Psoriatic Arthritis

Research published during the past month focused mostly on sex differences, biomarkers, and treatment. Sex differences in psoriatic arthritis (PsA) are a significant focus of current research. One major question is how clinical features differ between men and women. Furer and colleagues investigated differences in musculoskeletal ultrasonographic features between men and women with PsA. In a prospective study including 70 men and 88 women, they demonstrated that although the total synovitis and tenosynovitis scores were similar between the two sexes, compared with women, men had higher total ultrasound and gray scale enthesitis scores (both P = .01) and sonographic active inflammatory score (P = .005). Given the uncertainty associated with the clinical diagnosis of enthesitis, this study emphasizes the importance of careful ultrasonographic evaluation when evaluating enthesitis patients, especially women.

It is important to investigate pregnancy outcomes in women with inflammatory arthritis, including PsA, to appropriately counsel and manage patients in the reproductive-age group. Preeclampsia is an important pregnancy outcome that is less well studied in PsA. Secher and colleagues analyzed data from registries in Sweden and Denmark that included singleton pregnant women with rheumatoid arthritis (n = 1739), axial spondyloarthritis (n = 819), and PsA (n = 489) who were matched with 17,390, 8190, and 4890 control pregnant women, respectively. They found that compared with the control women, the risk for preeclampsia was much higher in women with PsA (adjusted odds ratio [aOR; adjusted for country, maternal age, parity, year of delivery, body mass index (BMI), smoking, and education] 1.85; 95% CI 1.10-3.12), with the risk being primarily driven by the receipt of monotherapy for PsA before pregnancy (aOR 2.72; 95% CI 1.44-5.13), probably reflecting the presence of more severe disease. Women with PsA who tend to have higher BMI and active disease need to be counseled about the risk for preeclampsia and be carefully monitored.

The Disease Activity index for PsA (DAPSA) is a validated instrument used in clinical practice to assess PsA disease activity. One drawback of this instrument is that it requires testing for C-reactive protein (CRP), the results of which may not be available immediately, making it difficult to use DAPSA for implementing treating-to-target strategies during a clinic visit. To alleviate this issue, a quick quantitative CRP (qCRP) assay was developed. In a multicenter, cross-sectional study including 104 patients with PsA and available CRP values (measured by routine laboratory and qCRP assays), Proft and colleagues demonstrated that 98.1% of patients were similarly categorized into disease activity groups (remission and low, moderate, and high disease activity) using DAPSA based on qCRP (Q-DAPSA) and DAPSA. The agreement between the two instruments was excellent (weighted Cohen kappa 0.980; 95% CI 0.952-1.000). Thus, the Q-DAPSA may be used in place of DAPSA when evaluating PsA disease activity.

Regarding treatment, in an exploratory analysis of SELECT-PsA 1, McInnes and colleagues demonstrated that, at week 104, a similar proportion of patients receiving 15/30 mg upadacitinib vs adalimumab achieved ≥ 20% improvement in the American College of Rheumatology (ACR20) criteria (69.0%/69.5% vs 63.4%), whereas significantly more patients receiving 30 mg upadacitinib vs adalimumab achieved minimal disease activity (45.9% vs 37.8%; P < .05). The safety profiles of upadacitinib and adalimumab were comparable. Moreover, analyses of 52-week outcome data from the ongoing phase 3 KEEPsAKE 1 study of risankizumab (IL-23 inhibitor) by Kristensen and colleagues showed that among patients who received risankizumab continuously, the ACR20 response increased from 57.3% at week 24 to 70.0% at week 52. No new safety signals were identified. Thus, upadacitinib and risankizumab are newer, safe, and effective disease-modifying antirheumatic drugs for PsA.

Research published during the past month focused mostly on sex differences, biomarkers, and treatment. Sex differences in psoriatic arthritis (PsA) are a significant focus of current research. One major question is how clinical features differ between men and women. Furer and colleagues investigated differences in musculoskeletal ultrasonographic features between men and women with PsA. In a prospective study including 70 men and 88 women, they demonstrated that although the total synovitis and tenosynovitis scores were similar between the two sexes, compared with women, men had higher total ultrasound and gray scale enthesitis scores (both P = .01) and sonographic active inflammatory score (P = .005). Given the uncertainty associated with the clinical diagnosis of enthesitis, this study emphasizes the importance of careful ultrasonographic evaluation when evaluating enthesitis patients, especially women.

It is important to investigate pregnancy outcomes in women with inflammatory arthritis, including PsA, to appropriately counsel and manage patients in the reproductive-age group. Preeclampsia is an important pregnancy outcome that is less well studied in PsA. Secher and colleagues analyzed data from registries in Sweden and Denmark that included singleton pregnant women with rheumatoid arthritis (n = 1739), axial spondyloarthritis (n = 819), and PsA (n = 489) who were matched with 17,390, 8190, and 4890 control pregnant women, respectively. They found that compared with the control women, the risk for preeclampsia was much higher in women with PsA (adjusted odds ratio [aOR; adjusted for country, maternal age, parity, year of delivery, body mass index (BMI), smoking, and education] 1.85; 95% CI 1.10-3.12), with the risk being primarily driven by the receipt of monotherapy for PsA before pregnancy (aOR 2.72; 95% CI 1.44-5.13), probably reflecting the presence of more severe disease. Women with PsA who tend to have higher BMI and active disease need to be counseled about the risk for preeclampsia and be carefully monitored.

The Disease Activity index for PsA (DAPSA) is a validated instrument used in clinical practice to assess PsA disease activity. One drawback of this instrument is that it requires testing for C-reactive protein (CRP), the results of which may not be available immediately, making it difficult to use DAPSA for implementing treating-to-target strategies during a clinic visit. To alleviate this issue, a quick quantitative CRP (qCRP) assay was developed. In a multicenter, cross-sectional study including 104 patients with PsA and available CRP values (measured by routine laboratory and qCRP assays), Proft and colleagues demonstrated that 98.1% of patients were similarly categorized into disease activity groups (remission and low, moderate, and high disease activity) using DAPSA based on qCRP (Q-DAPSA) and DAPSA. The agreement between the two instruments was excellent (weighted Cohen kappa 0.980; 95% CI 0.952-1.000). Thus, the Q-DAPSA may be used in place of DAPSA when evaluating PsA disease activity.

Regarding treatment, in an exploratory analysis of SELECT-PsA 1, McInnes and colleagues demonstrated that, at week 104, a similar proportion of patients receiving 15/30 mg upadacitinib vs adalimumab achieved ≥ 20% improvement in the American College of Rheumatology (ACR20) criteria (69.0%/69.5% vs 63.4%), whereas significantly more patients receiving 30 mg upadacitinib vs adalimumab achieved minimal disease activity (45.9% vs 37.8%; P < .05). The safety profiles of upadacitinib and adalimumab were comparable. Moreover, analyses of 52-week outcome data from the ongoing phase 3 KEEPsAKE 1 study of risankizumab (IL-23 inhibitor) by Kristensen and colleagues showed that among patients who received risankizumab continuously, the ACR20 response increased from 57.3% at week 24 to 70.0% at week 52. No new safety signals were identified. Thus, upadacitinib and risankizumab are newer, safe, and effective disease-modifying antirheumatic drugs for PsA.

Research published during the past month focused mostly on sex differences, biomarkers, and treatment. Sex differences in psoriatic arthritis (PsA) are a significant focus of current research. One major question is how clinical features differ between men and women. Furer and colleagues investigated differences in musculoskeletal ultrasonographic features between men and women with PsA. In a prospective study including 70 men and 88 women, they demonstrated that although the total synovitis and tenosynovitis scores were similar between the two sexes, compared with women, men had higher total ultrasound and gray scale enthesitis scores (both P = .01) and sonographic active inflammatory score (P = .005). Given the uncertainty associated with the clinical diagnosis of enthesitis, this study emphasizes the importance of careful ultrasonographic evaluation when evaluating enthesitis patients, especially women.

It is important to investigate pregnancy outcomes in women with inflammatory arthritis, including PsA, to appropriately counsel and manage patients in the reproductive-age group. Preeclampsia is an important pregnancy outcome that is less well studied in PsA. Secher and colleagues analyzed data from registries in Sweden and Denmark that included singleton pregnant women with rheumatoid arthritis (n = 1739), axial spondyloarthritis (n = 819), and PsA (n = 489) who were matched with 17,390, 8190, and 4890 control pregnant women, respectively. They found that compared with the control women, the risk for preeclampsia was much higher in women with PsA (adjusted odds ratio [aOR; adjusted for country, maternal age, parity, year of delivery, body mass index (BMI), smoking, and education] 1.85; 95% CI 1.10-3.12), with the risk being primarily driven by the receipt of monotherapy for PsA before pregnancy (aOR 2.72; 95% CI 1.44-5.13), probably reflecting the presence of more severe disease. Women with PsA who tend to have higher BMI and active disease need to be counseled about the risk for preeclampsia and be carefully monitored.

