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Upadacitinib offers effective disease control in PsA

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Key clinical point: A higher proportion of patients with psoriatic arthritis (PsA) receiving 15 mg upadacitinib achieved low disease activity (LDA) or remission after the first 6 months of treatment, with the difference being visible even after 1 year of treatment, compared to those who received a placebo.

Major finding: At week 24, a higher proportion of patients receiving 15 mg upadacitinib vs. placebo achieved Disease Activity in PsA LDA (range 35%-48% vs. 4%-16%; P < .05) and remission (range 7%-11% vs. 0%-3%; P < .05), with the responses sustained until 56 weeks.

Study details: This was a post hoc analysis of the SELECT-PsA 1 and SELECT-PsA 2 trials including 1386 adults with PsA and prior inadequate response/intolerance to ≥1 non-biologic or biologic disease-modifying antirheumatic drugs who were randomly assigned to receive upadacitinib (15 or 30 mg), adalimumab, or placebo.

Disclosures: This study was funded by AbbVie, Inc. Four authors declared being current or former employees or stockholders of AbbVie, and other authors reported ties with various sources.

Source: Mease P et al. Disease control with upadacitinib in patients with psoriatic arthritis: A post hoc analysis of the randomized, placebo-controlled SELECT-PsA 1 and 2 phase 3 trials. Rheumatol Ther. 2022 (May 23). Doi: 10.1007/s40744-022-00449-6

 

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Key clinical point: A higher proportion of patients with psoriatic arthritis (PsA) receiving 15 mg upadacitinib achieved low disease activity (LDA) or remission after the first 6 months of treatment, with the difference being visible even after 1 year of treatment, compared to those who received a placebo.

Major finding: At week 24, a higher proportion of patients receiving 15 mg upadacitinib vs. placebo achieved Disease Activity in PsA LDA (range 35%-48% vs. 4%-16%; P < .05) and remission (range 7%-11% vs. 0%-3%; P < .05), with the responses sustained until 56 weeks.

Study details: This was a post hoc analysis of the SELECT-PsA 1 and SELECT-PsA 2 trials including 1386 adults with PsA and prior inadequate response/intolerance to ≥1 non-biologic or biologic disease-modifying antirheumatic drugs who were randomly assigned to receive upadacitinib (15 or 30 mg), adalimumab, or placebo.

Disclosures: This study was funded by AbbVie, Inc. Four authors declared being current or former employees or stockholders of AbbVie, and other authors reported ties with various sources.

Source: Mease P et al. Disease control with upadacitinib in patients with psoriatic arthritis: A post hoc analysis of the randomized, placebo-controlled SELECT-PsA 1 and 2 phase 3 trials. Rheumatol Ther. 2022 (May 23). Doi: 10.1007/s40744-022-00449-6

 

Key clinical point: A higher proportion of patients with psoriatic arthritis (PsA) receiving 15 mg upadacitinib achieved low disease activity (LDA) or remission after the first 6 months of treatment, with the difference being visible even after 1 year of treatment, compared to those who received a placebo.

Major finding: At week 24, a higher proportion of patients receiving 15 mg upadacitinib vs. placebo achieved Disease Activity in PsA LDA (range 35%-48% vs. 4%-16%; P < .05) and remission (range 7%-11% vs. 0%-3%; P < .05), with the responses sustained until 56 weeks.

Study details: This was a post hoc analysis of the SELECT-PsA 1 and SELECT-PsA 2 trials including 1386 adults with PsA and prior inadequate response/intolerance to ≥1 non-biologic or biologic disease-modifying antirheumatic drugs who were randomly assigned to receive upadacitinib (15 or 30 mg), adalimumab, or placebo.

Disclosures: This study was funded by AbbVie, Inc. Four authors declared being current or former employees or stockholders of AbbVie, and other authors reported ties with various sources.

Source: Mease P et al. Disease control with upadacitinib in patients with psoriatic arthritis: A post hoc analysis of the randomized, placebo-controlled SELECT-PsA 1 and 2 phase 3 trials. Rheumatol Ther. 2022 (May 23). Doi: 10.1007/s40744-022-00449-6

 

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Enthesitis resolves regardless of medication used in PsA

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Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) achieved resolution of enthesitis within a year of initiating nonsteroidal anti-inflammatory drugs (NSAID) or disease-modifying antirheumatic drugs (DMARD), although the odds were lower in patients with high joint disease activity at baseline.

Major finding: Complete resolution of enthesitis was achieved by 86.12% of patients within a mean period of 8.73 months from therapy initiation, with higher joint activity at baseline being associated with a lower chance of enthesitis resolution (odds ratio 0.97; P = .01).

Study details: Findings are from a retrospective analysis of prospectively collected data of 526 patients with PsA and enthesitis who received no treatment/only NSAID (n = 142), conventional DMARD ± NSAID but without targeted DMARD (n = 196), or targeted DMARD with or without other medications (n = 188).

Disclosures: Dr. Mathew and Dr. Chandran received funding from the National Psoriasis Foundation and University of Toronto, respectively. The authors declared no conflicts of interest.

Source: Mathew AJ et al. Effectiveness of disease modifying anti-rheumatic drugs for enthesitis in a prospective longitudinal psoriatic arthritis cohort. J Rheumatol. 2022 (Jun 1). Doi: 10.3899/jrheum.211231

 

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Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) achieved resolution of enthesitis within a year of initiating nonsteroidal anti-inflammatory drugs (NSAID) or disease-modifying antirheumatic drugs (DMARD), although the odds were lower in patients with high joint disease activity at baseline.

Major finding: Complete resolution of enthesitis was achieved by 86.12% of patients within a mean period of 8.73 months from therapy initiation, with higher joint activity at baseline being associated with a lower chance of enthesitis resolution (odds ratio 0.97; P = .01).

Study details: Findings are from a retrospective analysis of prospectively collected data of 526 patients with PsA and enthesitis who received no treatment/only NSAID (n = 142), conventional DMARD ± NSAID but without targeted DMARD (n = 196), or targeted DMARD with or without other medications (n = 188).

Disclosures: Dr. Mathew and Dr. Chandran received funding from the National Psoriasis Foundation and University of Toronto, respectively. The authors declared no conflicts of interest.

Source: Mathew AJ et al. Effectiveness of disease modifying anti-rheumatic drugs for enthesitis in a prospective longitudinal psoriatic arthritis cohort. J Rheumatol. 2022 (Jun 1). Doi: 10.3899/jrheum.211231

 

Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) achieved resolution of enthesitis within a year of initiating nonsteroidal anti-inflammatory drugs (NSAID) or disease-modifying antirheumatic drugs (DMARD), although the odds were lower in patients with high joint disease activity at baseline.

Major finding: Complete resolution of enthesitis was achieved by 86.12% of patients within a mean period of 8.73 months from therapy initiation, with higher joint activity at baseline being associated with a lower chance of enthesitis resolution (odds ratio 0.97; P = .01).

Study details: Findings are from a retrospective analysis of prospectively collected data of 526 patients with PsA and enthesitis who received no treatment/only NSAID (n = 142), conventional DMARD ± NSAID but without targeted DMARD (n = 196), or targeted DMARD with or without other medications (n = 188).

Disclosures: Dr. Mathew and Dr. Chandran received funding from the National Psoriasis Foundation and University of Toronto, respectively. The authors declared no conflicts of interest.

Source: Mathew AJ et al. Effectiveness of disease modifying anti-rheumatic drugs for enthesitis in a prospective longitudinal psoriatic arthritis cohort. J Rheumatol. 2022 (Jun 1). Doi: 10.3899/jrheum.211231

 

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Commentary: Evaluating New Treatments and Cardiovascular Risk in PsA, July 2022

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Dr. Chandran scans the journals, so you don't have to!

Vinod Chandran, MBBS, MD, DM, PhD
Inhibition of the Janus kinase-signal transducer and activator of transcription (JAK-STAT) pathway by JAK inhibitors is efficacious in psoriatic arthritis (PsA). On the basis of the results of the pivotal SELECT-PsA 1 and SELECT-PsA 2 trials, upadacitinib, a selective JAK1 inhibitor, was recently approved for the treatment of PsA. However, data on longer-term disease control is still of interest. In a post hoc analysis of SELECT-PsA 1 and SELECT-PsA 2, Mease and colleagues assessed the proportion of patients achieving low disease activity or remission, as defined by validated measures such as the Disease Activity Index in Psoriatic Arthritis, Psoriatic Arthritis Disease Activity Scores, and minimal disease activity at 24 and 56 weeks. They showed that at week 24 a higher proportion of patients receiving 15 mg upadacitinib vs placebo achieved low disease activity on the Disease Activity Index in Psoriatic Arthritis (range 35%-48% vs 4%-16%; P < .05) and remission (range 7%-11% vs 0%-3%; P < .05), with the responses sustained until week 56. Thus, upadacitinib provides sustained disease control in PsA and is an effective oral therapy.

