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Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

Itching and the subsequent scratching behavior are linked to a majority of 

 symptoms and exert the most influence on one’s quality of life, according to new findings, and this can help inform endpoint selection in clinical research on PN treatments.

This data resulted from a new qualitative study assessing 21 adult patients with PN, conducted given recent reports of a lack of substantial qualitative research—including focus group research and interviews, for example—on PN symptoms and patient quality of life.

This new qualitative study was led by Danielle Rodriguez, PhD, from Evidera in Seattle, Washington. Rodriguez and colleagues felt that expanding upon existing research on the lives of patients with the debilitating neuroimmune skin condition would be invaluable to the field.

“The main objective of this study was to conduct qualitative research to document the burden of illness in PN using direct patient input,” Rodriguez and colleagues wrote. “The study was part of a larger project that also aimed to validate published patient-reported outcome measures using the peak pruritus numerical rating scale (NRS) score, the sleep disturbance NRS score, and Morning Sleep Diary in people with PN.”

The investigators carried out their qualitative research, and the researchers involved were affiliated with the contract research organization Evidera. The investigators utilized one-on-one telephone discussions with English-speaking adults from the US and in the age range of 18 years or older, with the participants having been diagnosed with PN for at least half a year.

Those recruited by the research team had to have severe pruritus—identified as a peak pruritus NRS score of ≥7—and have moderate-to-severe disturbance of sleep with a sleep disturbance NRS score of ≥4 at the time of their screening. Investigators recruited in the time between September 2020 and March 2021, using patient panels, associations, and social media, and interviews took place in the same time frame.

During the team’s interviews with participants, the team had them describe their most troublesome symptoms as well as the effects the symptoms had on the participants’ lives. The questions specifically asked about itching-related effects.

The investigators also gathered data on participant demographics and medical history, including participants’ self-reported races and ethnicities, with those involved each being given $150 as compensation. For the team to allow for the confidentiality of their research, they utilized unique identifiers and they de-identified, transcribed, and reviewed interviews for accuracy.

The investigators’ coded transcripts of their interviews were given a content analysis through ATLAS.ti software, and they assessed a saturation of concepts to point out when zero new information was found. Additionally, the investigators tailored their training for the study personnel and feedback so as to enhance consistency of the resulting data.

The research team ended up with 21 adult participants that had cases of PN and were interviewed in the study, with those included reporting a mean age of 53.1 years and being 71% female and 86% White. The most commonly noted symptoms of PN were shown to be itch, bleeding/scabbing, pain, lumps/bumps, burning, skin dryness, crust found on patients’ skin, stinging, discoloration, lesions/sores, and raw skin.

When the investigators looked at the symptoms specified as their worst, they found that 88% reported itching as being the most troublesome of the symptoms. PN was shown to have affected these individuals’ life qualities, resulting in disruptions of patients’ sleep, mood, social activities, lives each day, personal relationships, and work or school, with the team finding the one impacting the most was PN’s influence on mood and feelings.

“These findings can be used to guide the selection of end points for assessing patient-relevant outcomes in clinical trials and should help capture treatment benefits that are important to patients with PN,” they wrote. “These findings may also be useful for patient-centric decision-making in clinical practice.”

Rodriguez D, Kwatra SG, Dias-Barbosa C, et al. Patient Perspectives on Living With Severe Prurigo Nodularis. JAMA Dermatol. Published online September 20, 2023. doi:10.1001/jamadermatol.2023.3251.

Fofana F﻿, Dias-Barbosa C﻿, Rodriguez D﻿, et al. A literature review of patient-reported outcome measures used in assessment of sleep disturbance in atopic dermatitis. Presented at: 29th European Academy of Dermatology and Venereology Virtual Congress; October, 29-31, 2020.

Articles

This new qualitative data may be helpful both for patient-centric decision-making for clinicians as well as endpoints in future research on prurigo nodularis.


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Itch, Scratching Behavior Most Influential on Quality of Life for Individuals with Prurigo Nodularis

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.