The Disease Activity index for PsA (DAPSA) is a validated instrument used in clinical practice to assess PsA disease activity. One drawback of this instrument is that it requires testing for C-reactive protein (CRP), the results of which may not be available immediately, making it difficult to use DAPSA for implementing treating-to-target strategies during a clinic visit. To alleviate this issue, a quick quantitative CRP (qCRP) assay was developed. In a multicenter, cross-sectional study including 104 patients with PsA and available CRP values (measured by routine laboratory and qCRP assays), Proft and colleagues demonstrated that 98.1% of patients were similarly categorized into disease activity groups (remission and low, moderate, and high disease activity) using DAPSA based on qCRP (Q-DAPSA) and DAPSA. The agreement between the two instruments was excellent (weighted Cohen kappa 0.980; 95% CI 0.952-1.000). Thus, the Q-DAPSA may be used in place of DAPSA when evaluating PsA disease activity.

Regarding treatment, in an exploratory analysis of SELECT-PsA 1, McInnes and colleagues demonstrated that, at week 104, a similar proportion of patients receiving 15/30 mg upadacitinib vs adalimumab achieved ≥ 20% improvement in the American College of Rheumatology (ACR20) criteria (69.0%/69.5% vs 63.4%), whereas significantly more patients receiving 30 mg upadacitinib vs adalimumab achieved minimal disease activity (45.9% vs 37.8%; P < .05). The safety profiles of upadacitinib and adalimumab were comparable. Moreover, analyses of 52-week outcome data from the ongoing phase 3 KEEPsAKE 1 study of risankizumab (IL-23 inhibitor) by Kristensen and colleagues showed that among patients who received risankizumab continuously, the ACR20 response increased from 57.3% at week 24 to 70.0% at week 52. No new safety signals were identified. Thus, upadacitinib and risankizumab are newer, safe, and effective disease-modifying antirheumatic drugs for PsA.

Competition between five biologic drugs and their skinny-label biosimilars saved Medicare an estimated $1.5 billion during 2015-2020. But these savings accruing to Medicare and the availability of those and other biosimilars through skinny labeling is under threat from recent court rulings, according to a research letter published online in JAMA Internal Medicine.

The authors highlighted the need for such savings by noting that, while biologics comprise less than 5% of prescription drug use, their price tag amounts to about 40% of U.S. drug spending, Biologic manufacturers often delay the availability of biosimilars for additional years beyond the original patent expiration through further patents for supplemental indications. To provide a counterbalance, federal law allows the Food and Drug Administration to approve “skinny-label” generics and biosimilars that carve out patent-protected indications or regulatory exclusivities. But once a generic drug reaches the market through this process with a skinny label, it may often be substituted for indications that go beyond the ones listed on the skinny label. In fact, some state laws mandate that pharmacists substitute interchangeable generics for brand-name drugs, helping to decrease drug prices. In response to legal threats to the skinny-label pathway, Alexander C. Egilman and colleagues at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, assessed the frequency of approval and marketing of skinny-label biosimilars from 2015 to 2021 and the resultant savings to Medicare.

TheaDesign/Thinkstock

The authors estimated annual Part B (clinician-administered) savings from skinny-label biosimilars through 2020 by comparing actual biologic and skinny-label biosimilar spending with estimated biologic spending without competition using the Medicare Dashboard. They assumed that the unit price of the biologic would increase at its 5-year compound annual growth rate prior to competition.

In that period, the FDA approved 33 biosimilars linked to 11 biologics. Among them, 22 (66.7%) had a skinny label. Of 21 biosimilars marketed before 2022, 13 (61.9%) were launched with a skinny label. Of the 8 biologics linked to these 21 biosimilars, 5 of the first-to-market biosimilars had skinny labels (bevacizumab, filgrastim, infliximab, pegfilgrastim, and rituximab), leading to earlier competition through 2021.

The estimated $1.5 billion in savings to Medicare from these skinny-label biosimilars over the 2015-2020 span represents 4.9% of the $30.2 billion that Medicare spent on the five biologics during this period. The researchers pointed out that once adalimumab (Humira) faces skinny-label biosimilar competition in 2023, savings will likely grow substantially.

In response to the research letter, an editor’s note by JAMA Internal Medicine Editorial Fellow Eric Ward, MD, and JAMA Internal Medicine Editor at Large and Online Editor Robert Steinbrook, MD, stated that, between 2015 and 2019, 24 (43%) of 56 brand-name drugs had competition from skinny-labeled generic formulations after first becoming available as generics.

The editors also referenced a JAMA Viewpoints article from 2021 that reviewed the most recent case challenging the skinny-label pathway in which GlaxoSmithKline sued Teva for its marketing of a skinny-label generic of the brand-name beta-blocker carvedilol (Coreg) that the plaintive claimed “induced physicians to prescribe carvedilol for indications that had been carved out by Teva’s skinny label, thus infringing GlaxoSmithKline’s patents.” A $235 million judgment against Teva was overturned by a district court and then reversed again by a Federal Circuit court that, after receiving criticism, reconsidered the case, and a panel affirmed the judgment against Teva.

“The Federal Circuit panel’s decision has the potential to put generic drugs that fail to adequately carve out indications from the brand name labeling at risk for damages related to infringement,” the authors wrote. Similar claims of infringement are being heard in other courts, they wrote, and they urged careful targeting of skinny-label carveouts, and suggest also that challenges to the arguments used against Teva focus on preservation of First Amendment rights as protection for lawful and accurate speech in drug labels.

“The legal uncertainties are likely to continue, as manufacturers pursue novel and complex strategies to protect the patents and regulatory exclusivities of brand-name drugs and biologics,” Dr. Ward and Dr. Steinbrook wrote, adding that “the path forward is for Congress to enact additional legislation that reaffirms and strengthens the permissibility of skinny labeling.”

The research letter’s corresponding author, Ameet Sarpatwari, PhD, JD, assistant professor at Harvard Medical School, and assistant director for the Harvard Program On Regulation, Therapeutics, And Law, echoed concerns over the Teva case in an interview. “There has certainly been concern that should the appellate decision stand, there will be a chilling effect. As the lone dissenter in that case noted, ‘no skinny-label generic is safe.’ I think many generic and biosimilar manufacturers are awaiting to see whether the Supreme Court will take the case.”

He added: “I do not believe the likelihood of skinny-label-supportive legislation making it through Congress will be greatly diminished in a divided Congress. Democrats and Republicans alike should seek to promote competition in the marketplace, which is what the skinny-labeling pathway accomplishes.”

The authors reported no relevant conflicts of interest. The research was funded by a grant from Arnold Ventures.

Competition between five biologic drugs and their skinny-label biosimilars saved Medicare an estimated $1.5 billion during 2015-2020. But these savings accruing to Medicare and the availability of those and other biosimilars through skinny labeling is under threat from recent court rulings, according to a research letter published online in JAMA Internal Medicine.

The authors highlighted the need for such savings by noting that, while biologics comprise less than 5% of prescription drug use, their price tag amounts to about 40% of U.S. drug spending, Biologic manufacturers often delay the availability of biosimilars for additional years beyond the original patent expiration through further patents for supplemental indications. To provide a counterbalance, federal law allows the Food and Drug Administration to approve “skinny-label” generics and biosimilars that carve out patent-protected indications or regulatory exclusivities. But once a generic drug reaches the market through this process with a skinny label, it may often be substituted for indications that go beyond the ones listed on the skinny label. In fact, some state laws mandate that pharmacists substitute interchangeable generics for brand-name drugs, helping to decrease drug prices. In response to legal threats to the skinny-label pathway, Alexander C. Egilman and colleagues at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, assessed the frequency of approval and marketing of skinny-label biosimilars from 2015 to 2021 and the resultant savings to Medicare.

TheaDesign/Thinkstock

The authors estimated annual Part B (clinician-administered) savings from skinny-label biosimilars through 2020 by comparing actual biologic and skinny-label biosimilar spending with estimated biologic spending without competition using the Medicare Dashboard. They assumed that the unit price of the biologic would increase at its 5-year compound annual growth rate prior to competition.

