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Commentary: Factors in Psoriatic Arthritis Development and Treatment Response, June 2022
Infections have long been identified as possible triggers for psoriasis and psoriatic arthritis (PsA) onset. Thrastardottir and colleagues evaluated the association between sites where the culture sample was obtained, the culture result, and pathogens and incident PsA and psoriasis. They obtained data on all samples sent for bacterial culture in the Stockholm region of Sweden (313,235 bacterial cultures from 128,982 individuals) from January 1, 2004, to December 31, 2006. Among all samples sent for culture, a pharyngeal sample was associated with a higher risk for PsA onset within the next 50 days compared with urine (hazard ratio [HR] 8.78; 95% CI 3.23-23.91), nasopharyngeal (HR 8.26; 95% CI 2.23-30.63), or blood (HR 25.22; 95% CI 3.12-204.13) samples. Streptococcal infections in the pharynx or at any other site were not associated with an increased risk for PsA. Similar associations were found for psoriasis, but not for rheumatoid arthritis. These results indicate that having sent a pharyngeal sample for culture was associated with an increased risk for psoriatic disease onset, suggesting that the site of infection—rather than the pathogen—is associated with the increased risk. These intriguing results support the need to further study the role of site and type of infection and antibiotic use on psoriatic disease onset.
With regard to other risk factors for PsA, a meta-analysis by Pouw and colleagues looked at 29 studies including adult patients with psoriasis with or without concurrent PsA or adult patients with psoriasis who developed PsA. The analysis showed that the body surface area affected by psoriasis was significantly higher in patients with psoriasis and concurrent PsA vs patients with only psoriasis (mean difference 5.31; 95% CI 1.78-8.83). Severe psoriasis was a significant predictor of concurrent PsA (odds ratio 3.34; P < .001). Thus, optimum care of patients with PsA requires excellent collaboration between rheumatologists and dermatologists.
Factors such as sex and body mass index (BMI) are likely to have a role in PsA treatment response but have not been extensively evaluated. To address this issue, Mease and colleagues conducted a post hoc analysis of the phase 3 SEAM-PsA trial including 851 patients who were methotrexate (MTX)/biologics naive and had early PsA. They were randomly assigned to receive MTX + placebo, etanercept + placebo, or MTX + etanercept. The study demonstrated that at week 24 a higher proportion of men vs women receiving MTX + etanercept achieved the American College of Rheumatology 20% criteria (ACR20) (71.5% vs 58.3%; P = .0194) and minimal disease activity (MDA) (45.8% vs 25.2%; P = .0003). A higher proportion of patients with a BMI ≤ 30 vs > 30 in all treatment groups achieved MDA (all P < .05), and those in the MTX + etanercept group achieved ACR20 (P = .0241). Thus, men (vs women) and those with lower BMI experience significantly better outcomes with treatment. When counseling patients about response to treatment, sex and BMI need to be taken into consideration. Moreover, further research is required to confirm and identify the reasons underlying these findings and to optimize treatment outcomes.
Another post hoc study explored the association between baseline disease activity and achieving the treatment target in PsA. Mease and colleagues analysed data from the phase 3 PALACE 4 study including 175 patients who were disease-modifying antirheumatic drug (DMARD)–naive and had active PsA. They received 30 mg apremilast twice daily. The study found that at week 52, remission or low disease activity according to the Clinical Disease Activity Index for Psoriatic Arthritis was achieved in 61.7% of patients with moderate disease activity vs 28.2% of these with high disease activity at baseline. Thus, DMARD-naive patients with moderate (vs high) disease activity at baseline are more likely to achieve low disease activity after apremilast therapy.
Infections have long been identified as possible triggers for psoriasis and psoriatic arthritis (PsA) onset. Thrastardottir and colleagues evaluated the association between sites where the culture sample was obtained, the culture result, and pathogens and incident PsA and psoriasis. They obtained data on all samples sent for bacterial culture in the Stockholm region of Sweden (313,235 bacterial cultures from 128,982 individuals) from January 1, 2004, to December 31, 2006. Among all samples sent for culture, a pharyngeal sample was associated with a higher risk for PsA onset within the next 50 days compared with urine (hazard ratio [HR] 8.78; 95% CI 3.23-23.91), nasopharyngeal (HR 8.26; 95% CI 2.23-30.63), or blood (HR 25.22; 95% CI 3.12-204.13) samples. Streptococcal infections in the pharynx or at any other site were not associated with an increased risk for PsA. Similar associations were found for psoriasis, but not for rheumatoid arthritis. These results indicate that having sent a pharyngeal sample for culture was associated with an increased risk for psoriatic disease onset, suggesting that the site of infection—rather than the pathogen—is associated with the increased risk. These intriguing results support the need to further study the role of site and type of infection and antibiotic use on psoriatic disease onset.
With regard to other risk factors for PsA, a meta-analysis by Pouw and colleagues looked at 29 studies including adult patients with psoriasis with or without concurrent PsA or adult patients with psoriasis who developed PsA. The analysis showed that the body surface area affected by psoriasis was significantly higher in patients with psoriasis and concurrent PsA vs patients with only psoriasis (mean difference 5.31; 95% CI 1.78-8.83). Severe psoriasis was a significant predictor of concurrent PsA (odds ratio 3.34; P < .001). Thus, optimum care of patients with PsA requires excellent collaboration between rheumatologists and dermatologists.
Factors such as sex and body mass index (BMI) are likely to have a role in PsA treatment response but have not been extensively evaluated. To address this issue, Mease and colleagues conducted a post hoc analysis of the phase 3 SEAM-PsA trial including 851 patients who were methotrexate (MTX)/biologics naive and had early PsA. They were randomly assigned to receive MTX + placebo, etanercept + placebo, or MTX + etanercept. The study demonstrated that at week 24 a higher proportion of men vs women receiving MTX + etanercept achieved the American College of Rheumatology 20% criteria (ACR20) (71.5% vs 58.3%; P = .0194) and minimal disease activity (MDA) (45.8% vs 25.2%; P = .0003). A higher proportion of patients with a BMI ≤ 30 vs > 30 in all treatment groups achieved MDA (all P < .05), and those in the MTX + etanercept group achieved ACR20 (P = .0241). Thus, men (vs women) and those with lower BMI experience significantly better outcomes with treatment. When counseling patients about response to treatment, sex and BMI need to be taken into consideration. Moreover, further research is required to confirm and identify the reasons underlying these findings and to optimize treatment outcomes.
Another post hoc study explored the association between baseline disease activity and achieving the treatment target in PsA. Mease and colleagues analysed data from the phase 3 PALACE 4 study including 175 patients who were disease-modifying antirheumatic drug (DMARD)–naive and had active PsA. They received 30 mg apremilast twice daily. The study found that at week 52, remission or low disease activity according to the Clinical Disease Activity Index for Psoriatic Arthritis was achieved in 61.7% of patients with moderate disease activity vs 28.2% of these with high disease activity at baseline. Thus, DMARD-naive patients with moderate (vs high) disease activity at baseline are more likely to achieve low disease activity after apremilast therapy.
Infections have long been identified as possible triggers for psoriasis and psoriatic arthritis (PsA) onset. Thrastardottir and colleagues evaluated the association between sites where the culture sample was obtained, the culture result, and pathogens and incident PsA and psoriasis. They obtained data on all samples sent for bacterial culture in the Stockholm region of Sweden (313,235 bacterial cultures from 128,982 individuals) from January 1, 2004, to December 31, 2006. Among all samples sent for culture, a pharyngeal sample was associated with a higher risk for PsA onset within the next 50 days compared with urine (hazard ratio [HR] 8.78; 95% CI 3.23-23.91), nasopharyngeal (HR 8.26; 95% CI 2.23-30.63), or blood (HR 25.22; 95% CI 3.12-204.13) samples. Streptococcal infections in the pharynx or at any other site were not associated with an increased risk for PsA. Similar associations were found for psoriasis, but not for rheumatoid arthritis. These results indicate that having sent a pharyngeal sample for culture was associated with an increased risk for psoriatic disease onset, suggesting that the site of infection—rather than the pathogen—is associated with the increased risk. These intriguing results support the need to further study the role of site and type of infection and antibiotic use on psoriatic disease onset.