 

Advanced targeted therapies have proven safety and efficacy over conventional therapies, often dramatically improving signs and symptoms. However, it is also desirable that such expensive therapies also show benefit in other outcomes, such as work productivity and quality of life. To evaluate work productivity and daily activity impairment and health-related quality of life in patients with inflammatory arthritis (rheumatoid arthritis, n = 95; PsA, n = 69, and axial spondyloarthritis, n = 95) treated with golimumab, Dejaco and colleagues conducted a prospective, multicenter study in Austria. A total of 110 of these patients were followed for 24 months. At 24 months after golimumab initiation, there was significant improvement in total work productivity, presenteeism, activity impairment, and quality-of-life scores. Thus, golimumab, in addition to reducing disease activity, improved work productivity, activity, and health-related quality of life in patients with inflammatory arthritis, including PsA.

 

Cardiovascular disease (CVD) remains a major comorbidity in patients with PsA. This observation was once again confirmed in an observational, cross-sectional, case-control study including 207 patients with PsA and 414 matched controls from France. Degboe and colleagues demonstrated that patients with PsA had a higher prevalence of cardiovascular events and cardiovascular risk factors, such as high body mass index, triglyceride level, and hypertension, compared with controls. The proportion of patients with PsA who were estimated to have very high cardiovascular risk factors (≥ 10%) increased when SCORE (European Society of Cardiology Systematic Coronary Risk Evaluation) and QRISK2 (British Heart Foundation) equations considered the additional risk attributable to PsA. However, risk predictions scores such as SCORE and QRISK2 perform poorly in patients with PsA. To identify novel inflammatory and metabolic parameters associated with cardiovascular disease, Schwartz and colleagues looked at 18F-fluorodeoxyglucose (FDG) PET-CT uptake in a cross-sectional analysis of a prospective study including 39 patients with biologic-treatment-naive PsA and 56 age-sex matched controls without PsA. They found that coronary artery disease (CAD) was significantly associated with visceral adiposity and FDG uptake in the bone marrow, liver, spleen, and subcutaneous adipose tissue. Thus, inflammatory and metabolic parameters, including visceral adiposity, potentially contribute to subclinical CAD in patients with PsA and may in the future be used to refine CVD risk and be targets for CAD preventive treatments.

Author and Disclosure Information

Vinod Chandran, MBBS, MD, DM, PhD, Associate Professor, Department of Medicine, University of Toledo, Toronto, Ontario, Canada

Vinod Chandran, MBBS, MD, DM, PhD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Amgen; Bristol-Myers Squibb; Eli Lilly; Janssen; Novartis; Pfizer; UCB

Received research grant from: Amgen; AbbVie; Eli Lilly

Spousal employment: Eli Lilly; AstraZeneca

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Vinod Chandran, MBBS, MD, DM, PhD, Associate Professor, Department of Medicine, University of Toledo, Toronto, Ontario, Canada

Vinod Chandran, MBBS, MD, DM, PhD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Amgen; Bristol-Myers Squibb; Eli Lilly; Janssen; Novartis; Pfizer; UCB

Received research grant from: Amgen; AbbVie; Eli Lilly

Spousal employment: Eli Lilly; AstraZeneca

Author and Disclosure Information

Vinod Chandran, MBBS, MD, DM, PhD, Associate Professor, Department of Medicine, University of Toledo, Toronto, Ontario, Canada

Vinod Chandran, MBBS, MD, DM, PhD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Amgen; Bristol-Myers Squibb; Eli Lilly; Janssen; Novartis; Pfizer; UCB

Received research grant from: Amgen; AbbVie; Eli Lilly

Spousal employment: Eli Lilly; AstraZeneca

Dr. Chandran scans the journals, so you don't have to!
Dr. Chandran scans the journals, so you don't have to!

Vinod Chandran, MBBS, MD, DM, PhD
Inhibition of the Janus kinase-signal transducer and activator of transcription (JAK-STAT) pathway by JAK inhibitors is efficacious in psoriatic arthritis (PsA). On the basis of the results of the pivotal SELECT-PsA 1 and SELECT-PsA 2 trials, upadacitinib, a selective JAK1 inhibitor, was recently approved for the treatment of PsA. However, data on longer-term disease control is still of interest. In a post hoc analysis of SELECT-PsA 1 and SELECT-PsA 2, Mease and colleagues assessed the proportion of patients achieving low disease activity or remission, as defined by validated measures such as the Disease Activity Index in Psoriatic Arthritis, Psoriatic Arthritis Disease Activity Scores, and minimal disease activity at 24 and 56 weeks. They showed that at week 24 a higher proportion of patients receiving 15 mg upadacitinib vs placebo achieved low disease activity on the Disease Activity Index in Psoriatic Arthritis (range 35%-48% vs 4%-16%; P < .05) and remission (range 7%-11% vs 0%-3%; P < .05), with the responses sustained until week 56. Thus, upadacitinib provides sustained disease control in PsA and is an effective oral therapy.

 

Advanced targeted therapies have proven safety and efficacy over conventional therapies, often dramatically improving signs and symptoms. However, it is also desirable that such expensive therapies also show benefit in other outcomes, such as work productivity and quality of life. To evaluate work productivity and daily activity impairment and health-related quality of life in patients with inflammatory arthritis (rheumatoid arthritis, n = 95; PsA, n = 69, and axial spondyloarthritis, n = 95) treated with golimumab, Dejaco and colleagues conducted a prospective, multicenter study in Austria. A total of 110 of these patients were followed for 24 months. At 24 months after golimumab initiation, there was significant improvement in total work productivity, presenteeism, activity impairment, and quality-of-life scores. Thus, golimumab, in addition to reducing disease activity, improved work productivity, activity, and health-related quality of life in patients with inflammatory arthritis, including PsA.

 

Cardiovascular disease (CVD) remains a major comorbidity in patients with PsA. This observation was once again confirmed in an observational, cross-sectional, case-control study including 207 patients with PsA and 414 matched controls from France. Degboe and colleagues demonstrated that patients with PsA had a higher prevalence of cardiovascular events and cardiovascular risk factors, such as high body mass index, triglyceride level, and hypertension, compared with controls. The proportion of patients with PsA who were estimated to have very high cardiovascular risk factors (≥ 10%) increased when SCORE (European Society of Cardiology Systematic Coronary Risk Evaluation) and QRISK2 (British Heart Foundation) equations considered the additional risk attributable to PsA. However, risk predictions scores such as SCORE and QRISK2 perform poorly in patients with PsA. To identify novel inflammatory and metabolic parameters associated with cardiovascular disease, Schwartz and colleagues looked at 18F-fluorodeoxyglucose (FDG) PET-CT uptake in a cross-sectional analysis of a prospective study including 39 patients with biologic-treatment-naive PsA and 56 age-sex matched controls without PsA. They found that coronary artery disease (CAD) was significantly associated with visceral adiposity and FDG uptake in the bone marrow, liver, spleen, and subcutaneous adipose tissue. Thus, inflammatory and metabolic parameters, including visceral adiposity, potentially contribute to subclinical CAD in patients with PsA and may in the future be used to refine CVD risk and be targets for CAD preventive treatments.

Vinod Chandran, MBBS, MD, DM, PhD
Inhibition of the Janus kinase-signal transducer and activator of transcription (JAK-STAT) pathway by JAK inhibitors is efficacious in psoriatic arthritis (PsA). On the basis of the results of the pivotal SELECT-PsA 1 and SELECT-PsA 2 trials, upadacitinib, a selective JAK1 inhibitor, was recently approved for the treatment of PsA. However, data on longer-term disease control is still of interest. In a post hoc analysis of SELECT-PsA 1 and SELECT-PsA 2, Mease and colleagues assessed the proportion of patients achieving low disease activity or remission, as defined by validated measures such as the Disease Activity Index in Psoriatic Arthritis, Psoriatic Arthritis Disease Activity Scores, and minimal disease activity at 24 and 56 weeks. They showed that at week 24 a higher proportion of patients receiving 15 mg upadacitinib vs placebo achieved low disease activity on the Disease Activity Index in Psoriatic Arthritis (range 35%-48% vs 4%-16%; P < .05) and remission (range 7%-11% vs 0%-3%; P < .05), with the responses sustained until week 56. Thus, upadacitinib provides sustained disease control in PsA and is an effective oral therapy.

 

Advanced targeted therapies have proven safety and efficacy over conventional therapies, often dramatically improving signs and symptoms. However, it is also desirable that such expensive therapies also show benefit in other outcomes, such as work productivity and quality of life. To evaluate work productivity and daily activity impairment and health-related quality of life in patients with inflammatory arthritis (rheumatoid arthritis, n = 95; PsA, n = 69, and axial spondyloarthritis, n = 95) treated with golimumab, Dejaco and colleagues conducted a prospective, multicenter study in Austria. A total of 110 of these patients were followed for 24 months. At 24 months after golimumab initiation, there was significant improvement in total work productivity, presenteeism, activity impairment, and quality-of-life scores. Thus, golimumab, in addition to reducing disease activity, improved work productivity, activity, and health-related quality of life in patients with inflammatory arthritis, including PsA.