In that period, the FDA approved 33 biosimilars linked to 11 biologics. Among them, 22 (66.7%) had a skinny label. Of 21 biosimilars marketed before 2022, 13 (61.9%) were launched with a skinny label. Of the 8 biologics linked to these 21 biosimilars, 5 of the first-to-market biosimilars had skinny labels (bevacizumab, filgrastim, infliximab, pegfilgrastim, and rituximab), leading to earlier competition through 2021.

The estimated $1.5 billion in savings to Medicare from these skinny-label biosimilars over the 2015-2020 span represents 4.9% of the $30.2 billion that Medicare spent on the five biologics during this period. The researchers pointed out that once adalimumab (Humira) faces skinny-label biosimilar competition in 2023, savings will likely grow substantially.

In response to the research letter, an editor’s note by JAMA Internal Medicine Editorial Fellow Eric Ward, MD, and JAMA Internal Medicine Editor at Large and Online Editor Robert Steinbrook, MD, stated that, between 2015 and 2019, 24 (43%) of 56 brand-name drugs had competition from skinny-labeled generic formulations after first becoming available as generics.

The editors also referenced a JAMA Viewpoints article from 2021 that reviewed the most recent case challenging the skinny-label pathway in which GlaxoSmithKline sued Teva for its marketing of a skinny-label generic of the brand-name beta-blocker carvedilol (Coreg) that the plaintive claimed “induced physicians to prescribe carvedilol for indications that had been carved out by Teva’s skinny label, thus infringing GlaxoSmithKline’s patents.” A $235 million judgment against Teva was overturned by a district court and then reversed again by a Federal Circuit court that, after receiving criticism, reconsidered the case, and a panel affirmed the judgment against Teva.

“The Federal Circuit panel’s decision has the potential to put generic drugs that fail to adequately carve out indications from the brand name labeling at risk for damages related to infringement,” the authors wrote. Similar claims of infringement are being heard in other courts, they wrote, and they urged careful targeting of skinny-label carveouts, and suggest also that challenges to the arguments used against Teva focus on preservation of First Amendment rights as protection for lawful and accurate speech in drug labels.

“The legal uncertainties are likely to continue, as manufacturers pursue novel and complex strategies to protect the patents and regulatory exclusivities of brand-name drugs and biologics,” Dr. Ward and Dr. Steinbrook wrote, adding that “the path forward is for Congress to enact additional legislation that reaffirms and strengthens the permissibility of skinny labeling.”

The research letter’s corresponding author, Ameet Sarpatwari, PhD, JD, assistant professor at Harvard Medical School, and assistant director for the Harvard Program On Regulation, Therapeutics, And Law, echoed concerns over the Teva case in an interview. “There has certainly been concern that should the appellate decision stand, there will be a chilling effect. As the lone dissenter in that case noted, ‘no skinny-label generic is safe.’ I think many generic and biosimilar manufacturers are awaiting to see whether the Supreme Court will take the case.”

He added: “I do not believe the likelihood of skinny-label-supportive legislation making it through Congress will be greatly diminished in a divided Congress. Democrats and Republicans alike should seek to promote competition in the marketplace, which is what the skinny-labeling pathway accomplishes.”

The authors reported no relevant conflicts of interest. The research was funded by a grant from Arnold Ventures.

Competition between five biologic drugs and their skinny-label biosimilars saved Medicare an estimated $1.5 billion during 2015-2020. But these savings accruing to Medicare and the availability of those and other biosimilars through skinny labeling is under threat from recent court rulings, according to a research letter published online in JAMA Internal Medicine.

The authors highlighted the need for such savings by noting that, while biologics comprise less than 5% of prescription drug use, their price tag amounts to about 40% of U.S. drug spending, Biologic manufacturers often delay the availability of biosimilars for additional years beyond the original patent expiration through further patents for supplemental indications. To provide a counterbalance, federal law allows the Food and Drug Administration to approve “skinny-label” generics and biosimilars that carve out patent-protected indications or regulatory exclusivities. But once a generic drug reaches the market through this process with a skinny label, it may often be substituted for indications that go beyond the ones listed on the skinny label. In fact, some state laws mandate that pharmacists substitute interchangeable generics for brand-name drugs, helping to decrease drug prices. In response to legal threats to the skinny-label pathway, Alexander C. Egilman and colleagues at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, assessed the frequency of approval and marketing of skinny-label biosimilars from 2015 to 2021 and the resultant savings to Medicare.

TheaDesign/Thinkstock

The authors estimated annual Part B (clinician-administered) savings from skinny-label biosimilars through 2020 by comparing actual biologic and skinny-label biosimilar spending with estimated biologic spending without competition using the Medicare Dashboard. They assumed that the unit price of the biologic would increase at its 5-year compound annual growth rate prior to competition.

In that period, the FDA approved 33 biosimilars linked to 11 biologics. Among them, 22 (66.7%) had a skinny label. Of 21 biosimilars marketed before 2022, 13 (61.9%) were launched with a skinny label. Of the 8 biologics linked to these 21 biosimilars, 5 of the first-to-market biosimilars had skinny labels (bevacizumab, filgrastim, infliximab, pegfilgrastim, and rituximab), leading to earlier competition through 2021.

The estimated $1.5 billion in savings to Medicare from these skinny-label biosimilars over the 2015-2020 span represents 4.9% of the $30.2 billion that Medicare spent on the five biologics during this period. The researchers pointed out that once adalimumab (Humira) faces skinny-label biosimilar competition in 2023, savings will likely grow substantially.

In response to the research letter, an editor’s note by JAMA Internal Medicine Editorial Fellow Eric Ward, MD, and JAMA Internal Medicine Editor at Large and Online Editor Robert Steinbrook, MD, stated that, between 2015 and 2019, 24 (43%) of 56 brand-name drugs had competition from skinny-labeled generic formulations after first becoming available as generics.

The editors also referenced a JAMA Viewpoints article from 2021 that reviewed the most recent case challenging the skinny-label pathway in which GlaxoSmithKline sued Teva for its marketing of a skinny-label generic of the brand-name beta-blocker carvedilol (Coreg) that the plaintive claimed “induced physicians to prescribe carvedilol for indications that had been carved out by Teva’s skinny label, thus infringing GlaxoSmithKline’s patents.” A $235 million judgment against Teva was overturned by a district court and then reversed again by a Federal Circuit court that, after receiving criticism, reconsidered the case, and a panel affirmed the judgment against Teva.

“The Federal Circuit panel’s decision has the potential to put generic drugs that fail to adequately carve out indications from the brand name labeling at risk for damages related to infringement,” the authors wrote. Similar claims of infringement are being heard in other courts, they wrote, and they urged careful targeting of skinny-label carveouts, and suggest also that challenges to the arguments used against Teva focus on preservation of First Amendment rights as protection for lawful and accurate speech in drug labels.

“The legal uncertainties are likely to continue, as manufacturers pursue novel and complex strategies to protect the patents and regulatory exclusivities of brand-name drugs and biologics,” Dr. Ward and Dr. Steinbrook wrote, adding that “the path forward is for Congress to enact additional legislation that reaffirms and strengthens the permissibility of skinny labeling.”

The research letter’s corresponding author, Ameet Sarpatwari, PhD, JD, assistant professor at Harvard Medical School, and assistant director for the Harvard Program On Regulation, Therapeutics, And Law, echoed concerns over the Teva case in an interview. “There has certainly been concern that should the appellate decision stand, there will be a chilling effect. As the lone dissenter in that case noted, ‘no skinny-label generic is safe.’ I think many generic and biosimilar manufacturers are awaiting to see whether the Supreme Court will take the case.”

He added: “I do not believe the likelihood of skinny-label-supportive legislation making it through Congress will be greatly diminished in a divided Congress. Democrats and Republicans alike should seek to promote competition in the marketplace, which is what the skinny-labeling pathway accomplishes.”

The authors reported no relevant conflicts of interest. The research was funded by a grant from Arnold Ventures.

Rheumatologists tend to order the same types of tests to monitor their patients’ responses to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), but they vary widely in how often they order tests and how they respond to abnormal results, responses to a survey suggest.

“The study found that, although guidelines exist, people didn’t follow them consistently. They also responded to abnormal test results in wildly different ways,” senior study author Philip C. Robinson, MBChB, PhD, of the University of Queensland, Herston, Australia, said in an interview.