With regard to other risk factors for PsA, a meta-analysis by Pouw and colleagues looked at 29 studies including adult patients with psoriasis with or without concurrent PsA or adult patients with psoriasis who developed PsA. The analysis showed that the body surface area affected by psoriasis was significantly higher in patients with psoriasis and concurrent PsA vs patients with only psoriasis (mean difference 5.31; 95% CI 1.78-8.83). Severe psoriasis was a significant predictor of concurrent PsA (odds ratio 3.34; P < .001). Thus, optimum care of patients with PsA requires excellent collaboration between rheumatologists and dermatologists.
Factors such as sex and body mass index (BMI) are likely to have a role in PsA treatment response but have not been extensively evaluated. To address this issue, Mease and colleagues conducted a post hoc analysis of the phase 3 SEAM-PsA trial including 851 patients who were methotrexate (MTX)/biologics naive and had early PsA. They were randomly assigned to receive MTX + placebo, etanercept + placebo, or MTX + etanercept. The study demonstrated that at week 24 a higher proportion of men vs women receiving MTX + etanercept achieved the American College of Rheumatology 20% criteria (ACR20) (71.5% vs 58.3%; P = .0194) and minimal disease activity (MDA) (45.8% vs 25.2%; P = .0003). A higher proportion of patients with a BMI ≤ 30 vs > 30 in all treatment groups achieved MDA (all P < .05), and those in the MTX + etanercept group achieved ACR20 (P = .0241). Thus, men (vs women) and those with lower BMI experience significantly better outcomes with treatment. When counseling patients about response to treatment, sex and BMI need to be taken into consideration. Moreover, further research is required to confirm and identify the reasons underlying these findings and to optimize treatment outcomes.
Another post hoc study explored the association between baseline disease activity and achieving the treatment target in PsA. Mease and colleagues analysed data from the phase 3 PALACE 4 study including 175 patients who were disease-modifying antirheumatic drug (DMARD)–naive and had active PsA. They received 30 mg apremilast twice daily. The study found that at week 52, remission or low disease activity according to the Clinical Disease Activity Index for Psoriatic Arthritis was achieved in 61.7% of patients with moderate disease activity vs 28.2% of these with high disease activity at baseline. Thus, DMARD-naive patients with moderate (vs high) disease activity at baseline are more likely to achieve low disease activity after apremilast therapy.
Abortion debate may affect Rx decisions for pregnant women
Obstetrician Beverly Gray, MD, is already seeing the effects of the Roe v. Wade abortion debate in her North Carolina practice.
The state allows abortion but requires that women get counseling with a qualified health professional 72 hours before the procedure. “Aside from that, we still have patients asking for more efficacious contraceptive methods just in case,” said Dr. Gray, residency director and division director for women’s community and population health and associate professor for obstetrics and gynecology at Duke University, Durham, N.C.
Patients and staff in her clinic have also been approaching her about tubal ligation. “They’re asking about additional birth control methods because they’re concerned about what’s going to happen” with the challenge to the historic Roe v. Wade decision in the Supreme Court and subsequent actions in the states to restrict or ban abortion, she said.
This has implications not just for abortion but for medications known to affect pregnancy. “What I’m really worried about is physicians will be withholding medicine because they’re concerned about teratogenic effects,” said Dr. Gray.
With more states issuing restrictions on abortion, doctors are worried that patients needing certain drugs to maintain their lupus flares, cancer, or other diseases may decide not to take them in the event they accidentally become pregnant. If the drug is known to affect the fetus, the fear is a patient who lives in a state with abortion restrictions will no longer have the option to terminate a pregnancy.
Instead, a scenario may arise in which the patient – and their physician – may opt not to treat at all with an otherwise lifesaving medication, experts told this news organization.
The U.S. landscape on abortion restrictions
A leaked draft of a U.S. Supreme Court opinion on Mississippi’s 15-week abortion ban has sent the medical community into a tailspin. The case, Dobbs v. Jackson Women’s Health Organization, challenges the 1973 Roe v. Wade decision that affirms the constitutional right to abortion. It’s anticipated the high court will decide on the case in June.
Although the upcoming decision is subject to change, the draft indicated the high court would uphold the Mississippi ban. This would essentially overturn the 1973 ruling. An earlier Supreme Court decision allowing a Texas law banning abortion at 6 weeks suggests the court may already be heading in this direction. At the state level, legislatures have been moving on divergent paths – some taking steps to preserve abortion rights, others initiating restrictions.
More than 100 abortion restrictions in 19 states took effect in 2021, according to the Guttmacher Institute, which tracks such metrics. In 2022, “two key themes are anti-abortion policymakers’ continued pursuit of various types of abortion bans and restrictions on medication abortion,” the institute reported.
Forty-six states and the District of Columbia have introduced 2,025 restrictions or proactive measures on sexual and reproductive health and rights so far this year. The latest tally from Guttmacher, updated in late May, revealed that 11 states so far have enacted 42 abortion restrictions. A total of 6 states (Arizona, Florida, Idaho, Kentucky, Oklahoma, and Wyoming) have issued nine bans on abortion.
Comparatively, 11 states have enacted 19 protective abortion measures.
Twenty-two states have introduced 117 restrictions on medication abortions, which account for 54% of U.S. abortions. This includes seven measures that would ban medication abortion outright, according to Guttmacher. Kentucky and South Dakota collectively have enacted 14 restrictions on medication abortion, as well as provisions that ban mailing of abortion pills.
Chilling effect on prescribing
Some physicians anticipate that drugs such as the “morning-after” pill (levonorgestrel) will become less available as restrictions go into effect, since these are medications designed to prevent pregnancy.*
However, the ongoing effort to put a lid on abortion measures has prompted concerns about a trickle-down effect on other medications that are otherwise life-changing or lifesaving to patients but pose a risk to the fetus.
Several drugs are well documented to affect fetal growth and development of the fetus, ranging from mild, transitory effects to severe, permanent birth defects, said Ronald G. Grifka, MD, chief medical officer of University of Michigan Health-West and clinical professor of pediatrics at the University of Michigan Medical School, Ann Arbor. “As new medications are developed, we will need heightened attention to make sure they are safe for the fetus,” he added.
Certain teratogenic medications are associated with a high risk of abortion even though this isn’t their primary use, noted Christina Chambers, PhD, MPH, co-director of the Center for Better Beginnings and associate director with the Altman Clinical & Translational Research Institute at the University of California, San Diego.
“I don’t think anyone would intentionally take these drugs to induce spontaneous abortion. But if the drugs pose a risk for it, I can see how the laws might be stretched” to include them, said Dr. Chambers.
Methotrexate, a medication for autoimmune disorders, has a high risk of spontaneous abortion. So do acne medications such as isotretinoin.
Patients are usually told they’re not supposed to get pregnant on these drugs because there’s a high risk of pregnancy loss and risk of malformations and potential learning problems in the fetus. But many pregnancies aren’t planned, said Dr. Chambers. “Patients may forget about the side effects or think their birth control will protect them. And the next time they refill the medication, they may not hear about the warnings again.”
With a restrictive abortion law or ban in effect, a woman might think: “I won’t take this drug because if there’s any potential that I might get pregnant, I won’t have the option to abort an at-risk pregnancy.” Women and their doctors, for that matter, don’t want to put themselves in this position, said Dr. Chambers.
Rheumatologist Megan Clowse, MD, who prescribes several medications that potentially cause major birth defects and pregnancy loss, worries about the ramifications of these accumulating bans.
“Methotrexate has been a leading drug for us for decades for rheumatoid arthritis. Mycophenolate is a vital drug for lupus,” said Dr. Clowse, associate professor of medicine at Duke University’s division of rheumatology and immunology.
Both methotrexate and mycophenolate pose about a 40% risk of pregnancy loss and significantly increase the risk for birth defects. “I’m definitely concerned that there might be doctors or women who elect not to use those medications in women of reproductive age because of the potential risk for pregnancy and absence of abortion rights,” said Dr. Clowse.
These situations might force women to use contraceptives they don’t want to use, such as hormonal implants or intrauterine devices, she added. Another side effect is that women and their partners may decide to abstain from sex.
The iPLEDGE factor
Some rheumatology drugs like lenalidomide (Revlimid) require a valid negative pregnancy test in a lab every month. Similarly, the iPLEDGE Risk Evaluation and Mitigation Strategy seeks to reduce the teratogenicity of isotretinoin by requiring two types of birth control and regular pregnancy tests by users.
