of veterans with Chron’s disease and ulcerative colitis who received maintenance originator infliximab between 2017 and 2019.

Of the 790 patients included in the analysis, adverse outcomes occurred in 35.6% of patients at 12 months (35.6% in the switch cohort and 35.3% in the non-switch group). No statistically significant differences in infusion reaction, serious reaction, or immunogenicity rates were observed between both groups.

Study Observes Low Switch Back Rates in Infliximab Biosimilar ABP 710

ABP 710 is an FDA-approved drug for the treatment of inflammatory bowel disease (IBD)-related, immune-mediated diseases such as CD and UC.

Patients with IBD who received the infliximab biosimilar ABP 710 (infliximab-axxq) persisted on treatment during a median follow-up period of 295 days. Further, although most patients switched from the originator, the switch back rate back to the reference drug was generally low.

During the study follow-up period, 74.5% of switchers and 51.3% of infliximab-naïve patients remained on ABP 710 treatment without a treatment gap.

California’s Proposed Insulin Biosimilar Plan

California Insulin Biosimilar Plan Could Save $100 Million in Annual Spending

A cross-sectional analysis of California’s strategy to provide its own low-cost and price-transparent biosimilar 

 to in-state patients showed the proposal could lead to an approximate $100 million decrease in health care spending through the state.

“Insurers and pharmacy benefit managers can incentivize patients to switch to lower-cost products through tools such as formulary placement and out-of-pocket costs,” investigators wrote. “However, including state-led insulin products only on formularies for California plans may require administrative changes, such as using a different plan identification for the California portion of nationwide plans.”

Investigators believe the strategy may be applicable across other states and within other fields with high-cost therapies.

The biosimilars month in review highlights infliximab biosimilars data presented at Digestive Disease Week (DDW) 2023, California’s proposed plan to produce and market biosimilar insulin at production-equivalent prices, and new FDA approvals.

Biosimilars Month in Review: May 2023

, Shilpa Venkatachalam, PhD, MPH, Director, Patient Centered Research Operations and Ethical Oversight, co-principal investigator of ArthritisPower, CreakyJoints, discussed her recent study, “Managing Psoriatic Arthritis: Patients’ Views and Attitudes to Using an Online Wellness Program.” The data, presented at 

European Congress of Rheumatology (EULAR)

 2023, evaluated the interest of patients with 

 (PsA) to enroll in an online wellness program.

Results indicated that although more than 90% of respondents reported being “somewhat likely” or “very likely” to regularly engage with an online coach or dedicate 1 to 2 hours per week learning about nutrition, exercise, sleep, and stress management if given the opportunity, only 8.7% of participants were currently enrolled in a structured wellness program. Common barriers to initiating wellness changes were costs and not having the energy to make changes.

What initially inspired your team to assess treatment optimization psoriatic arthritis by using self-reported information from this patient population?

People living with psoriatic arthritis (PsA) regularly confront decisions about how to optimize treatment of their chronic disease. While their interactions with their physicians and health care team impact their disease outcomes through the prescribing of medications and other complementary therapies, we also know that lifestyle modifications, such as nutrition, exercise, sleep, and stress management can positively affect disease outcomes.

In addition, we know that many patients are very interested in understanding additional treatment modalities to manage their overall health and disease. We want to provide patients with reliable and evidence-based information that they can use for self-management as well as for making more informed medical decisions alongside their clinicians.

In your opinion, why do you believe patient-reported outcomes (PROs) are an essential part of disease management?

At CreakyJoints and the Global Healthy Living Foundation (GHLF), we always encourage people living with chronic disease to put themselves at the center of their care by engaging in shared decision-making with their physicians regarding how they progress towards their disease management goals. Patient-reported outcomes are a huge part of this endeavor – they are validated and standardized measures to communicate information directly from the patient who lives with the disease to their health care team.

In addition, in diseases like psoriatic arthritis, some of the data that comes from patients through PROs cannot be garnered through blood work or imaging; we don’t really see pain or fatigue in blood work. But we know that these are bothersome symptoms and important to resolve for patients. One way we can get this information is via PROs and when combined with clinical data, it can provide really useful information to the care team.

PROs allow for people living with a disease to get into the habit of tracking symptoms that matter to them; it puts what matters to those living with a disease at top and center particularly if they are using something like our ArthritisPower Research Registry application, which can show (for example) how symptoms ebb and flow over time.

It also allows patients to be invested in their own care and treatment management alongside their clinician too. Integrating PRO collection into disease management provides a richer understanding of the day-to-day patient experience of disease, while relying less on recall and subjective assessment at periodic doctors’ appointments.

The value of PROs cannot be discounted especially as we think of patient-centered and patient evidence-based care. In fact, given the importance of this topic, we recently 

 as part of a podcast called “Relatable Rheumatology” on the value of PROs that we conducted with Dr Susan Goodman of the Hospital of Special Surgery and a patient partner Shelley Fritz where we talked about the value of PROs for patients and for clinicians.

Did the results of the study surprise you?

In our study, “Managing Psoriatic Arthritis: Patients’ Views and Attitudes to Using an Online Wellness Program,” and in collaboration with clinicians Elaine Husni, MD, MPH, and Len Calabrese, DO, rheumatologists and researchers from the Cleveland Clinic, and patients, the GHLF conducted an online survey.

The questions in the survey were designed to gather information about participants' previous experiences with online wellness programs, their motivations for participating, and their interest in an online program.