Spherix Global Insights, a leading provider of market research, conducted a survey using a sample of 81 rheumatologists, 83 gastroenterologists, and 80 dermatologists to evaluate adoption rates, experiences, concerns, and future expectations of 

Findings revealed the adalimumab (Humira) is steadily losing its popularity as the biosimilar market continues to expand, according to the third quarter update of Spherix Global Insights’ 

Special Topix™: Biosimilars Today and Tomorrow

However, the embracement of biosimilars varied among different specialties, with dermatologists demonstrating the highest resistance to change. Approximately half of dermatologists surveyed said they were unlikely to prescribe a biosimilar option outright over the reference adalimumab. However, rheumatologists and gastroenterologists were less resistant to the change.

Although adalimumab-adbm (Cyltezo), the first adalimumab biosimilar granted interchangeability by the US Food and Drug Administration (FDA), had a slight edge among recent adalimumab biosimilar launches, adalimumab-atto (Amjevita) was the most recognizable adalimumab biosimilar among the surveyed group. These results are unsurprising as adalimumab-atto was the first FDA-approved adalimumab biosimilar.

Despite a broad understanding of current biosimilars, many specialists expressed they did not know how to differentiate between the recently available biosimilar options.

, Stephen Pagnotta, executive director and biosimilar commercial lead at Boehringer Ingelheim, explained the significance of an interchangeable designation.

“A biosimilar with an interchangeable designation can be auto-substituted for the reference product by a pharmacist,” Pagnotta said. “Pharmacist-mediated auto-substitution could mean fewer administrative hurdles, which can potentially help patients get their medications faster than they would get non-interchangeable biosimilars.”

The gastroenterologists and dermatologists surveyed expressed an increase in asking for an adalimumab biosimilar, of which a growing majority were willing to prescribe the biosimilar option; indicating a decrease in those willing to argue for the reference product.

Dermatologists surveyed were largely neutral towards biosimilars (58%), although 38% reported being uncomfortable with initiating a non-medical switch from the branded drug to a biosimilar. They also reported patient concern as the main reason why an adalimumab biosimilar may be deemed inappropriate.

Gastroenterologists were overall unopposed to prescribing biosimilars, with 24% reporting being significantly more confident prescribing biosimilars vs the reference adalimumab and 55% stating they would be extremely comfortable initiating a biologic naïve patient on a biosimilar. This trend continued to be demonstrated with their comfort of biosimilar approvals, with 92% reporting being either strongly in favor or neutral to the clinical evidence required for approvals.

Four out of 10 rheumatologists believed patients stable on current treatment are inappropriate candidates for a switch to an adalimumab biosimilar. However, the vast majority (94%) of rheumatologists were comfortable with the biosimilar approval process. While most (53%) believed biosimilars would not provide savings to their practice, 92% believed they would deliver savings to the overall health system.

Although more biosimilar options continue to become available to the US market, specialists surveyed stated their overall use of the reference product has remained generally consistent over the past year. Despite this, the adalimumab share has declined 10% since adalimumab-atto and other competitors have entered the market.

“Going forward, efficacy is top of mind as prescribers’ leading concern when it comes to the adoption of the adalimumab biosimilars, followed by safety concerns, and an overall lack of cost savings,” the Spherix Global Insights statement concluded.

Amgen’s Amjevita remains the frontrunner in the US adalimumab biosimilars market, despite increased competition, according to Spherix Global Insights.

 Spherix Global Insights. (2023, September 14). https://www.spherixglobalinsights.com/amgens-amjevita-remains-the-frontrunner/

FDA approves Amjevita, a biosimilar to Humira

. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-amjevita-biosimilar-humira

Advancing access to affordable treatment: The US launch of Adalimumab-ADBM

. HCP Live. https://www.hcplive.com/view/advancing-access-to-affordable-treatment-the-us-launch-of-adalimumab-adbm

Although most clinicians surveyed are unopposed to prescribing adalimumab biosimilars, hesitancies surrounding prescribing practices and an uncertainty of cost savings remains. 

Biosimilars

Survey Reveals Adalimumab-atto Maintains Leadership in US Adalimumab Biosimilars Market

Connor Iapoce is an associate editor for 

 and joined the MJH Life Sciences team in April 2021. He graduated from The College of New Jersey with a degree in Journalism and Professional Writing. He enjoys listening to records, going to concerts, and playing with his cat Squish. You can reach him at 

A systematic review and meta-analysis of available evidence do not support the role of topical non-steroidal anti-inflammatory drugs (NSAID) for the treatment of 

The analysis identified adverse effects of long-term topical NSAID use, including persistent corneal epithelial defects, delayed corneal epithelial healing, superficial punctate keratitis, corneal infiltrations, and corneal and scleral ulcerations and melts.