“The take-home message of this study is that everyone is doing something different, which means that the system likely has a lot of low-value activity and that money is being wasted,” he added. “However, we don’t have the evidence to guide people to make better choices.”

The literature on laboratory monitoring of people taking csDMARDs for rheumatic disease is scant, the authors wrote in BMC Rheumatology, and current guidelines on csDMARD monitoring vary, likely because of the lack of high-quality evidence for specific monitoring regimens.

“An enormous amount of money is spent on DMARD monitoring with little evidence to support current practices,” Dr. Robinson said. So he and his colleagues asked rheumatologists and rheumatology trainees about their attitudes and practices related to laboratory monitoring of csDMARDs in an online questionnaire.

They used the Australian Rheumatology Association newsletter to invite around 530 Australian rheumatologists and trainees, around 4,500 of Dr. Robinson’s Twitter followers, and 25 Australian and overseas email contacts, to respond to questions about csDMARDs they prescribed, frequency and patterns of monitoring, influences of additional factors and combination therapy, responses to abnormal tests, and attitudes toward monitoring frequency.

The researchers based their questions on csDMARD monitoring guidelines published by the American College of Rheumatology (which recommends monitoring every 2-4 weeks from initiation to 3 months, every 8-12 weeks during months 3-6, and every 12 weeks from 6 months onward), and from the British Society for Rheumatology (whose guidance is similar but bases monitoring frequency on how long DMARD doses remain stable).

The 221 valid responses they collected included 53 from Australia and 39 from the United States. Overall, 53% of respondents were in public practice, 56% were women, and 56% had practiced rheumatology for 11 or more years.

Respondents reported more frequent monitoring of patients with multiple comorbidities and those taking csDMARD combinations, including methotrexate and leflunomide. Responses to abnormal monitoring results varied widely, and 40% of respondents reported that monitoring tests are performed too often. Compared with females, males reported greater tolerance of significant test abnormalities before acting. They also were more likely to report that guidelines recommend, and doctors perform, tests too frequently.
 

Testing, monitoring patterns can differ from current guidelines

Rheumatologists who were asked to comment on the survey welcomed its results.

They came as no surprise to Daniel E. Furst, MD, professor emeritus of medicine at the University of California, Los Angeles.

“Most guidelines point out in the introduction that they are recommendations and need to be modified by specific patient and environmental needs,” he noted in an interview.

Stephen Myers, MD, assistant professor of clinical medicine in the division of rheumatology at the University of Southern California, Los Angeles, said: “The findings seem generally consistent with my observed practices and those of my peers, with the exception of sulfasalazine, which we tend to monitor every 3 months, similar to the way we monitor other csDMARDs.”

Caoilfhionn Connolly, MD, MSc, postdoctoral fellow in rheumatology at Johns Hopkins University, Baltimore, called “the variability in monitoring somewhat surprising given that both the American College of Rheumatology and the British Society for Rheumatology provide guidance statements on optimal monitoring.

“As the authors highlight,” she added, “the variability in monitoring and response to lab abnormalities is likely driven by the lack of a high-quality evidence base, which should ideally be derived from clinical trials.”

Medication monitoring is critical to ensuring patient safety in rheumatology and other specialties, said Puja Khanna, MD, MPH, a rheumatologist and clinical associate professor of medicine at the University of Michigan, Ann Arbor.

Dr. Khanna described how in 2018, the Michigan Medicine health care system revisited its processes and protocols for medication monitoring.

Previously, “we were reliant on society guidelines that were not used consistently across the academic and community rheumatology practices,” she said. “Using lean thinking methodology, we found that we lacked familiarity with laboratory monitoring protocols amongst the interdisciplinary teams involved in the process and that we had a clear need for consensus.

“A consistent departmental protocol was created to help streamline the workflow for ancillary support staff, to close identified operational gaps, and to reduce delays in monitoring that impacted safe practice patterns,” Dr. Khanna added.

“We developed standardized medication- and disease-based monitoring protocols for eight medical specialties, where the person who writes a prescription that requires monitoring can utilize standard work flows to enroll the patient in the medication monitoring program and have dedicated ancillary support staff follow the results periodically and alert clinicians in a timely manner,” she explained. “Almost 15,000 patients are currently monitored in this collaborative program involving clinicians, nurses, pharmacists, and IT and administrative teams.”
 

Guidelines may not capture clinical realities of csDMARD monitoring

Dr. Myers and colleagues may monitor testing more intensively if, for example, a patient becomes ill, has side effects, or has taken medication incorrectly. But they’ll less intensively monitor a patient who’s been stable on a csDMARD.

“In my current academic practice, deciding lab monitoring frequency is left up to physicians. In my previous private practice experience, lab monitoring seemed to be more frequent than the current guidelines for many patients, compared to public or academic practice,” he said. “It would be interesting to compare monitoring practices in private, public, and academic settings.

“The clinical reality is that frequent monitoring depends on the regular follow-up, which for some patients is difficult, due to socioeconomic factors including lack of childcare and public transport,” Dr. Myers added.

Dr. Khanna mentioned that “guidelines tend to provide details of extant practice patterns, usually taken from evidence-based data. With monitoring, however, that is tough to achieve, unless substantial data can be found in large national registries of patients on immunosuppressive medications.”

Experience and comfort with using immunosuppressive medications, and medicolegal liability considerations, especially because many immunomodulatory agents confer adverse effects, can contribute to clinicians’ behaviors varying from guidelines, she added.
 

A good scoping review, and further research needed

“This article did what it was supposed to do: Define the various approaches to monitoring,” Dr. Furst said. “It is the next steps that will make a difference in practice.

“Next steps ... may require delving into large observational data sets such as registries to ascertain the consequences of different monitoring strategies for various patient groups and disparate drugs and drug combinations,” added Dr. Furst, who coauthored a 2017 review summarizing guidelines for laboratory monitoring in patients with rheumatoid arthritis.

“A significant oversight is the lack of consideration regarding monitoring for corticosteroids, which are well known to have very consequential adverse events and require careful monitoring,” Dr. Furst observed.

“The difference between men’s and women’s monitoring strategies is of some interest,” he added, “but will only be important if it leads to an understanding of and change in monitoring recommendations.”

Dr. Connolly also noted the differences in strategies between male and female respondents.

“Of interest, male respondents were more likely to feel that monitoring was performed too frequently and were also more tolerant of significant abnormalities,” she said. “This begs the question of whether rheumatologist gender differentially impacts other areas of clinical practice.”

Despite the small sample size that limits generalizability, the results provide preliminary insight into the varied practices among rheumatologists worldwide, Dr. Connolly added.

“Given the frequency of csDMARD prescription, the study highlights the clinical unmet need for a more robust evidence base to guide clinical practice,” she said. “The study also adds to important efforts to provide high-value care to patients with rheumatic diseases and may form the basis for larger studies to facilitate the pragmatic utilization of lab monitoring and ultimately optimize both the quality and value of rheumatological care globally.”

Dr. Robinson and coauthors urged further research. “We need more studies of higher quality to help inform the best strategy for protecting our patients from harm from our commonly used rheumatic medicines,” he said.

Dr. Robinson and two coauthors reported relationships with pharmaceutical companies. The remaining authors and all uninvolved sources, who commented by email, reported no relevant relationships. The study received no funding.

Rheumatologists tend to order the same types of tests to monitor their patients’ responses to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), but they vary widely in how often they order tests and how they respond to abnormal results, responses to a survey suggest.

“The study found that, although guidelines exist, people didn’t follow them consistently. They also responded to abnormal test results in wildly different ways,” senior study author Philip C. Robinson, MBChB, PhD, of the University of Queensland, Herston, Australia, said in an interview.

“The take-home message of this study is that everyone is doing something different, which means that the system likely has a lot of low-value activity and that money is being wasted,” he added. “However, we don’t have the evidence to guide people to make better choices.”

The literature on laboratory monitoring of people taking csDMARDs for rheumatic disease is scant, the authors wrote in BMC Rheumatology, and current guidelines on csDMARD monitoring vary, likely because of the lack of high-quality evidence for specific monitoring regimens.

“An enormous amount of money is spent on DMARD monitoring with little evidence to support current practices,” Dr. Robinson said. So he and his colleagues asked rheumatologists and rheumatology trainees about their attitudes and practices related to laboratory monitoring of csDMARDs in an online questionnaire.

They used the Australian Rheumatology Association newsletter to invite around 530 Australian rheumatologists and trainees, around 4,500 of Dr. Robinson’s Twitter followers, and 25 Australian and overseas email contacts, to respond to questions about csDMARDs they prescribed, frequency and patterns of monitoring, influences of additional factors and combination therapy, responses to abnormal tests, and attitudes toward monitoring frequency.