 

Cardiovascular disease (CVD) remains a major comorbidity in patients with PsA. This observation was once again confirmed in an observational, cross-sectional, case-control study including 207 patients with PsA and 414 matched controls from France. Degboe and colleagues demonstrated that patients with PsA had a higher prevalence of cardiovascular events and cardiovascular risk factors, such as high body mass index, triglyceride level, and hypertension, compared with controls. The proportion of patients with PsA who were estimated to have very high cardiovascular risk factors (≥ 10%) increased when SCORE (European Society of Cardiology Systematic Coronary Risk Evaluation) and QRISK2 (British Heart Foundation) equations considered the additional risk attributable to PsA. However, risk predictions scores such as SCORE and QRISK2 perform poorly in patients with PsA. To identify novel inflammatory and metabolic parameters associated with cardiovascular disease, Schwartz and colleagues looked at 18F-fluorodeoxyglucose (FDG) PET-CT uptake in a cross-sectional analysis of a prospective study including 39 patients with biologic-treatment-naive PsA and 56 age-sex matched controls without PsA. They found that coronary artery disease (CAD) was significantly associated with visceral adiposity and FDG uptake in the bone marrow, liver, spleen, and subcutaneous adipose tissue. Thus, inflammatory and metabolic parameters, including visceral adiposity, potentially contribute to subclinical CAD in patients with PsA and may in the future be used to refine CVD risk and be targets for CAD preventive treatments.

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No more ‘escape hatch’: Post Roe, new worries about meds linked to birth defects

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As states ban or limit abortion in the wake of the demise of Roe v. Wade, physicians are turning their attention to widely-used drugs that can cause birth defects. At issue: Should these drugs still be prescribed to women of childbearing age if they don’t have the option of terminating their pregnancies?

javi_indy/ Thinkstock

“Doctors are going to understandably be terrified that a patient may become pregnant using a teratogen that they have prescribed,” said University of Pittsburgh rheumatologist Mehret Birru Talabi, MD, PhD, who works in a state where the future of abortion rights is uncertain. “While this was a feared outcome before Roe v. Wade was overturned, abortion provided an escape hatch by which women could avoid having to continue a pregnancy and potentially raise a child with congenital anomalies. I believe that prescribing is going to become much more defensive and conservative. Some clinicians may choose not to prescribe these medications to patients who have childbearing potential, even if they don’t have much risk for pregnancy.”

Other physicians expressed similar concerns in interviews. Duke University, Durham, N.C., rheumatologist Megan E. B. Clowse, MD, MPH, fears that physicians will be wary of prescribing a variety of medications – including new ones for which there are few pregnancy data – if abortion is unavailable. “Women who receive these new or teratogenic medications will likely lose their reproductive autonomy and be forced to choose between having sexual relationships with men, obtaining procedures that make them permanently sterile, or using contraception that may cause intolerable side effects,” she said. “I am very concerned that young women with rheumatic disease will now be left with active disease resulting in joint damage and renal failure.”

Abortion is now banned in at least six states, according to The New York Times. That number may rise to 16 as more restrictions become law. Another five states aren’t expected to ban abortion soon but have implemented gestational age limits on abortion or are expected to adopt them. In another nine states, courts or lawmakers will decide whether abortion remains legal.

Only 20 states and the District of Columbia have firm abortion protections in place.

Numerous drugs are considered teratogens, which means they may cause birth defects. Thalidomide is the most infamous, but there are many more, including several used in rheumatology, dermatology, and gastroenterology. Among the most widely used teratogenic medications are the acne drugs isotretinoin and methotrexate, which are used to treat a variety of conditions, such as cancer, rheumatoid arthritis, and psoriasis.



Dr. Clowse, who helps manage an industry-supported website devoted to reproductive care for women with lupus (www.LupusPregnancy.org), noted that several drugs linked to birth defects and pregnancy loss are commonly prescribed in rheumatology.

“Methotrexate is the most common medication and has been the cornerstone of rheumatoid arthritis [treatment] for at least two decades,” she said. “Mycophenolate is our best medication to treat lupus nephritis, which is inflammation in the kidneys caused by lupus. This is a common complication for young women with lupus, and all of our guideline-recommended treatment regimens include a medication that causes pregnancy loss and birth defects, either mycophenolate or cyclophosphamide.”

Rheumatologists also prescribe a large number of new drugs for which there are few data about pregnancy risks. “It typically takes about two decades to have sufficient data about the safety of our medications,” she said.

Reflecting the sensitivity of the topic, Dr. Clowse made clear that her opinions don’t represent the views of her institution. She works in North Carolina, where the fate of abortion rights is uncertain, according to The New York Times.

What about alternatives? “The short answer is that some of these medications work really well and sometimes much better than the nonteratogenic alternatives,” said Dr. Birru Talabi. “I’m worried about methotrexate. It has been used to induce abortions but is primarily used in the United States as a highly effective treatment for cancer as well as a myriad of rheumatic diseases. If legislators try to restrict access to methotrexate, we may see increasing disability and even death among people who need this medication but cannot access it.”

Rheumatologists aren’t the only physicians who are worrying about the fates of their patients in a new era of abortion restrictions. Gastroenterologist Sunanda Kane, MD, MSPH, of the Mayo Clinic, Rochester, Minn., said several teratogenic medications are used in her field to treat constipation, viral hepatitis, and inflammatory bowel disease.

“When treating women of childbearing age, there are usually alternatives. If we do prescribe a medication with a high teratogenic potential, we counsel and document that we have discussed two forms of birth control to avoid pregnancy. We usually do not prescribe a drug with teratogenic potential with the ‘out’ being an abortion if a pregnancy does occur,” she said. However, “if abortion is not even on the table as an option, we may be much less likely to prescribe these medications. This will be particularly true in patients who clearly do not have the means to travel to have an abortion in any situation.”

Abortion is expected to remain legal in Minnesota, where Dr. Kane practices, but it may be restricted or banned in nearby Wisconsin, depending on the state legislature. None of her patients have had abortions after becoming pregnant while taking the medications, she said, although she “did have a patient who because of her religious faith did not have an abortion after exposure and ended up with a stillbirth.”



The crackdown on abortion won’t just pose risks to patients who take potentially dangerous medications, physicians said. Dr. Kane said pregnancy itself is a significant risk for patients with “very active, uncontrolled gastrointestinal conditions where a pregnancy could be harmful to the mother’s health or result in offspring that are very unhealthy.” These include decompensated cirrhosis, uncontrolled Crohn’s disease or ulcerative colitis, refractory gastroparesis, uncontrolled celiac sprue, and chronic pancreatitis, she said.

“There have been times when after shared decisionmaking, a patient with very active inflammatory bowel disease has decided to terminate the pregnancy because of her own ongoing health issues,” she said. “Not having this option will potentially lead to disastrous results.”

Dr. Clowse, the Duke University rheumatologist, echoed Dr. Kane’s concerns about women who are too sick to bear children. “The removal of abortion rights puts the lives and quality of life for women with rheumatic disease at risk. For patients with lupus and other systemic rheumatic disease, pregnancy can be medically catastrophic, leading to permanent harm and even death to the woman and her offspring. I am worried that women in these conditions will die without lifesaving pregnancy terminations, due to worries about the legal consequences for their physicians.”

The U.S. Supreme Court’s ruling that overturned Roe v. Wade has also raised the prospect that the court could ultimately allow birth control to be restricted or outlawed.

While the ruling states that “nothing in this opinion should be understood to cast doubt on precedents that do not concern abortion,” Justice Clarence Thomas wrote a concurrence in which he said that the court should reconsider a 1960s ruling that forbids the banning of contraceptives. Republicans have dismissed concerns about bans being allowed, although Democrats, including the president and vice president, starkly warn that they could happen.

“If we as providers have to be concerned that there will be an unplanned pregnancy because of the lack of access to contraception,” Dr. Kane said, “this will have significant downstream consequences to the kind of care we can provide and might just drive some providers to not give care to female patients at all given this concern.”

The physicians quoted in this article report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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As states ban or limit abortion in the wake of the demise of Roe v. Wade, physicians are turning their attention to widely-used drugs that can cause birth defects. At issue: Should these drugs still be prescribed to women of childbearing age if they don’t have the option of terminating their pregnancies?

javi_indy/ Thinkstock

“Doctors are going to understandably be terrified that a patient may become pregnant using a teratogen that they have prescribed,” said University of Pittsburgh rheumatologist Mehret Birru Talabi, MD, PhD, who works in a state where the future of abortion rights is uncertain. “While this was a feared outcome before Roe v. Wade was overturned, abortion provided an escape hatch by which women could avoid having to continue a pregnancy and potentially raise a child with congenital anomalies. I believe that prescribing is going to become much more defensive and conservative. Some clinicians may choose not to prescribe these medications to patients who have childbearing potential, even if they don’t have much risk for pregnancy.”