“Considering that long-term use of topical NSAIDs can have undesirable side effects, particularly on the cornea, we discourage the liberal use of topical NSAIDs for CSC,” wrote the investigative team, led by Yousif Subhi, MD, PhD, department of ophthalmology, Rigshospitalet.

One of the most common forms of maculopathy, CSC is an exudative maculopathy with primary presentation in adult males aged 30 to 50 years. Half-dose photodynamic therapy is the mainstay of CSC treatment, but an ongoing shortage of verteporfin may limit treatment access.

 A better understanding of the efficacy of other treatment modalities, including the use of topical NSAIDs, could become more important as a result.

Evidence is conflicting on the role of topical NSAID therapy in CSC.

 In this analysis, Subhi and colleagues systematically reviewed the available literature on their efficacy in the treatment of CSC. The investigative team searched 11 literature databases in December 2022 for any study describing NSAID treatment for CSC.

The analysis required a diagnosis of CSC to be made using a minimum of fundus examination and optical coherence tomography. Investigators considered studies using topical NSAIDs, alone or in combination with other treatments. Overall, a total of 13 eligible studies were included in the study: 13 were eligible for the systematic review and 5 were eligible for the meta-analysis.

Data were collected from a total of 1001 eyes of 994 patients with CSC. The studies were made up of 6 case reports, 2 cohort studies, and 5 non-randomized comparative studies. In studies where specified, topical NSAIDs used were bromfenac 0.09%, diclofenac 0.1%, ketorolac 0.4% and 0.5%, pranprofen 0.1%, and nepafenac 0.1% and 0.3%.

Investigators indicated the studies were predominantly cases with acute CSC and several case studies reported treatment outcomes simultaneously with discontinuation of corticosteroid use, which complicated the evaluation of treatment.

The meta-analysis consisted of 899 patients with CSC, of which 381 received topical NSAID and 518 received no treatment. Baseline BCVA was similar between those treated with topical NSAIDs and the control group (0.02 logMAR [95% CI, –0.01 to 0.06 logMAR]; 

The change in BCVA was slightly improved in those treated with NSAIDs at the 1-month follow-up –0.04 logMAR [95% CI, –0.07 to –0.01 logMAR; 

 = .01) However, the change in BCVA again did not differ significantly between treatment groups at the 3-month follow-up –0.03 logMAR; 95% CI, –0.06 to 0.003 logMAR; 

Regarding anatomic outcomes, investigators observed no significant benefit in complete subretinal fluid resolution at the 1-month follow-up (odds ratio [OR], 1.20 [95% CI, 0.81 – 1.76]; 

 = .37) or at the 3-month follow-up (OR, 1.17 [95% CI, 0.86 to 1.59]; 

“Taken together, available evidence does not support the use of topical NSAIDs for the treatment of CSC,” investigators wrote.

Larsson JME, Boberg-Ans LC, Vangsted A, et al. Topical non-steroidal anti-inflammatory drugs for central serous chorioretinopathy: A systematic review and meta-analysis [published online ahead of print, 2023 Aug 8]. Acta Ophthalmol. 2023;10.1111/aos.15743. doi:10.1111/aos.15743

Sirks, M.J., van Dijk, E.H.C., Rosenberg, N. et al. (2020) Clinical impact of the worldwide shortage of verteporfin (Visudyne®) on ophthalmic care. Acta Ophthalmologica, 100, e1522–e1532.

Bahadorani, S., Maclean, K., Wannamaker, K., Chu, E.R., Gresores, N., Sohn, J.-H. et al. (2019) Treatment of central serous chorioretinopathy with topical NSAIDs. Clinical Ophthalmology, 13, 1543–1548.

The systematic review and meta-analysis of 13 studies found no evidence to support the use of topical NSAIDs for the treatment of central serous chorioretinopathy. 

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Evidence Does Not Support Topical NSAID Use for Central Serous Chorioretinopathy

A counterfactual approach to the ‘life-years gained from screening–computed tomography’ (LYFS-CT) 

 screening model can maintain the model’s accuracy and reduce disparities for African-Americans, according to recent findings, without reducing eligibility for both Hispanic and Asian Americans.