We were not surprised by the results of the study, but we were a little disheartened that so few participated or had access to a wellness program. About a third of patients expressed a preference for a wellness program that included direct online interaction with a trained professional (34.0%), followed by attending an online course (16.4%) and reading written material (16.0%).

We know through increasing research on this topic that successful treatment of any chronic disease, including psoriatic arthritis, requires a holistic approach that goes beyond diagnosis and taking medication. This study tells us that while PsA patients are willing to add wellness education and lifestyle adaptations to their disease management strategy, those programs need to be both accessible and affordable to optimize participation.

Does your team plan on doing any further research on e-coaching wellness platforms for the improvement and management of lifestyle changes in this patient population?

At the Global Healthy Living Foundation, our commitment is always to provide patients with resources and evidence-based information for the optimal management of their disease. We have several resources that can help patients interested in wellness including Psoriatic Arthritis Wellness: A Newsletter Series to Help You Feel Better with PsA and Psoriatic Arthritis Wellness Center, created in collaboration with United Rheumatology. Our goal at GHLF is to help patients live better. We know that wellness programs can be costly and are often not covered by insurance. We are constantly working to make resources that include wellness available to our patient community so they can live better.

While most patients were interested in an online wellness program for managing their psoriatic arthritis, barriers, such as cost and fatigue, hindered their initiation of lifestyle adaptations.

Shilpa Venkatachalam, PhD, MPH: Patient Perspectives of an Online Wellness Program for PsA Management

In a cohort of women with fibromyalgia, land-based multicomponent exercise was shown to improve physical fatigue, while water-based exercise exhibited improvements in general fatigue as well as sleep quality, according to a study published in 

Archives of Physical Medicine and Rehabilitation

 However, the magnitude of the changes was deemed small-to-medium, and the benefits were not sustained after exercise cessation.

More than 80% of patient with fibromyalgia report severe fatigue or significant sleep difficulties.

 These patients often categorize these symptoms as the most important clinical feature of fibromyalgia besides pain. While exercise is recommended for the management of these symptoms, there is no consensus on whether land- or water-based exercise is more beneficial and advisable.

“Although a recent meta-analysis suggested that both settings seem to provide similar benefits for fatigue reduction, the number of high-quality studies is scarce and precludes firm conclusions,” wrote Blanca Gavilán-Carrera, PhD, Department of Internal Medicine, Hospital Universitario Virgen de las Nieves, Granada, Spain, and colleagues.

 “Given that type of exercise and the setting could differentially benefit various outcomes, to better understand the effectiveness of both land- and water-based interventions is important from both research and clinical perspectives.”

Investigators aimed to determine the effectiveness of land- and water-based exercise on fatigue and sleep quality in women with fibromyalgia during a 24-week intervention. They also explored the persistence of these changes in the 12-week period after exercise cessation.

The quasi-experimental study enrolled patients from fibromyalgia patient associations in 7 provinces of Andalusia, Spain, and university facilities. Participants were assigned to land-based exercise, water-based exercise, or a no exercise control group.

Assessments were taken at baseline, week 24, and week 36. The primary outcome measures were the Multidimensional Fatigue Inventory (MFI) and the Pittsburgh Sleep Quality Index (PSQI).

The intervention groups received a comparable multicomponent exercise program for the duration of the study (3 non-consecutive days per week, 45-60 minutes per session). Each intervention, intended to improve physical fitness components, was divided into a warm-up (8 – 10 minutes), conditioning section (15 – 17 minutes), aerobic section (15 – 25 minutes), and cool-down (10 minutes). The water-based exercise program was performed in a chest-high, warm pool.

The study enrolled 250 women with fibromyalgia, with a mean age of 50.8 years. A total of 83 patients were placed in the land-based exercise group, 85 were placed in the water-based exercise group, and 82 received no exercise intervention.

In comparison to the control group, patients in the land-based exercise group reported improved physical fatigue (mean difference -0.9 units; 95% confidence interval [CI] -1.7 to -.1; Cohen's d = .4). Similarly, patients in the water-based group had improved general fatigue (-.8; 95% CI -1.4 to -.1; d = .4), and global sleep quality (-1.6; 95% CI -2.7 to -.6; d = .6). The water-based exercise cohort had improved global sleep quality when compared with the land-based exercise cohort (-1.2; 95% CI -2.2 to -.1; d = .4).

The changes were not maintained at the 36-week mark.

Investigators noted that participants could only partially be randomly allocated due to the inability to maintain adequate temperature in the pools in certain study locations. However, the trial quality may have been more impactful on the treatment effect size than randomization alone.

“These findings support strategies that include exercise in management of fatigue and sleep quality in fibromyalgia and warrant further research examining the relevance of exercising regularly to sustain such benefits,” investigators concluded.

Gavilán-Carrera B, Borges-Cosic M, Álvarez-Gallardo IC, et al. Effectiveness of land- and water-based exercise on fatigue and sleep quality in women with fibromyalgia: the al-Ándalus quasi-experimental study [published online ahead of print, 2023 May 26]. Arch Phys Med Rehabil. 2023;S0003-9993(23)00306-4. doi:10.1016/j.apmr.2023.04.028

Andrade A, Vilarino GT, Sieczkowska SM, Coimbra DR, Bevilacqua GG, Steffens R de AK. The relationship between sleep quality and fibromyalgia symptoms. J. Health Psychol. 2020;25:1176–86

Patients in the land- and water-based exercise intervention groups demonstrated greater improvements in fatigue when compared with controls.