For isotretinoin specifically, abortion restrictions “could lead to increased adherence to pregnancy prevention measures which are already stringent in iPLEDGE. But on the other hand, it could lead to reduced willingness of physicians to prescribe or patients to take the medication,” said Dr. Chambers.
With programs like iPLEDGE in effect, the rate of pregnancies and abortions that occur in dermatology are relatively low, said Jenny Murase, MD, associate clinical professor of dermatology at the University of California, San Francisco.
Nevertheless, as a physician who regularly prescribes medications like isotretinoin in women of childbearing age, “it’s terrifying to me that a woman wouldn’t have the option to terminate the pregnancy if a teratogenic effect from the medication caused a severe birth defect,” said Dr. Murase.
Dermatologists use other teratogenic medications such as thalidomide, mycophenolate mofetil, and methotrexate for chronic dermatologic disease like psoriasis and atopic dermatitis.
The situation is especially tricky for dermatologists since most patients – about 80% – never discuss their pregnancy with their specialist prior to pregnancy initiation. Dr. Murase recalls when a patient with chronic plaque psoriasis on methotrexate in her late 40s became pregnant and had an abortion even before Dr. Murase became aware of the pregnancy.
Because dermatologists routinely prescribe long-term medications for chronic diseases like acne, psoriasis, and atopic dermatitis, it is important to have a conversation regarding the risks and benefits of long-term medication should a pregnancy occur in any woman of childbearing age, she said.
Fewer women in clinical trials?
Abortion restrictions could possibly discourage women of reproductive age to participate in a clinical trial for a new medication, said Dr. Chambers.
A female patient with a chronic disease who’s randomized to receive a new medication may be required to use certain types of birth control because of unknown potential adverse effects the drug may have on the fetus. But in some cases, accidental pregnancies happen.
The participant in the trial may say, “I don’t know enough about the safety of this drug in pregnancy, and I’ve already taken it. I want to terminate the pregnancy,” said Dr. Chambers. Thinking ahead, a woman may decide not to do the trial to avoid the risk of getting pregnant and not having the option to terminate the pregnancy.
This could apply to new drugs such as antiviral treatments, or medications for severe chronic disease that typically have no clinical trial data in pregnancy prior to initial release into the market.
Women may start taking the drug without thinking about getting pregnant, then realize there are no safety data and become concerned about its effects on a future pregnancy.
The question is: Will abortion restrictions have a chilling effect on these new drugs as well? Patients and their doctors may decide not to try it until more data are available. “I can see where abortion restrictions would change the risk or benefit calculation in thinking about what you do or don’t prescribe or take during reproductive age,” said Dr. Chambers.
The upside of restrictions?
If there’s a positive side to these developments with abortion bans, it may encourage women taking new medications or joining clinical trials to think even more carefully about adherence to effective contraception, said Dr. Chambers.
Some methods are more effective than others, she emphasized. “When you have an unplanned pregnancy, it could mean that the method you used wasn’t optimal or you weren’t using it as recommended.” A goal moving forward is to encourage more thoughtful use of highly effective contraceptives, thus reducing the number of unplanned pregnancies, she added.
If patients are taking methotrexate, “the time to think about pregnancy is before getting pregnant so you can switch to a drug that’s compatible with pregnancy,” she said.
This whole thought process regarding pregnancy planning could work toward useful health goals, said Dr. Chambers. “Nobody thinks termination is the preferred method, but planning ahead should involve a discussion of what works best for the patient.”
Patients do have other choices, said Dr. Grifka. “Fortunately, there are many commonly prescribed medications which cross the placenta and have no ill effects on the fetus.”
Talking to patients about choices
Dr. Clowse, who spends a lot of time training rheumatologists, encourages them to have conversations with patients about pregnancy planning. It’s a lot to manage, getting the right drug to a female patient with chronic illness, especially in this current climate of abortion upheaval, she noted.
Her approach is to have an open and honest conversation with patients about their concerns and fears, what the realities are, and what the potential future options are for certain rheumatology drugs in the United States.
Some women who see what’s happening across the country may become so risk averse that they may choose to die rather than take a lifesaving drug that poses certain risks under new restrictions.
“I think that’s tragic,” said Dr. Clowse.
To help their patients, Dr. Gray believes physicians across specialties should better educate themselves about physiology in pregnancy and how to counsel patients on the impact of not taking medications in pregnancy.
In her view, it’s almost coercive to say to a patient, “You really need to have effective contraception if I’m going to give you this lifesaving or quality-of-life-improving medication.”
When confronting such scenarios, Dr. Gray doesn’t think physicians need to change how they counsel patients about contraception. “I don’t think we should be putting pressure on patients to consider other permanent methods just because there’s a lack of abortion options.”
Patients will eventually make those decisions for themselves, she said. “They’re going to want a more efficacious method because they’re worried about not having access to abortion if they get pregnant.”
Dr. Gray reports being a site principal investigator for a phase 3 trial for VeraCept IUD, funded by Sebela Pharmaceuticals. Dr. Clowse reports receiving research funding and doing consulting for GlaxoSmithKline.
*Correction, 6/2/2022: A previous version of this article misstated the intended use of drugs such as the “morning-after” pill (levonorgestrel). They are taken to prevent unintended pregnancy.
A version of this article first appeared on Medscape.com .
Obstetrician Beverly Gray, MD, is already seeing the effects of the Roe v. Wade abortion debate in her North Carolina practice.
The state allows abortion but requires that women get counseling with a qualified health professional 72 hours before the procedure. “Aside from that, we still have patients asking for more efficacious contraceptive methods just in case,” said Dr. Gray, residency director and division director for women’s community and population health and associate professor for obstetrics and gynecology at Duke University, Durham, N.C.
Patients and staff in her clinic have also been approaching her about tubal ligation. “They’re asking about additional birth control methods because they’re concerned about what’s going to happen” with the challenge to the historic Roe v. Wade decision in the Supreme Court and subsequent actions in the states to restrict or ban abortion, she said.
This has implications not just for abortion but for medications known to affect pregnancy. “What I’m really worried about is physicians will be withholding medicine because they’re concerned about teratogenic effects,” said Dr. Gray.
With more states issuing restrictions on abortion, doctors are worried that patients needing certain drugs to maintain their lupus flares, cancer, or other diseases may decide not to take them in the event they accidentally become pregnant. If the drug is known to affect the fetus, the fear is a patient who lives in a state with abortion restrictions will no longer have the option to terminate a pregnancy.
Instead, a scenario may arise in which the patient – and their physician – may opt not to treat at all with an otherwise lifesaving medication, experts told this news organization.
The U.S. landscape on abortion restrictions
A leaked draft of a U.S. Supreme Court opinion on Mississippi’s 15-week abortion ban has sent the medical community into a tailspin. The case, Dobbs v. Jackson Women’s Health Organization, challenges the 1973 Roe v. Wade decision that affirms the constitutional right to abortion. It’s anticipated the high court will decide on the case in June.
Although the upcoming decision is subject to change, the draft indicated the high court would uphold the Mississippi ban. This would essentially overturn the 1973 ruling. An earlier Supreme Court decision allowing a Texas law banning abortion at 6 weeks suggests the court may already be heading in this direction. At the state level, legislatures have been moving on divergent paths – some taking steps to preserve abortion rights, others initiating restrictions.
More than 100 abortion restrictions in 19 states took effect in 2021, according to the Guttmacher Institute, which tracks such metrics. In 2022, “two key themes are anti-abortion policymakers’ continued pursuit of various types of abortion bans and restrictions on medication abortion,” the institute reported.
Forty-six states and the District of Columbia have introduced 2,025 restrictions or proactive measures on sexual and reproductive health and rights so far this year. The latest tally from Guttmacher, updated in late May, revealed that 11 states so far have enacted 42 abortion restrictions. A total of 6 states (Arizona, Florida, Idaho, Kentucky, Oklahoma, and Wyoming) have issued nine bans on abortion.
Comparatively, 11 states have enacted 19 protective abortion measures.
Twenty-two states have introduced 117 restrictions on medication abortions, which account for 54% of U.S. abortions. This includes seven measures that would ban medication abortion outright, according to Guttmacher. Kentucky and South Dakota collectively have enacted 14 restrictions on medication abortion, as well as provisions that ban mailing of abortion pills.