The new findings came from a recent study conducted to determine the most effective strategies that are able to incorporate race and ethnicity into the LYFS-CT lung cancer prediction model, a model recommended by the American College of Chest Physicians for personalizing patients’ shared decision-making in screening for lung cancer.

Screenings for lung cancer involve asymptomatic patients, and the harms of screening for these individuals must not exceed the potential benefits. Merely lowering the eligibility risk- or benefit-thresholds and thus allowing for more minority patients could, consequently, be a bad strategy if those individuals would likely not benefit.

Current guidelines usually recommend 5 - 10 years minimum life expectancy in order to prevent those more likely to die from comorbid conditions to be negatively affected.

 That said, some racial groups often lack access to health care and preventing them may unjustly penalize those projected to have lower life expectancy only due to their race or ethnicity.

The new research into the LYFS-CT model was conducted to address this, and it was led by Rebecca Landy, PhD, from the Division of Cancer Epidemiology and Genetics at the National Cancer Institute in Bethesda, Maryland.

“LYFS-CT is particularly interesting to examine from the perspective of fairness because, unlike risk models, it explicitly incorporates life expectancy,” Landy and colleagues wrote. “Here, we examined the effect of different approaches to incorporating race and ethnicity in the LYFS-CT model on screening eligibility for a contemporary representative US population.”

The investigators set out to assess lung cancer screening eligibility within a contemporary representative US population, and they used 2 different approaches. In the first approach, the team refitted the LYFS-CT screening model by excluding patients’ ethnicity and race.

The second approach used by the investigators involved a counterfactual eligibility method which would recalculate life expectancy for racial and ethnic minority patients. It would substitute the White racial group and utilize the higher predicted expectancies of this group to prevent historically disadvantaged racial and ethnic groups from being underserved.

The research team used a comprehensive analysis with 2 submodels within LYFS-CT, and the 2 submodels were recalibrated and then validated without considering patient ethnicity or race. The team’s first submodel looked at risk of cancer death and looked at those drawn from a large clinical trial in the period between 1993 - 2001, with a smoking history (n = 39,180).

The second submodel focused on all-cause mortality among patients, and it was developed through the use of data taken from the National Health Interview Survey (NHIS) from 1997 - 2001. It covered individuals in the age range of 40 - 80 years who may have ever smoked (n = 74,842), and used follow-up data from until the last day of December 2006.

The investigators assessed individuals’ screening eligibility among NHIS participants from 2015 - 2018, in the age range of 50 - 80 years with a history of smoking. The data analysis from the team’s entire study was done between June 2021 and September 2022.

The research team’s primary outcomes were determined to be related to calibration, with comparisons of the LYFS-CT ‘NoRace’ model and the counterfactual approach, with a focus placed on the ratio of expected to observed (E/O) patient outcomes. The team additionally looked at the effects of such approaches on eligibility for screening and predicted the potential rise in life expectancy resulting from screening as estimated by the LYFS-CT model.

Overall, with the team’s NHIS 2015-2018 dataset covering former smokers in the age range of 50 - 80, the elimination of race or ethnicity from the submodels resulted in underestimated risks for lung cancer death and all-cause mortality in African Americans and overestimated mortality risks in those identified as Asian and Hispanic Americans.

Consequently, the investigators found that the LYFS-CT NoRace screening model ended up improving eligibility for Hispanic and Asian Americans by 108% and 73% but reduced it by 39% for African Americans.

They also found that the LYFS-CT using the counterfactual all-cause mortality model was able to better maintain calibration, with the team noting an increase in African American patient eligibility by a rate of 13% without reduction of eligibility for Asian or Hispanic American individuals.

“Race and ethnicity can represent risk pathways, such as environmental factors or other social determinants of health, that are difficult to ascertain in the clinic,” they wrote. “Thoughtful use of race and ethnicity data may account for important historical factors that have led to disparities. Thus, appropriate use of prediction models that include race and ethnicity can provide a powerful tool for reducing disparities.”

Landy R, Gomez I, Caverly TJ, et al. Methods for Using Race and Ethnicity in Prediction Models for Lung Cancer Screening Eligibility. JAMA Netw Open. 2023;6(9):e2331155. doi:10.1001/jamanetworkopen.2023.31155.

