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Rheumatology RCTs Have Lower Representation of Women as Authors
TOPLINE:
Women are underrepresented as authors in randomized controlled trials (RCTs) published in rheumatology from 2009 to 2023. RCTs from Africa had higher women representation as authors, while RCTs from Asia and Europe and industry-funded RCTs had lower representation of women.
METHODOLOGY:
- Researchers analyzed 1092 RCTs published in rheumatology from 2009 to 2023 involving 10,794 authors to evaluate the temporal trends and the factors influencing women’s authorship.
- The gender of authors was determined on the basis of their first names and countries of affiliation using a gender application programming interface service.
- The study assessed the association of women’s authorship with various factors using generalized estimating equations by considering women’s gender as the main binary outcome.
- Various covariates influencing women’s authorship such as geographic location, sponsorship type, intervention type, and journal impact factor were also evaluated.
TAKEAWAY:
- Overall, women accounted for 34.1% of authors in RCTs published in rheumatology from 2009 to 2023. They had less representation as first and last authors than men (36.8% vs 50.0% and 26.1% vs 61.2%, respectively).
- RCTs from Africa had higher odds of being authored by women than those from North America (odds ratio [OR], 2.34; 95% CI, 1.02-5.38). Women were also less represented as authors in RCTs from Asia and Europe.
- Their representation as authors was lower in industry-funded RCTs as well (OR, 0.64; 95% CI, 0.56-0.73).
- Women were less likely to be in senior author positions such as last (OR, 0.72) or penultimate (OR, 0.70; P < .001 for both) authors than in middle author positions.
IN PRACTICE:
“Implementing structured policies and supporting women through mentorship and leadership opportunities are crucial steps toward a more inclusive and dynamic research environment,” the authors wrote.
SOURCE:
This study was led by Kim Lauper, MD, Geneva University Hospitals, Division of Rheumatology and Faculty of Medicine, University of Geneva, Switzerland, and was published online on August 26, 2024, in medRxiv.
LIMITATIONS:
This study relied on binary gender data, which did not encompass nonbinary or other gender identities. Moreover, the accuracy of gender determination from names, although robust, had inherent limitations that could have affected the interpretation of results.
DISCLOSURES:
This study did not receive any funding. The authors declared no competing interests.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Women are underrepresented as authors in randomized controlled trials (RCTs) published in rheumatology from 2009 to 2023. RCTs from Africa had higher women representation as authors, while RCTs from Asia and Europe and industry-funded RCTs had lower representation of women.
METHODOLOGY:
- Researchers analyzed 1092 RCTs published in rheumatology from 2009 to 2023 involving 10,794 authors to evaluate the temporal trends and the factors influencing women’s authorship.
- The gender of authors was determined on the basis of their first names and countries of affiliation using a gender application programming interface service.
- The study assessed the association of women’s authorship with various factors using generalized estimating equations by considering women’s gender as the main binary outcome.
- Various covariates influencing women’s authorship such as geographic location, sponsorship type, intervention type, and journal impact factor were also evaluated.
TAKEAWAY:
- Overall, women accounted for 34.1% of authors in RCTs published in rheumatology from 2009 to 2023. They had less representation as first and last authors than men (36.8% vs 50.0% and 26.1% vs 61.2%, respectively).
- RCTs from Africa had higher odds of being authored by women than those from North America (odds ratio [OR], 2.34; 95% CI, 1.02-5.38). Women were also less represented as authors in RCTs from Asia and Europe.
- Their representation as authors was lower in industry-funded RCTs as well (OR, 0.64; 95% CI, 0.56-0.73).
- Women were less likely to be in senior author positions such as last (OR, 0.72) or penultimate (OR, 0.70; P < .001 for both) authors than in middle author positions.
IN PRACTICE:
“Implementing structured policies and supporting women through mentorship and leadership opportunities are crucial steps toward a more inclusive and dynamic research environment,” the authors wrote.
SOURCE:
This study was led by Kim Lauper, MD, Geneva University Hospitals, Division of Rheumatology and Faculty of Medicine, University of Geneva, Switzerland, and was published online on August 26, 2024, in medRxiv.
LIMITATIONS:
This study relied on binary gender data, which did not encompass nonbinary or other gender identities. Moreover, the accuracy of gender determination from names, although robust, had inherent limitations that could have affected the interpretation of results.
DISCLOSURES:
This study did not receive any funding. The authors declared no competing interests.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Women are underrepresented as authors in randomized controlled trials (RCTs) published in rheumatology from 2009 to 2023. RCTs from Africa had higher women representation as authors, while RCTs from Asia and Europe and industry-funded RCTs had lower representation of women.
METHODOLOGY:
- Researchers analyzed 1092 RCTs published in rheumatology from 2009 to 2023 involving 10,794 authors to evaluate the temporal trends and the factors influencing women’s authorship.
- The gender of authors was determined on the basis of their first names and countries of affiliation using a gender application programming interface service.
- The study assessed the association of women’s authorship with various factors using generalized estimating equations by considering women’s gender as the main binary outcome.
- Various covariates influencing women’s authorship such as geographic location, sponsorship type, intervention type, and journal impact factor were also evaluated.
TAKEAWAY:
- Overall, women accounted for 34.1% of authors in RCTs published in rheumatology from 2009 to 2023. They had less representation as first and last authors than men (36.8% vs 50.0% and 26.1% vs 61.2%, respectively).
- RCTs from Africa had higher odds of being authored by women than those from North America (odds ratio [OR], 2.34; 95% CI, 1.02-5.38). Women were also less represented as authors in RCTs from Asia and Europe.
- Their representation as authors was lower in industry-funded RCTs as well (OR, 0.64; 95% CI, 0.56-0.73).
- Women were less likely to be in senior author positions such as last (OR, 0.72) or penultimate (OR, 0.70; P < .001 for both) authors than in middle author positions.
IN PRACTICE:
“Implementing structured policies and supporting women through mentorship and leadership opportunities are crucial steps toward a more inclusive and dynamic research environment,” the authors wrote.
SOURCE:
This study was led by Kim Lauper, MD, Geneva University Hospitals, Division of Rheumatology and Faculty of Medicine, University of Geneva, Switzerland, and was published online on August 26, 2024, in medRxiv.
LIMITATIONS:
This study relied on binary gender data, which did not encompass nonbinary or other gender identities. Moreover, the accuracy of gender determination from names, although robust, had inherent limitations that could have affected the interpretation of results.
