Key clinical point: Levels of certain proteins found in the blood plasma affected the risk for development of psoriatic arthritis (PsA) and could serve as potential therapeutic targets for the condition.

Major finding: Apolipoprotein F increased the risk for PsA by 60% (odds ratio [OR] 1.69; P_FDR < .001), whereas interleukin-10 reduced the risk for PsA by 40% (OR 0.60; P_FDR = .034). Other proteins associated with an increased risk for PsA included tumor necrosis factor, V-type proton ATPase subunit G 2, receptor-type tyrosine protein phosphatase F, and septin-8.

Study details: This two-sample Mendelian randomization analysis included the data of 3537 patients with PsA and 262,844 control individuals without PsA from the FinnGen study and the data of 1837 unique plasma proteins from a genome-wide association study within the UK Biobank Pharma Proteomics Project.

Disclosures: This study was supported by the Natural Science Foundation of Guangxi Province and the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Zhao H, Zhou Y, Wang Z, Zhang X, Chen L, Hong Z. Plasma proteins and psoriatic arthritis: A proteome-wide Mendelian randomization study. Front Immunol. 15:1417564 (July 3). Doi: 10.3389/fimmu.2024.1417564 Source

Key clinical point: Levels of certain proteins found in the blood plasma affected the risk for development of psoriatic arthritis (PsA) and could serve as potential therapeutic targets for the condition.

Major finding: Apolipoprotein F increased the risk for PsA by 60% (odds ratio [OR] 1.69; P_FDR < .001), whereas interleukin-10 reduced the risk for PsA by 40% (OR 0.60; P_FDR = .034). Other proteins associated with an increased risk for PsA included tumor necrosis factor, V-type proton ATPase subunit G 2, receptor-type tyrosine protein phosphatase F, and septin-8.

Study details: This two-sample Mendelian randomization analysis included the data of 3537 patients with PsA and 262,844 control individuals without PsA from the FinnGen study and the data of 1837 unique plasma proteins from a genome-wide association study within the UK Biobank Pharma Proteomics Project.

Disclosures: This study was supported by the Natural Science Foundation of Guangxi Province and the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Zhao H, Zhou Y, Wang Z, Zhang X, Chen L, Hong Z. Plasma proteins and psoriatic arthritis: A proteome-wide Mendelian randomization study. Front Immunol. 15:1417564 (July 3). Doi: 10.3389/fimmu.2024.1417564 Source

Key clinical point: Levels of certain proteins found in the blood plasma affected the risk for development of psoriatic arthritis (PsA) and could serve as potential therapeutic targets for the condition.

Major finding: Apolipoprotein F increased the risk for PsA by 60% (odds ratio [OR] 1.69; P_FDR < .001), whereas interleukin-10 reduced the risk for PsA by 40% (OR 0.60; P_FDR = .034). Other proteins associated with an increased risk for PsA included tumor necrosis factor, V-type proton ATPase subunit G 2, receptor-type tyrosine protein phosphatase F, and septin-8.

Study details: This two-sample Mendelian randomization analysis included the data of 3537 patients with PsA and 262,844 control individuals without PsA from the FinnGen study and the data of 1837 unique plasma proteins from a genome-wide association study within the UK Biobank Pharma Proteomics Project.

Disclosures: This study was supported by the Natural Science Foundation of Guangxi Province and the National Natural Science Foundation of China. The authors declared no conflicts of interest.

Source: Zhao H, Zhou Y, Wang Z, Zhang X, Chen L, Hong Z. Plasma proteins and psoriatic arthritis: A proteome-wide Mendelian randomization study. Front Immunol. 15:1417564 (July 3). Doi: 10.3389/fimmu.2024.1417564 Source

Key clinical point: The presence of type 2 diabetes (T2D) and smoking history increased the risk for psoriatic arthritis (PsA) in patients with psoriasis; however, T2D seemed to have a greater impact than smoking history in increasing incidence rate of PsA.

Major finding: The risk for PsA was significantly higher in patients with psoriasis who did vs did not have T2D (hazard ratio [HR] 1.11; 95% CI 1.03-1.20) and in those with vs without smoking history (HR 1.11; 95% CI 1.06-1.17). However, the risk was not significant in patients with psoriasis and T2D with vs without smoking history (HR 1.05; 95% CI 0.92-1.20).

Study details: This retrospective cohort study included patients with psoriasis with or without T2D (n = 42,315 each), those with or without smoking history (n = 74,046 each), and those with T2D with or without smoking history (n = 13,065 each).

Disclosures: This study was funded by the Chung Shan Medical University Hospital research project. The authors declared no conflicts of interest.

Source: Huo A-P, Liao P-L, Leong P-Y, Wei JC-C. From psoriasis to psoriatic arthritis: Epidemiological insights from a retrospective cohort study of 74,046 patients. Front Med. 2024;11:1419722 (June 26). Doi: 10.3389/fmed.2024.1419722 Source

Key clinical point: The presence of type 2 diabetes (T2D) and smoking history increased the risk for psoriatic arthritis (PsA) in patients with psoriasis; however, T2D seemed to have a greater impact than smoking history in increasing incidence rate of PsA.

Major finding: The risk for PsA was significantly higher in patients with psoriasis who did vs did not have T2D (hazard ratio [HR] 1.11; 95% CI 1.03-1.20) and in those with vs without smoking history (HR 1.11; 95% CI 1.06-1.17). However, the risk was not significant in patients with psoriasis and T2D with vs without smoking history (HR 1.05; 95% CI 0.92-1.20).

Study details: This retrospective cohort study included patients with psoriasis with or without T2D (n = 42,315 each), those with or without smoking history (n = 74,046 each), and those with T2D with or without smoking history (n = 13,065 each).

Disclosures: This study was funded by the Chung Shan Medical University Hospital research project. The authors declared no conflicts of interest.

Source: Huo A-P, Liao P-L, Leong P-Y, Wei JC-C. From psoriasis to psoriatic arthritis: Epidemiological insights from a retrospective cohort study of 74,046 patients. Front Med. 2024;11:1419722 (June 26). Doi: 10.3389/fmed.2024.1419722 Source

Key clinical point: The presence of type 2 diabetes (T2D) and smoking history increased the risk for psoriatic arthritis (PsA) in patients with psoriasis; however, T2D seemed to have a greater impact than smoking history in increasing incidence rate of PsA.

Major finding: The risk for PsA was significantly higher in patients with psoriasis who did vs did not have T2D (hazard ratio [HR] 1.11; 95% CI 1.03-1.20) and in those with vs without smoking history (HR 1.11; 95% CI 1.06-1.17). However, the risk was not significant in patients with psoriasis and T2D with vs without smoking history (HR 1.05; 95% CI 0.92-1.20).

Study details: This retrospective cohort study included patients with psoriasis with or without T2D (n = 42,315 each), those with or without smoking history (n = 74,046 each), and those with T2D with or without smoking history (n = 13,065 each).

Disclosures: This study was funded by the Chung Shan Medical University Hospital research project. The authors declared no conflicts of interest.

Source: Huo A-P, Liao P-L, Leong P-Y, Wei JC-C. From psoriasis to psoriatic arthritis: Epidemiological insights from a retrospective cohort study of 74,046 patients. Front Med. 2024;11:1419722 (June 26). Doi: 10.3389/fmed.2024.1419722 Source

Key clinical point: In individuals with vs without psoriatic arthritis (PsA), periodontitis was highly prevalent and negatively affected oral Health-Related Quality of Life (HRQOL).