Chilling effect on prescribing
Some physicians anticipate that drugs such as the “morning-after” pill (levonorgestrel) will become less available as restrictions go into effect, since these are medications designed to prevent pregnancy.*
However, the ongoing effort to put a lid on abortion measures has prompted concerns about a trickle-down effect on other medications that are otherwise life-changing or lifesaving to patients but pose a risk to the fetus.
Several drugs are well documented to affect fetal growth and development of the fetus, ranging from mild, transitory effects to severe, permanent birth defects, said Ronald G. Grifka, MD, chief medical officer of University of Michigan Health-West and clinical professor of pediatrics at the University of Michigan Medical School, Ann Arbor. “As new medications are developed, we will need heightened attention to make sure they are safe for the fetus,” he added.
Certain teratogenic medications are associated with a high risk of abortion even though this isn’t their primary use, noted Christina Chambers, PhD, MPH, co-director of the Center for Better Beginnings and associate director with the Altman Clinical & Translational Research Institute at the University of California, San Diego.
“I don’t think anyone would intentionally take these drugs to induce spontaneous abortion. But if the drugs pose a risk for it, I can see how the laws might be stretched” to include them, said Dr. Chambers.
Methotrexate, a medication for autoimmune disorders, has a high risk of spontaneous abortion. So do acne medications such as isotretinoin.
Patients are usually told they’re not supposed to get pregnant on these drugs because there’s a high risk of pregnancy loss and risk of malformations and potential learning problems in the fetus. But many pregnancies aren’t planned, said Dr. Chambers. “Patients may forget about the side effects or think their birth control will protect them. And the next time they refill the medication, they may not hear about the warnings again.”
With a restrictive abortion law or ban in effect, a woman might think: “I won’t take this drug because if there’s any potential that I might get pregnant, I won’t have the option to abort an at-risk pregnancy.” Women and their doctors, for that matter, don’t want to put themselves in this position, said Dr. Chambers.
Rheumatologist Megan Clowse, MD, who prescribes several medications that potentially cause major birth defects and pregnancy loss, worries about the ramifications of these accumulating bans.
“Methotrexate has been a leading drug for us for decades for rheumatoid arthritis. Mycophenolate is a vital drug for lupus,” said Dr. Clowse, associate professor of medicine at Duke University’s division of rheumatology and immunology.
Both methotrexate and mycophenolate pose about a 40% risk of pregnancy loss and significantly increase the risk for birth defects. “I’m definitely concerned that there might be doctors or women who elect not to use those medications in women of reproductive age because of the potential risk for pregnancy and absence of abortion rights,” said Dr. Clowse.
These situations might force women to use contraceptives they don’t want to use, such as hormonal implants or intrauterine devices, she added. Another side effect is that women and their partners may decide to abstain from sex.
The iPLEDGE factor
Some rheumatology drugs like lenalidomide (Revlimid) require a valid negative pregnancy test in a lab every month. Similarly, the iPLEDGE Risk Evaluation and Mitigation Strategy seeks to reduce the teratogenicity of isotretinoin by requiring two types of birth control and regular pregnancy tests by users.
For isotretinoin specifically, abortion restrictions “could lead to increased adherence to pregnancy prevention measures which are already stringent in iPLEDGE. But on the other hand, it could lead to reduced willingness of physicians to prescribe or patients to take the medication,” said Dr. Chambers.
With programs like iPLEDGE in effect, the rate of pregnancies and abortions that occur in dermatology are relatively low, said Jenny Murase, MD, associate clinical professor of dermatology at the University of California, San Francisco.
Nevertheless, as a physician who regularly prescribes medications like isotretinoin in women of childbearing age, “it’s terrifying to me that a woman wouldn’t have the option to terminate the pregnancy if a teratogenic effect from the medication caused a severe birth defect,” said Dr. Murase.
Dermatologists use other teratogenic medications such as thalidomide, mycophenolate mofetil, and methotrexate for chronic dermatologic disease like psoriasis and atopic dermatitis.
The situation is especially tricky for dermatologists since most patients – about 80% – never discuss their pregnancy with their specialist prior to pregnancy initiation. Dr. Murase recalls when a patient with chronic plaque psoriasis on methotrexate in her late 40s became pregnant and had an abortion even before Dr. Murase became aware of the pregnancy.
Because dermatologists routinely prescribe long-term medications for chronic diseases like acne, psoriasis, and atopic dermatitis, it is important to have a conversation regarding the risks and benefits of long-term medication should a pregnancy occur in any woman of childbearing age, she said.
Fewer women in clinical trials?
Abortion restrictions could possibly discourage women of reproductive age to participate in a clinical trial for a new medication, said Dr. Chambers.
A female patient with a chronic disease who’s randomized to receive a new medication may be required to use certain types of birth control because of unknown potential adverse effects the drug may have on the fetus. But in some cases, accidental pregnancies happen.
The participant in the trial may say, “I don’t know enough about the safety of this drug in pregnancy, and I’ve already taken it. I want to terminate the pregnancy,” said Dr. Chambers. Thinking ahead, a woman may decide not to do the trial to avoid the risk of getting pregnant and not having the option to terminate the pregnancy.
This could apply to new drugs such as antiviral treatments, or medications for severe chronic disease that typically have no clinical trial data in pregnancy prior to initial release into the market.
Women may start taking the drug without thinking about getting pregnant, then realize there are no safety data and become concerned about its effects on a future pregnancy.
The question is: Will abortion restrictions have a chilling effect on these new drugs as well? Patients and their doctors may decide not to try it until more data are available. “I can see where abortion restrictions would change the risk or benefit calculation in thinking about what you do or don’t prescribe or take during reproductive age,” said Dr. Chambers.
The upside of restrictions?
If there’s a positive side to these developments with abortion bans, it may encourage women taking new medications or joining clinical trials to think even more carefully about adherence to effective contraception, said Dr. Chambers.
Some methods are more effective than others, she emphasized. “When you have an unplanned pregnancy, it could mean that the method you used wasn’t optimal or you weren’t using it as recommended.” A goal moving forward is to encourage more thoughtful use of highly effective contraceptives, thus reducing the number of unplanned pregnancies, she added.
If patients are taking methotrexate, “the time to think about pregnancy is before getting pregnant so you can switch to a drug that’s compatible with pregnancy,” she said.
This whole thought process regarding pregnancy planning could work toward useful health goals, said Dr. Chambers. “Nobody thinks termination is the preferred method, but planning ahead should involve a discussion of what works best for the patient.”
Patients do have other choices, said Dr. Grifka. “Fortunately, there are many commonly prescribed medications which cross the placenta and have no ill effects on the fetus.”
Talking to patients about choices
Dr. Clowse, who spends a lot of time training rheumatologists, encourages them to have conversations with patients about pregnancy planning. It’s a lot to manage, getting the right drug to a female patient with chronic illness, especially in this current climate of abortion upheaval, she noted.
Her approach is to have an open and honest conversation with patients about their concerns and fears, what the realities are, and what the potential future options are for certain rheumatology drugs in the United States.
Some women who see what’s happening across the country may become so risk averse that they may choose to die rather than take a lifesaving drug that poses certain risks under new restrictions.
“I think that’s tragic,” said Dr. Clowse.
To help their patients, Dr. Gray believes physicians across specialties should better educate themselves about physiology in pregnancy and how to counsel patients on the impact of not taking medications in pregnancy.
In her view, it’s almost coercive to say to a patient, “You really need to have effective contraception if I’m going to give you this lifesaving or quality-of-life-improving medication.”
When confronting such scenarios, Dr. Gray doesn’t think physicians need to change how they counsel patients about contraception. “I don’t think we should be putting pressure on patients to consider other permanent methods just because there’s a lack of abortion options.”
Patients will eventually make those decisions for themselves, she said. “They’re going to want a more efficacious method because they’re worried about not having access to abortion if they get pregnant.”
Dr. Gray reports being a site principal investigator for a phase 3 trial for VeraCept IUD, funded by Sebela Pharmaceuticals. Dr. Clowse reports receiving research funding and doing consulting for GlaxoSmithKline.
*Correction, 6/2/2022: A previous version of this article misstated the intended use of drugs such as the “morning-after” pill (levonorgestrel). They are taken to prevent unintended pregnancy.
A version of this article first appeared on Medscape.com .
Obstetrician Beverly Gray, MD, is already seeing the effects of the Roe v. Wade abortion debate in her North Carolina practice.