DISCLOSURES:
This study did not receive any funding. The authors declared no competing interests.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Rheumatology Clinic Interventions for Smoking, Blood Pressure ‘Make a Big Difference’
Two relatively simple interventions — addressing high blood pressure (BP) and smoking cessation — could make a huge difference for patients with rheumatic disease. Patients with autoimmune disease are up to three times more likely to develop cardiovascular disease (CVD) than the general population. In addition to compounding CVD, smoking is tied to the development of certain autoimmune conditions, as well as worse outcomes. Christie Bartels, MD, chief of the Division of Rheumatology at the University of Wisconsin School of Medicine and Public Health, Madison, has focused her research on improving cardiac health in inflammatory diseases. This news organization spoke with Bartels about two short interventions she developed that tackle hypertension and smoking cessation during regular visits, each taking less than 3 minutes.
How Do These Programs Address Cardiac Disease Prevention?
The BP and Quit Connect programs help clinics systematically address the two most modifiable risk factors for CVD: high BP and smoking. There’s also evidence that addressing these two risk factors improves outcomes in rheumatic diseases. Hypertension predicts an increase in lupus damage. Particularly in lupus nephritis, hypertension will increase the risk for CVD and kidney failure. People who use tobacco have worse outcomes in diseases like rheumatoid arthritis, psoriatic arthritis, and lupus, as well as more CVD, and antirheumatic drugs may not work as well.
In 90 seconds to 3 minutes, staff can do protocol-based care, which we’ve done across 20,000-plus visits. We showed we can improve population level rates of high BP and BP control, as well as increase smoking quitting rates across different patient settings.
What Is the Quit Connect Program?
The Quit Connect program is a 10- to 90-second point of care intervention. During rooming, staff (medical assistants and nurses) ask patients: “A) Do you smoke? and B) Have you thought about cutting back or quitting in the next 30 days?”
It turns out, when you ask the question that way, between a third and a half of people say that they’ve thought about cutting back or quitting. Then, we can get patients connected directly to Quitline, a free public service across all 50 states that smokers can use to get cessation support.
If patients are ready, we ask if we can arrange for them to receive a call from a Quitline coach about setting a quit date or receiving free nicotine replacement therapy. The beautiful thing is when that all happens, A) it’s free to the patient, and B) the results from the Quitline can be recorded right back to the electronic health record.
In our most recent publication in Arthritis Care & Research, we documented bringing Quit Connect to Grady Hospital in downtown Atlanta. It’s a safety net hospital, where 80% patients are Black and 70%-80% patients are on public insurance or uninsured. Using this protocol, we improved Quitline referrals 20-fold.
What Is the BP Connect Program?
At least half of the encounters in United States happen in specialty clinics. Unfortunately, when patients get their BP measured in a specialty clinic that’s not a cardiology or a vascular clinic, often, even if the pressure is high, the clinic doesn’t give patients feedback on that. The problem is because we haven’t said anything, that gives people the false reassurance that their BP is okay.
We’ve developed a 3-minute protocol to ask, advise, and connect. The idea is that if we measure a high BP, then we remeasure and confirm that it’s high. Then, we advise why it matters in rheumatic disease: Patients with rheumatic diseases are already at an increased risk for heart disease, and controlling BP can make a big difference. Then, we connect patients with high BP back to primary care.
Specifically, a SmartSet — an electronic medical record feature — prompts different actions based on confirmed high BP readings:
- If systolic BP ≥ 140-159, the SmartSet directs scheduling a visit to a nurse or primary care provider.
- If systolic BP ≥ 160-179, the next primary care visit anticipates the need to see a prescriber.
- If systolic BP ≥ 180, then the medical assistant or nurse at the visit is instructed to notify the provider who can arrange a provider-to-provider handoff for safety to exclude a hypertensive emergency.
That order goes to the scheduler to call primary care to coordinate follow-up. BP Connect doubled the likelihood of a guideline-recommended follow-up in primary care within 30 days. All patients benefited, and disparities decreased. BP Connect has had 1100 downloads, and both BP and Quit Connect programs are endorsed by the Centers for Disease Control and Prevention and Million Hearts.
How Do These Programs Affect Clinical Practice?
We developed these interventions with a health system engineer, and we time stamped everything. Part of the sustainability of this model is that it fits within a regular workflow. As a practicing rheumatologist, I understand that time is a precious commodity.
The interventions are in partnership with frontline staff. We’ve received feedback that they feel pride participating in these initiatives. They can say, because of me, 30 patients followed up last month for high BP, or 10 patients took a referral to the Quitline last year. We celebrate these accomplishments with the staff.
What Are the Next Steps for These Programs?
Public-facing toolkits for both BP and Quit Connect programs are available online. We have implemented [these programs] in a rural setting, in an urban setting, in Milwaukee and in Atlanta, and we are looking in the future to do a larger, multistate implementation study. If folks are interested, we’d love to partner with them to look at disseminating this further.
A version of this article appeared on Medscape.com.
Two relatively simple interventions — addressing high blood pressure (BP) and smoking cessation — could make a huge difference for patients with rheumatic disease. Patients with autoimmune disease are up to three times more likely to develop cardiovascular disease (CVD) than the general population. In addition to compounding CVD, smoking is tied to the development of certain autoimmune conditions, as well as worse outcomes. Christie Bartels, MD, chief of the Division of Rheumatology at the University of Wisconsin School of Medicine and Public Health, Madison, has focused her research on improving cardiac health in inflammatory diseases. This news organization spoke with Bartels about two short interventions she developed that tackle hypertension and smoking cessation during regular visits, each taking less than 3 minutes.
How Do These Programs Address Cardiac Disease Prevention?
The BP and Quit Connect programs help clinics systematically address the two most modifiable risk factors for CVD: high BP and smoking. There’s also evidence that addressing these two risk factors improves outcomes in rheumatic diseases. Hypertension predicts an increase in lupus damage. Particularly in lupus nephritis, hypertension will increase the risk for CVD and kidney failure. People who use tobacco have worse outcomes in diseases like rheumatoid arthritis, psoriatic arthritis, and lupus, as well as more CVD, and antirheumatic drugs may not work as well.
In 90 seconds to 3 minutes, staff can do protocol-based care, which we’ve done across 20,000-plus visits. We showed we can improve population level rates of high BP and BP control, as well as increase smoking quitting rates across different patient settings.
What Is the Quit Connect Program?
The Quit Connect program is a 10- to 90-second point of care intervention. During rooming, staff (medical assistants and nurses) ask patients: “A) Do you smoke? and B) Have you thought about cutting back or quitting in the next 30 days?”
It turns out, when you ask the question that way, between a third and a half of people say that they’ve thought about cutting back or quitting. Then, we can get patients connected directly to Quitline, a free public service across all 50 states that smokers can use to get cessation support.
If patients are ready, we ask if we can arrange for them to receive a call from a Quitline coach about setting a quit date or receiving free nicotine replacement therapy. The beautiful thing is when that all happens, A) it’s free to the patient, and B) the results from the Quitline can be recorded right back to the electronic health record.