Major finding: Individuals with vs without PsA were 2.67 times more likely to develop periodontitis (prevalence 57.0% vs 33.1%; odds ratio 2.67; P < .001), which was significantly associated with worsened oral HRQOL (odds ratio 1.92; P < .001). The mean Oral Impacts on Daily Performance scores, indicative of oral HRQOL, were also higher in individuals with vs without PsA (P < .001).

Study details: This case-control study included 86 individuals with PsA, 210 individuals with psoriasis, and 359 control individuals without psoriasis, all age 35-65 years and having ≥ 14 teeth.

Disclosures: This study was supported by the National Council for Scientific and Technological Development - CNPq, Brazil. The authors declared no conflicts of interest.

Source: Costa AA, Cota LOM, Esteves Lima RP, et al. The association between periodontitis and the impact of oral health on the quality of life of individuals with psoriasis and psoriatic arthritis. PLoS One. 2024;19(6):e0301158 (June 25). Doi: 10.1371/journal.pone.0301158 Source

Key clinical point: In individuals with vs without psoriatic arthritis (PsA), periodontitis was highly prevalent and negatively affected oral Health-Related Quality of Life (HRQOL).

Major finding: Individuals with vs without PsA were 2.67 times more likely to develop periodontitis (prevalence 57.0% vs 33.1%; odds ratio 2.67; P < .001), which was significantly associated with worsened oral HRQOL (odds ratio 1.92; P < .001). The mean Oral Impacts on Daily Performance scores, indicative of oral HRQOL, were also higher in individuals with vs without PsA (P < .001).

Study details: This case-control study included 86 individuals with PsA, 210 individuals with psoriasis, and 359 control individuals without psoriasis, all age 35-65 years and having ≥ 14 teeth.

Disclosures: This study was supported by the National Council for Scientific and Technological Development - CNPq, Brazil. The authors declared no conflicts of interest.

Source: Costa AA, Cota LOM, Esteves Lima RP, et al. The association between periodontitis and the impact of oral health on the quality of life of individuals with psoriasis and psoriatic arthritis. PLoS One. 2024;19(6):e0301158 (June 25). Doi: 10.1371/journal.pone.0301158 Source

Key clinical point: In individuals with vs without psoriatic arthritis (PsA), periodontitis was highly prevalent and negatively affected oral Health-Related Quality of Life (HRQOL).

Major finding: Individuals with vs without PsA were 2.67 times more likely to develop periodontitis (prevalence 57.0% vs 33.1%; odds ratio 2.67; P < .001), which was significantly associated with worsened oral HRQOL (odds ratio 1.92; P < .001). The mean Oral Impacts on Daily Performance scores, indicative of oral HRQOL, were also higher in individuals with vs without PsA (P < .001).

Study details: This case-control study included 86 individuals with PsA, 210 individuals with psoriasis, and 359 control individuals without psoriasis, all age 35-65 years and having ≥ 14 teeth.

Disclosures: This study was supported by the National Council for Scientific and Technological Development - CNPq, Brazil. The authors declared no conflicts of interest.

Source: Costa AA, Cota LOM, Esteves Lima RP, et al. The association between periodontitis and the impact of oral health on the quality of life of individuals with psoriasis and psoriatic arthritis. PLoS One. 2024;19(6):e0301158 (June 25). Doi: 10.1371/journal.pone.0301158 Source

Key clinical point: Around 25% patients with psoriatic arthritis (PsA) had a sedentary lifestyle (< 90 min of physical activity per week), with lack of physical activity associated with pain, worsened clinical activity, functionality, and disease impact.

Major finding: Overall, 25.9% of patients had a sedentary lifestyle. Patients with a sedentary vs non-sedentary lifestyle had more enthesitis, fatigue, higher disease activity, greater disease impact, and lower functionality (all P < .05). Sedentary lifestyle was also associated with increased risk for pain (odds ratio 1.5; P < .001).

Study details: This cross-sectional study included 232 patients with PsA aged 18-69 years with no radiographic damage or respiratory or cardiac diseases that limit physical activity.

Disclosures: This study did not receive any financial support. The authors declared no conflicts of interest. During the review, the reviewer declared a shared affiliation, with no collaboration, of the lead author to the handling editor.

Source: Toledano E, Chacón CC, Compán O, et al. Analysis of physical activity in psoriatic arthritis: Relationship with clinical and analytical parameters and comorbidity—description of the sedentary patient. Front Med. 2024;11:1385842 (June 23). Doi: 10.3389/fmed.2024.1385842 Source

Key clinical point: Around 25% patients with psoriatic arthritis (PsA) had a sedentary lifestyle (< 90 min of physical activity per week), with lack of physical activity associated with pain, worsened clinical activity, functionality, and disease impact.

Major finding: Overall, 25.9% of patients had a sedentary lifestyle. Patients with a sedentary vs non-sedentary lifestyle had more enthesitis, fatigue, higher disease activity, greater disease impact, and lower functionality (all P < .05). Sedentary lifestyle was also associated with increased risk for pain (odds ratio 1.5; P < .001).

Study details: This cross-sectional study included 232 patients with PsA aged 18-69 years with no radiographic damage or respiratory or cardiac diseases that limit physical activity.

Disclosures: This study did not receive any financial support. The authors declared no conflicts of interest. During the review, the reviewer declared a shared affiliation, with no collaboration, of the lead author to the handling editor.

Source: Toledano E, Chacón CC, Compán O, et al. Analysis of physical activity in psoriatic arthritis: Relationship with clinical and analytical parameters and comorbidity—description of the sedentary patient. Front Med. 2024;11:1385842 (June 23). Doi: 10.3389/fmed.2024.1385842 Source

Key clinical point: Around 25% patients with psoriatic arthritis (PsA) had a sedentary lifestyle (< 90 min of physical activity per week), with lack of physical activity associated with pain, worsened clinical activity, functionality, and disease impact.

Major finding: Overall, 25.9% of patients had a sedentary lifestyle. Patients with a sedentary vs non-sedentary lifestyle had more enthesitis, fatigue, higher disease activity, greater disease impact, and lower functionality (all P < .05). Sedentary lifestyle was also associated with increased risk for pain (odds ratio 1.5; P < .001).

Study details: This cross-sectional study included 232 patients with PsA aged 18-69 years with no radiographic damage or respiratory or cardiac diseases that limit physical activity.

Disclosures: This study did not receive any financial support. The authors declared no conflicts of interest. During the review, the reviewer declared a shared affiliation, with no collaboration, of the lead author to the handling editor.

Source: Toledano E, Chacón CC, Compán O, et al. Analysis of physical activity in psoriatic arthritis: Relationship with clinical and analytical parameters and comorbidity—description of the sedentary patient. Front Med. 2024;11:1385842 (June 23). Doi: 10.3389/fmed.2024.1385842 Source

Key clinical point: A genetic variant of the IL-13 gene that was designed to mimic the therapeutic effects of interleukin-13 (IL-13) inhibition was associated with an increased risk for psoriatic arthritis (PsA).

Major finding: IL-13 inhibition, genetically mimicked using an IL-13 gene variant was associated with an increased risk for PsA (odds ratio 37.39; P = 1.64×10^-9).

Study details: This two-sample Mendelian randomization study analyzed the data of 563,946 individuals with exposure to IL-13 inhibition while the genetic outcomes were assessed in 3609 patients with PsA and 9192 control individuals without PsA.

Disclosures: This study was supported by the National Institute for Health Research Manchester Biomedical Research Centre, UK. Three authors declared receiving grants, consulting fees, speaker fees, honoraria, or travel support from various sources unrelated to this study. Other authors declared no conflicts of interest.