The state allows abortion but requires that women get counseling with a qualified health professional 72 hours before the procedure. “Aside from that, we still have patients asking for more efficacious contraceptive methods just in case,” said Dr. Gray, residency director and division director for women’s community and population health and associate professor for obstetrics and gynecology at Duke University, Durham, N.C.
Patients and staff in her clinic have also been approaching her about tubal ligation. “They’re asking about additional birth control methods because they’re concerned about what’s going to happen” with the challenge to the historic Roe v. Wade decision in the Supreme Court and subsequent actions in the states to restrict or ban abortion, she said.
This has implications not just for abortion but for medications known to affect pregnancy. “What I’m really worried about is physicians will be withholding medicine because they’re concerned about teratogenic effects,” said Dr. Gray.
With more states issuing restrictions on abortion, doctors are worried that patients needing certain drugs to maintain their lupus flares, cancer, or other diseases may decide not to take them in the event they accidentally become pregnant. If the drug is known to affect the fetus, the fear is a patient who lives in a state with abortion restrictions will no longer have the option to terminate a pregnancy.
Instead, a scenario may arise in which the patient – and their physician – may opt not to treat at all with an otherwise lifesaving medication, experts told this news organization.
The U.S. landscape on abortion restrictions
A leaked draft of a U.S. Supreme Court opinion on Mississippi’s 15-week abortion ban has sent the medical community into a tailspin. The case, Dobbs v. Jackson Women’s Health Organization, challenges the 1973 Roe v. Wade decision that affirms the constitutional right to abortion. It’s anticipated the high court will decide on the case in June.
Although the upcoming decision is subject to change, the draft indicated the high court would uphold the Mississippi ban. This would essentially overturn the 1973 ruling. An earlier Supreme Court decision allowing a Texas law banning abortion at 6 weeks suggests the court may already be heading in this direction. At the state level, legislatures have been moving on divergent paths – some taking steps to preserve abortion rights, others initiating restrictions.
More than 100 abortion restrictions in 19 states took effect in 2021, according to the Guttmacher Institute, which tracks such metrics. In 2022, “two key themes are anti-abortion policymakers’ continued pursuit of various types of abortion bans and restrictions on medication abortion,” the institute reported.
Forty-six states and the District of Columbia have introduced 2,025 restrictions or proactive measures on sexual and reproductive health and rights so far this year. The latest tally from Guttmacher, updated in late May, revealed that 11 states so far have enacted 42 abortion restrictions. A total of 6 states (Arizona, Florida, Idaho, Kentucky, Oklahoma, and Wyoming) have issued nine bans on abortion.
Comparatively, 11 states have enacted 19 protective abortion measures.
Twenty-two states have introduced 117 restrictions on medication abortions, which account for 54% of U.S. abortions. This includes seven measures that would ban medication abortion outright, according to Guttmacher. Kentucky and South Dakota collectively have enacted 14 restrictions on medication abortion, as well as provisions that ban mailing of abortion pills.
Chilling effect on prescribing
Some physicians anticipate that drugs such as the “morning-after” pill (levonorgestrel) will become less available as restrictions go into effect, since these are medications designed to prevent pregnancy.*
However, the ongoing effort to put a lid on abortion measures has prompted concerns about a trickle-down effect on other medications that are otherwise life-changing or lifesaving to patients but pose a risk to the fetus.
Several drugs are well documented to affect fetal growth and development of the fetus, ranging from mild, transitory effects to severe, permanent birth defects, said Ronald G. Grifka, MD, chief medical officer of University of Michigan Health-West and clinical professor of pediatrics at the University of Michigan Medical School, Ann Arbor. “As new medications are developed, we will need heightened attention to make sure they are safe for the fetus,” he added.
Certain teratogenic medications are associated with a high risk of abortion even though this isn’t their primary use, noted Christina Chambers, PhD, MPH, co-director of the Center for Better Beginnings and associate director with the Altman Clinical & Translational Research Institute at the University of California, San Diego.
“I don’t think anyone would intentionally take these drugs to induce spontaneous abortion. But if the drugs pose a risk for it, I can see how the laws might be stretched” to include them, said Dr. Chambers.
Methotrexate, a medication for autoimmune disorders, has a high risk of spontaneous abortion. So do acne medications such as isotretinoin.
Patients are usually told they’re not supposed to get pregnant on these drugs because there’s a high risk of pregnancy loss and risk of malformations and potential learning problems in the fetus. But many pregnancies aren’t planned, said Dr. Chambers. “Patients may forget about the side effects or think their birth control will protect them. And the next time they refill the medication, they may not hear about the warnings again.”
With a restrictive abortion law or ban in effect, a woman might think: “I won’t take this drug because if there’s any potential that I might get pregnant, I won’t have the option to abort an at-risk pregnancy.” Women and their doctors, for that matter, don’t want to put themselves in this position, said Dr. Chambers.
Rheumatologist Megan Clowse, MD, who prescribes several medications that potentially cause major birth defects and pregnancy loss, worries about the ramifications of these accumulating bans.
“Methotrexate has been a leading drug for us for decades for rheumatoid arthritis. Mycophenolate is a vital drug for lupus,” said Dr. Clowse, associate professor of medicine at Duke University’s division of rheumatology and immunology.
Both methotrexate and mycophenolate pose about a 40% risk of pregnancy loss and significantly increase the risk for birth defects. “I’m definitely concerned that there might be doctors or women who elect not to use those medications in women of reproductive age because of the potential risk for pregnancy and absence of abortion rights,” said Dr. Clowse.
These situations might force women to use contraceptives they don’t want to use, such as hormonal implants or intrauterine devices, she added. Another side effect is that women and their partners may decide to abstain from sex.
The iPLEDGE factor
Some rheumatology drugs like lenalidomide (Revlimid) require a valid negative pregnancy test in a lab every month. Similarly, the iPLEDGE Risk Evaluation and Mitigation Strategy seeks to reduce the teratogenicity of isotretinoin by requiring two types of birth control and regular pregnancy tests by users.
For isotretinoin specifically, abortion restrictions “could lead to increased adherence to pregnancy prevention measures which are already stringent in iPLEDGE. But on the other hand, it could lead to reduced willingness of physicians to prescribe or patients to take the medication,” said Dr. Chambers.
With programs like iPLEDGE in effect, the rate of pregnancies and abortions that occur in dermatology are relatively low, said Jenny Murase, MD, associate clinical professor of dermatology at the University of California, San Francisco.
Nevertheless, as a physician who regularly prescribes medications like isotretinoin in women of childbearing age, “it’s terrifying to me that a woman wouldn’t have the option to terminate the pregnancy if a teratogenic effect from the medication caused a severe birth defect,” said Dr. Murase.
Dermatologists use other teratogenic medications such as thalidomide, mycophenolate mofetil, and methotrexate for chronic dermatologic disease like psoriasis and atopic dermatitis.
The situation is especially tricky for dermatologists since most patients – about 80% – never discuss their pregnancy with their specialist prior to pregnancy initiation. Dr. Murase recalls when a patient with chronic plaque psoriasis on methotrexate in her late 40s became pregnant and had an abortion even before Dr. Murase became aware of the pregnancy.
Because dermatologists routinely prescribe long-term medications for chronic diseases like acne, psoriasis, and atopic dermatitis, it is important to have a conversation regarding the risks and benefits of long-term medication should a pregnancy occur in any woman of childbearing age, she said.
Fewer women in clinical trials?
Abortion restrictions could possibly discourage women of reproductive age to participate in a clinical trial for a new medication, said Dr. Chambers.
A female patient with a chronic disease who’s randomized to receive a new medication may be required to use certain types of birth control because of unknown potential adverse effects the drug may have on the fetus. But in some cases, accidental pregnancies happen.
The participant in the trial may say, “I don’t know enough about the safety of this drug in pregnancy, and I’ve already taken it. I want to terminate the pregnancy,” said Dr. Chambers. Thinking ahead, a woman may decide not to do the trial to avoid the risk of getting pregnant and not having the option to terminate the pregnancy.
This could apply to new drugs such as antiviral treatments, or medications for severe chronic disease that typically have no clinical trial data in pregnancy prior to initial release into the market.
Women may start taking the drug without thinking about getting pregnant, then realize there are no safety data and become concerned about its effects on a future pregnancy.