In our most recent publication in Arthritis Care & Research, we documented bringing Quit Connect to Grady Hospital in downtown Atlanta. It’s a safety net hospital, where 80% patients are Black and 70%-80% patients are on public insurance or uninsured. Using this protocol, we improved Quitline referrals 20-fold.
What Is the BP Connect Program?
At least half of the encounters in United States happen in specialty clinics. Unfortunately, when patients get their BP measured in a specialty clinic that’s not a cardiology or a vascular clinic, often, even if the pressure is high, the clinic doesn’t give patients feedback on that. The problem is because we haven’t said anything, that gives people the false reassurance that their BP is okay.
We’ve developed a 3-minute protocol to ask, advise, and connect. The idea is that if we measure a high BP, then we remeasure and confirm that it’s high. Then, we advise why it matters in rheumatic disease: Patients with rheumatic diseases are already at an increased risk for heart disease, and controlling BP can make a big difference. Then, we connect patients with high BP back to primary care.
Specifically, a SmartSet — an electronic medical record feature — prompts different actions based on confirmed high BP readings:
- If systolic BP ≥ 140-159, the SmartSet directs scheduling a visit to a nurse or primary care provider.
- If systolic BP ≥ 160-179, the next primary care visit anticipates the need to see a prescriber.
- If systolic BP ≥ 180, then the medical assistant or nurse at the visit is instructed to notify the provider who can arrange a provider-to-provider handoff for safety to exclude a hypertensive emergency.
That order goes to the scheduler to call primary care to coordinate follow-up. BP Connect doubled the likelihood of a guideline-recommended follow-up in primary care within 30 days. All patients benefited, and disparities decreased. BP Connect has had 1100 downloads, and both BP and Quit Connect programs are endorsed by the Centers for Disease Control and Prevention and Million Hearts.
How Do These Programs Affect Clinical Practice?
We developed these interventions with a health system engineer, and we time stamped everything. Part of the sustainability of this model is that it fits within a regular workflow. As a practicing rheumatologist, I understand that time is a precious commodity.
The interventions are in partnership with frontline staff. We’ve received feedback that they feel pride participating in these initiatives. They can say, because of me, 30 patients followed up last month for high BP, or 10 patients took a referral to the Quitline last year. We celebrate these accomplishments with the staff.
What Are the Next Steps for These Programs?
Public-facing toolkits for both BP and Quit Connect programs are available online. We have implemented [these programs] in a rural setting, in an urban setting, in Milwaukee and in Atlanta, and we are looking in the future to do a larger, multistate implementation study. If folks are interested, we’d love to partner with them to look at disseminating this further.
A version of this article appeared on Medscape.com.
Two relatively simple interventions — addressing high blood pressure (BP) and smoking cessation — could make a huge difference for patients with rheumatic disease. Patients with autoimmune disease are up to three times more likely to develop cardiovascular disease (CVD) than the general population. In addition to compounding CVD, smoking is tied to the development of certain autoimmune conditions, as well as worse outcomes. Christie Bartels, MD, chief of the Division of Rheumatology at the University of Wisconsin School of Medicine and Public Health, Madison, has focused her research on improving cardiac health in inflammatory diseases. This news organization spoke with Bartels about two short interventions she developed that tackle hypertension and smoking cessation during regular visits, each taking less than 3 minutes.
How Do These Programs Address Cardiac Disease Prevention?
The BP and Quit Connect programs help clinics systematically address the two most modifiable risk factors for CVD: high BP and smoking. There’s also evidence that addressing these two risk factors improves outcomes in rheumatic diseases. Hypertension predicts an increase in lupus damage. Particularly in lupus nephritis, hypertension will increase the risk for CVD and kidney failure. People who use tobacco have worse outcomes in diseases like rheumatoid arthritis, psoriatic arthritis, and lupus, as well as more CVD, and antirheumatic drugs may not work as well.
In 90 seconds to 3 minutes, staff can do protocol-based care, which we’ve done across 20,000-plus visits. We showed we can improve population level rates of high BP and BP control, as well as increase smoking quitting rates across different patient settings.
What Is the Quit Connect Program?
The Quit Connect program is a 10- to 90-second point of care intervention. During rooming, staff (medical assistants and nurses) ask patients: “A) Do you smoke? and B) Have you thought about cutting back or quitting in the next 30 days?”
It turns out, when you ask the question that way, between a third and a half of people say that they’ve thought about cutting back or quitting. Then, we can get patients connected directly to Quitline, a free public service across all 50 states that smokers can use to get cessation support.
If patients are ready, we ask if we can arrange for them to receive a call from a Quitline coach about setting a quit date or receiving free nicotine replacement therapy. The beautiful thing is when that all happens, A) it’s free to the patient, and B) the results from the Quitline can be recorded right back to the electronic health record.
In our most recent publication in Arthritis Care & Research, we documented bringing Quit Connect to Grady Hospital in downtown Atlanta. It’s a safety net hospital, where 80% patients are Black and 70%-80% patients are on public insurance or uninsured. Using this protocol, we improved Quitline referrals 20-fold.
What Is the BP Connect Program?
At least half of the encounters in United States happen in specialty clinics. Unfortunately, when patients get their BP measured in a specialty clinic that’s not a cardiology or a vascular clinic, often, even if the pressure is high, the clinic doesn’t give patients feedback on that. The problem is because we haven’t said anything, that gives people the false reassurance that their BP is okay.
We’ve developed a 3-minute protocol to ask, advise, and connect. The idea is that if we measure a high BP, then we remeasure and confirm that it’s high. Then, we advise why it matters in rheumatic disease: Patients with rheumatic diseases are already at an increased risk for heart disease, and controlling BP can make a big difference. Then, we connect patients with high BP back to primary care.
Specifically, a SmartSet — an electronic medical record feature — prompts different actions based on confirmed high BP readings:
- If systolic BP ≥ 140-159, the SmartSet directs scheduling a visit to a nurse or primary care provider.
- If systolic BP ≥ 160-179, the next primary care visit anticipates the need to see a prescriber.
- If systolic BP ≥ 180, then the medical assistant or nurse at the visit is instructed to notify the provider who can arrange a provider-to-provider handoff for safety to exclude a hypertensive emergency.
That order goes to the scheduler to call primary care to coordinate follow-up. BP Connect doubled the likelihood of a guideline-recommended follow-up in primary care within 30 days. All patients benefited, and disparities decreased. BP Connect has had 1100 downloads, and both BP and Quit Connect programs are endorsed by the Centers for Disease Control and Prevention and Million Hearts.
How Do These Programs Affect Clinical Practice?
We developed these interventions with a health system engineer, and we time stamped everything. Part of the sustainability of this model is that it fits within a regular workflow. As a practicing rheumatologist, I understand that time is a precious commodity.