Other physicians expressed similar concerns in interviews. Duke University, Durham, N.C., rheumatologist Megan E. B. Clowse, MD, MPH, fears that physicians will be wary of prescribing a variety of medications – including new ones for which there are few pregnancy data – if abortion is unavailable. “Women who receive these new or teratogenic medications will likely lose their reproductive autonomy and be forced to choose between having sexual relationships with men, obtaining procedures that make them permanently sterile, or using contraception that may cause intolerable side effects,” she said. “I am very concerned that young women with rheumatic disease will now be left with active disease resulting in joint damage and renal failure.”

Abortion is now banned in at least six states, according to The New York Times. That number may rise to 16 as more restrictions become law. Another five states aren’t expected to ban abortion soon but have implemented gestational age limits on abortion or are expected to adopt them. In another nine states, courts or lawmakers will decide whether abortion remains legal.

Only 20 states and the District of Columbia have firm abortion protections in place.

Numerous drugs are considered teratogens, which means they may cause birth defects. Thalidomide is the most infamous, but there are many more, including several used in rheumatology, dermatology, and gastroenterology. Among the most widely used teratogenic medications are the acne drugs isotretinoin and methotrexate, which are used to treat a variety of conditions, such as cancer, rheumatoid arthritis, and psoriasis.



Dr. Clowse, who helps manage an industry-supported website devoted to reproductive care for women with lupus (www.LupusPregnancy.org), noted that several drugs linked to birth defects and pregnancy loss are commonly prescribed in rheumatology.

“Methotrexate is the most common medication and has been the cornerstone of rheumatoid arthritis [treatment] for at least two decades,” she said. “Mycophenolate is our best medication to treat lupus nephritis, which is inflammation in the kidneys caused by lupus. This is a common complication for young women with lupus, and all of our guideline-recommended treatment regimens include a medication that causes pregnancy loss and birth defects, either mycophenolate or cyclophosphamide.”

Rheumatologists also prescribe a large number of new drugs for which there are few data about pregnancy risks. “It typically takes about two decades to have sufficient data about the safety of our medications,” she said.

Reflecting the sensitivity of the topic, Dr. Clowse made clear that her opinions don’t represent the views of her institution. She works in North Carolina, where the fate of abortion rights is uncertain, according to The New York Times.

What about alternatives? “The short answer is that some of these medications work really well and sometimes much better than the nonteratogenic alternatives,” said Dr. Birru Talabi. “I’m worried about methotrexate. It has been used to induce abortions but is primarily used in the United States as a highly effective treatment for cancer as well as a myriad of rheumatic diseases. If legislators try to restrict access to methotrexate, we may see increasing disability and even death among people who need this medication but cannot access it.”

Rheumatologists aren’t the only physicians who are worrying about the fates of their patients in a new era of abortion restrictions. Gastroenterologist Sunanda Kane, MD, MSPH, of the Mayo Clinic, Rochester, Minn., said several teratogenic medications are used in her field to treat constipation, viral hepatitis, and inflammatory bowel disease.

“When treating women of childbearing age, there are usually alternatives. If we do prescribe a medication with a high teratogenic potential, we counsel and document that we have discussed two forms of birth control to avoid pregnancy. We usually do not prescribe a drug with teratogenic potential with the ‘out’ being an abortion if a pregnancy does occur,” she said. However, “if abortion is not even on the table as an option, we may be much less likely to prescribe these medications. This will be particularly true in patients who clearly do not have the means to travel to have an abortion in any situation.”

Abortion is expected to remain legal in Minnesota, where Dr. Kane practices, but it may be restricted or banned in nearby Wisconsin, depending on the state legislature. None of her patients have had abortions after becoming pregnant while taking the medications, she said, although she “did have a patient who because of her religious faith did not have an abortion after exposure and ended up with a stillbirth.”



The crackdown on abortion won’t just pose risks to patients who take potentially dangerous medications, physicians said. Dr. Kane said pregnancy itself is a significant risk for patients with “very active, uncontrolled gastrointestinal conditions where a pregnancy could be harmful to the mother’s health or result in offspring that are very unhealthy.” These include decompensated cirrhosis, uncontrolled Crohn’s disease or ulcerative colitis, refractory gastroparesis, uncontrolled celiac sprue, and chronic pancreatitis, she said.

“There have been times when after shared decisionmaking, a patient with very active inflammatory bowel disease has decided to terminate the pregnancy because of her own ongoing health issues,” she said. “Not having this option will potentially lead to disastrous results.”

Dr. Clowse, the Duke University rheumatologist, echoed Dr. Kane’s concerns about women who are too sick to bear children. “The removal of abortion rights puts the lives and quality of life for women with rheumatic disease at risk. For patients with lupus and other systemic rheumatic disease, pregnancy can be medically catastrophic, leading to permanent harm and even death to the woman and her offspring. I am worried that women in these conditions will die without lifesaving pregnancy terminations, due to worries about the legal consequences for their physicians.”

The U.S. Supreme Court’s ruling that overturned Roe v. Wade has also raised the prospect that the court could ultimately allow birth control to be restricted or outlawed.

While the ruling states that “nothing in this opinion should be understood to cast doubt on precedents that do not concern abortion,” Justice Clarence Thomas wrote a concurrence in which he said that the court should reconsider a 1960s ruling that forbids the banning of contraceptives. Republicans have dismissed concerns about bans being allowed, although Democrats, including the president and vice president, starkly warn that they could happen.

“If we as providers have to be concerned that there will be an unplanned pregnancy because of the lack of access to contraception,” Dr. Kane said, “this will have significant downstream consequences to the kind of care we can provide and might just drive some providers to not give care to female patients at all given this concern.”

The physicians quoted in this article report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

As states ban or limit abortion in the wake of the demise of Roe v. Wade, physicians are turning their attention to widely-used drugs that can cause birth defects. At issue: Should these drugs still be prescribed to women of childbearing age if they don’t have the option of terminating their pregnancies?

javi_indy/ Thinkstock

“Doctors are going to understandably be terrified that a patient may become pregnant using a teratogen that they have prescribed,” said University of Pittsburgh rheumatologist Mehret Birru Talabi, MD, PhD, who works in a state where the future of abortion rights is uncertain. “While this was a feared outcome before Roe v. Wade was overturned, abortion provided an escape hatch by which women could avoid having to continue a pregnancy and potentially raise a child with congenital anomalies. I believe that prescribing is going to become much more defensive and conservative. Some clinicians may choose not to prescribe these medications to patients who have childbearing potential, even if they don’t have much risk for pregnancy.”

Other physicians expressed similar concerns in interviews. Duke University, Durham, N.C., rheumatologist Megan E. B. Clowse, MD, MPH, fears that physicians will be wary of prescribing a variety of medications – including new ones for which there are few pregnancy data – if abortion is unavailable. “Women who receive these new or teratogenic medications will likely lose their reproductive autonomy and be forced to choose between having sexual relationships with men, obtaining procedures that make them permanently sterile, or using contraception that may cause intolerable side effects,” she said. “I am very concerned that young women with rheumatic disease will now be left with active disease resulting in joint damage and renal failure.”

Abortion is now banned in at least six states, according to The New York Times. That number may rise to 16 as more restrictions become law. Another five states aren’t expected to ban abortion soon but have implemented gestational age limits on abortion or are expected to adopt them. In another nine states, courts or lawmakers will decide whether abortion remains legal.

Only 20 states and the District of Columbia have firm abortion protections in place.

Numerous drugs are considered teratogens, which means they may cause birth defects. Thalidomide is the most infamous, but there are many more, including several used in rheumatology, dermatology, and gastroenterology. Among the most widely used teratogenic medications are the acne drugs isotretinoin and methotrexate, which are used to treat a variety of conditions, such as cancer, rheumatoid arthritis, and psoriasis.



Dr. Clowse, who helps manage an industry-supported website devoted to reproductive care for women with lupus (www.LupusPregnancy.org), noted that several drugs linked to birth defects and pregnancy loss are commonly prescribed in rheumatology.

“Methotrexate is the most common medication and has been the cornerstone of rheumatoid arthritis [treatment] for at least two decades,” she said. “Mycophenolate is our best medication to treat lupus nephritis, which is inflammation in the kidneys caused by lupus. This is a common complication for young women with lupus, and all of our guideline-recommended treatment regimens include a medication that causes pregnancy loss and birth defects, either mycophenolate or cyclophosphamide.”

Rheumatologists also prescribe a large number of new drugs for which there are few data about pregnancy risks. “It typically takes about two decades to have sufficient data about the safety of our medications,” she said.