The question is: Will abortion restrictions have a chilling effect on these new drugs as well? Patients and their doctors may decide not to try it until more data are available. “I can see where abortion restrictions would change the risk or benefit calculation in thinking about what you do or don’t prescribe or take during reproductive age,” said Dr. Chambers.
The upside of restrictions?
If there’s a positive side to these developments with abortion bans, it may encourage women taking new medications or joining clinical trials to think even more carefully about adherence to effective contraception, said Dr. Chambers.
Some methods are more effective than others, she emphasized. “When you have an unplanned pregnancy, it could mean that the method you used wasn’t optimal or you weren’t using it as recommended.” A goal moving forward is to encourage more thoughtful use of highly effective contraceptives, thus reducing the number of unplanned pregnancies, she added.
If patients are taking methotrexate, “the time to think about pregnancy is before getting pregnant so you can switch to a drug that’s compatible with pregnancy,” she said.
This whole thought process regarding pregnancy planning could work toward useful health goals, said Dr. Chambers. “Nobody thinks termination is the preferred method, but planning ahead should involve a discussion of what works best for the patient.”
Patients do have other choices, said Dr. Grifka. “Fortunately, there are many commonly prescribed medications which cross the placenta and have no ill effects on the fetus.”
Talking to patients about choices
Dr. Clowse, who spends a lot of time training rheumatologists, encourages them to have conversations with patients about pregnancy planning. It’s a lot to manage, getting the right drug to a female patient with chronic illness, especially in this current climate of abortion upheaval, she noted.
Her approach is to have an open and honest conversation with patients about their concerns and fears, what the realities are, and what the potential future options are for certain rheumatology drugs in the United States.
Some women who see what’s happening across the country may become so risk averse that they may choose to die rather than take a lifesaving drug that poses certain risks under new restrictions.
“I think that’s tragic,” said Dr. Clowse.
To help their patients, Dr. Gray believes physicians across specialties should better educate themselves about physiology in pregnancy and how to counsel patients on the impact of not taking medications in pregnancy.
In her view, it’s almost coercive to say to a patient, “You really need to have effective contraception if I’m going to give you this lifesaving or quality-of-life-improving medication.”
When confronting such scenarios, Dr. Gray doesn’t think physicians need to change how they counsel patients about contraception. “I don’t think we should be putting pressure on patients to consider other permanent methods just because there’s a lack of abortion options.”
Patients will eventually make those decisions for themselves, she said. “They’re going to want a more efficacious method because they’re worried about not having access to abortion if they get pregnant.”
Dr. Gray reports being a site principal investigator for a phase 3 trial for VeraCept IUD, funded by Sebela Pharmaceuticals. Dr. Clowse reports receiving research funding and doing consulting for GlaxoSmithKline.
*Correction, 6/2/2022: A previous version of this article misstated the intended use of drugs such as the “morning-after” pill (levonorgestrel). They are taken to prevent unintended pregnancy.
A version of this article first appeared on Medscape.com .
IL-22 may serve as a biomarker of response to TNFi and IL-17i in PsA
Key clinical point: Interleukin-22 (IL-22) can be used as a biomarker to predict response to tumor necrosis factor inhibitors (TNFi) and IL-17 inhibitors (IL-17i) in patients with psoriatic arthritis (PsA).
Major finding: After 1 year of IL-17i therapy, a higher proportion of patients with low vs high IL-22 levels achieved Disease Activity in PsA (DAPSA) remission (90% vs 15.3%, P = .0006) and Minimal Disease Activity (MDA; 100% vs 46.1%, P = .0075), with the rate of achieving DAPSA remission and MDA at 1 year significantly higher in patients with high IL-22 levels who received TNFi vs IL-17-i and in patients with low IL-22 levels who received IL-17i vs TNFi.
Study details: Findings are from a retrospective study including 47 patients with PsA who were treated with TNFi or IL-17i for ≥1 year.
Disclosures: This study was partly supported by Research on Rare and Interactable Diseases and Research Grant-In-Aid for Scientific Research by the Ministry of Health, Labour, and Welfare of Japan; and other sources. Y Tanaka and S Nakayamada declared receiving consulting fees, speaking fees, honoraria, and research grants from several sources.
Source: Miyagawa I et al. Impact of serum interleukin-22 as a biomarker for the differential use of molecular targeted drugs in psoriatic arthritis: a retrospective study. Arthritis Res Ther. 2022;24:86 (Apr 15). Doi: 10.1186/s13075-022-02771-4
Key clinical point: Interleukin-22 (IL-22) can be used as a biomarker to predict response to tumor necrosis factor inhibitors (TNFi) and IL-17 inhibitors (IL-17i) in patients with psoriatic arthritis (PsA).
Major finding: After 1 year of IL-17i therapy, a higher proportion of patients with low vs high IL-22 levels achieved Disease Activity in PsA (DAPSA) remission (90% vs 15.3%, P = .0006) and Minimal Disease Activity (MDA; 100% vs 46.1%, P = .0075), with the rate of achieving DAPSA remission and MDA at 1 year significantly higher in patients with high IL-22 levels who received TNFi vs IL-17-i and in patients with low IL-22 levels who received IL-17i vs TNFi.
Study details: Findings are from a retrospective study including 47 patients with PsA who were treated with TNFi or IL-17i for ≥1 year.
Disclosures: This study was partly supported by Research on Rare and Interactable Diseases and Research Grant-In-Aid for Scientific Research by the Ministry of Health, Labour, and Welfare of Japan; and other sources. Y Tanaka and S Nakayamada declared receiving consulting fees, speaking fees, honoraria, and research grants from several sources.
Source: Miyagawa I et al. Impact of serum interleukin-22 as a biomarker for the differential use of molecular targeted drugs in psoriatic arthritis: a retrospective study. Arthritis Res Ther. 2022;24:86 (Apr 15). Doi: 10.1186/s13075-022-02771-4
Key clinical point: Interleukin-22 (IL-22) can be used as a biomarker to predict response to tumor necrosis factor inhibitors (TNFi) and IL-17 inhibitors (IL-17i) in patients with psoriatic arthritis (PsA).
Major finding: After 1 year of IL-17i therapy, a higher proportion of patients with low vs high IL-22 levels achieved Disease Activity in PsA (DAPSA) remission (90% vs 15.3%, P = .0006) and Minimal Disease Activity (MDA; 100% vs 46.1%, P = .0075), with the rate of achieving DAPSA remission and MDA at 1 year significantly higher in patients with high IL-22 levels who received TNFi vs IL-17-i and in patients with low IL-22 levels who received IL-17i vs TNFi.
Study details: Findings are from a retrospective study including 47 patients with PsA who were treated with TNFi or IL-17i for ≥1 year.
Disclosures: This study was partly supported by Research on Rare and Interactable Diseases and Research Grant-In-Aid for Scientific Research by the Ministry of Health, Labour, and Welfare of Japan; and other sources. Y Tanaka and S Nakayamada declared receiving consulting fees, speaking fees, honoraria, and research grants from several sources.
Source: Miyagawa I et al. Impact of serum interleukin-22 as a biomarker for the differential use of molecular targeted drugs in psoriatic arthritis: a retrospective study. Arthritis Res Ther. 2022;24:86 (Apr 15). Doi: 10.1186/s13075-022-02771-4
Secukinumab safe and effective as a first-line biologic for PsA
Key clinical point: A dose of 300 mg secukinumab vs placebo showed rapid and significant improvements in the signs and symptoms of psoriatic arthritis (PsA) along with a tolerable safety profile in a US-only cohort of biologic-naive patients with PsA.
Major finding: At week 16, a significantly higher proportion of patients receiving 300 mg secukinumab vs placebo achieved ≥20% (odds ratio [OR] 3.51; P = .0011), ≥50% (OR 6.30; P = .0038), and ≥70% (OR 10.50; P = .0243) improvement in American College of Rheumatology score, with response maintained through week 52. Diarrhea (5.8%), hypertension (4.9%), and upper respiratory tract infections (5.8%) were the most common adverse events, mostly of mild or moderate severity.
Study details: This phase 4 CHOICE study included 258 biologic-naive patients with moderate-to-severe PsA who were randomly assigned to receive 300 mg secukinumab, 150 mg secukinumab, or placebo.
Disclosures: This study was supported by Novartis Pharmaceuticals Corporation. Four authors declared being employees and shareholders of Novartis Pharmaceuticals Corporation and other authors reported ties with various sources, including Novartis.