The interventions are in partnership with frontline staff. We’ve received feedback that they feel pride participating in these initiatives. They can say, because of me, 30 patients followed up last month for high BP, or 10 patients took a referral to the Quitline last year. We celebrate these accomplishments with the staff.
What Are the Next Steps for These Programs?
Public-facing toolkits for both BP and Quit Connect programs are available online. We have implemented [these programs] in a rural setting, in an urban setting, in Milwaukee and in Atlanta, and we are looking in the future to do a larger, multistate implementation study. If folks are interested, we’d love to partner with them to look at disseminating this further.
A version of this article appeared on Medscape.com.
Presence of Central Sensitization Should Be Considered During PsA Treatment
Key clinical point: Nearly two out of three patients with psoriatic arthritis (PsA) had clinically significant central sensitization (CS), with the severity of psoriasis, anxiety level, and sleep quality being independent predictors of worse CS Inventory (CSI) scores.
Major finding: Overall, 65.1% patients had clinically significant CS, with a CSI score ≥ 40, with the severity of psoriasis and disease activity scores for PsA being positively associated with CSI scores (correlation coefficient 0.393-0.652; P < .001). The Psoriasis Area Severity Index (odds ratio [OR] 9.70; P = .017), General Anxiety Disorder-7 (OR 2.89; P = .014), and Insomnia Severity Index (OR 5.56; P = .041) scores were independent predictors of CS.
Study details: This cross-sectional observational study included 103 patients with PsA (age 18-75 years) with a mean CSI score of 45.4.
Disclosures: This study did not receive any financial support. The authors declared no conflicts of interest.
Source: Kaya MN, Tecer D, Kılıç Ö, et al. Impact of central sensitization on clinical and functional aspects of psoriatic arthritis. Medicina. 2024;60(9):1449 (Sept 4). Source
Key clinical point: Nearly two out of three patients with psoriatic arthritis (PsA) had clinically significant central sensitization (CS), with the severity of psoriasis, anxiety level, and sleep quality being independent predictors of worse CS Inventory (CSI) scores.
Major finding: Overall, 65.1% patients had clinically significant CS, with a CSI score ≥ 40, with the severity of psoriasis and disease activity scores for PsA being positively associated with CSI scores (correlation coefficient 0.393-0.652; P < .001). The Psoriasis Area Severity Index (odds ratio [OR] 9.70; P = .017), General Anxiety Disorder-7 (OR 2.89; P = .014), and Insomnia Severity Index (OR 5.56; P = .041) scores were independent predictors of CS.
Study details: This cross-sectional observational study included 103 patients with PsA (age 18-75 years) with a mean CSI score of 45.4.
Disclosures: This study did not receive any financial support. The authors declared no conflicts of interest.
Source: Kaya MN, Tecer D, Kılıç Ö, et al. Impact of central sensitization on clinical and functional aspects of psoriatic arthritis. Medicina. 2024;60(9):1449 (Sept 4). Source
Key clinical point: Nearly two out of three patients with psoriatic arthritis (PsA) had clinically significant central sensitization (CS), with the severity of psoriasis, anxiety level, and sleep quality being independent predictors of worse CS Inventory (CSI) scores.
Major finding: Overall, 65.1% patients had clinically significant CS, with a CSI score ≥ 40, with the severity of psoriasis and disease activity scores for PsA being positively associated with CSI scores (correlation coefficient 0.393-0.652; P < .001). The Psoriasis Area Severity Index (odds ratio [OR] 9.70; P = .017), General Anxiety Disorder-7 (OR 2.89; P = .014), and Insomnia Severity Index (OR 5.56; P = .041) scores were independent predictors of CS.
Study details: This cross-sectional observational study included 103 patients with PsA (age 18-75 years) with a mean CSI score of 45.4.
Disclosures: This study did not receive any financial support. The authors declared no conflicts of interest.
Source: Kaya MN, Tecer D, Kılıç Ö, et al. Impact of central sensitization on clinical and functional aspects of psoriatic arthritis. Medicina. 2024;60(9):1449 (Sept 4). Source
Bimekizumab Shows Long-Term Safety and Efficacy in Biologic-Naive and TNFi-IR PsA Patients
Key clinical point: Bimekizumab demonstrated consistent safety and sustained efficacy for up to 2 years in patients with psoriatic arthritis (PsA) who were biologic-naive or inadequately responsive to tumor necrosis factor inhibitors (TNFi-IR).
Major finding: From weeks 52 to 104, the incidence of treatment emergent adverse events (TEAE) was consistent with previous studies, with no new safety signals. SARS-CoV2 infection (18.6 per 100 patient-years) was the most common TEAE. Approximately 50% biologic-naive and TNFi-IR patients maintained a ≥50% improvement in the American College of Rheumatology response.
Study details: This open-label extension (BE-VITAL) of two phase 3 trials included biologic-naive (n = 852) and TNFi-IR (n = 400) patients with PsA who were randomly assigned to receive bimekizumab, placebo with crossover to bimekizumab at week 16, or adalimumab followed by bimekizumab at week 52.
Disclosures: This study was sponsored by UCB Pharma. Five authors declared being employees or shareholders of UCB Pharma. LC Coates declared being an editorial board member of Rheumatology and Therapy. Other authors declared having ties with various sources, including UCB.
Source: Mease PJ, Merola JF, Tanaka Y, et al. Safety and efficacy of bimekizumab in patients with psoriatic arthritis: 2-year results from two phase 3 studies. Rheumatol Ther. 2024 (Aug 31). doi: 10.1007/s40744-024-00708-8 Source
Key clinical point: Bimekizumab demonstrated consistent safety and sustained efficacy for up to 2 years in patients with psoriatic arthritis (PsA) who were biologic-naive or inadequately responsive to tumor necrosis factor inhibitors (TNFi-IR).
Major finding: From weeks 52 to 104, the incidence of treatment emergent adverse events (TEAE) was consistent with previous studies, with no new safety signals. SARS-CoV2 infection (18.6 per 100 patient-years) was the most common TEAE. Approximately 50% biologic-naive and TNFi-IR patients maintained a ≥50% improvement in the American College of Rheumatology response.
Study details: This open-label extension (BE-VITAL) of two phase 3 trials included biologic-naive (n = 852) and TNFi-IR (n = 400) patients with PsA who were randomly assigned to receive bimekizumab, placebo with crossover to bimekizumab at week 16, or adalimumab followed by bimekizumab at week 52.
Disclosures: This study was sponsored by UCB Pharma. Five authors declared being employees or shareholders of UCB Pharma. LC Coates declared being an editorial board member of Rheumatology and Therapy. Other authors declared having ties with various sources, including UCB.