Reflecting the sensitivity of the topic, Dr. Clowse made clear that her opinions don’t represent the views of her institution. She works in North Carolina, where the fate of abortion rights is uncertain, according to The New York Times.

What about alternatives? “The short answer is that some of these medications work really well and sometimes much better than the nonteratogenic alternatives,” said Dr. Birru Talabi. “I’m worried about methotrexate. It has been used to induce abortions but is primarily used in the United States as a highly effective treatment for cancer as well as a myriad of rheumatic diseases. If legislators try to restrict access to methotrexate, we may see increasing disability and even death among people who need this medication but cannot access it.”

Rheumatologists aren’t the only physicians who are worrying about the fates of their patients in a new era of abortion restrictions. Gastroenterologist Sunanda Kane, MD, MSPH, of the Mayo Clinic, Rochester, Minn., said several teratogenic medications are used in her field to treat constipation, viral hepatitis, and inflammatory bowel disease.

“When treating women of childbearing age, there are usually alternatives. If we do prescribe a medication with a high teratogenic potential, we counsel and document that we have discussed two forms of birth control to avoid pregnancy. We usually do not prescribe a drug with teratogenic potential with the ‘out’ being an abortion if a pregnancy does occur,” she said. However, “if abortion is not even on the table as an option, we may be much less likely to prescribe these medications. This will be particularly true in patients who clearly do not have the means to travel to have an abortion in any situation.”

Abortion is expected to remain legal in Minnesota, where Dr. Kane practices, but it may be restricted or banned in nearby Wisconsin, depending on the state legislature. None of her patients have had abortions after becoming pregnant while taking the medications, she said, although she “did have a patient who because of her religious faith did not have an abortion after exposure and ended up with a stillbirth.”



The crackdown on abortion won’t just pose risks to patients who take potentially dangerous medications, physicians said. Dr. Kane said pregnancy itself is a significant risk for patients with “very active, uncontrolled gastrointestinal conditions where a pregnancy could be harmful to the mother’s health or result in offspring that are very unhealthy.” These include decompensated cirrhosis, uncontrolled Crohn’s disease or ulcerative colitis, refractory gastroparesis, uncontrolled celiac sprue, and chronic pancreatitis, she said.

“There have been times when after shared decisionmaking, a patient with very active inflammatory bowel disease has decided to terminate the pregnancy because of her own ongoing health issues,” she said. “Not having this option will potentially lead to disastrous results.”

Dr. Clowse, the Duke University rheumatologist, echoed Dr. Kane’s concerns about women who are too sick to bear children. “The removal of abortion rights puts the lives and quality of life for women with rheumatic disease at risk. For patients with lupus and other systemic rheumatic disease, pregnancy can be medically catastrophic, leading to permanent harm and even death to the woman and her offspring. I am worried that women in these conditions will die without lifesaving pregnancy terminations, due to worries about the legal consequences for their physicians.”

The U.S. Supreme Court’s ruling that overturned Roe v. Wade has also raised the prospect that the court could ultimately allow birth control to be restricted or outlawed.

While the ruling states that “nothing in this opinion should be understood to cast doubt on precedents that do not concern abortion,” Justice Clarence Thomas wrote a concurrence in which he said that the court should reconsider a 1960s ruling that forbids the banning of contraceptives. Republicans have dismissed concerns about bans being allowed, although Democrats, including the president and vice president, starkly warn that they could happen.

“If we as providers have to be concerned that there will be an unplanned pregnancy because of the lack of access to contraception,” Dr. Kane said, “this will have significant downstream consequences to the kind of care we can provide and might just drive some providers to not give care to female patients at all given this concern.”

The physicians quoted in this article report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Treat-to-target strategy with tapering proves effective in PsA and axSpA

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Aiming for a disease activity target while reducing biologic therapy could be a winning approach for patients with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), according to the results of a new study presented at the annual European Congress of Rheumatology.

The findings show that a treat-to-target (T2T) strategy with tapering using a tumor necrosis factor (TNF) inhibitor produces results that are noninferior to a T2T strategy that doesn’t include tapering in these patients.

Dr. Celia Michielsens

“Our study has for the first time shown that a treat-to-target tapering strategy is just as good as full-dose continuation, while reducing medication use substantially,” first author Celia Michielsens, MD, a PhD student and researcher at Sint Maartenskliniek in Nijmegen, the Netherlands, said in an interview before her presentation of the study during an oral abstract session at the congress. “Stepwise tapering is also better than fixed-dose reduction or discontinuation, since it is much more individualized.”

The study is now published in Annals of the Rheumatic Diseases.



In the randomized, controlled, open-label, noninferiority study, researchers enrolled patients with PsA or axSpA who were using a TNF inhibitor such as etanercept, adalimumab, or infliximab, and had stable low disease activity for at least 6 months. Patients needed to have a Psoriatic Arthritis Disease Activity Score (PASDAS) of 3.2 or less, or an Ankylosing Spondylitis Disease Activity Score (ASDAS) of at 2.1 or less. In cases of flare, patients were treated with NSAIDs and/or glucorticoids, and if they still had not reached low disease activity after a month, their previous TNF inhibitor dose was reinstated to the last effective interval or dosage, which was maintained throughout the study period. When the patient was already using a full TNF-inhibitor dose or if dose adjustment did not suffice, patients were switched to another biologic or targeted synthetic disease-modifying antirheumatic drug (DMARD).

Participants were randomized, from January 2019 to June 2021, to a tapering or a nontapering T2T strategy in a 2:1 fashion. Then researchers then followed them for 12 months and aimed to determine if the tapering strategy proved noninferior to not tapering within a predefined 20% margin for noninferiority, which Dr. Michielsens said was derived from other studies and what her group determined to be “an acceptable risk.”

Results show strategy is ‘feasible in daily clinical care’

A total of 81 patients – 42 with PsA and 39 with axSpA – were in the group with tapering, and 41 were in the group without tapering: 22 with PsA and 19 with axSpA.

At 12 months, researchers found that 69% of the patients in the group with tapering had low disease activity, measured via the PASDAS and ASDAS, compared with 73% in patients who did not taper. And those in the tapering group saw their medication use dramatically reduced. At the 12-month mark, they were taking just 53% of the defined daily dose for maintenance, compared with 91% of the defined daily dose for the group that didn’t taper.

The researchers were able to successfully taper 72% of the patients in the tapering group, with 28% of them discontinuing their TNF-inhibitor medication entirely. The incidence of flares was 85% in the tapering group and 78% in the nontapering group, a nonsignificant difference (P = .32).

The start of a new medication or an increase in use of an existing medication was more frequent in the tapering group, and significantly so for NSAIDs. An increase in NSAID use was seen in 54% of the tapering group and in just 24% of the nontapering group (P = .002).

Conventional synthetic DMARD use went up in the tapering group, compared with the nontapering group, but this was only among the PsA patients and the change in use was not statistically significant. There were also more frequent increases in glucocorticoid use in the tapering group, compared with the nontapering group, but this was not significant.

Dr. Michielsens said the findings show the value of an individualized approach in treating patients with PsA or axSpA.



“Our study – and those [studies] in rheumatoid arthritis earlier – deliver the highest quality of evidence that disease activity–guided dose personalization can, and in fact should, be used in clinical practice,” she said. “Our pragmatic treat-to-target tapering strategy is feasible in daily clinical care, although treat-to-target using PASDAS and ASDAS needs some implementation. In shared decision-making with patients, a 50% reduction in TNFi use is obtainable, while maintaining low disease activity.”

The increase in the use of NSAIDs is something to be aware of, but it is “not concerning,” Dr. Michielsens added. She pointed out that the NSAID use was typically temporary, used when flares arose, and that the drugs are effective, safe, and inexpensive. She also noted that the use of TNF blockers decreased more than the use of NSAIDs increased.

“This seems a perfectly acceptable trade-off that can be discussed with your patient,” she said.

The 12-month duration of the study is likely long enough to show that the tapering strategy works, Dr. Michielsens said. In rheumatoid arthritis studies, for example, differences in strategies didn’t change after 1 year.

“That said, we are doing an observational extension study to provide more insights in the long-term effects of this treat-to-target strategy,” she said. “At the end of this summer, all patients will have completed their extended follow-up period – a 12-month observational period – so hopefully we can present the results next year at EULAR.”

This study received funding from ReumaNederland. Dr. Michielsens did not have any financial interests to disclose. Two coauthors reported financial relationships with numerous pharmaceutical companies.

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Aiming for a disease activity target while reducing biologic therapy could be a winning approach for patients with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), according to the results of a new study presented at the annual European Congress of Rheumatology.

The findings show that a treat-to-target (T2T) strategy with tapering using a tumor necrosis factor (TNF) inhibitor produces results that are noninferior to a T2T strategy that doesn’t include tapering in these patients.