The researchers based their questions on csDMARD monitoring guidelines published by the American College of Rheumatology (which recommends monitoring every 2-4 weeks from initiation to 3 months, every 8-12 weeks during months 3-6, and every 12 weeks from 6 months onward), and from the British Society for Rheumatology (whose guidance is similar but bases monitoring frequency on how long DMARD doses remain stable).

The 221 valid responses they collected included 53 from Australia and 39 from the United States. Overall, 53% of respondents were in public practice, 56% were women, and 56% had practiced rheumatology for 11 or more years.

Respondents reported more frequent monitoring of patients with multiple comorbidities and those taking csDMARD combinations, including methotrexate and leflunomide. Responses to abnormal monitoring results varied widely, and 40% of respondents reported that monitoring tests are performed too often. Compared with females, males reported greater tolerance of significant test abnormalities before acting. They also were more likely to report that guidelines recommend, and doctors perform, tests too frequently.
 

Testing, monitoring patterns can differ from current guidelines

Rheumatologists who were asked to comment on the survey welcomed its results.

They came as no surprise to Daniel E. Furst, MD, professor emeritus of medicine at the University of California, Los Angeles.

“Most guidelines point out in the introduction that they are recommendations and need to be modified by specific patient and environmental needs,” he noted in an interview.

Stephen Myers, MD, assistant professor of clinical medicine in the division of rheumatology at the University of Southern California, Los Angeles, said: “The findings seem generally consistent with my observed practices and those of my peers, with the exception of sulfasalazine, which we tend to monitor every 3 months, similar to the way we monitor other csDMARDs.”

Caoilfhionn Connolly, MD, MSc, postdoctoral fellow in rheumatology at Johns Hopkins University, Baltimore, called “the variability in monitoring somewhat surprising given that both the American College of Rheumatology and the British Society for Rheumatology provide guidance statements on optimal monitoring.

“As the authors highlight,” she added, “the variability in monitoring and response to lab abnormalities is likely driven by the lack of a high-quality evidence base, which should ideally be derived from clinical trials.”

Medication monitoring is critical to ensuring patient safety in rheumatology and other specialties, said Puja Khanna, MD, MPH, a rheumatologist and clinical associate professor of medicine at the University of Michigan, Ann Arbor.

Dr. Khanna described how in 2018, the Michigan Medicine health care system revisited its processes and protocols for medication monitoring.

Previously, “we were reliant on society guidelines that were not used consistently across the academic and community rheumatology practices,” she said. “Using lean thinking methodology, we found that we lacked familiarity with laboratory monitoring protocols amongst the interdisciplinary teams involved in the process and that we had a clear need for consensus.

“A consistent departmental protocol was created to help streamline the workflow for ancillary support staff, to close identified operational gaps, and to reduce delays in monitoring that impacted safe practice patterns,” Dr. Khanna added.

“We developed standardized medication- and disease-based monitoring protocols for eight medical specialties, where the person who writes a prescription that requires monitoring can utilize standard work flows to enroll the patient in the medication monitoring program and have dedicated ancillary support staff follow the results periodically and alert clinicians in a timely manner,” she explained. “Almost 15,000 patients are currently monitored in this collaborative program involving clinicians, nurses, pharmacists, and IT and administrative teams.”
 

Guidelines may not capture clinical realities of csDMARD monitoring

Dr. Myers and colleagues may monitor testing more intensively if, for example, a patient becomes ill, has side effects, or has taken medication incorrectly. But they’ll less intensively monitor a patient who’s been stable on a csDMARD.

“In my current academic practice, deciding lab monitoring frequency is left up to physicians. In my previous private practice experience, lab monitoring seemed to be more frequent than the current guidelines for many patients, compared to public or academic practice,” he said. “It would be interesting to compare monitoring practices in private, public, and academic settings.

“The clinical reality is that frequent monitoring depends on the regular follow-up, which for some patients is difficult, due to socioeconomic factors including lack of childcare and public transport,” Dr. Myers added.

Dr. Khanna mentioned that “guidelines tend to provide details of extant practice patterns, usually taken from evidence-based data. With monitoring, however, that is tough to achieve, unless substantial data can be found in large national registries of patients on immunosuppressive medications.”

Experience and comfort with using immunosuppressive medications, and medicolegal liability considerations, especially because many immunomodulatory agents confer adverse effects, can contribute to clinicians’ behaviors varying from guidelines, she added.
 

A good scoping review, and further research needed

“This article did what it was supposed to do: Define the various approaches to monitoring,” Dr. Furst said. “It is the next steps that will make a difference in practice.

“Next steps ... may require delving into large observational data sets such as registries to ascertain the consequences of different monitoring strategies for various patient groups and disparate drugs and drug combinations,” added Dr. Furst, who coauthored a 2017 review summarizing guidelines for laboratory monitoring in patients with rheumatoid arthritis.

“A significant oversight is the lack of consideration regarding monitoring for corticosteroids, which are well known to have very consequential adverse events and require careful monitoring,” Dr. Furst observed.

“The difference between men’s and women’s monitoring strategies is of some interest,” he added, “but will only be important if it leads to an understanding of and change in monitoring recommendations.”

Dr. Connolly also noted the differences in strategies between male and female respondents.

“Of interest, male respondents were more likely to feel that monitoring was performed too frequently and were also more tolerant of significant abnormalities,” she said. “This begs the question of whether rheumatologist gender differentially impacts other areas of clinical practice.”

Despite the small sample size that limits generalizability, the results provide preliminary insight into the varied practices among rheumatologists worldwide, Dr. Connolly added.

“Given the frequency of csDMARD prescription, the study highlights the clinical unmet need for a more robust evidence base to guide clinical practice,” she said. “The study also adds to important efforts to provide high-value care to patients with rheumatic diseases and may form the basis for larger studies to facilitate the pragmatic utilization of lab monitoring and ultimately optimize both the quality and value of rheumatological care globally.”

Dr. Robinson and coauthors urged further research. “We need more studies of higher quality to help inform the best strategy for protecting our patients from harm from our commonly used rheumatic medicines,” he said.

Dr. Robinson and two coauthors reported relationships with pharmaceutical companies. The remaining authors and all uninvolved sources, who commented by email, reported no relevant relationships. The study received no funding.

Rheumatologists tend to order the same types of tests to monitor their patients’ responses to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), but they vary widely in how often they order tests and how they respond to abnormal results, responses to a survey suggest.

“The study found that, although guidelines exist, people didn’t follow them consistently. They also responded to abnormal test results in wildly different ways,” senior study author Philip C. Robinson, MBChB, PhD, of the University of Queensland, Herston, Australia, said in an interview.

“The take-home message of this study is that everyone is doing something different, which means that the system likely has a lot of low-value activity and that money is being wasted,” he added. “However, we don’t have the evidence to guide people to make better choices.”

The literature on laboratory monitoring of people taking csDMARDs for rheumatic disease is scant, the authors wrote in BMC Rheumatology, and current guidelines on csDMARD monitoring vary, likely because of the lack of high-quality evidence for specific monitoring regimens.

“An enormous amount of money is spent on DMARD monitoring with little evidence to support current practices,” Dr. Robinson said. So he and his colleagues asked rheumatologists and rheumatology trainees about their attitudes and practices related to laboratory monitoring of csDMARDs in an online questionnaire.

They used the Australian Rheumatology Association newsletter to invite around 530 Australian rheumatologists and trainees, around 4,500 of Dr. Robinson’s Twitter followers, and 25 Australian and overseas email contacts, to respond to questions about csDMARDs they prescribed, frequency and patterns of monitoring, influences of additional factors and combination therapy, responses to abnormal tests, and attitudes toward monitoring frequency.

The researchers based their questions on csDMARD monitoring guidelines published by the American College of Rheumatology (which recommends monitoring every 2-4 weeks from initiation to 3 months, every 8-12 weeks during months 3-6, and every 12 weeks from 6 months onward), and from the British Society for Rheumatology (whose guidance is similar but bases monitoring frequency on how long DMARD doses remain stable).

The 221 valid responses they collected included 53 from Australia and 39 from the United States. Overall, 53% of respondents were in public practice, 56% were women, and 56% had practiced rheumatology for 11 or more years.