Source: Mease PJ, Merola JF, Tanaka Y, et al. Safety and efficacy of bimekizumab in patients with psoriatic arthritis: 2-year results from two phase 3 studies. Rheumatol Ther. 2024 (Aug 31). doi: 10.1007/s40744-024-00708-8 Source
Key clinical point: Bimekizumab demonstrated consistent safety and sustained efficacy for up to 2 years in patients with psoriatic arthritis (PsA) who were biologic-naive or inadequately responsive to tumor necrosis factor inhibitors (TNFi-IR).
Major finding: From weeks 52 to 104, the incidence of treatment emergent adverse events (TEAE) was consistent with previous studies, with no new safety signals. SARS-CoV2 infection (18.6 per 100 patient-years) was the most common TEAE. Approximately 50% biologic-naive and TNFi-IR patients maintained a ≥50% improvement in the American College of Rheumatology response.
Study details: This open-label extension (BE-VITAL) of two phase 3 trials included biologic-naive (n = 852) and TNFi-IR (n = 400) patients with PsA who were randomly assigned to receive bimekizumab, placebo with crossover to bimekizumab at week 16, or adalimumab followed by bimekizumab at week 52.
Disclosures: This study was sponsored by UCB Pharma. Five authors declared being employees or shareholders of UCB Pharma. LC Coates declared being an editorial board member of Rheumatology and Therapy. Other authors declared having ties with various sources, including UCB.
Source: Mease PJ, Merola JF, Tanaka Y, et al. Safety and efficacy of bimekizumab in patients with psoriatic arthritis: 2-year results from two phase 3 studies. Rheumatol Ther. 2024 (Aug 31). doi: 10.1007/s40744-024-00708-8 Source
Guselkumab Shows Early and Sustained Efficacy in PsA
Key clinical point: Guselkumab treatment every 4 or 8 weeks (Q4W/Q8W) showed minimal clinically important improvements (MCII) in Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) after the first dose and sustained disease control for up to 1 year in patients with psoriatic arthritis (PsA).
Major finding: Both guselkumab doses (Q4W and Q8W) vs placebo led to early achievement of MCII in cDAPSA (hazard ratio 1.6-1.7; all P < .0001), with higher response rates at week 4 (P < .01). Achieving early MCII in cDAPSA was associated with sustained disease control at 24 and 52 weeks (odds ratio 1.4-3.5; all P < .05).
Study details: This post hoc analysis of phase 3 trials, DISCOVER-1 and DISCOVER-2, included 1120 patients with active PsA who received guselkumab (Q4W or Q8W) or placebo with a crossover to guselkumab Q4W at week 24.
Disclosures: This study was supported by Janssen Research & Development (JRD), LLC. Four authors declared being employees or shareholders of JRD or other sources. Several authors declared having ties with various sources, including JRD.
Source: Curtis JR, Deodhar A, Soriano ER, et al. Early Improvements with guselkumab associate with sustained control of psoriatic arthritis: Post hoc analyses of two phase 3 trials. Rheumatol Ther. 2024 (Sept 11). doi: 10.1007/s40744-024-00702-0 Source
Key clinical point: Guselkumab treatment every 4 or 8 weeks (Q4W/Q8W) showed minimal clinically important improvements (MCII) in Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) after the first dose and sustained disease control for up to 1 year in patients with psoriatic arthritis (PsA).
Major finding: Both guselkumab doses (Q4W and Q8W) vs placebo led to early achievement of MCII in cDAPSA (hazard ratio 1.6-1.7; all P < .0001), with higher response rates at week 4 (P < .01). Achieving early MCII in cDAPSA was associated with sustained disease control at 24 and 52 weeks (odds ratio 1.4-3.5; all P < .05).
Study details: This post hoc analysis of phase 3 trials, DISCOVER-1 and DISCOVER-2, included 1120 patients with active PsA who received guselkumab (Q4W or Q8W) or placebo with a crossover to guselkumab Q4W at week 24.
Disclosures: This study was supported by Janssen Research & Development (JRD), LLC. Four authors declared being employees or shareholders of JRD or other sources. Several authors declared having ties with various sources, including JRD.
Source: Curtis JR, Deodhar A, Soriano ER, et al. Early Improvements with guselkumab associate with sustained control of psoriatic arthritis: Post hoc analyses of two phase 3 trials. Rheumatol Ther. 2024 (Sept 11). doi: 10.1007/s40744-024-00702-0 Source
Key clinical point: Guselkumab treatment every 4 or 8 weeks (Q4W/Q8W) showed minimal clinically important improvements (MCII) in Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) after the first dose and sustained disease control for up to 1 year in patients with psoriatic arthritis (PsA).
Major finding: Both guselkumab doses (Q4W and Q8W) vs placebo led to early achievement of MCII in cDAPSA (hazard ratio 1.6-1.7; all P < .0001), with higher response rates at week 4 (P < .01). Achieving early MCII in cDAPSA was associated with sustained disease control at 24 and 52 weeks (odds ratio 1.4-3.5; all P < .05).
Study details: This post hoc analysis of phase 3 trials, DISCOVER-1 and DISCOVER-2, included 1120 patients with active PsA who received guselkumab (Q4W or Q8W) or placebo with a crossover to guselkumab Q4W at week 24.
Disclosures: This study was supported by Janssen Research & Development (JRD), LLC. Four authors declared being employees or shareholders of JRD or other sources. Several authors declared having ties with various sources, including JRD.
Source: Curtis JR, Deodhar A, Soriano ER, et al. Early Improvements with guselkumab associate with sustained control of psoriatic arthritis: Post hoc analyses of two phase 3 trials. Rheumatol Ther. 2024 (Sept 11). doi: 10.1007/s40744-024-00702-0 Source
Potential Predictive Biomarkers for Biologic Treatment Response in PsA
Key clinical point: Treatment with biologics, such as tumor necrosis factor inhibitors (TNFi) and interleukin-17 inhibitors (IL-17i), altered serum levels of matrix metalloproteinase-3 (MMP3), S100 calcium-binding protein A8 (S100A8), acid phosphatase 5, tartrate resistant (ACP5), and CXC motif chemokine 10 (CXCL10), with initial levels of these biomarkers effectively predicting treatment response to biologics in patients with psoriatic arthritis (PsA).
Major finding: The serum levels of MMP3, S100A8, ACP5, CCL2, and CXCL10 were significantly reduced with TNFi (all P < .05), whereas ACP5 and CCL2 levels increased with IL-17i (both P < .05). The baseline levels of MMP3, S100A8, ACP5, and CXCL10 effectively predicted response to biologic treatment (area under the receiver operating characteristic curve > 0.8).
Study details: This study retrospectively analyzed data from 205 patients with PsA who did (n = 130) or did not (n = 75) receive biologics or conventional synthetic disease-modifying antirheumatic drugs and 56 patients with psoriasis without arthritis, of whom 28 patients received biologics.