Source: Zhao SS, Hyrich K, Yiu Z, et al. Genetically proxied IL-13 inhibition is associated with risk of psoriatic disease: Mendelian randomization study. Arthritis Rheumatol. 2024 (July 8). Doi: 10.1002/art.42942 Source

Key clinical point: A genetic variant of the IL-13 gene that was designed to mimic the therapeutic effects of interleukin-13 (IL-13) inhibition was associated with an increased risk for psoriatic arthritis (PsA).

Major finding: IL-13 inhibition, genetically mimicked using an IL-13 gene variant was associated with an increased risk for PsA (odds ratio 37.39; P = 1.64×10^-9).

Study details: This two-sample Mendelian randomization study analyzed the data of 563,946 individuals with exposure to IL-13 inhibition while the genetic outcomes were assessed in 3609 patients with PsA and 9192 control individuals without PsA.

Disclosures: This study was supported by the National Institute for Health Research Manchester Biomedical Research Centre, UK. Three authors declared receiving grants, consulting fees, speaker fees, honoraria, or travel support from various sources unrelated to this study. Other authors declared no conflicts of interest.

Source: Zhao SS, Hyrich K, Yiu Z, et al. Genetically proxied IL-13 inhibition is associated with risk of psoriatic disease: Mendelian randomization study. Arthritis Rheumatol. 2024 (July 8). Doi: 10.1002/art.42942 Source

Key clinical point: A genetic variant of the IL-13 gene that was designed to mimic the therapeutic effects of interleukin-13 (IL-13) inhibition was associated with an increased risk for psoriatic arthritis (PsA).

Major finding: IL-13 inhibition, genetically mimicked using an IL-13 gene variant was associated with an increased risk for PsA (odds ratio 37.39; P = 1.64×10^-9).

Study details: This two-sample Mendelian randomization study analyzed the data of 563,946 individuals with exposure to IL-13 inhibition while the genetic outcomes were assessed in 3609 patients with PsA and 9192 control individuals without PsA.

Disclosures: This study was supported by the National Institute for Health Research Manchester Biomedical Research Centre, UK. Three authors declared receiving grants, consulting fees, speaker fees, honoraria, or travel support from various sources unrelated to this study. Other authors declared no conflicts of interest.

Source: Zhao SS, Hyrich K, Yiu Z, et al. Genetically proxied IL-13 inhibition is associated with risk of psoriatic disease: Mendelian randomization study. Arthritis Rheumatol. 2024 (July 8). Doi: 10.1002/art.42942 Source

Pharmacist Mark Mikhael has lost 50 pounds over the past 12 months. He no longer has diabetes and finds himself “at my ideal body weight,” with his cholesterol below 200 for the first time in 20 years. “I feel fantastic,” he said.

Like millions of others, Mr. Mikhael credits the new class of weight loss drugs. But he isn’t using brand-name Wegovy or Zepbound. Mr. Mikhael, CEO of Orlando, Florida–based Olympia Pharmaceuticals, has been getting by with his own supply: injecting himself with copies of the drugs formulated by his company.

He’s far from alone. Mr. Mikhael and other industry officials estimate that several large compounding pharmacies like his are provisioning up to 2 million American patients with regular doses of semaglutide, the scientific name for Novo Nordisk’s Wegovy, Ozempic, and Rybelsus formulations, or tirzepatide, the active ingredient in Eli Lilly’s Zepbound and Mounjaro.

The drug-making behemoths fiercely oppose that compounding business. Novo Nordisk and Lilly lump the compounders together with Internet cowboys and unregulated medical spas peddling bogus semaglutide, and have high-powered legal teams trying to stop them. Novo Nordisk has filed at least 21 lawsuits nationwide against companies making purported copies of its drugs, said Brianna Kelley, a spokesperson for the company, and urges doctors to avoid them. The Food and Drug Administration (FDA), too, has cautioned about the potential danger of the compounds, and leading obesity medicine groups starkly warn patients against their use.

But this isn’t an illegal black market, though it has shades of gray.

The FDA allows and even encourages compounding pharmacies to produce and sell copycats when a drug is in short supply, and the wildly popular glucagon-like peptide 1 (GLP-1) drugs have enduring shortages — first reported in March 2022 for semaglutide and in December 2022 for tirzepatide. The drugs have registered unprecedented success in weight loss. They are also showing promise against heart, kidney, and liver diseases and are being tested against conditions as diverse as Alzheimer’s disease and drug addiction.

In recent years, the US health care system has come to depend on compounding pharmacies, many of which are run as nonprofits, to plug supply holes of crucial drugs like cancer medicines cisplatin, methotrexate, and 5-fluorouracil.

Most compounded drugs are old, cheap generics. Semaglutide and tirzepatide, on the other hand, are under patent and earn Novo Nordisk and Lilly billions of dollars a year. Sales of the diabetes and weight loss drugs in 2024 made Novo Nordisk Europe’s most valuable company and Lilly the world’s biggest pharmaceutical company.

While the companies can’t keep up with demand, they heatedly dispute the right of compounders to make and sell copies. Lilly spokesperson Kristiane Silva Bello said her company was “deeply concerned” about “serious health risks” from compounded drugs that “should not be on the market.”

Yet marketed they are. Even Hims & Hers Health — the telemedicine prescriber that got its start with erectile dysfunction drugs — is now peddling compounded semaglutide. It ran ads for the drugs during NBA playoff games. (According to a Hunterbrook Media report, Hims & Hers’ semaglutide supplier has faced legal scrutiny.)

The compounded forms are significantly cheaper than the branded drugs. Patients pay about $100-$450 a month, compared with list prices of roughly $1,000-$1,400 for Lilly and Novo Nordisk products.

Five compounders and distributors interviewed for this article said they conduct due diligence on every lot of semaglutide or tirzepatide they buy or produce, upholding standards of purity, sterility, and consistency similar to those practiced in the commercial drug industry. Compounders operate under strict federal and state standards, they noted.

However, the raw materials used in the compounded forms may differ from those produced for Novo Nordisk and Lilly, said GLP-1 coinventor Jens Juul Holst, of the University of Copenhagen, adding that care must be taken in drug production lest it cause potentially harmful immune reactions.

To date, according to FDA spokespeople, reports of side effects from taking compounded versions haven’t raised major alarms. But everyone with knowledge of the industry, including the compounders themselves, worry that a single batch of a poorly made drug could kill or maim people and destroy confidence in their business.

“I liken the compounding industry to the airline industry,” Mr. Mikhael said. “When you have an airline crash, it hurts everybody.”
 

Warnings From the Past

The industry endured just such a catastrophe in 2012, when the New England Compounding Center released a contaminated injectable steroid that killed at least 64 people and harmed hundreds more.

In response, Congress and the FDA had strengthened oversight. Mr. Mikhael’s company is an outsourcing facility, or 503B compounding pharmacy — so-named for a section of the 2013 law that set new requirements for drug compounders. The companies are licensed to make slightly different versions of FDA-approved drugs in response to shortages or a patient’s special needs.

The law created two classes of compounding pharmacies: The FDA regulates the larger 503B compounders with standards like commercial drug companies, while 503A pharmacies make smaller lots of drugs and are largely overseen by state boards of pharmacy.

The 503A facilities also are producing compounded semaglutide and tirzepatide for hundreds of thousands of patients. Like the 503Bs, these operations take the active ingredient, produced as a powder in FDA-registered factories, mostly in China, then reconstitute it with sterile water and an antimicrobial in small glass vials.