Dr. Celia Michielsens

“Our study has for the first time shown that a treat-to-target tapering strategy is just as good as full-dose continuation, while reducing medication use substantially,” first author Celia Michielsens, MD, a PhD student and researcher at Sint Maartenskliniek in Nijmegen, the Netherlands, said in an interview before her presentation of the study during an oral abstract session at the congress. “Stepwise tapering is also better than fixed-dose reduction or discontinuation, since it is much more individualized.”

The study is now published in Annals of the Rheumatic Diseases.



In the randomized, controlled, open-label, noninferiority study, researchers enrolled patients with PsA or axSpA who were using a TNF inhibitor such as etanercept, adalimumab, or infliximab, and had stable low disease activity for at least 6 months. Patients needed to have a Psoriatic Arthritis Disease Activity Score (PASDAS) of 3.2 or less, or an Ankylosing Spondylitis Disease Activity Score (ASDAS) of at 2.1 or less. In cases of flare, patients were treated with NSAIDs and/or glucorticoids, and if they still had not reached low disease activity after a month, their previous TNF inhibitor dose was reinstated to the last effective interval or dosage, which was maintained throughout the study period. When the patient was already using a full TNF-inhibitor dose or if dose adjustment did not suffice, patients were switched to another biologic or targeted synthetic disease-modifying antirheumatic drug (DMARD).

Participants were randomized, from January 2019 to June 2021, to a tapering or a nontapering T2T strategy in a 2:1 fashion. Then researchers then followed them for 12 months and aimed to determine if the tapering strategy proved noninferior to not tapering within a predefined 20% margin for noninferiority, which Dr. Michielsens said was derived from other studies and what her group determined to be “an acceptable risk.”

Results show strategy is ‘feasible in daily clinical care’

A total of 81 patients – 42 with PsA and 39 with axSpA – were in the group with tapering, and 41 were in the group without tapering: 22 with PsA and 19 with axSpA.

At 12 months, researchers found that 69% of the patients in the group with tapering had low disease activity, measured via the PASDAS and ASDAS, compared with 73% in patients who did not taper. And those in the tapering group saw their medication use dramatically reduced. At the 12-month mark, they were taking just 53% of the defined daily dose for maintenance, compared with 91% of the defined daily dose for the group that didn’t taper.

The researchers were able to successfully taper 72% of the patients in the tapering group, with 28% of them discontinuing their TNF-inhibitor medication entirely. The incidence of flares was 85% in the tapering group and 78% in the nontapering group, a nonsignificant difference (P = .32).

The start of a new medication or an increase in use of an existing medication was more frequent in the tapering group, and significantly so for NSAIDs. An increase in NSAID use was seen in 54% of the tapering group and in just 24% of the nontapering group (P = .002).

Conventional synthetic DMARD use went up in the tapering group, compared with the nontapering group, but this was only among the PsA patients and the change in use was not statistically significant. There were also more frequent increases in glucocorticoid use in the tapering group, compared with the nontapering group, but this was not significant.

Dr. Michielsens said the findings show the value of an individualized approach in treating patients with PsA or axSpA.



“Our study – and those [studies] in rheumatoid arthritis earlier – deliver the highest quality of evidence that disease activity–guided dose personalization can, and in fact should, be used in clinical practice,” she said. “Our pragmatic treat-to-target tapering strategy is feasible in daily clinical care, although treat-to-target using PASDAS and ASDAS needs some implementation. In shared decision-making with patients, a 50% reduction in TNFi use is obtainable, while maintaining low disease activity.”

The increase in the use of NSAIDs is something to be aware of, but it is “not concerning,” Dr. Michielsens added. She pointed out that the NSAID use was typically temporary, used when flares arose, and that the drugs are effective, safe, and inexpensive. She also noted that the use of TNF blockers decreased more than the use of NSAIDs increased.

“This seems a perfectly acceptable trade-off that can be discussed with your patient,” she said.

The 12-month duration of the study is likely long enough to show that the tapering strategy works, Dr. Michielsens said. In rheumatoid arthritis studies, for example, differences in strategies didn’t change after 1 year.

“That said, we are doing an observational extension study to provide more insights in the long-term effects of this treat-to-target strategy,” she said. “At the end of this summer, all patients will have completed their extended follow-up period – a 12-month observational period – so hopefully we can present the results next year at EULAR.”

This study received funding from ReumaNederland. Dr. Michielsens did not have any financial interests to disclose. Two coauthors reported financial relationships with numerous pharmaceutical companies.

Aiming for a disease activity target while reducing biologic therapy could be a winning approach for patients with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), according to the results of a new study presented at the annual European Congress of Rheumatology.

The findings show that a treat-to-target (T2T) strategy with tapering using a tumor necrosis factor (TNF) inhibitor produces results that are noninferior to a T2T strategy that doesn’t include tapering in these patients.

Dr. Celia Michielsens

“Our study has for the first time shown that a treat-to-target tapering strategy is just as good as full-dose continuation, while reducing medication use substantially,” first author Celia Michielsens, MD, a PhD student and researcher at Sint Maartenskliniek in Nijmegen, the Netherlands, said in an interview before her presentation of the study during an oral abstract session at the congress. “Stepwise tapering is also better than fixed-dose reduction or discontinuation, since it is much more individualized.”

The study is now published in Annals of the Rheumatic Diseases.



In the randomized, controlled, open-label, noninferiority study, researchers enrolled patients with PsA or axSpA who were using a TNF inhibitor such as etanercept, adalimumab, or infliximab, and had stable low disease activity for at least 6 months. Patients needed to have a Psoriatic Arthritis Disease Activity Score (PASDAS) of 3.2 or less, or an Ankylosing Spondylitis Disease Activity Score (ASDAS) of at 2.1 or less. In cases of flare, patients were treated with NSAIDs and/or glucorticoids, and if they still had not reached low disease activity after a month, their previous TNF inhibitor dose was reinstated to the last effective interval or dosage, which was maintained throughout the study period. When the patient was already using a full TNF-inhibitor dose or if dose adjustment did not suffice, patients were switched to another biologic or targeted synthetic disease-modifying antirheumatic drug (DMARD).

Participants were randomized, from January 2019 to June 2021, to a tapering or a nontapering T2T strategy in a 2:1 fashion. Then researchers then followed them for 12 months and aimed to determine if the tapering strategy proved noninferior to not tapering within a predefined 20% margin for noninferiority, which Dr. Michielsens said was derived from other studies and what her group determined to be “an acceptable risk.”

Results show strategy is ‘feasible in daily clinical care’

A total of 81 patients – 42 with PsA and 39 with axSpA – were in the group with tapering, and 41 were in the group without tapering: 22 with PsA and 19 with axSpA.

At 12 months, researchers found that 69% of the patients in the group with tapering had low disease activity, measured via the PASDAS and ASDAS, compared with 73% in patients who did not taper. And those in the tapering group saw their medication use dramatically reduced. At the 12-month mark, they were taking just 53% of the defined daily dose for maintenance, compared with 91% of the defined daily dose for the group that didn’t taper.

The researchers were able to successfully taper 72% of the patients in the tapering group, with 28% of them discontinuing their TNF-inhibitor medication entirely. The incidence of flares was 85% in the tapering group and 78% in the nontapering group, a nonsignificant difference (P = .32).

The start of a new medication or an increase in use of an existing medication was more frequent in the tapering group, and significantly so for NSAIDs. An increase in NSAID use was seen in 54% of the tapering group and in just 24% of the nontapering group (P = .002).

Conventional synthetic DMARD use went up in the tapering group, compared with the nontapering group, but this was only among the PsA patients and the change in use was not statistically significant. There were also more frequent increases in glucocorticoid use in the tapering group, compared with the nontapering group, but this was not significant.

Dr. Michielsens said the findings show the value of an individualized approach in treating patients with PsA or axSpA.



“Our study – and those [studies] in rheumatoid arthritis earlier – deliver the highest quality of evidence that disease activity–guided dose personalization can, and in fact should, be used in clinical practice,” she said. “Our pragmatic treat-to-target tapering strategy is feasible in daily clinical care, although treat-to-target using PASDAS and ASDAS needs some implementation. In shared decision-making with patients, a 50% reduction in TNFi use is obtainable, while maintaining low disease activity.”

The increase in the use of NSAIDs is something to be aware of, but it is “not concerning,” Dr. Michielsens added. She pointed out that the NSAID use was typically temporary, used when flares arose, and that the drugs are effective, safe, and inexpensive. She also noted that the use of TNF blockers decreased more than the use of NSAIDs increased.

“This seems a perfectly acceptable trade-off that can be discussed with your patient,” she said.

The 12-month duration of the study is likely long enough to show that the tapering strategy works, Dr. Michielsens said. In rheumatoid arthritis studies, for example, differences in strategies didn’t change after 1 year.

“That said, we are doing an observational extension study to provide more insights in the long-term effects of this treat-to-target strategy,” she said. “At the end of this summer, all patients will have completed their extended follow-up period – a 12-month observational period – so hopefully we can present the results next year at EULAR.”