Disclosures: This study was partially funded by the Canadian Institute of Health Research, with additional funding provided by the Krembil Foundation. The authors declared no conflicts of interest.
Source: Offenheim R, Cruz-Correa OF, Ganatra D, Gladman DD. Candidate biomarkers for response to treatment in psoriatic disease. J Rheumatol. 2024 (Sept 1). doi: 10.3899/jrheum.2024-0396 Source
Key clinical point: Treatment with biologics, such as tumor necrosis factor inhibitors (TNFi) and interleukin-17 inhibitors (IL-17i), altered serum levels of matrix metalloproteinase-3 (MMP3), S100 calcium-binding protein A8 (S100A8), acid phosphatase 5, tartrate resistant (ACP5), and CXC motif chemokine 10 (CXCL10), with initial levels of these biomarkers effectively predicting treatment response to biologics in patients with psoriatic arthritis (PsA).
Major finding: The serum levels of MMP3, S100A8, ACP5, CCL2, and CXCL10 were significantly reduced with TNFi (all P < .05), whereas ACP5 and CCL2 levels increased with IL-17i (both P < .05). The baseline levels of MMP3, S100A8, ACP5, and CXCL10 effectively predicted response to biologic treatment (area under the receiver operating characteristic curve > 0.8).
Study details: This study retrospectively analyzed data from 205 patients with PsA who did (n = 130) or did not (n = 75) receive biologics or conventional synthetic disease-modifying antirheumatic drugs and 56 patients with psoriasis without arthritis, of whom 28 patients received biologics.
Disclosures: This study was partially funded by the Canadian Institute of Health Research, with additional funding provided by the Krembil Foundation. The authors declared no conflicts of interest.
Source: Offenheim R, Cruz-Correa OF, Ganatra D, Gladman DD. Candidate biomarkers for response to treatment in psoriatic disease. J Rheumatol. 2024 (Sept 1). doi: 10.3899/jrheum.2024-0396 Source
Key clinical point: Treatment with biologics, such as tumor necrosis factor inhibitors (TNFi) and interleukin-17 inhibitors (IL-17i), altered serum levels of matrix metalloproteinase-3 (MMP3), S100 calcium-binding protein A8 (S100A8), acid phosphatase 5, tartrate resistant (ACP5), and CXC motif chemokine 10 (CXCL10), with initial levels of these biomarkers effectively predicting treatment response to biologics in patients with psoriatic arthritis (PsA).
Major finding: The serum levels of MMP3, S100A8, ACP5, CCL2, and CXCL10 were significantly reduced with TNFi (all P < .05), whereas ACP5 and CCL2 levels increased with IL-17i (both P < .05). The baseline levels of MMP3, S100A8, ACP5, and CXCL10 effectively predicted response to biologic treatment (area under the receiver operating characteristic curve > 0.8).
Study details: This study retrospectively analyzed data from 205 patients with PsA who did (n = 130) or did not (n = 75) receive biologics or conventional synthetic disease-modifying antirheumatic drugs and 56 patients with psoriasis without arthritis, of whom 28 patients received biologics.
Disclosures: This study was partially funded by the Canadian Institute of Health Research, with additional funding provided by the Krembil Foundation. The authors declared no conflicts of interest.
Source: Offenheim R, Cruz-Correa OF, Ganatra D, Gladman DD. Candidate biomarkers for response to treatment in psoriatic disease. J Rheumatol. 2024 (Sept 1). doi: 10.3899/jrheum.2024-0396 Source
PsA Patients Initiating bDMARD Face High Risk for Interstitial Lung Disease
Key clinical point: Patients with psoriatic arthritis (PsA) initiating biologic disease-modifying antirheumatic drugs (bDMARD) had a significantly higher risk for interstitial lung disease (ILD) than control individuals in the general population; with methotrexate co-medication not being a risk factor for ILD.
Major finding: The 5-year risk for ILD was significantly higher in patients with PsA vs individuals in the general population (adjusted hazard ratio [aHR] 4.4; 95% CI 2.8-7.0). The risk for ILD did not increase among patients with PsA who did vs did not use methotrexate as co-medication (aHR 1.0; 95% CI 0.4-2.2).
Study details: This observational cohort study included 10,919 patients with PsA and 29,478 patients with rheumatoid arthritis from five Nordic rheumatology registers (all age ≥ 18 years) who initiated bDMARD treatment, along with 362,087 control individuals from the general population.
Disclosures: This study was supported by NordForsk, Foreum, and other sources. Several authors declared receiving grants, honoraria, or consulting fees from or having other ties with various sources.
Source: Provan SA, Ljung L, Kristianslund EK, et al. Interstitial lung disease in rheumatoid or psoriatic arthritis patients initiating biologics, and controls - Data from five Nordic registries. J Rheumatol. 2024 (Sept 1). doi: 0.3899/jrheum.2024-0252 Source
Key clinical point: Patients with psoriatic arthritis (PsA) initiating biologic disease-modifying antirheumatic drugs (bDMARD) had a significantly higher risk for interstitial lung disease (ILD) than control individuals in the general population; with methotrexate co-medication not being a risk factor for ILD.
Major finding: The 5-year risk for ILD was significantly higher in patients with PsA vs individuals in the general population (adjusted hazard ratio [aHR] 4.4; 95% CI 2.8-7.0). The risk for ILD did not increase among patients with PsA who did vs did not use methotrexate as co-medication (aHR 1.0; 95% CI 0.4-2.2).
Study details: This observational cohort study included 10,919 patients with PsA and 29,478 patients with rheumatoid arthritis from five Nordic rheumatology registers (all age ≥ 18 years) who initiated bDMARD treatment, along with 362,087 control individuals from the general population.
Disclosures: This study was supported by NordForsk, Foreum, and other sources. Several authors declared receiving grants, honoraria, or consulting fees from or having other ties with various sources.
Source: Provan SA, Ljung L, Kristianslund EK, et al. Interstitial lung disease in rheumatoid or psoriatic arthritis patients initiating biologics, and controls - Data from five Nordic registries. J Rheumatol. 2024 (Sept 1). doi: 0.3899/jrheum.2024-0252 Source
Key clinical point: Patients with psoriatic arthritis (PsA) initiating biologic disease-modifying antirheumatic drugs (bDMARD) had a significantly higher risk for interstitial lung disease (ILD) than control individuals in the general population; with methotrexate co-medication not being a risk factor for ILD.
Major finding: The 5-year risk for ILD was significantly higher in patients with PsA vs individuals in the general population (adjusted hazard ratio [aHR] 4.4; 95% CI 2.8-7.0). The risk for ILD did not increase among patients with PsA who did vs did not use methotrexate as co-medication (aHR 1.0; 95% CI 0.4-2.2).