Respondents reported more frequent monitoring of patients with multiple comorbidities and those taking csDMARD combinations, including methotrexate and leflunomide. Responses to abnormal monitoring results varied widely, and 40% of respondents reported that monitoring tests are performed too often. Compared with females, males reported greater tolerance of significant test abnormalities before acting. They also were more likely to report that guidelines recommend, and doctors perform, tests too frequently.
 

Testing, monitoring patterns can differ from current guidelines

Rheumatologists who were asked to comment on the survey welcomed its results.

They came as no surprise to Daniel E. Furst, MD, professor emeritus of medicine at the University of California, Los Angeles.

“Most guidelines point out in the introduction that they are recommendations and need to be modified by specific patient and environmental needs,” he noted in an interview.

Stephen Myers, MD, assistant professor of clinical medicine in the division of rheumatology at the University of Southern California, Los Angeles, said: “The findings seem generally consistent with my observed practices and those of my peers, with the exception of sulfasalazine, which we tend to monitor every 3 months, similar to the way we monitor other csDMARDs.”

Caoilfhionn Connolly, MD, MSc, postdoctoral fellow in rheumatology at Johns Hopkins University, Baltimore, called “the variability in monitoring somewhat surprising given that both the American College of Rheumatology and the British Society for Rheumatology provide guidance statements on optimal monitoring.

“As the authors highlight,” she added, “the variability in monitoring and response to lab abnormalities is likely driven by the lack of a high-quality evidence base, which should ideally be derived from clinical trials.”

Medication monitoring is critical to ensuring patient safety in rheumatology and other specialties, said Puja Khanna, MD, MPH, a rheumatologist and clinical associate professor of medicine at the University of Michigan, Ann Arbor.

Dr. Khanna described how in 2018, the Michigan Medicine health care system revisited its processes and protocols for medication monitoring.

Previously, “we were reliant on society guidelines that were not used consistently across the academic and community rheumatology practices,” she said. “Using lean thinking methodology, we found that we lacked familiarity with laboratory monitoring protocols amongst the interdisciplinary teams involved in the process and that we had a clear need for consensus.

“A consistent departmental protocol was created to help streamline the workflow for ancillary support staff, to close identified operational gaps, and to reduce delays in monitoring that impacted safe practice patterns,” Dr. Khanna added.

“We developed standardized medication- and disease-based monitoring protocols for eight medical specialties, where the person who writes a prescription that requires monitoring can utilize standard work flows to enroll the patient in the medication monitoring program and have dedicated ancillary support staff follow the results periodically and alert clinicians in a timely manner,” she explained. “Almost 15,000 patients are currently monitored in this collaborative program involving clinicians, nurses, pharmacists, and IT and administrative teams.”
 

Guidelines may not capture clinical realities of csDMARD monitoring

Dr. Myers and colleagues may monitor testing more intensively if, for example, a patient becomes ill, has side effects, or has taken medication incorrectly. But they’ll less intensively monitor a patient who’s been stable on a csDMARD.

“In my current academic practice, deciding lab monitoring frequency is left up to physicians. In my previous private practice experience, lab monitoring seemed to be more frequent than the current guidelines for many patients, compared to public or academic practice,” he said. “It would be interesting to compare monitoring practices in private, public, and academic settings.

“The clinical reality is that frequent monitoring depends on the regular follow-up, which for some patients is difficult, due to socioeconomic factors including lack of childcare and public transport,” Dr. Myers added.

Dr. Khanna mentioned that “guidelines tend to provide details of extant practice patterns, usually taken from evidence-based data. With monitoring, however, that is tough to achieve, unless substantial data can be found in large national registries of patients on immunosuppressive medications.”

Experience and comfort with using immunosuppressive medications, and medicolegal liability considerations, especially because many immunomodulatory agents confer adverse effects, can contribute to clinicians’ behaviors varying from guidelines, she added.
 

A good scoping review, and further research needed

“This article did what it was supposed to do: Define the various approaches to monitoring,” Dr. Furst said. “It is the next steps that will make a difference in practice.

“Next steps ... may require delving into large observational data sets such as registries to ascertain the consequences of different monitoring strategies for various patient groups and disparate drugs and drug combinations,” added Dr. Furst, who coauthored a 2017 review summarizing guidelines for laboratory monitoring in patients with rheumatoid arthritis.

“A significant oversight is the lack of consideration regarding monitoring for corticosteroids, which are well known to have very consequential adverse events and require careful monitoring,” Dr. Furst observed.

“The difference between men’s and women’s monitoring strategies is of some interest,” he added, “but will only be important if it leads to an understanding of and change in monitoring recommendations.”

Dr. Connolly also noted the differences in strategies between male and female respondents.

“Of interest, male respondents were more likely to feel that monitoring was performed too frequently and were also more tolerant of significant abnormalities,” she said. “This begs the question of whether rheumatologist gender differentially impacts other areas of clinical practice.”

Despite the small sample size that limits generalizability, the results provide preliminary insight into the varied practices among rheumatologists worldwide, Dr. Connolly added.

“Given the frequency of csDMARD prescription, the study highlights the clinical unmet need for a more robust evidence base to guide clinical practice,” she said. “The study also adds to important efforts to provide high-value care to patients with rheumatic diseases and may form the basis for larger studies to facilitate the pragmatic utilization of lab monitoring and ultimately optimize both the quality and value of rheumatological care globally.”

Dr. Robinson and coauthors urged further research. “We need more studies of higher quality to help inform the best strategy for protecting our patients from harm from our commonly used rheumatic medicines,” he said.

Dr. Robinson and two coauthors reported relationships with pharmaceutical companies. The remaining authors and all uninvolved sources, who commented by email, reported no relevant relationships. The study received no funding.

Key clinical point: In patients with psoriatic arthritis (PsA), the percentages of some T_reg cell subgroups and the levels of T_reg-related cytokines, such as transforming growth factor-beta (TGFβ), were decreased.

Major finding: Compared with control individuals without PsA, patients with PsA had a similar proportion of T_reg cells (P = .071), with no significant difference in the proportion of OKT8⁺ T_reg cells (P = .679) and significantly decreased CD4⁺ T_reg cells (standardized mean difference [SMD] −1.501; P = .023). TGFβ levels were lower in patients with PsA vs healthy controls (SMD −2.199; P = .003).

Study details: Findings are from a meta-analysis of 12 studies including 525 patients with PsA and 414 control individuals.

Disclosures: This study was supported by the National Natural Science Foundation of China and other sources. The authors declared no conflict of interests.

Source: Su QY et al. Peripheral T_reg levels and transforming growth factor-β (TGFβ) in patients with psoriatic arthritis: A systematic review meta-analysis. Adv Ther. 2022 (Oct 26). Doi: 10.1007/s12325-022-02337-5

Key clinical point: In patients with psoriatic arthritis (PsA), the percentages of some T_reg cell subgroups and the levels of T_reg-related cytokines, such as transforming growth factor-beta (TGFβ), were decreased.

Major finding: Compared with control individuals without PsA, patients with PsA had a similar proportion of T_reg cells (P = .071), with no significant difference in the proportion of OKT8⁺ T_reg cells (P = .679) and significantly decreased CD4⁺ T_reg cells (standardized mean difference [SMD] −1.501; P = .023). TGFβ levels were lower in patients with PsA vs healthy controls (SMD −2.199; P = .003).

Study details: Findings are from a meta-analysis of 12 studies including 525 patients with PsA and 414 control individuals.

Disclosures: This study was supported by the National Natural Science Foundation of China and other sources. The authors declared no conflict of interests.

Source: Su QY et al. Peripheral T_reg levels and transforming growth factor-β (TGFβ) in patients with psoriatic arthritis: A systematic review meta-analysis. Adv Ther. 2022 (Oct 26). Doi: 10.1007/s12325-022-02337-5

Key clinical point: In patients with psoriatic arthritis (PsA), the percentages of some T_reg cell subgroups and the levels of T_reg-related cytokines, such as transforming growth factor-beta (TGFβ), were decreased.

Major finding: Compared with control individuals without PsA, patients with PsA had a similar proportion of T_reg cells (P = .071), with no significant difference in the proportion of OKT8⁺ T_reg cells (P = .679) and significantly decreased CD4⁺ T_reg cells (standardized mean difference [SMD] −1.501; P = .023). TGFβ levels were lower in patients with PsA vs healthy controls (SMD −2.199; P = .003).

Study details: Findings are from a meta-analysis of 12 studies including 525 patients with PsA and 414 control individuals.

Disclosures: This study was supported by the National Natural Science Foundation of China and other sources. The authors declared no conflict of interests.