Together, the compounding pharmacies may account for up to 30% of the semaglutide sold in the United States, Mr. Mikhael said, although he cautions that is a “wild ballpark figure” since no one, including the FDA, is tracking sales in the industry.

The compounders say the companies should increase production if they’re worried about competition. Like the dozens of other drugs they produce for hospitals and medical practices, the compounders say, the two diet drugs are essential products.

“If you don’t want a 503B facility to make a copy, it’s pretty simple: Don’t go short,” said Lee Rosebush, chair of a trade association for 503B pharmacies. “FDA created this system because these are necessary drugs.”

Novo Nordisk hasn’t specified why it can’t keep up with demand, but the bottleneck apparently lies in the company’s inability to fill and sterilize enough of its special drug auto-injectors, said Evan Seigerman, a managing director at BMO Capital Markets.

The company announced June 24 that it was investing $4.1 billion in new production lines at its Clayton, North Carolina, site. In 2023, the FDA issued a warning over procedural violations at the site and separate cautions at an Indiana facility that Novo Nordisk took over recently.
 

Compounding for Dummies

At least 28 companies, mostly in China, are registered with the FDA to produce or distribute semaglutide. At least half the companies have entered the market in the past 12 months, driving the raw material’s price down by 35%, according to Scott Welch, who runs a 503A pharmacy in Arlington, Virginia.

Compounders can buy powdered semaglutide from some US distributors for less than $4,000 a gram, said Matthew Johnson, president and CEO of distributor Pharma Source Direct. That comes out to as little as $10 per weekly 2.5-microgram dose – not including overhead and other costs.

While Ozempic or Wegovy patients use a Novo Nordisk device to inject the drug, patients using compounded products draw them from a vial with a small needle, like the device diabetics use for insulin.

Some medical practices provide the compounded drug to patients as part of a weight loss package, with markups. In July 2023, Tabitha Ries, a single mother of six who works as a home health care aide in Garfield, Washington, found an online clinic that charged her $1,000 for 3 months of semaglutide along with counseling. She has lost 35 pounds.

She gets the drug from Mindful Weight Loss, a mostly telehealth-based operation led by physician Vivek Gupta, MD, of Manhattan Beach, California. Dr. Gupta said he’s prescribed the weight loss drugs to 1,500 patients, with about 60% using compounded versions from a 503A pharmacy.

He hasn’t seen any essential difference in patients using the branded and compounded forms, although “some people say the compounding is a little less effective,” Dr. Gupta said.

There’s some risk in using the non–FDA-approved product, he acknowledged, and he requires patients to sign an informed consent waiver.

“Nothing in life is without risk, but I would also argue that the status quo is not safe for people who need the medicine and can’t get it,” he said. “They’re constantly triggered by all this food that’s causing their weight to go up and their sugar to go high, increasing their insulin resistance and affecting their limbs and eyes.”

Compounding semaglutide is a helpful sideline for pharmacists like him, Mr. Welch said, especially given the pinch on drug sale revenue that has led many independents to close in recent years. He figures he earns 95% of his revenue from compounding drugs, rather than traditional prescriptions.

It’s important to distinguish compounded semaglutide from unregulated powders sold as “generic Ozempic” and the like, which may be contaminated or counterfeit, said FDA spokesperson Amanda Hils. But since compounded forms of the drug are not FDA approved, those who make, prescribe, or use them also should have “an increased level of responsibility or awareness,” she said.
 

Corporate Battles

Novo Nordisk and Lilly, in lawsuits each company has filed against competitors, say their own testing has found bacteria and other impurities in products made by compounding pharmacies. The companies also report patent infringement, but compounders, pointing to the FDA loophole for drugs in shortage, appear to have defeated that argument for now.

When the FDA removes the drugs from the shortage list, 503B compounders must immediately stop selling them. Smaller compounders may be able to produce their products for a reduced number of patients, said Scott Brunner, CEO of the Alliance for Pharmacy Compounding, which represents 503A compounders.

The evaporation of the compounded drug supply could come as a shock to patients.

“I dread it,” said David Wertheimer, an internist in Franklin Lakes, New Jersey, who prescribes compounded semaglutide to some patients. “People are not going to be able to plunk down a grand every month. A lot of people will go off the drug, and that’s a shame.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Pharmacist Mark Mikhael has lost 50 pounds over the past 12 months. He no longer has diabetes and finds himself “at my ideal body weight,” with his cholesterol below 200 for the first time in 20 years. “I feel fantastic,” he said.

Like millions of others, Mr. Mikhael credits the new class of weight loss drugs. But he isn’t using brand-name Wegovy or Zepbound. Mr. Mikhael, CEO of Orlando, Florida–based Olympia Pharmaceuticals, has been getting by with his own supply: injecting himself with copies of the drugs formulated by his company.

He’s far from alone. Mr. Mikhael and other industry officials estimate that several large compounding pharmacies like his are provisioning up to 2 million American patients with regular doses of semaglutide, the scientific name for Novo Nordisk’s Wegovy, Ozempic, and Rybelsus formulations, or tirzepatide, the active ingredient in Eli Lilly’s Zepbound and Mounjaro.

The drug-making behemoths fiercely oppose that compounding business. Novo Nordisk and Lilly lump the compounders together with Internet cowboys and unregulated medical spas peddling bogus semaglutide, and have high-powered legal teams trying to stop them. Novo Nordisk has filed at least 21 lawsuits nationwide against companies making purported copies of its drugs, said Brianna Kelley, a spokesperson for the company, and urges doctors to avoid them. The Food and Drug Administration (FDA), too, has cautioned about the potential danger of the compounds, and leading obesity medicine groups starkly warn patients against their use.

But this isn’t an illegal black market, though it has shades of gray.

The FDA allows and even encourages compounding pharmacies to produce and sell copycats when a drug is in short supply, and the wildly popular glucagon-like peptide 1 (GLP-1) drugs have enduring shortages — first reported in March 2022 for semaglutide and in December 2022 for tirzepatide. The drugs have registered unprecedented success in weight loss. They are also showing promise against heart, kidney, and liver diseases and are being tested against conditions as diverse as Alzheimer’s disease and drug addiction.

In recent years, the US health care system has come to depend on compounding pharmacies, many of which are run as nonprofits, to plug supply holes of crucial drugs like cancer medicines cisplatin, methotrexate, and 5-fluorouracil.

Most compounded drugs are old, cheap generics. Semaglutide and tirzepatide, on the other hand, are under patent and earn Novo Nordisk and Lilly billions of dollars a year. Sales of the diabetes and weight loss drugs in 2024 made Novo Nordisk Europe’s most valuable company and Lilly the world’s biggest pharmaceutical company.

While the companies can’t keep up with demand, they heatedly dispute the right of compounders to make and sell copies. Lilly spokesperson Kristiane Silva Bello said her company was “deeply concerned” about “serious health risks” from compounded drugs that “should not be on the market.”

Yet marketed they are. Even Hims & Hers Health — the telemedicine prescriber that got its start with erectile dysfunction drugs — is now peddling compounded semaglutide. It ran ads for the drugs during NBA playoff games. (According to a Hunterbrook Media report, Hims & Hers’ semaglutide supplier has faced legal scrutiny.)

The compounded forms are significantly cheaper than the branded drugs. Patients pay about $100-$450 a month, compared with list prices of roughly $1,000-$1,400 for Lilly and Novo Nordisk products.