This study received funding from ReumaNederland. Dr. Michielsens did not have any financial interests to disclose. Two coauthors reported financial relationships with numerous pharmaceutical companies.

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FROM THE EULAR 2022 CONGRESS

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Benefits of a very low energy diet in patients with PsA and concomitant obesity

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Key clinical point: A structured 12-month weight-loss treatment with very low energy diet (VLED) showed positive effects on body weight and physical fitness without affecting the muscle strength in patients with psoriatic arthritis (PsA) and obesity.

Major finding: At month 12, the median weight loss was 16.1 kg in patients with PsA and obesity and 16.6 kg in control individuals with obesity. At month 6, the muscle strength of the lower extremities and physical functioning improved in patients with PsA and control individuals (all P < .001), which were maintained till month 12 (all P < .01). The hand-grip strength remained unchanged in both the groups.

Study details: The findings are a secondary analysis of a prospective open intervention study including 46 patients with PsA and body mass index of ≥33 kg/m2 and 52 matched control individuals with obesity, all of whom received weight-loss treatment with VLED.

Disclosures: This study was supported by the Swedish state, Health and Medical Care Executive Board of the Västra Götaland, and other sources. The authors declared no conflicts of interest.

Source: Bilberg A et al. The impact of a structured weight-loss treatment on physical fitness in patients with psoriatic arthritis and obesity compared to matched controls: a prospective interventional study. Clin Rheumatol. 2022 (Jun 1). Doi: 10.1007/s10067-022-06164-5

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Key clinical point: A structured 12-month weight-loss treatment with very low energy diet (VLED) showed positive effects on body weight and physical fitness without affecting the muscle strength in patients with psoriatic arthritis (PsA) and obesity.

Major finding: At month 12, the median weight loss was 16.1 kg in patients with PsA and obesity and 16.6 kg in control individuals with obesity. At month 6, the muscle strength of the lower extremities and physical functioning improved in patients with PsA and control individuals (all P < .001), which were maintained till month 12 (all P < .01). The hand-grip strength remained unchanged in both the groups.

Study details: The findings are a secondary analysis of a prospective open intervention study including 46 patients with PsA and body mass index of ≥33 kg/m2 and 52 matched control individuals with obesity, all of whom received weight-loss treatment with VLED.

Disclosures: This study was supported by the Swedish state, Health and Medical Care Executive Board of the Västra Götaland, and other sources. The authors declared no conflicts of interest.

Source: Bilberg A et al. The impact of a structured weight-loss treatment on physical fitness in patients with psoriatic arthritis and obesity compared to matched controls: a prospective interventional study. Clin Rheumatol. 2022 (Jun 1). Doi: 10.1007/s10067-022-06164-5

Key clinical point: A structured 12-month weight-loss treatment with very low energy diet (VLED) showed positive effects on body weight and physical fitness without affecting the muscle strength in patients with psoriatic arthritis (PsA) and obesity.

Major finding: At month 12, the median weight loss was 16.1 kg in patients with PsA and obesity and 16.6 kg in control individuals with obesity. At month 6, the muscle strength of the lower extremities and physical functioning improved in patients with PsA and control individuals (all P < .001), which were maintained till month 12 (all P < .01). The hand-grip strength remained unchanged in both the groups.

Study details: The findings are a secondary analysis of a prospective open intervention study including 46 patients with PsA and body mass index of ≥33 kg/m2 and 52 matched control individuals with obesity, all of whom received weight-loss treatment with VLED.

Disclosures: This study was supported by the Swedish state, Health and Medical Care Executive Board of the Västra Götaland, and other sources. The authors declared no conflicts of interest.

Source: Bilberg A et al. The impact of a structured weight-loss treatment on physical fitness in patients with psoriatic arthritis and obesity compared to matched controls: a prospective interventional study. Clin Rheumatol. 2022 (Jun 1). Doi: 10.1007/s10067-022-06164-5

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PsA: MCP-1 may serve as a biomarker in identifying isolated asymptomatic diastolic dysfunction

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Key clinical point: Monocyte chemotactic protein-1 (MCP-1) can serve as a biomarker for diagnosing asymptomatic diastolic dysfunction (DD) in patients with psoriatic arthritis (PsA).

Major finding: The serum MCP-1 concentration was significantly higher in patients with vs. without DD (366.6 vs. 277.5 pg/mL; P = .0017). Patients with serum MCP-1 concentration of >347.6 vs. ≤347.6 pg/mL had a 7.74-fold higher chance of developing DD (specificity 86.36%; sensitivity 55%) and showed a higher late peak diastolic mitral inflow velocity characterized by a lower E/A ratio (0.68 vs. 1.11; P = .000002).

Study details: Findings are from a random, prospective study including 63 patients with axial and peripheral PsA and without clinical manifestations of heart failure.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Bursac IU et al. Predictive value of monocyte chemoattractant protein-1 in the development of diastolic dysfunction in patients with psoriatic arthritis. Dis Markers. 2022;2022: 4433313 (Jun 3). Doi:  10.1155/2022/4433313

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Key clinical point: Monocyte chemotactic protein-1 (MCP-1) can serve as a biomarker for diagnosing asymptomatic diastolic dysfunction (DD) in patients with psoriatic arthritis (PsA).

Major finding: The serum MCP-1 concentration was significantly higher in patients with vs. without DD (366.6 vs. 277.5 pg/mL; P = .0017). Patients with serum MCP-1 concentration of >347.6 vs. ≤347.6 pg/mL had a 7.74-fold higher chance of developing DD (specificity 86.36%; sensitivity 55%) and showed a higher late peak diastolic mitral inflow velocity characterized by a lower E/A ratio (0.68 vs. 1.11; P = .000002).

Study details: Findings are from a random, prospective study including 63 patients with axial and peripheral PsA and without clinical manifestations of heart failure.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Bursac IU et al. Predictive value of monocyte chemoattractant protein-1 in the development of diastolic dysfunction in patients with psoriatic arthritis. Dis Markers. 2022;2022: 4433313 (Jun 3). Doi:  10.1155/2022/4433313

Key clinical point: Monocyte chemotactic protein-1 (MCP-1) can serve as a biomarker for diagnosing asymptomatic diastolic dysfunction (DD) in patients with psoriatic arthritis (PsA).

Major finding: The serum MCP-1 concentration was significantly higher in patients with vs. without DD (366.6 vs. 277.5 pg/mL; P = .0017). Patients with serum MCP-1 concentration of >347.6 vs. ≤347.6 pg/mL had a 7.74-fold higher chance of developing DD (specificity 86.36%; sensitivity 55%) and showed a higher late peak diastolic mitral inflow velocity characterized by a lower E/A ratio (0.68 vs. 1.11; P = .000002).

Study details: Findings are from a random, prospective study including 63 patients with axial and peripheral PsA and without clinical manifestations of heart failure.

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

Source: Bursac IU et al. Predictive value of monocyte chemoattractant protein-1 in the development of diastolic dysfunction in patients with psoriatic arthritis. Dis Markers. 2022;2022: 4433313 (Jun 3). Doi:  10.1155/2022/4433313

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Identifying contributors to CAD in patients with PsA

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Key clinical point: Inflammatory and metabolic parameters, including visceral adiposity, potentially contribute to subclinical coronary artery disease (CAD) in patients with psoriatic arthritis (PsA).

Major finding: CAD was significantly associated with visceral adiposity (standardized β 0.681; P = .002), and fluorodeoxyglucose (FDG) uptake in the bone marrow (standardized β 0.488; P = .008), liver (standardized β 0.619; P < .001), spleen (standardized β 0.523; P = .004), and subcutaneous adipose tissue (standardized β 0.524; P = .003). Visceral (P = .005) and subcutaneous (P = .004) adiposity and liver FDG uptake (P = .03) were higher in patients with PsA vs. controls without PsA.

Study details: Findings are from a cross-sectional analysis of a prospective study including 39 patients with biologic-naive PsA and 56 age-sex matched controls without PsA.

Disclosures: This study was funded by the US National Institute of Allergy and Infectious Disease, the US National Heart, Lung, and Blood Institute, and National Psoriasis Foundation. N Mehta declared serving as consultant and receiving grants and other payments from several sources.

Source: Schwartz DM et al. PET/CT-based characterization of 18F-FDG uptake in various tissues reveals novel potential contributions to coronary artery disease in psoriatic arthritis. Front Immunol. 2022;13:909760 (Jun 2). Doi: 10.3389/fimmu.2022.909760

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Key clinical point: Inflammatory and metabolic parameters, including visceral adiposity, potentially contribute to subclinical coronary artery disease (CAD) in patients with psoriatic arthritis (PsA).