Source: Su QY et al. Peripheral T_reg levels and transforming growth factor-β (TGFβ) in patients with psoriatic arthritis: A systematic review meta-analysis. Adv Ther. 2022 (Oct 26). Doi: 10.1007/s12325-022-02337-5

Key clinical point: Serum calprotectin (CLP) serves as an important inflammatory biomarker for diagnosing and monitoring disease activity in psoriatic arthritis (PsA).

Major finding: Participants with PsA vs control individuals without psoriasis or PsA had higher median CLP levels (3.816 vs 0.707 μg/mL; P < .001). The concentration of serum CLP decreased significantly along with the disease activity from 3.816 at baseline to 2.052, 1.681, and 1.655 μg/mL at 3, 6, and 12 months, respectively (all P < .001).

Study details: Findings are from a longitudinal study including 71 patients with PsA, 55 patients with psoriasis, and 50 control individuals.

Disclosures: This study was supported by the interdisciplinary clinical research project of Peking University First Hospital, China, and other sources. The authors declared no conflict of interests.

Source: Li B et al. Serum calprotectin as a promising inflammatory biomarker in psoriatic arthritis: A 1-year longitudinal study. Rheumatol Ther. 2022 (Oct 21). Doi: 10.1007/s40744-022-00501-5

Key clinical point: Serum calprotectin (CLP) serves as an important inflammatory biomarker for diagnosing and monitoring disease activity in psoriatic arthritis (PsA).

Major finding: Participants with PsA vs control individuals without psoriasis or PsA had higher median CLP levels (3.816 vs 0.707 μg/mL; P < .001). The concentration of serum CLP decreased significantly along with the disease activity from 3.816 at baseline to 2.052, 1.681, and 1.655 μg/mL at 3, 6, and 12 months, respectively (all P < .001).

Study details: Findings are from a longitudinal study including 71 patients with PsA, 55 patients with psoriasis, and 50 control individuals.

Disclosures: This study was supported by the interdisciplinary clinical research project of Peking University First Hospital, China, and other sources. The authors declared no conflict of interests.

Source: Li B et al. Serum calprotectin as a promising inflammatory biomarker in psoriatic arthritis: A 1-year longitudinal study. Rheumatol Ther. 2022 (Oct 21). Doi: 10.1007/s40744-022-00501-5

Key clinical point: Serum calprotectin (CLP) serves as an important inflammatory biomarker for diagnosing and monitoring disease activity in psoriatic arthritis (PsA).

Major finding: Participants with PsA vs control individuals without psoriasis or PsA had higher median CLP levels (3.816 vs 0.707 μg/mL; P < .001). The concentration of serum CLP decreased significantly along with the disease activity from 3.816 at baseline to 2.052, 1.681, and 1.655 μg/mL at 3, 6, and 12 months, respectively (all P < .001).

Study details: Findings are from a longitudinal study including 71 patients with PsA, 55 patients with psoriasis, and 50 control individuals.

Disclosures: This study was supported by the interdisciplinary clinical research project of Peking University First Hospital, China, and other sources. The authors declared no conflict of interests.

Source: Li B et al. Serum calprotectin as a promising inflammatory biomarker in psoriatic arthritis: A 1-year longitudinal study. Rheumatol Ther. 2022 (Oct 21). Doi: 10.1007/s40744-022-00501-5

Key clinical point: The Disease Activity index for Psoriatic Arthritis (DAPSA) based on a quick quantitative C-reactive protein (qCRP) assay (Q-DAPSA) showed perfect agreement with conventional DAPSA in the majority of patients with PsA.

Major finding: Overall, 98.1% of patients were similarly categorized into disease activity groups (remission and low, moderate, and high disease activity) using Q-DAPSA and DAPSA, with both indices showing identical numerical values in 57.7% of patients.

Study details: Findings are from a multicenter, cross-sectional study including 104 patients with PsA and available CRP values (measured by routine laboratory and quick qCRP assays).

Disclosures: This study was partially supported by Novartis. The authors declared receiving grants, personal fees, or support for attending meetings and travels from Novartis and other sources.

Source: Proft F et al. Evaluation of the Disease Activity index for PSoriatic Arthritis (DAPSA) with a quick quantitative C reactive protein assay (Q-DAPSA) in patients with psoriatic arthritis: A prospective multicentre cross-sectional study. RMD Open. 2022;8:e002626 (Nov 2). Doi: 10.1136/rmdopen-2022-002626

Key clinical point: The Disease Activity index for Psoriatic Arthritis (DAPSA) based on a quick quantitative C-reactive protein (qCRP) assay (Q-DAPSA) showed perfect agreement with conventional DAPSA in the majority of patients with PsA.

Major finding: Overall, 98.1% of patients were similarly categorized into disease activity groups (remission and low, moderate, and high disease activity) using Q-DAPSA and DAPSA, with both indices showing identical numerical values in 57.7% of patients.

Study details: Findings are from a multicenter, cross-sectional study including 104 patients with PsA and available CRP values (measured by routine laboratory and quick qCRP assays).

Disclosures: This study was partially supported by Novartis. The authors declared receiving grants, personal fees, or support for attending meetings and travels from Novartis and other sources.

Source: Proft F et al. Evaluation of the Disease Activity index for PSoriatic Arthritis (DAPSA) with a quick quantitative C reactive protein assay (Q-DAPSA) in patients with psoriatic arthritis: A prospective multicentre cross-sectional study. RMD Open. 2022;8:e002626 (Nov 2). Doi: 10.1136/rmdopen-2022-002626

Key clinical point: The Disease Activity index for Psoriatic Arthritis (DAPSA) based on a quick quantitative C-reactive protein (qCRP) assay (Q-DAPSA) showed perfect agreement with conventional DAPSA in the majority of patients with PsA.

Major finding: Overall, 98.1% of patients were similarly categorized into disease activity groups (remission and low, moderate, and high disease activity) using Q-DAPSA and DAPSA, with both indices showing identical numerical values in 57.7% of patients.

Study details: Findings are from a multicenter, cross-sectional study including 104 patients with PsA and available CRP values (measured by routine laboratory and quick qCRP assays).

Disclosures: This study was partially supported by Novartis. The authors declared receiving grants, personal fees, or support for attending meetings and travels from Novartis and other sources.

Source: Proft F et al. Evaluation of the Disease Activity index for PSoriatic Arthritis (DAPSA) with a quick quantitative C reactive protein assay (Q-DAPSA) in patients with psoriatic arthritis: A prospective multicentre cross-sectional study. RMD Open. 2022;8:e002626 (Nov 2). Doi: 10.1136/rmdopen-2022-002626

Key clinical point: The addition of ultrasound-detected features, such as tenosynovitis and enthesitis, to the CASPAR (ClASsification criteria for Psoriatic Arthritis) scoring system improved its diagnostic utility.

Major finding: Specificity improved (84.0% to 91.4%) and sensitivity was similar (94.5% to 95.7%) after ultrasound features, such as tenosynovitis and enthesitis, were integrated in the original CASPAR criteria which had been based on physical examination.

Study details: Findings are from a cross-sectional study including 326 participants, of which 164 were diagnosed with PsA.

Disclosures: This study was supported by the Interdisciplinary Clinical Research Project of the Peking University First Hospital, China, and other sources. The authors declared no conflict of interests.

Source: Geng Y et al. Improved diagnostic performance of CASPAR criteria with integration of ultrasound. Front Immunol. 2022;13:935132 (Oct 10). Doi: 10.3389/fimmu.2022.935132

Key clinical point: The addition of ultrasound-detected features, such as tenosynovitis and enthesitis, to the CASPAR (ClASsification criteria for Psoriatic Arthritis) scoring system improved its diagnostic utility.

Major finding: Specificity improved (84.0% to 91.4%) and sensitivity was similar (94.5% to 95.7%) after ultrasound features, such as tenosynovitis and enthesitis, were integrated in the original CASPAR criteria which had been based on physical examination.

Study details: Findings are from a cross-sectional study including 326 participants, of which 164 were diagnosed with PsA.

Disclosures: This study was supported by the Interdisciplinary Clinical Research Project of the Peking University First Hospital, China, and other sources. The authors declared no conflict of interests.

Source: Geng Y et al. Improved diagnostic performance of CASPAR criteria with integration of ultrasound. Front Immunol. 2022;13:935132 (Oct 10). Doi: 10.3389/fimmu.2022.935132

Key clinical point: The addition of ultrasound-detected features, such as tenosynovitis and enthesitis, to the CASPAR (ClASsification criteria for Psoriatic Arthritis) scoring system improved its diagnostic utility.