Five compounders and distributors interviewed for this article said they conduct due diligence on every lot of semaglutide or tirzepatide they buy or produce, upholding standards of purity, sterility, and consistency similar to those practiced in the commercial drug industry. Compounders operate under strict federal and state standards, they noted.

However, the raw materials used in the compounded forms may differ from those produced for Novo Nordisk and Lilly, said GLP-1 coinventor Jens Juul Holst, of the University of Copenhagen, adding that care must be taken in drug production lest it cause potentially harmful immune reactions.

To date, according to FDA spokespeople, reports of side effects from taking compounded versions haven’t raised major alarms. But everyone with knowledge of the industry, including the compounders themselves, worry that a single batch of a poorly made drug could kill or maim people and destroy confidence in their business.

“I liken the compounding industry to the airline industry,” Mr. Mikhael said. “When you have an airline crash, it hurts everybody.”
 

Warnings From the Past

The industry endured just such a catastrophe in 2012, when the New England Compounding Center released a contaminated injectable steroid that killed at least 64 people and harmed hundreds more.

In response, Congress and the FDA had strengthened oversight. Mr. Mikhael’s company is an outsourcing facility, or 503B compounding pharmacy — so-named for a section of the 2013 law that set new requirements for drug compounders. The companies are licensed to make slightly different versions of FDA-approved drugs in response to shortages or a patient’s special needs.

The law created two classes of compounding pharmacies: The FDA regulates the larger 503B compounders with standards like commercial drug companies, while 503A pharmacies make smaller lots of drugs and are largely overseen by state boards of pharmacy.

The 503A facilities also are producing compounded semaglutide and tirzepatide for hundreds of thousands of patients. Like the 503Bs, these operations take the active ingredient, produced as a powder in FDA-registered factories, mostly in China, then reconstitute it with sterile water and an antimicrobial in small glass vials.

Together, the compounding pharmacies may account for up to 30% of the semaglutide sold in the United States, Mr. Mikhael said, although he cautions that is a “wild ballpark figure” since no one, including the FDA, is tracking sales in the industry.

The compounders say the companies should increase production if they’re worried about competition. Like the dozens of other drugs they produce for hospitals and medical practices, the compounders say, the two diet drugs are essential products.

“If you don’t want a 503B facility to make a copy, it’s pretty simple: Don’t go short,” said Lee Rosebush, chair of a trade association for 503B pharmacies. “FDA created this system because these are necessary drugs.”

Novo Nordisk hasn’t specified why it can’t keep up with demand, but the bottleneck apparently lies in the company’s inability to fill and sterilize enough of its special drug auto-injectors, said Evan Seigerman, a managing director at BMO Capital Markets.

The company announced June 24 that it was investing $4.1 billion in new production lines at its Clayton, North Carolina, site. In 2023, the FDA issued a warning over procedural violations at the site and separate cautions at an Indiana facility that Novo Nordisk took over recently.
 

Compounding for Dummies

At least 28 companies, mostly in China, are registered with the FDA to produce or distribute semaglutide. At least half the companies have entered the market in the past 12 months, driving the raw material’s price down by 35%, according to Scott Welch, who runs a 503A pharmacy in Arlington, Virginia.

Compounders can buy powdered semaglutide from some US distributors for less than $4,000 a gram, said Matthew Johnson, president and CEO of distributor Pharma Source Direct. That comes out to as little as $10 per weekly 2.5-microgram dose – not including overhead and other costs.

While Ozempic or Wegovy patients use a Novo Nordisk device to inject the drug, patients using compounded products draw them from a vial with a small needle, like the device diabetics use for insulin.

Some medical practices provide the compounded drug to patients as part of a weight loss package, with markups. In July 2023, Tabitha Ries, a single mother of six who works as a home health care aide in Garfield, Washington, found an online clinic that charged her $1,000 for 3 months of semaglutide along with counseling. She has lost 35 pounds.

She gets the drug from Mindful Weight Loss, a mostly telehealth-based operation led by physician Vivek Gupta, MD, of Manhattan Beach, California. Dr. Gupta said he’s prescribed the weight loss drugs to 1,500 patients, with about 60% using compounded versions from a 503A pharmacy.

He hasn’t seen any essential difference in patients using the branded and compounded forms, although “some people say the compounding is a little less effective,” Dr. Gupta said.

There’s some risk in using the non–FDA-approved product, he acknowledged, and he requires patients to sign an informed consent waiver.

“Nothing in life is without risk, but I would also argue that the status quo is not safe for people who need the medicine and can’t get it,” he said. “They’re constantly triggered by all this food that’s causing their weight to go up and their sugar to go high, increasing their insulin resistance and affecting their limbs and eyes.”

Compounding semaglutide is a helpful sideline for pharmacists like him, Mr. Welch said, especially given the pinch on drug sale revenue that has led many independents to close in recent years. He figures he earns 95% of his revenue from compounding drugs, rather than traditional prescriptions.

It’s important to distinguish compounded semaglutide from unregulated powders sold as “generic Ozempic” and the like, which may be contaminated or counterfeit, said FDA spokesperson Amanda Hils. But since compounded forms of the drug are not FDA approved, those who make, prescribe, or use them also should have “an increased level of responsibility or awareness,” she said.
 

Corporate Battles

Novo Nordisk and Lilly, in lawsuits each company has filed against competitors, say their own testing has found bacteria and other impurities in products made by compounding pharmacies. The companies also report patent infringement, but compounders, pointing to the FDA loophole for drugs in shortage, appear to have defeated that argument for now.

When the FDA removes the drugs from the shortage list, 503B compounders must immediately stop selling them. Smaller compounders may be able to produce their products for a reduced number of patients, said Scott Brunner, CEO of the Alliance for Pharmacy Compounding, which represents 503A compounders.

The evaporation of the compounded drug supply could come as a shock to patients.

“I dread it,” said David Wertheimer, an internist in Franklin Lakes, New Jersey, who prescribes compounded semaglutide to some patients. “People are not going to be able to plunk down a grand every month. A lot of people will go off the drug, and that’s a shame.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Pharmacist Mark Mikhael has lost 50 pounds over the past 12 months. He no longer has diabetes and finds himself “at my ideal body weight,” with his cholesterol below 200 for the first time in 20 years. “I feel fantastic,” he said.

Like millions of others, Mr. Mikhael credits the new class of weight loss drugs. But he isn’t using brand-name Wegovy or Zepbound. Mr. Mikhael, CEO of Orlando, Florida–based Olympia Pharmaceuticals, has been getting by with his own supply: injecting himself with copies of the drugs formulated by his company.

He’s far from alone. Mr. Mikhael and other industry officials estimate that several large compounding pharmacies like his are provisioning up to 2 million American patients with regular doses of semaglutide, the scientific name for Novo Nordisk’s Wegovy, Ozempic, and Rybelsus formulations, or tirzepatide, the active ingredient in Eli Lilly’s Zepbound and Mounjaro.

The drug-making behemoths fiercely oppose that compounding business. Novo Nordisk and Lilly lump the compounders together with Internet cowboys and unregulated medical spas peddling bogus semaglutide, and have high-powered legal teams trying to stop them. Novo Nordisk has filed at least 21 lawsuits nationwide against companies making purported copies of its drugs, said Brianna Kelley, a spokesperson for the company, and urges doctors to avoid them. The Food and Drug Administration (FDA), too, has cautioned about the potential danger of the compounds, and leading obesity medicine groups starkly warn patients against their use.

But this isn’t an illegal black market, though it has shades of gray.