Study details: This observational cohort study included 10,919 patients with PsA and 29,478 patients with rheumatoid arthritis from five Nordic rheumatology registers (all age ≥ 18 years) who initiated bDMARD treatment, along with 362,087 control individuals from the general population.
Disclosures: This study was supported by NordForsk, Foreum, and other sources. Several authors declared receiving grants, honoraria, or consulting fees from or having other ties with various sources.
Source: Provan SA, Ljung L, Kristianslund EK, et al. Interstitial lung disease in rheumatoid or psoriatic arthritis patients initiating biologics, and controls - Data from five Nordic registries. J Rheumatol. 2024 (Sept 1). doi: 0.3899/jrheum.2024-0252 Source
Bimekizumab Bests Risankizumab in PsA
Key clinical point: Bimekizumab showed better clinical efficacy outcomes than risankizumab in patients with psoriatic arthritis (PsA) who were biologic-naive or showed inadequate response to tumor necrosis factor inhibitors (TNFi-IR).
Major finding: At week 52, bimekizumab vs risankizumab led to a higher likelihood of achieving ≥70% improvement in the American College of Rheumatology response in biologic-naive (adjusted odds ratio [aOR] 1.80; P < .001) and TNFi-IR (aOR 3.69; P < .001) patients. It was also linked to greater odds of minimal disease activity response in TNFi-IR patients (aOR 2.43; P = .003).
Study details: This matching-adjusted indirect comparison of data from four phase 3 trials (BE OPTIMAL, BE COMPLETE, KEEPsAKE-1, and KEEPsAKE-2) that involved biologic-naive or TNFi-IR patients with PsA who received bimekizumab (n = 698) or risankizumab (n = 589).
Disclosures: This study was supported by UCB Pharma and the National Institute of Health and Care Research Manchester Biomedical Research Centre, UK. Four authors declared being employees and shareholders of UCB Pharma. Other authors declared having ties with various sources, including UCB Pharma.
Source: Mease PJ, Warren RB, Nash P, et al. Comparative effectiveness of bimekizumab and risankizumab in patients with psoriatic arthritis at 52 weeks assessed using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 (Aug 9). doi: 10.1007/s40744-024-00706-w Source
Key clinical point: Bimekizumab showed better clinical efficacy outcomes than risankizumab in patients with psoriatic arthritis (PsA) who were biologic-naive or showed inadequate response to tumor necrosis factor inhibitors (TNFi-IR).
Major finding: At week 52, bimekizumab vs risankizumab led to a higher likelihood of achieving ≥70% improvement in the American College of Rheumatology response in biologic-naive (adjusted odds ratio [aOR] 1.80; P < .001) and TNFi-IR (aOR 3.69; P < .001) patients. It was also linked to greater odds of minimal disease activity response in TNFi-IR patients (aOR 2.43; P = .003).
Study details: This matching-adjusted indirect comparison of data from four phase 3 trials (BE OPTIMAL, BE COMPLETE, KEEPsAKE-1, and KEEPsAKE-2) that involved biologic-naive or TNFi-IR patients with PsA who received bimekizumab (n = 698) or risankizumab (n = 589).
Disclosures: This study was supported by UCB Pharma and the National Institute of Health and Care Research Manchester Biomedical Research Centre, UK. Four authors declared being employees and shareholders of UCB Pharma. Other authors declared having ties with various sources, including UCB Pharma.
Source: Mease PJ, Warren RB, Nash P, et al. Comparative effectiveness of bimekizumab and risankizumab in patients with psoriatic arthritis at 52 weeks assessed using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 (Aug 9). doi: 10.1007/s40744-024-00706-w Source
Key clinical point: Bimekizumab showed better clinical efficacy outcomes than risankizumab in patients with psoriatic arthritis (PsA) who were biologic-naive or showed inadequate response to tumor necrosis factor inhibitors (TNFi-IR).
Major finding: At week 52, bimekizumab vs risankizumab led to a higher likelihood of achieving ≥70% improvement in the American College of Rheumatology response in biologic-naive (adjusted odds ratio [aOR] 1.80; P < .001) and TNFi-IR (aOR 3.69; P < .001) patients. It was also linked to greater odds of minimal disease activity response in TNFi-IR patients (aOR 2.43; P = .003).
Study details: This matching-adjusted indirect comparison of data from four phase 3 trials (BE OPTIMAL, BE COMPLETE, KEEPsAKE-1, and KEEPsAKE-2) that involved biologic-naive or TNFi-IR patients with PsA who received bimekizumab (n = 698) or risankizumab (n = 589).
Disclosures: This study was supported by UCB Pharma and the National Institute of Health and Care Research Manchester Biomedical Research Centre, UK. Four authors declared being employees and shareholders of UCB Pharma. Other authors declared having ties with various sources, including UCB Pharma.
Source: Mease PJ, Warren RB, Nash P, et al. Comparative effectiveness of bimekizumab and risankizumab in patients with psoriatic arthritis at 52 weeks assessed using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 (Aug 9). doi: 10.1007/s40744-024-00706-w Source
DMARD-Naive and DMARD-Failure PsA Patients Show Similar Imaging Profile
Key clinical point: Patients with psoriatic arthritis (PsA) who were disease-modifying antirheumatic drug (DMARD)-naive or non-responders to previous conventional synthetic DMARD treatment (DMARD-failure) showed similar inflammation and structural damage on imaging.
Major finding: After adjusting for patient characteristics, structural imaging parameters including Achilles tendon structural damage and Joint Space Narrowing scores (both P > .6) were similar in DMARD-naive and DMARD-failure patients. Additionally, inflammatory imaging parameters (P > .2) showed no significant differences between the two groups, indicating that failing a DMARD was not associated with worsened imaging outcomes.
Study details: This cross-sectional study evaluated 80 patients with PsA from TOFA-PREDICT trial who were either DMARD-naive (n = 40) or DMARD non-responders (n = 40).
Disclosures: This study was supported by Pfizer. The collaboration project was co-funded by the public-private partnerships allowance by Health~Holland, Top Sector Life Sciences & Health. Six authors declared receiving research grants, consulting fees, and support from various sources, including Pfizer. Other authors declared no conflicts of interest.
Source: Renkli NÖ, Kleinrensink NJ, Spierings J, et al, and the TOFA-PREDICT author group. Multimodal imaging of structural damage and inflammation in psoriatic arthritis: A comparison of DMARD-naive and DMARD-failure patients. Rheumatology (Oxford). 2024 (Aug 17). doi: 10.1093/rheumatology/keae450 Source
Key clinical point: Patients with psoriatic arthritis (PsA) who were disease-modifying antirheumatic drug (DMARD)-naive or non-responders to previous conventional synthetic DMARD treatment (DMARD-failure) showed similar inflammation and structural damage on imaging.