Major finding: Specificity improved (84.0% to 91.4%) and sensitivity was similar (94.5% to 95.7%) after ultrasound features, such as tenosynovitis and enthesitis, were integrated in the original CASPAR criteria which had been based on physical examination.

Study details: Findings are from a cross-sectional study including 326 participants, of which 164 were diagnosed with PsA.

Disclosures: This study was supported by the Interdisciplinary Clinical Research Project of the Peking University First Hospital, China, and other sources. The authors declared no conflict of interests.

Source: Geng Y et al. Improved diagnostic performance of CASPAR criteria with integration of ultrasound. Front Immunol. 2022;13:935132 (Oct 10). Doi: 10.3389/fimmu.2022.935132

Key clinical point: Patients with psoriatic arthritis (PsA) were more likely to have cardiovascular diseases (CVD) and metabolic syndrome (MS) than patients with rheumatoid arthritis (RA).

Major finding: MS (odds ratio [OR] 1.54; P = .002) and CVD (OR 6.13; P = .001) were more frequently observed in patients with PsA vs RA.

Study details: Findings are from a cross-sectional study including 197 patients with PsA and 279 patients with RA.

Disclosures: This study was supported by Peking University First Hospital, China, and other sources. The authors declared no conflict of interests.

Source: Li B et al. Discrepancy in metabolic syndrome between psoriatic arthritis and rheumatoid arthritis: A direct comparison of two cohorts in one center. Rheumatol Ther. 2022 (Oct 20). Doi: 10.1007/s40744-022-00502-4

Key clinical point: Patients with psoriatic arthritis (PsA) were more likely to have cardiovascular diseases (CVD) and metabolic syndrome (MS) than patients with rheumatoid arthritis (RA).

Major finding: MS (odds ratio [OR] 1.54; P = .002) and CVD (OR 6.13; P = .001) were more frequently observed in patients with PsA vs RA.

Study details: Findings are from a cross-sectional study including 197 patients with PsA and 279 patients with RA.

Disclosures: This study was supported by Peking University First Hospital, China, and other sources. The authors declared no conflict of interests.

Source: Li B et al. Discrepancy in metabolic syndrome between psoriatic arthritis and rheumatoid arthritis: A direct comparison of two cohorts in one center. Rheumatol Ther. 2022 (Oct 20). Doi: 10.1007/s40744-022-00502-4

Key clinical point: Patients with psoriatic arthritis (PsA) were more likely to have cardiovascular diseases (CVD) and metabolic syndrome (MS) than patients with rheumatoid arthritis (RA).

Major finding: MS (odds ratio [OR] 1.54; P = .002) and CVD (OR 6.13; P = .001) were more frequently observed in patients with PsA vs RA.

Study details: Findings are from a cross-sectional study including 197 patients with PsA and 279 patients with RA.

Disclosures: This study was supported by Peking University First Hospital, China, and other sources. The authors declared no conflict of interests.

Source: Li B et al. Discrepancy in metabolic syndrome between psoriatic arthritis and rheumatoid arthritis: A direct comparison of two cohorts in one center. Rheumatol Ther. 2022 (Oct 20). Doi: 10.1007/s40744-022-00502-4

Key clinical point: Among patients with psoriatic arthritis (PsA), sonographic enthesitis was more prevalent in men than women.

Major finding: Compared with women, men had higher total ultrasound and gray scale enthesitis scores (both P = .01) and sonographic active inflammatory score (P = .005), as reflected by higher hypoechogenicity, thickening, and enthesophytes (P < .05), with the male sex being associated with a significantly higher ultrasound inflammatory enthesitis score (P = .02).

Study details: Findings are from a prospective study including 158 patients with PsA, of which 70 patients were men and 88 were women.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Furer V et al. Sex-based differences in sonographic and clinical findings among patients with psoriatic arthritis. J Rheumatol. 2022 (Oct 15). Doi: 10.3899/jrheum.220547

Key clinical point: Among patients with psoriatic arthritis (PsA), sonographic enthesitis was more prevalent in men than women.

Major finding: Compared with women, men had higher total ultrasound and gray scale enthesitis scores (both P = .01) and sonographic active inflammatory score (P = .005), as reflected by higher hypoechogenicity, thickening, and enthesophytes (P < .05), with the male sex being associated with a significantly higher ultrasound inflammatory enthesitis score (P = .02).

Study details: Findings are from a prospective study including 158 patients with PsA, of which 70 patients were men and 88 were women.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Furer V et al. Sex-based differences in sonographic and clinical findings among patients with psoriatic arthritis. J Rheumatol. 2022 (Oct 15). Doi: 10.3899/jrheum.220547

Key clinical point: Among patients with psoriatic arthritis (PsA), sonographic enthesitis was more prevalent in men than women.

Major finding: Compared with women, men had higher total ultrasound and gray scale enthesitis scores (both P = .01) and sonographic active inflammatory score (P = .005), as reflected by higher hypoechogenicity, thickening, and enthesophytes (P < .05), with the male sex being associated with a significantly higher ultrasound inflammatory enthesitis score (P = .02).

Study details: Findings are from a prospective study including 158 patients with PsA, of which 70 patients were men and 88 were women.

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

Source: Furer V et al. Sex-based differences in sonographic and clinical findings among patients with psoriatic arthritis. J Rheumatol. 2022 (Oct 15). Doi: 10.3899/jrheum.220547

Key clinical point: Patients with psoriatic arthritis (PsA) experienced a slowing of radiographic progression during treatment with etanercept.

Major finding: In patients with available pre-etanercept radiographic data, the annualized radiographic progression was significantly lower with etanercept during the first 18 months than during the pre-etanercept treatment period (P < .005), and a higher proportion of patients showed no progression during etanercept treatment (61.7%) than during the pre-etanercept period (55.3%).

Study details: Findings are from a real-world, noninterventional study including 1821 participants who started treatment with etanercept, of which 1378 patients had rheumatoid arthritis and 440 patients had PsA.

Disclosures: This study was funded by Pfizer. Five authors declared being current or former employees of Pfizer, and the other authors reported ties with several sources, including Pfizer.

Source: Wassenberg S et al. Etanercept is effective and halts radiographic progression in rheumatoid arthritis and psoriatic arthritis: Final results from a German non-interventional study (PRERA). Rheumatol Ther. 2022 (Oct 17). Doi: 10.1007/s40744-022-00491-4

Key clinical point: Patients with psoriatic arthritis (PsA) experienced a slowing of radiographic progression during treatment with etanercept.

Major finding: In patients with available pre-etanercept radiographic data, the annualized radiographic progression was significantly lower with etanercept during the first 18 months than during the pre-etanercept treatment period (P < .005), and a higher proportion of patients showed no progression during etanercept treatment (61.7%) than during the pre-etanercept period (55.3%).

Study details: Findings are from a real-world, noninterventional study including 1821 participants who started treatment with etanercept, of which 1378 patients had rheumatoid arthritis and 440 patients had PsA.

Disclosures: This study was funded by Pfizer. Five authors declared being current or former employees of Pfizer, and the other authors reported ties with several sources, including Pfizer.

Source: Wassenberg S et al. Etanercept is effective and halts radiographic progression in rheumatoid arthritis and psoriatic arthritis: Final results from a German non-interventional study (PRERA). Rheumatol Ther. 2022 (Oct 17). Doi: 10.1007/s40744-022-00491-4

Key clinical point: Patients with psoriatic arthritis (PsA) experienced a slowing of radiographic progression during treatment with etanercept.

Major finding: In patients with available pre-etanercept radiographic data, the annualized radiographic progression was significantly lower with etanercept during the first 18 months than during the pre-etanercept treatment period (P < .005), and a higher proportion of patients showed no progression during etanercept treatment (61.7%) than during the pre-etanercept period (55.3%).

Study details: Findings are from a real-world, noninterventional study including 1821 participants who started treatment with etanercept, of which 1378 patients had rheumatoid arthritis and 440 patients had PsA.

Disclosures: This study was funded by Pfizer. Five authors declared being current or former employees of Pfizer, and the other authors reported ties with several sources, including Pfizer.

Source: Wassenberg S et al. Etanercept is effective and halts radiographic progression in rheumatoid arthritis and psoriatic arthritis: Final results from a German non-interventional study (PRERA). Rheumatol Ther. 2022 (Oct 17). Doi: 10.1007/s40744-022-00491-4