The FDA allows and even encourages compounding pharmacies to produce and sell copycats when a drug is in short supply, and the wildly popular glucagon-like peptide 1 (GLP-1) drugs have enduring shortages — first reported in March 2022 for semaglutide and in December 2022 for tirzepatide. The drugs have registered unprecedented success in weight loss. They are also showing promise against heart, kidney, and liver diseases and are being tested against conditions as diverse as Alzheimer’s disease and drug addiction.

In recent years, the US health care system has come to depend on compounding pharmacies, many of which are run as nonprofits, to plug supply holes of crucial drugs like cancer medicines cisplatin, methotrexate, and 5-fluorouracil.

Most compounded drugs are old, cheap generics. Semaglutide and tirzepatide, on the other hand, are under patent and earn Novo Nordisk and Lilly billions of dollars a year. Sales of the diabetes and weight loss drugs in 2024 made Novo Nordisk Europe’s most valuable company and Lilly the world’s biggest pharmaceutical company.

While the companies can’t keep up with demand, they heatedly dispute the right of compounders to make and sell copies. Lilly spokesperson Kristiane Silva Bello said her company was “deeply concerned” about “serious health risks” from compounded drugs that “should not be on the market.”

Yet marketed they are. Even Hims & Hers Health — the telemedicine prescriber that got its start with erectile dysfunction drugs — is now peddling compounded semaglutide. It ran ads for the drugs during NBA playoff games. (According to a Hunterbrook Media report, Hims & Hers’ semaglutide supplier has faced legal scrutiny.)

The compounded forms are significantly cheaper than the branded drugs. Patients pay about $100-$450 a month, compared with list prices of roughly $1,000-$1,400 for Lilly and Novo Nordisk products.

Five compounders and distributors interviewed for this article said they conduct due diligence on every lot of semaglutide or tirzepatide they buy or produce, upholding standards of purity, sterility, and consistency similar to those practiced in the commercial drug industry. Compounders operate under strict federal and state standards, they noted.

However, the raw materials used in the compounded forms may differ from those produced for Novo Nordisk and Lilly, said GLP-1 coinventor Jens Juul Holst, of the University of Copenhagen, adding that care must be taken in drug production lest it cause potentially harmful immune reactions.

To date, according to FDA spokespeople, reports of side effects from taking compounded versions haven’t raised major alarms. But everyone with knowledge of the industry, including the compounders themselves, worry that a single batch of a poorly made drug could kill or maim people and destroy confidence in their business.

“I liken the compounding industry to the airline industry,” Mr. Mikhael said. “When you have an airline crash, it hurts everybody.”
 

Warnings From the Past

The industry endured just such a catastrophe in 2012, when the New England Compounding Center released a contaminated injectable steroid that killed at least 64 people and harmed hundreds more.

In response, Congress and the FDA had strengthened oversight. Mr. Mikhael’s company is an outsourcing facility, or 503B compounding pharmacy — so-named for a section of the 2013 law that set new requirements for drug compounders. The companies are licensed to make slightly different versions of FDA-approved drugs in response to shortages or a patient’s special needs.

The law created two classes of compounding pharmacies: The FDA regulates the larger 503B compounders with standards like commercial drug companies, while 503A pharmacies make smaller lots of drugs and are largely overseen by state boards of pharmacy.

The 503A facilities also are producing compounded semaglutide and tirzepatide for hundreds of thousands of patients. Like the 503Bs, these operations take the active ingredient, produced as a powder in FDA-registered factories, mostly in China, then reconstitute it with sterile water and an antimicrobial in small glass vials.

Together, the compounding pharmacies may account for up to 30% of the semaglutide sold in the United States, Mr. Mikhael said, although he cautions that is a “wild ballpark figure” since no one, including the FDA, is tracking sales in the industry.

The compounders say the companies should increase production if they’re worried about competition. Like the dozens of other drugs they produce for hospitals and medical practices, the compounders say, the two diet drugs are essential products.

“If you don’t want a 503B facility to make a copy, it’s pretty simple: Don’t go short,” said Lee Rosebush, chair of a trade association for 503B pharmacies. “FDA created this system because these are necessary drugs.”

Novo Nordisk hasn’t specified why it can’t keep up with demand, but the bottleneck apparently lies in the company’s inability to fill and sterilize enough of its special drug auto-injectors, said Evan Seigerman, a managing director at BMO Capital Markets.

The company announced June 24 that it was investing $4.1 billion in new production lines at its Clayton, North Carolina, site. In 2023, the FDA issued a warning over procedural violations at the site and separate cautions at an Indiana facility that Novo Nordisk took over recently.
 

Compounding for Dummies

At least 28 companies, mostly in China, are registered with the FDA to produce or distribute semaglutide. At least half the companies have entered the market in the past 12 months, driving the raw material’s price down by 35%, according to Scott Welch, who runs a 503A pharmacy in Arlington, Virginia.

Compounders can buy powdered semaglutide from some US distributors for less than $4,000 a gram, said Matthew Johnson, president and CEO of distributor Pharma Source Direct. That comes out to as little as $10 per weekly 2.5-microgram dose – not including overhead and other costs.

While Ozempic or Wegovy patients use a Novo Nordisk device to inject the drug, patients using compounded products draw them from a vial with a small needle, like the device diabetics use for insulin.

Some medical practices provide the compounded drug to patients as part of a weight loss package, with markups. In July 2023, Tabitha Ries, a single mother of six who works as a home health care aide in Garfield, Washington, found an online clinic that charged her $1,000 for 3 months of semaglutide along with counseling. She has lost 35 pounds.

She gets the drug from Mindful Weight Loss, a mostly telehealth-based operation led by physician Vivek Gupta, MD, of Manhattan Beach, California. Dr. Gupta said he’s prescribed the weight loss drugs to 1,500 patients, with about 60% using compounded versions from a 503A pharmacy.

He hasn’t seen any essential difference in patients using the branded and compounded forms, although “some people say the compounding is a little less effective,” Dr. Gupta said.

There’s some risk in using the non–FDA-approved product, he acknowledged, and he requires patients to sign an informed consent waiver.

“Nothing in life is without risk, but I would also argue that the status quo is not safe for people who need the medicine and can’t get it,” he said. “They’re constantly triggered by all this food that’s causing their weight to go up and their sugar to go high, increasing their insulin resistance and affecting their limbs and eyes.”

Compounding semaglutide is a helpful sideline for pharmacists like him, Mr. Welch said, especially given the pinch on drug sale revenue that has led many independents to close in recent years. He figures he earns 95% of his revenue from compounding drugs, rather than traditional prescriptions.

It’s important to distinguish compounded semaglutide from unregulated powders sold as “generic Ozempic” and the like, which may be contaminated or counterfeit, said FDA spokesperson Amanda Hils. But since compounded forms of the drug are not FDA approved, those who make, prescribe, or use them also should have “an increased level of responsibility or awareness,” she said.
 

Corporate Battles

Novo Nordisk and Lilly, in lawsuits each company has filed against competitors, say their own testing has found bacteria and other impurities in products made by compounding pharmacies. The companies also report patent infringement, but compounders, pointing to the FDA loophole for drugs in shortage, appear to have defeated that argument for now.

When the FDA removes the drugs from the shortage list, 503B compounders must immediately stop selling them. Smaller compounders may be able to produce their products for a reduced number of patients, said Scott Brunner, CEO of the Alliance for Pharmacy Compounding, which represents 503A compounders.

The evaporation of the compounded drug supply could come as a shock to patients.