Major finding: CAD was significantly associated with visceral adiposity (standardized β 0.681; P = .002), and fluorodeoxyglucose (FDG) uptake in the bone marrow (standardized β 0.488; P = .008), liver (standardized β 0.619; P < .001), spleen (standardized β 0.523; P = .004), and subcutaneous adipose tissue (standardized β 0.524; P = .003). Visceral (P = .005) and subcutaneous (P = .004) adiposity and liver FDG uptake (P = .03) were higher in patients with PsA vs. controls without PsA.

Study details: Findings are from a cross-sectional analysis of a prospective study including 39 patients with biologic-naive PsA and 56 age-sex matched controls without PsA.

Disclosures: This study was funded by the US National Institute of Allergy and Infectious Disease, the US National Heart, Lung, and Blood Institute, and National Psoriasis Foundation. N Mehta declared serving as consultant and receiving grants and other payments from several sources.

Source: Schwartz DM et al. PET/CT-based characterization of 18F-FDG uptake in various tissues reveals novel potential contributions to coronary artery disease in psoriatic arthritis. Front Immunol. 2022;13:909760 (Jun 2). Doi: 10.3389/fimmu.2022.909760

Key clinical point: Inflammatory and metabolic parameters, including visceral adiposity, potentially contribute to subclinical coronary artery disease (CAD) in patients with psoriatic arthritis (PsA).

Major finding: CAD was significantly associated with visceral adiposity (standardized β 0.681; P = .002), and fluorodeoxyglucose (FDG) uptake in the bone marrow (standardized β 0.488; P = .008), liver (standardized β 0.619; P < .001), spleen (standardized β 0.523; P = .004), and subcutaneous adipose tissue (standardized β 0.524; P = .003). Visceral (P = .005) and subcutaneous (P = .004) adiposity and liver FDG uptake (P = .03) were higher in patients with PsA vs. controls without PsA.

Study details: Findings are from a cross-sectional analysis of a prospective study including 39 patients with biologic-naive PsA and 56 age-sex matched controls without PsA.

Disclosures: This study was funded by the US National Institute of Allergy and Infectious Disease, the US National Heart, Lung, and Blood Institute, and National Psoriasis Foundation. N Mehta declared serving as consultant and receiving grants and other payments from several sources.

Source: Schwartz DM et al. PET/CT-based characterization of 18F-FDG uptake in various tissues reveals novel potential contributions to coronary artery disease in psoriatic arthritis. Front Immunol. 2022;13:909760 (Jun 2). Doi: 10.3389/fimmu.2022.909760

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Higher prevalence of cardiovascular risk factors and cardiovascular events in PsA

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Key clinical point: Compared with the general population, patients with psoriatic arthritis (PsA) had a higher prevalence of cardiovascular events (CVE) and cardiovascular risk factors (CVRF) in real-life conditions, with CVRF being higher in patients with PsA as estimated using either SCORE-PsA or QRISK2-PsA cardiovascular risk algorithms.

Major finding: Patients with PsA vs. controls had a higher prevalence of CVE (8.7% vs. 4.1%; P = .03) and CVRF, such as high body mass index (26.6 vs. 25.2; P = .001), triglyceride level (1.24 vs. 1.06; P = .001) and hypertension (34.4% vs. 26.3%; P = .03). The proportion of patients with PsA who were estimated to have a very high CVRF (≥10%) increased when SCORE (25.4% to 27.4%) and QRISK2 (44.9% to 53.2%) equations considered the additional risk attributable to PsA.

Study details: Findings are from an observational, cross-sectional, case-control study including 207 patients with PsA and 414 matched controls.

Disclosures: This study did not report any funding. The authors declared no conflicts of interest.

Source: Degboe Y et al. Increased cardiovascular risk in psoriatic arthritis: results from a case-control monocentric study. Front Med. 2022;8:785719 (May 19). Doi: 10.3389/fmed.2022.785719

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Key clinical point: Compared with the general population, patients with psoriatic arthritis (PsA) had a higher prevalence of cardiovascular events (CVE) and cardiovascular risk factors (CVRF) in real-life conditions, with CVRF being higher in patients with PsA as estimated using either SCORE-PsA or QRISK2-PsA cardiovascular risk algorithms.

Major finding: Patients with PsA vs. controls had a higher prevalence of CVE (8.7% vs. 4.1%; P = .03) and CVRF, such as high body mass index (26.6 vs. 25.2; P = .001), triglyceride level (1.24 vs. 1.06; P = .001) and hypertension (34.4% vs. 26.3%; P = .03). The proportion of patients with PsA who were estimated to have a very high CVRF (≥10%) increased when SCORE (25.4% to 27.4%) and QRISK2 (44.9% to 53.2%) equations considered the additional risk attributable to PsA.

Study details: Findings are from an observational, cross-sectional, case-control study including 207 patients with PsA and 414 matched controls.

Disclosures: This study did not report any funding. The authors declared no conflicts of interest.

Source: Degboe Y et al. Increased cardiovascular risk in psoriatic arthritis: results from a case-control monocentric study. Front Med. 2022;8:785719 (May 19). Doi: 10.3389/fmed.2022.785719

Key clinical point: Compared with the general population, patients with psoriatic arthritis (PsA) had a higher prevalence of cardiovascular events (CVE) and cardiovascular risk factors (CVRF) in real-life conditions, with CVRF being higher in patients with PsA as estimated using either SCORE-PsA or QRISK2-PsA cardiovascular risk algorithms.

Major finding: Patients with PsA vs. controls had a higher prevalence of CVE (8.7% vs. 4.1%; P = .03) and CVRF, such as high body mass index (26.6 vs. 25.2; P = .001), triglyceride level (1.24 vs. 1.06; P = .001) and hypertension (34.4% vs. 26.3%; P = .03). The proportion of patients with PsA who were estimated to have a very high CVRF (≥10%) increased when SCORE (25.4% to 27.4%) and QRISK2 (44.9% to 53.2%) equations considered the additional risk attributable to PsA.

Study details: Findings are from an observational, cross-sectional, case-control study including 207 patients with PsA and 414 matched controls.

Disclosures: This study did not report any funding. The authors declared no conflicts of interest.

Source: Degboe Y et al. Increased cardiovascular risk in psoriatic arthritis: results from a case-control monocentric study. Front Med. 2022;8:785719 (May 19). Doi: 10.3389/fmed.2022.785719

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Presence of crystals in synovial fluid tied with higher disease burden in PsA

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Key clinical point: The prevalence of crystals in the synovial fluid was higher in patients with psoriatic arthritis (PsA) than in those with gonarthrosis and indicated increased disease activity and declining physical abilities in patients with PsA.

Major finding: Synovial fluid crystals were present in a significantly higher proportion of patients with PsA vs. gonarthrosis (23.7% vs. 0%; P < .001), with the presence of crystals being associated with an increased odds of severe pain (odds ratio [OR] 157.25), high disease activity (OR 15.96), and severe disability (OR 13.60; all P < .001).

Study details: Findings are from a retrospective case-control study including 156 patients with PsA and 50 patients with gonarthrosis.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Geneva-Popova M et al. Assessment of crystals in the synovial fluid of psoriatic arthritis patients in relation to disease activity. Diagnostics (Basel). 2022;12(5):1260 (May 18). Doi:  10.3390/diagnostics12051260

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Key clinical point: The prevalence of crystals in the synovial fluid was higher in patients with psoriatic arthritis (PsA) than in those with gonarthrosis and indicated increased disease activity and declining physical abilities in patients with PsA.

Major finding: Synovial fluid crystals were present in a significantly higher proportion of patients with PsA vs. gonarthrosis (23.7% vs. 0%; P < .001), with the presence of crystals being associated with an increased odds of severe pain (odds ratio [OR] 157.25), high disease activity (OR 15.96), and severe disability (OR 13.60; all P < .001).

Study details: Findings are from a retrospective case-control study including 156 patients with PsA and 50 patients with gonarthrosis.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Geneva-Popova M et al. Assessment of crystals in the synovial fluid of psoriatic arthritis patients in relation to disease activity. Diagnostics (Basel). 2022;12(5):1260 (May 18). Doi:  10.3390/diagnostics12051260

Key clinical point: The prevalence of crystals in the synovial fluid was higher in patients with psoriatic arthritis (PsA) than in those with gonarthrosis and indicated increased disease activity and declining physical abilities in patients with PsA.

Major finding: Synovial fluid crystals were present in a significantly higher proportion of patients with PsA vs. gonarthrosis (23.7% vs. 0%; P < .001), with the presence of crystals being associated with an increased odds of severe pain (odds ratio [OR] 157.25), high disease activity (OR 15.96), and severe disability (OR 13.60; all P < .001).

Study details: Findings are from a retrospective case-control study including 156 patients with PsA and 50 patients with gonarthrosis.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Geneva-Popova M et al. Assessment of crystals in the synovial fluid of psoriatic arthritis patients in relation to disease activity. Diagnostics (Basel). 2022;12(5):1260 (May 18). Doi:  10.3390/diagnostics12051260

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