Source: Nguyen T et al. Secukinumab in US biologic-naive patients with psoriatic arthritis: Results from the randomized, placebo-controlled CHOICE study. J Rheumatol. 2022 (Apr 15). Doi: 10.3899/jrheum.210912
Key clinical point: A dose of 300 mg secukinumab vs placebo showed rapid and significant improvements in the signs and symptoms of psoriatic arthritis (PsA) along with a tolerable safety profile in a US-only cohort of biologic-naive patients with PsA.
Major finding: At week 16, a significantly higher proportion of patients receiving 300 mg secukinumab vs placebo achieved ≥20% (odds ratio [OR] 3.51; P = .0011), ≥50% (OR 6.30; P = .0038), and ≥70% (OR 10.50; P = .0243) improvement in American College of Rheumatology score, with response maintained through week 52. Diarrhea (5.8%), hypertension (4.9%), and upper respiratory tract infections (5.8%) were the most common adverse events, mostly of mild or moderate severity.
Study details: This phase 4 CHOICE study included 258 biologic-naive patients with moderate-to-severe PsA who were randomly assigned to receive 300 mg secukinumab, 150 mg secukinumab, or placebo.
Disclosures: This study was supported by Novartis Pharmaceuticals Corporation. Four authors declared being employees and shareholders of Novartis Pharmaceuticals Corporation and other authors reported ties with various sources, including Novartis.
Source: Nguyen T et al. Secukinumab in US biologic-naive patients with psoriatic arthritis: Results from the randomized, placebo-controlled CHOICE study. J Rheumatol. 2022 (Apr 15). Doi: 10.3899/jrheum.210912
Key clinical point: A dose of 300 mg secukinumab vs placebo showed rapid and significant improvements in the signs and symptoms of psoriatic arthritis (PsA) along with a tolerable safety profile in a US-only cohort of biologic-naive patients with PsA.
Major finding: At week 16, a significantly higher proportion of patients receiving 300 mg secukinumab vs placebo achieved ≥20% (odds ratio [OR] 3.51; P = .0011), ≥50% (OR 6.30; P = .0038), and ≥70% (OR 10.50; P = .0243) improvement in American College of Rheumatology score, with response maintained through week 52. Diarrhea (5.8%), hypertension (4.9%), and upper respiratory tract infections (5.8%) were the most common adverse events, mostly of mild or moderate severity.
Study details: This phase 4 CHOICE study included 258 biologic-naive patients with moderate-to-severe PsA who were randomly assigned to receive 300 mg secukinumab, 150 mg secukinumab, or placebo.
Disclosures: This study was supported by Novartis Pharmaceuticals Corporation. Four authors declared being employees and shareholders of Novartis Pharmaceuticals Corporation and other authors reported ties with various sources, including Novartis.
Source: Nguyen T et al. Secukinumab in US biologic-naive patients with psoriatic arthritis: Results from the randomized, placebo-controlled CHOICE study. J Rheumatol. 2022 (Apr 15). Doi: 10.3899/jrheum.210912
Meta-analysis evaluates impact of bDMARD on QoL in PsA
Key clinical point: Biological disease-modifying antirheumatic drugs (bDMARD) significantly improved the quality of life (QoL) in patients with psoriatic arthritis (PsA) compared with placebo.
Major finding: The Health Assessment Questionnaire Disability Index (mean difference [MD] −0.21), Dermatology Life Quality Index (MD −4.36), and Short Form 36 Questionnaire physical (MD 3.76) and mental (MD 1.76; all P < .00001) component summaries improved significantly with bDMARD vs placebo. However, bDMARD showed no significant advantage or disadvantage over methotrexate or tofacitinib.
Study details: This was a meta-analysis of 37 randomized controlled trials including 14,115 patients with PsA who received non-bDMARD, placebo, or bDMARD alone or in combination with non-bDMARD.
Disclosures: This work was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.
Source: Lu Y et al. Effects of bDMARDs on quality of life in patients with psoriatic arthritis: Meta-analysis. BMJ Open. 2022;12:e058497 (Apr 12). Doi: 10.1136/bmjopen-2021-058497
Key clinical point: Biological disease-modifying antirheumatic drugs (bDMARD) significantly improved the quality of life (QoL) in patients with psoriatic arthritis (PsA) compared with placebo.
Major finding: The Health Assessment Questionnaire Disability Index (mean difference [MD] −0.21), Dermatology Life Quality Index (MD −4.36), and Short Form 36 Questionnaire physical (MD 3.76) and mental (MD 1.76; all P < .00001) component summaries improved significantly with bDMARD vs placebo. However, bDMARD showed no significant advantage or disadvantage over methotrexate or tofacitinib.
Study details: This was a meta-analysis of 37 randomized controlled trials including 14,115 patients with PsA who received non-bDMARD, placebo, or bDMARD alone or in combination with non-bDMARD.
Disclosures: This work was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.
Source: Lu Y et al. Effects of bDMARDs on quality of life in patients with psoriatic arthritis: Meta-analysis. BMJ Open. 2022;12:e058497 (Apr 12). Doi: 10.1136/bmjopen-2021-058497
Key clinical point: Biological disease-modifying antirheumatic drugs (bDMARD) significantly improved the quality of life (QoL) in patients with psoriatic arthritis (PsA) compared with placebo.
Major finding: The Health Assessment Questionnaire Disability Index (mean difference [MD] −0.21), Dermatology Life Quality Index (MD −4.36), and Short Form 36 Questionnaire physical (MD 3.76) and mental (MD 1.76; all P < .00001) component summaries improved significantly with bDMARD vs placebo. However, bDMARD showed no significant advantage or disadvantage over methotrexate or tofacitinib.
Study details: This was a meta-analysis of 37 randomized controlled trials including 14,115 patients with PsA who received non-bDMARD, placebo, or bDMARD alone or in combination with non-bDMARD.
Disclosures: This work was supported by the National Natural Science Foundation of China. The authors declared no conflicts of interest.
Source: Lu Y et al. Effects of bDMARDs on quality of life in patients with psoriatic arthritis: Meta-analysis. BMJ Open. 2022;12:e058497 (Apr 12). Doi: 10.1136/bmjopen-2021-058497
PsA: Baseline disease activity predicts achievement of treatment targets with apremilast
Key clinical point: Disease-modifying antirheumatic drug (DMARD)-naive patients with moderate vs high disease activity at baseline were more likely to achieve Clinical Disease Activity Index for Psoriatic Arthritis (PsA) treatment targets following apremilast therapy.
Major finding: At week 52, remission or low disease activity was achieved by approximately twice the number of patients with moderate vs high disease activity (61.7% vs 28.2%) at baseline, regardless of one or multiple PsA manifestations.
Study details: Findings are from a post hoc analysis of the phase 3 PALACE 4 study including 175 DMARD-naive patients with active PsA who received 30 mg apremilast.
Disclosures: This study received writing support from Amgen. Three authors declared being employees and stockholders of Amgen. The other authors reported ties with several sources, including Amgen.
Source: Mease PJ et al. Baseline disease activity predicts achievement of cDAPSA treatment targets with apremilast: Phase 3 results in DMARD-naive patients with psoriatic arthritis. J Rheumatol. 2022 (Apr 15). Doi: 10.3899/jrheum.210906
Key clinical point: Disease-modifying antirheumatic drug (DMARD)-naive patients with moderate vs high disease activity at baseline were more likely to achieve Clinical Disease Activity Index for Psoriatic Arthritis (PsA) treatment targets following apremilast therapy.
Major finding: At week 52, remission or low disease activity was achieved by approximately twice the number of patients with moderate vs high disease activity (61.7% vs 28.2%) at baseline, regardless of one or multiple PsA manifestations.
Study details: Findings are from a post hoc analysis of the phase 3 PALACE 4 study including 175 DMARD-naive patients with active PsA who received 30 mg apremilast.
Disclosures: This study received writing support from Amgen. Three authors declared being employees and stockholders of Amgen. The other authors reported ties with several sources, including Amgen.
Source: Mease PJ et al. Baseline disease activity predicts achievement of cDAPSA treatment targets with apremilast: Phase 3 results in DMARD-naive patients with psoriatic arthritis. J Rheumatol. 2022 (Apr 15). Doi: 10.3899/jrheum.210906
Key clinical point: Disease-modifying antirheumatic drug (DMARD)-naive patients with moderate vs high disease activity at baseline were more likely to achieve Clinical Disease Activity Index for Psoriatic Arthritis (PsA) treatment targets following apremilast therapy.