“I dread it,” said David Wertheimer, an internist in Franklin Lakes, New Jersey, who prescribes compounded semaglutide to some patients. “People are not going to be able to plunk down a grand every month. A lot of people will go off the drug, and that’s a shame.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Key clinical point: Multimorbidity was present in nearly 50% of patients with psoriatic arthritis (PsA) and significantly affected the physical aspects of their quality of life.

Major finding: Multimorbidity was observed in 50.2% patients, with cardiovascular diseases being the most prevalent comorbidity. Patients with vs without multimorbidity had worsened scores for various 36-Item Short Form Health Survey domains, including bodily pain (34.7 vs 47.5; P < .01), physical functioning (52.1 vs 63.1; P < .01), and ability to perform roles due to physical health problems (28.5 vs 42.8; P < .01).

Study details: This cross-sectional observational study included 267 patients with PsA, age > 18 years.

Disclosures: This study was supported by a grant from the National Centre for Research and Development, Warsaw, Poland. The authors declared no conflicts of interest.

Source: Biedroń G, Wilk M, Nowakowski J, et al. Impact of comorbidities on patient-reported outcomes in psoriatic arthritis: A single centre cohort study. Rheumatol Int. Published online 2024;44:1435-1443. Doi: 10.1007/s00296-024-05632-2 Source

Key clinical point: Multimorbidity was present in nearly 50% of patients with psoriatic arthritis (PsA) and significantly affected the physical aspects of their quality of life.

Major finding: Multimorbidity was observed in 50.2% patients, with cardiovascular diseases being the most prevalent comorbidity. Patients with vs without multimorbidity had worsened scores for various 36-Item Short Form Health Survey domains, including bodily pain (34.7 vs 47.5; P < .01), physical functioning (52.1 vs 63.1; P < .01), and ability to perform roles due to physical health problems (28.5 vs 42.8; P < .01).

Study details: This cross-sectional observational study included 267 patients with PsA, age > 18 years.

Disclosures: This study was supported by a grant from the National Centre for Research and Development, Warsaw, Poland. The authors declared no conflicts of interest.

Source: Biedroń G, Wilk M, Nowakowski J, et al. Impact of comorbidities on patient-reported outcomes in psoriatic arthritis: A single centre cohort study. Rheumatol Int. Published online 2024;44:1435-1443. Doi: 10.1007/s00296-024-05632-2 Source

Key clinical point: Multimorbidity was present in nearly 50% of patients with psoriatic arthritis (PsA) and significantly affected the physical aspects of their quality of life.

Major finding: Multimorbidity was observed in 50.2% patients, with cardiovascular diseases being the most prevalent comorbidity. Patients with vs without multimorbidity had worsened scores for various 36-Item Short Form Health Survey domains, including bodily pain (34.7 vs 47.5; P < .01), physical functioning (52.1 vs 63.1; P < .01), and ability to perform roles due to physical health problems (28.5 vs 42.8; P < .01).

Study details: This cross-sectional observational study included 267 patients with PsA, age > 18 years.

Disclosures: This study was supported by a grant from the National Centre for Research and Development, Warsaw, Poland. The authors declared no conflicts of interest.

Source: Biedroń G, Wilk M, Nowakowski J, et al. Impact of comorbidities on patient-reported outcomes in psoriatic arthritis: A single centre cohort study. Rheumatol Int. Published online 2024;44:1435-1443. Doi: 10.1007/s00296-024-05632-2 Source

Key clinical point: The onset rate of psoriatic arthritis (PsA) in patients with psoriasis was lower with biologics than with methotrexate, with topical therapy being associated with the lowest rate.

Major finding: Treatment with biologics vs methotrexate significantly reduced the risk of developing PsA (adjusted hazard ratio [aHR] 0.46; 95% CI 0.35-0.62); however, biologics were associated with an increased risk of developing PsA when compared to topical therapy (aHR 2.16; 95% CI 1.44-3.24). Prior exposure to at least two biologics (odds ratio [OR] 6.09; P < .001) or methotrexate (OR 1.88; P = .026) was tied to increased PsA risk.

Study details: This retrospective cohort study included 58,671 patients with psoriasis treated with biologics, methotrexate, phototherapy, or topical therapy; patients who received phototherapy or topical therapy did not undergo any prior systemic treatment.

Disclosures: This study was supported by an educational grant from Janssen Pharmaceuticals. Alen Zabotti declared being an editorial board member of Rheumatology and Therapy. The other authors declared no conflicts of interest.

Source: Watad A, Zabotti A, Patt YS, et al. From psoriasis to psoriatic arthritis: Decoding the impact of treatment modalities on the prevention of psoriatic arthritis. Rheumatol Ther. 2024;11:963-976 (June 7). Doi: 10.1007/s40744-024-00680-3 Source

Key clinical point: The onset rate of psoriatic arthritis (PsA) in patients with psoriasis was lower with biologics than with methotrexate, with topical therapy being associated with the lowest rate.

Major finding: Treatment with biologics vs methotrexate significantly reduced the risk of developing PsA (adjusted hazard ratio [aHR] 0.46; 95% CI 0.35-0.62); however, biologics were associated with an increased risk of developing PsA when compared to topical therapy (aHR 2.16; 95% CI 1.44-3.24). Prior exposure to at least two biologics (odds ratio [OR] 6.09; P < .001) or methotrexate (OR 1.88; P = .026) was tied to increased PsA risk.

Study details: This retrospective cohort study included 58,671 patients with psoriasis treated with biologics, methotrexate, phototherapy, or topical therapy; patients who received phototherapy or topical therapy did not undergo any prior systemic treatment.

Disclosures: This study was supported by an educational grant from Janssen Pharmaceuticals. Alen Zabotti declared being an editorial board member of Rheumatology and Therapy. The other authors declared no conflicts of interest.

Source: Watad A, Zabotti A, Patt YS, et al. From psoriasis to psoriatic arthritis: Decoding the impact of treatment modalities on the prevention of psoriatic arthritis. Rheumatol Ther. 2024;11:963-976 (June 7). Doi: 10.1007/s40744-024-00680-3 Source

Key clinical point: The onset rate of psoriatic arthritis (PsA) in patients with psoriasis was lower with biologics than with methotrexate, with topical therapy being associated with the lowest rate.

Major finding: Treatment with biologics vs methotrexate significantly reduced the risk of developing PsA (adjusted hazard ratio [aHR] 0.46; 95% CI 0.35-0.62); however, biologics were associated with an increased risk of developing PsA when compared to topical therapy (aHR 2.16; 95% CI 1.44-3.24). Prior exposure to at least two biologics (odds ratio [OR] 6.09; P < .001) or methotrexate (OR 1.88; P = .026) was tied to increased PsA risk.

Study details: This retrospective cohort study included 58,671 patients with psoriasis treated with biologics, methotrexate, phototherapy, or topical therapy; patients who received phototherapy or topical therapy did not undergo any prior systemic treatment.

Disclosures: This study was supported by an educational grant from Janssen Pharmaceuticals. Alen Zabotti declared being an editorial board member of Rheumatology and Therapy. The other authors declared no conflicts of interest.

Source: Watad A, Zabotti A, Patt YS, et al. From psoriasis to psoriatic arthritis: Decoding the impact of treatment modalities on the prevention of psoriatic arthritis. Rheumatol Ther. 2024;11:963-976 (June 7). Doi: 10.1007/s40744-024-00680-3 Source

Key clinical point: Patients with psoriatic arthritis (PsA) who did vs did not have Achilles tendon (AT) pain reported severe functional impairment and disability.