Major finding: After adjusting for patient characteristics, structural imaging parameters including Achilles tendon structural damage and Joint Space Narrowing scores (both P > .6) were similar in DMARD-naive and DMARD-failure patients. Additionally, inflammatory imaging parameters (P > .2) showed no significant differences between the two groups, indicating that failing a DMARD was not associated with worsened imaging outcomes.
Study details: This cross-sectional study evaluated 80 patients with PsA from TOFA-PREDICT trial who were either DMARD-naive (n = 40) or DMARD non-responders (n = 40).
Disclosures: This study was supported by Pfizer. The collaboration project was co-funded by the public-private partnerships allowance by Health~Holland, Top Sector Life Sciences & Health. Six authors declared receiving research grants, consulting fees, and support from various sources, including Pfizer. Other authors declared no conflicts of interest.
Source: Renkli NÖ, Kleinrensink NJ, Spierings J, et al, and the TOFA-PREDICT author group. Multimodal imaging of structural damage and inflammation in psoriatic arthritis: A comparison of DMARD-naive and DMARD-failure patients. Rheumatology (Oxford). 2024 (Aug 17). doi: 10.1093/rheumatology/keae450 Source
Key clinical point: Patients with psoriatic arthritis (PsA) who were disease-modifying antirheumatic drug (DMARD)-naive or non-responders to previous conventional synthetic DMARD treatment (DMARD-failure) showed similar inflammation and structural damage on imaging.
Major finding: After adjusting for patient characteristics, structural imaging parameters including Achilles tendon structural damage and Joint Space Narrowing scores (both P > .6) were similar in DMARD-naive and DMARD-failure patients. Additionally, inflammatory imaging parameters (P > .2) showed no significant differences between the two groups, indicating that failing a DMARD was not associated with worsened imaging outcomes.
Study details: This cross-sectional study evaluated 80 patients with PsA from TOFA-PREDICT trial who were either DMARD-naive (n = 40) or DMARD non-responders (n = 40).
Disclosures: This study was supported by Pfizer. The collaboration project was co-funded by the public-private partnerships allowance by Health~Holland, Top Sector Life Sciences & Health. Six authors declared receiving research grants, consulting fees, and support from various sources, including Pfizer. Other authors declared no conflicts of interest.
Source: Renkli NÖ, Kleinrensink NJ, Spierings J, et al, and the TOFA-PREDICT author group. Multimodal imaging of structural damage and inflammation in psoriatic arthritis: A comparison of DMARD-naive and DMARD-failure patients. Rheumatology (Oxford). 2024 (Aug 17). doi: 10.1093/rheumatology/keae450 Source
Risankizumab Safe for Long-Term Use in PsA
Key clinical point: This largest and longest safety analysis on risankizumab demonstrated its long-term safety in patients with psoriatic arthritis (PsA), consistent with previously published reports.
Major finding: The rate of treatment-emergent adverse events (AE) was 142.6 events per 100 patient-years (E/100 PY), serious AE was 8.6 E/100 PY, and AE leading to discontinuation was 1.8 E/100 PY. The rates of serious infections, cancer, major cardiovascular events, and hepatic events remained consistent or decreased in frequency through 6 months or 1 year. No additional safety concerns were reported.
Study details: This integrated safety analysis used data from four phase 2-3 trials involving 1542 patients with PsA and 20 phase 1-4 trials involving 3658 patients with plaque psoriasis, all of whom received ≥1 dose of risankizumab.
Disclosures: This study was funded by AbbVie. Risankizumab was jointly developed by AbbVie and Boehringer Ingelheim. Five authors declared being full-time employees of and may own stock or stock options of AbbVie. Other authors declared having ties with various sources, including AbbVie.
Source: Gordon KB, Blauvelt A, Bachelez H, et al. Long-term safety of risankizumab in patients with psoriatic disease: A comprehensive analysis from clinical trials. Dermatol Ther (Heidelb). 2024;14:2523-2538 (Aug 17). doi: 10.1007/s13555-024-01238-5 Source
Key clinical point: This largest and longest safety analysis on risankizumab demonstrated its long-term safety in patients with psoriatic arthritis (PsA), consistent with previously published reports.
Major finding: The rate of treatment-emergent adverse events (AE) was 142.6 events per 100 patient-years (E/100 PY), serious AE was 8.6 E/100 PY, and AE leading to discontinuation was 1.8 E/100 PY. The rates of serious infections, cancer, major cardiovascular events, and hepatic events remained consistent or decreased in frequency through 6 months or 1 year. No additional safety concerns were reported.
Study details: This integrated safety analysis used data from four phase 2-3 trials involving 1542 patients with PsA and 20 phase 1-4 trials involving 3658 patients with plaque psoriasis, all of whom received ≥1 dose of risankizumab.
Disclosures: This study was funded by AbbVie. Risankizumab was jointly developed by AbbVie and Boehringer Ingelheim. Five authors declared being full-time employees of and may own stock or stock options of AbbVie. Other authors declared having ties with various sources, including AbbVie.
Source: Gordon KB, Blauvelt A, Bachelez H, et al. Long-term safety of risankizumab in patients with psoriatic disease: A comprehensive analysis from clinical trials. Dermatol Ther (Heidelb). 2024;14:2523-2538 (Aug 17). doi: 10.1007/s13555-024-01238-5 Source
Key clinical point: This largest and longest safety analysis on risankizumab demonstrated its long-term safety in patients with psoriatic arthritis (PsA), consistent with previously published reports.
Major finding: The rate of treatment-emergent adverse events (AE) was 142.6 events per 100 patient-years (E/100 PY), serious AE was 8.6 E/100 PY, and AE leading to discontinuation was 1.8 E/100 PY. The rates of serious infections, cancer, major cardiovascular events, and hepatic events remained consistent or decreased in frequency through 6 months or 1 year. No additional safety concerns were reported.
Study details: This integrated safety analysis used data from four phase 2-3 trials involving 1542 patients with PsA and 20 phase 1-4 trials involving 3658 patients with plaque psoriasis, all of whom received ≥1 dose of risankizumab.
Disclosures: This study was funded by AbbVie. Risankizumab was jointly developed by AbbVie and Boehringer Ingelheim. Five authors declared being full-time employees of and may own stock or stock options of AbbVie. Other authors declared having ties with various sources, including AbbVie.
Source: Gordon KB, Blauvelt A, Bachelez H, et al. Long-term safety of risankizumab in patients with psoriatic disease: A comprehensive analysis from clinical trials. Dermatol Ther (Heidelb). 2024;14:2523-2538 (Aug 17). doi: 10.1007/s13555-024-01238-5 Source