Cheung LC﻿, Berg CD﻿, Castle PE﻿, Katki HA﻿, Chaturvedi AK﻿. Life-gained-based versus risk-based selection of smokers for lung cancer screening. Ann Intern Med. 2019;171(9):623-632. doi:10.7326/M19-1263.

Wilt TJ﻿, Harris RP﻿, Qaseem A﻿; High Value Care Task Force of the American College of Physicians. Screening for cancer: advice for high-value care from the American College of Physicians.

This new data indicates that there may be potential for clinicians to maintain their typical lung cancer screening model’s accuracy and also reduce racial and ethnic disparities.


Lung Cancer

Specific Use of Race, Ethnicity Data in Screening Model May Reduce Lung Cancer Screening Disparities

Interstitial lung disease is a serious life-limiting condition which can occur in people with rheumatoid arthritis. How does one monitor this condition? Test your knowledge with this quiz.

Rheumatoid Arthritis Quizzes

Rheumatoid Arthritis Quiz: Monitoring ILD in RA

Abigail Brooks is an assistant editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Although intervention increased HCV RNA testing compared to patients in the standard of care group, treatment uptake was unaffected.

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CONNECT Study: Intervention Improves HCV Testing, But Not Treatment

A review of Japan post-marketing data support the biosimilar in use for psoriasis, rheumatoid arthritis, Crohn's disease and ulcerative colitis.

Infliximab Biosimilar CT-P13 Provides Consistent Safety, Efficacy Across 4 Diseases

Biosimilar infliximab-dyyb proves successful in achieving and maintaining the control of non-infectious uveitis in the study cohort. 

Infliximab Biosimilar Maintains Inflammation Control in Non-Infectious Uveitis

A network meta-analysis lends "compelling" support to the practice of switching patients with RA from biologics to less costly biosimilars at 6 months.

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Switch from TNF Inhibitors to Biosimilars Provides Consistent Rheumatoid Arthritis Outcomes

This new research concluded that the unclear nature of safety outcomes indicated additional research and enhanced monitoring of patients’ adverse events may be necessary.


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Post-COVID 19 Rehabilitation Interventions May Lead to Improvements, Further Research Needed

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Nehad Soloman, MD, believes acknowledging the cultural and social dynamics impacting patients' healthcare decisions and establishing a personal connection with patients can help overcome initial barriers to care.

Lupus

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Nehad Soloman, MD: Addressing Health Disparities in Rheumatology

Artifical intelligence use is growing across medicine. From imaging to chatbots, ophthalmology is the center of one of these transformations.

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Geographic Atrophy

Seeing is Believing: The Role of Artificial Intelligence in Ophthalmology

This retrospective study from Japan highlighted several key elements linked to a generalized pustular psoriasis diagnosis among individuals with psoriasis vulgaris.


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Psoriatic Arthritis, Tonsillitis Among Most Common Comorbidities Linked to Generalized Pustular Psoriasis

Patients with fibromyalgia receiving CBT experienced significant improvements in pain interference and larger decreases in pain catastrophizing post-treatment.

Fibromyalgia

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CBT Reduces Pain Catastrophizing Post-Treatment in Fibromyalgia

Patrick Campbell is the managing editor of HCPLive. Formerly the editorial lead of Endocrinology Network, Practical Cardiology, and Rheumatology Network, Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. He now helps to lead coverage in each of these respective areas for HCPLive. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter with the Pocono Record in Stroudsburg, PA, and Star News Group in Manasquan, NJ. He also touts experience in multimedia, having spent time as a multimedia specialist with NJ Advance Media and multimedia coordinator at the Pocono Record. Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

Elevated serum endotrophin levels, but not urinary endotrophin levels, predict increased risk of kidney complications and mortality in type 1 diabetes.

Type 1 Diabetes

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Latest News

Itch, Scratching Behavior Most Influential on Quality of Life for Individuals with Prurigo Nodularis

Survey Reveals Adalimumab-atto Maintains Leadership in US Adalimumab Biosimilars Market

Evidence Does Not Support Topical NSAID Use for Central Serous Chorioretinopathy

Specific Use of Race, Ethnicity Data in Screening Model May Reduce Lung Cancer Screening Disparities

Rheumatoid Arthritis Quiz: Monitoring ILD in RA