Major finding: Patients with PsA with vs without AT pain had significantly greater AT-related morning stiffness (90.9% vs 9.1%; P < .001), impaired AT function (median heel raise repetition rate 0.72 vs 1.24; P = .005), worse Psoriatic Arthritis Impact of Disease questionnaire score (mean 5.52 vs 3.38; P = .018), and pain on passive dorsiflexion (36.4% vs 0%; P = .011) and resisted plantarflexion (45.5% vs 0%; P = .003).

Study details: This cross-sectional, observational study included 22 patients with PsA with (n = 11) and without (n = 11) self-reported AT pain and 11 healthy individuals without PsA or AT pain.

Disclosures: This study was funded by a Glasgow (UK) Caledonian University-funded PhD studentship. The authors declared no conflicts of interest.

Source: Patience A, Steultjens M, Siebert S, Hendry G. Significant functional impairment and disability in individuals with psoriatic arthritis and Achilles tendon pain: A cross-sectional observational study. Rheumatol Int. 2024;44:1469-1479 (June 8). Doi: 10.1007/s00296-024-05629-x Source

Key clinical point: Patients with psoriatic arthritis (PsA) who did vs did not have Achilles tendon (AT) pain reported severe functional impairment and disability.

Major finding: Patients with PsA with vs without AT pain had significantly greater AT-related morning stiffness (90.9% vs 9.1%; P < .001), impaired AT function (median heel raise repetition rate 0.72 vs 1.24; P = .005), worse Psoriatic Arthritis Impact of Disease questionnaire score (mean 5.52 vs 3.38; P = .018), and pain on passive dorsiflexion (36.4% vs 0%; P = .011) and resisted plantarflexion (45.5% vs 0%; P = .003).

Study details: This cross-sectional, observational study included 22 patients with PsA with (n = 11) and without (n = 11) self-reported AT pain and 11 healthy individuals without PsA or AT pain.

Disclosures: This study was funded by a Glasgow (UK) Caledonian University-funded PhD studentship. The authors declared no conflicts of interest.

Source: Patience A, Steultjens M, Siebert S, Hendry G. Significant functional impairment and disability in individuals with psoriatic arthritis and Achilles tendon pain: A cross-sectional observational study. Rheumatol Int. 2024;44:1469-1479 (June 8). Doi: 10.1007/s00296-024-05629-x Source

Key clinical point: Patients with psoriatic arthritis (PsA) who did vs did not have Achilles tendon (AT) pain reported severe functional impairment and disability.

Major finding: Patients with PsA with vs without AT pain had significantly greater AT-related morning stiffness (90.9% vs 9.1%; P < .001), impaired AT function (median heel raise repetition rate 0.72 vs 1.24; P = .005), worse Psoriatic Arthritis Impact of Disease questionnaire score (mean 5.52 vs 3.38; P = .018), and pain on passive dorsiflexion (36.4% vs 0%; P = .011) and resisted plantarflexion (45.5% vs 0%; P = .003).

Study details: This cross-sectional, observational study included 22 patients with PsA with (n = 11) and without (n = 11) self-reported AT pain and 11 healthy individuals without PsA or AT pain.

Disclosures: This study was funded by a Glasgow (UK) Caledonian University-funded PhD studentship. The authors declared no conflicts of interest.

Source: Patience A, Steultjens M, Siebert S, Hendry G. Significant functional impairment and disability in individuals with psoriatic arthritis and Achilles tendon pain: A cross-sectional observational study. Rheumatol Int. 2024;44:1469-1479 (June 8). Doi: 10.1007/s00296-024-05629-x Source

Key clinical point: The risk of developing psoriatic arthritis (PsA) varied across different manifestations of psoriasis, with psoriasis vulgaris posing the highest risk.

Major finding: Compared with control individuals without psoriasis, patients with psoriasis vulgaris had the highest risk for incident PsA (hazard ratio [HR] 87.7; P < .0001), followed by those with generalized pustular psoriasis (HR 26.8; P < .0001) and pustulosis palmoplantaris (HR 15.3; P < .0001). The risk for PsA was marginally elevated in female vs male patients with psoriasis vulgaris (HR 1.1; P = .002).

Study details: This population-based retrospective cohort study included patients with psoriasis vulgaris (n = 35,281), pustulosis palmoplantaris (n = 9639), or generalized pustular psoriasis (n = 2281) who were propensity-score matched with an equal number of control individuals without psoriasis.

Disclosures: This study was funded by the Cluster of Excellence "Precision Medicine in Chronic Inflammation" (Deutsche Forschungsgemeinschaft) and other sources. Some authors declared having ties with various sources or serving as editorial board members for Frontiers.

Source: Gershater B, Bieber K, Vorobyev A, et al. Differential risks of psoriatic arthritis development in patients with varied psoriasis manifestations: A sex- and ethnicity-specific analysis. Front Med. 2024;11:1385491 (June 20). Doi: 10.3389/fmed.2024.1385491 Source

Key clinical point: The risk of developing psoriatic arthritis (PsA) varied across different manifestations of psoriasis, with psoriasis vulgaris posing the highest risk.

Major finding: Compared with control individuals without psoriasis, patients with psoriasis vulgaris had the highest risk for incident PsA (hazard ratio [HR] 87.7; P < .0001), followed by those with generalized pustular psoriasis (HR 26.8; P < .0001) and pustulosis palmoplantaris (HR 15.3; P < .0001). The risk for PsA was marginally elevated in female vs male patients with psoriasis vulgaris (HR 1.1; P = .002).

Study details: This population-based retrospective cohort study included patients with psoriasis vulgaris (n = 35,281), pustulosis palmoplantaris (n = 9639), or generalized pustular psoriasis (n = 2281) who were propensity-score matched with an equal number of control individuals without psoriasis.

Disclosures: This study was funded by the Cluster of Excellence "Precision Medicine in Chronic Inflammation" (Deutsche Forschungsgemeinschaft) and other sources. Some authors declared having ties with various sources or serving as editorial board members for Frontiers.

Source: Gershater B, Bieber K, Vorobyev A, et al. Differential risks of psoriatic arthritis development in patients with varied psoriasis manifestations: A sex- and ethnicity-specific analysis. Front Med. 2024;11:1385491 (June 20). Doi: 10.3389/fmed.2024.1385491 Source

Key clinical point: The risk of developing psoriatic arthritis (PsA) varied across different manifestations of psoriasis, with psoriasis vulgaris posing the highest risk.

Major finding: Compared with control individuals without psoriasis, patients with psoriasis vulgaris had the highest risk for incident PsA (hazard ratio [HR] 87.7; P < .0001), followed by those with generalized pustular psoriasis (HR 26.8; P < .0001) and pustulosis palmoplantaris (HR 15.3; P < .0001). The risk for PsA was marginally elevated in female vs male patients with psoriasis vulgaris (HR 1.1; P = .002).

Study details: This population-based retrospective cohort study included patients with psoriasis vulgaris (n = 35,281), pustulosis palmoplantaris (n = 9639), or generalized pustular psoriasis (n = 2281) who were propensity-score matched with an equal number of control individuals without psoriasis.

Disclosures: This study was funded by the Cluster of Excellence "Precision Medicine in Chronic Inflammation" (Deutsche Forschungsgemeinschaft) and other sources. Some authors declared having ties with various sources or serving as editorial board members for Frontiers.

Source: Gershater B, Bieber K, Vorobyev A, et al. Differential risks of psoriatic arthritis development in patients with varied psoriasis manifestations: A sex- and ethnicity-specific analysis. Front Med. 2024;11:1385491 (June 20). Doi: 10.3389/fmed.2024.1385491 Source