Major finding: At week 52, remission or low disease activity was achieved by approximately twice the number of patients with moderate vs high disease activity (61.7% vs 28.2%) at baseline, regardless of one or multiple PsA manifestations.
Study details: Findings are from a post hoc analysis of the phase 3 PALACE 4 study including 175 DMARD-naive patients with active PsA who received 30 mg apremilast.
Disclosures: This study received writing support from Amgen. Three authors declared being employees and stockholders of Amgen. The other authors reported ties with several sources, including Amgen.
Source: Mease PJ et al. Baseline disease activity predicts achievement of cDAPSA treatment targets with apremilast: Phase 3 results in DMARD-naive patients with psoriatic arthritis. J Rheumatol. 2022 (Apr 15). Doi: 10.3899/jrheum.210906
Meta-analysis evaluates degree of skin involvement in patients with PsA vs only psoriasis
Key clinical point: Patients with psoriasis and concurrent psoriatic arthritis (PsA) reported more extensive skin disease than patients with only psoriasis, with psoriasis severity being significantly associated with higher odds of concurrent PsA.
Major finding: Body surface area scores were significantly higher in patients with psoriasis and concurrent PsA vs patients with only psoriasis (mean difference 5.31; 95% CI 1.78-8.83), with severe psoriasis being a significant predictor of concurrent PsA (odds ratio 3.34; P < .001).
Study details: This was a meta-analysis of 29 studies including adult patients with psoriasis with or without concurrent PsA or adult patients with psoriasis who developed PsA.
Disclosures: This study did not receive any funding. JM Laar declared receiving research grants and honoraria from several sources.
Source: Pouw JN et al. Do patients with psoriatic arthritis have more severe skin disease than patients with psoriasis only? A systematic review and meta-analysis. Dermatology. 2022 (May 12). Doi: 10.1159/000524231
Key clinical point: Patients with psoriasis and concurrent psoriatic arthritis (PsA) reported more extensive skin disease than patients with only psoriasis, with psoriasis severity being significantly associated with higher odds of concurrent PsA.
Major finding: Body surface area scores were significantly higher in patients with psoriasis and concurrent PsA vs patients with only psoriasis (mean difference 5.31; 95% CI 1.78-8.83), with severe psoriasis being a significant predictor of concurrent PsA (odds ratio 3.34; P < .001).
Study details: This was a meta-analysis of 29 studies including adult patients with psoriasis with or without concurrent PsA or adult patients with psoriasis who developed PsA.
Disclosures: This study did not receive any funding. JM Laar declared receiving research grants and honoraria from several sources.
Source: Pouw JN et al. Do patients with psoriatic arthritis have more severe skin disease than patients with psoriasis only? A systematic review and meta-analysis. Dermatology. 2022 (May 12). Doi: 10.1159/000524231
Key clinical point: Patients with psoriasis and concurrent psoriatic arthritis (PsA) reported more extensive skin disease than patients with only psoriasis, with psoriasis severity being significantly associated with higher odds of concurrent PsA.
Major finding: Body surface area scores were significantly higher in patients with psoriasis and concurrent PsA vs patients with only psoriasis (mean difference 5.31; 95% CI 1.78-8.83), with severe psoriasis being a significant predictor of concurrent PsA (odds ratio 3.34; P < .001).
Study details: This was a meta-analysis of 29 studies including adult patients with psoriasis with or without concurrent PsA or adult patients with psoriasis who developed PsA.
Disclosures: This study did not receive any funding. JM Laar declared receiving research grants and honoraria from several sources.
Source: Pouw JN et al. Do patients with psoriatic arthritis have more severe skin disease than patients with psoriasis only? A systematic review and meta-analysis. Dermatology. 2022 (May 12). Doi: 10.1159/000524231
Osteophytes are the most common lesions in PsA patients receiving bDMARD
Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) who received biological disease-modifying antirheumatic drug (bDMARD) therapy showed osteoproliferative lesions on a lumbar radiograph, with osteophytes being the most common.
Major finding: Osteophytes were the most common lesions and were detected in 42.3% of patients, with 18.1% of patients being diagnosed with grade ≥2 osteophytes. At least one syndesmophyte was detected in 24.2% of patients, with 9.3% and 19.8% of patients showing bridging and corner syndesmophytes, respectively. Ambiguous lesions were detected in 7.1% of patients.
Study details: Findings are from an analysis of 182 patients with PsA who received bDMARD therapy and underwent lumbar radiography assessment.
Disclosures: This research was funded by Hacettepe Rheumatology Society, Turkey. The authors declared no conflicts of interest.
Source: Ayan G et al. Degenerative and inflammatory osteoproliferations in lumbar radiographs in psoriatic arthritis patients. J Clin Med. 2022;11(7):2009 (Apr 3). Doi: 10.3390/jcm11072009
Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) who received biological disease-modifying antirheumatic drug (bDMARD) therapy showed osteoproliferative lesions on a lumbar radiograph, with osteophytes being the most common.
Major finding: Osteophytes were the most common lesions and were detected in 42.3% of patients, with 18.1% of patients being diagnosed with grade ≥2 osteophytes. At least one syndesmophyte was detected in 24.2% of patients, with 9.3% and 19.8% of patients showing bridging and corner syndesmophytes, respectively. Ambiguous lesions were detected in 7.1% of patients.
Study details: Findings are from an analysis of 182 patients with PsA who received bDMARD therapy and underwent lumbar radiography assessment.
Disclosures: This research was funded by Hacettepe Rheumatology Society, Turkey. The authors declared no conflicts of interest.
Source: Ayan G et al. Degenerative and inflammatory osteoproliferations in lumbar radiographs in psoriatic arthritis patients. J Clin Med. 2022;11(7):2009 (Apr 3). Doi: 10.3390/jcm11072009
Key clinical point: A substantial proportion of patients with psoriatic arthritis (PsA) who received biological disease-modifying antirheumatic drug (bDMARD) therapy showed osteoproliferative lesions on a lumbar radiograph, with osteophytes being the most common.
Major finding: Osteophytes were the most common lesions and were detected in 42.3% of patients, with 18.1% of patients being diagnosed with grade ≥2 osteophytes. At least one syndesmophyte was detected in 24.2% of patients, with 9.3% and 19.8% of patients showing bridging and corner syndesmophytes, respectively. Ambiguous lesions were detected in 7.1% of patients.
Study details: Findings are from an analysis of 182 patients with PsA who received bDMARD therapy and underwent lumbar radiography assessment.
Disclosures: This research was funded by Hacettepe Rheumatology Society, Turkey. The authors declared no conflicts of interest.
Source: Ayan G et al. Degenerative and inflammatory osteoproliferations in lumbar radiographs in psoriatic arthritis patients. J Clin Med. 2022;11(7):2009 (Apr 3). Doi: 10.3390/jcm11072009
Site of infection linked to PsA onset regardless of pathogen
Key clinical point: Having sent a pharyngeal sample for culture was associated with an increased risk for psoriatic arthritis (PsA) onset, indicating site of infection being associated with the increased PsA risk rather than the pathogen.
Major finding: Among all samples sent for culture, a pharyngeal sample was associated with a higher risk for PsA onset within first 50 days compared with a urine (hazard ratio [HR] 8.78; 95% CI 3.23-23.91), nasopharyngeal (HR 8.26; 95% CI 2.23-30.63), or blood (HR 25.22; 95% CI 3.12-204.13) sample; however, streptococcal infections in the pharynx or at any other site were not associated with an increased risk for PsA.
Study details: Findings are from a population-based cohort study including 313,235 bacterial cultures from 128,982 individuals.
Disclosures: The study was supported by the Landspitali University Hospital, Iceland. A Ogdie and T Love declared serving as consultants and receiving grants and reimbursement from several sources.
Source: Thrastardottir T et al. Strong site-specific association of pharyngeal cultures with the onset of psoriatic arthritis and psoriasis, regardless of pathogen. Rheumatology (Oxford). 2022 (Apr 23). Doi: 10.1093/rheumatology/keac253
Key clinical point: Having sent a pharyngeal sample for culture was associated with an increased risk for psoriatic arthritis (PsA) onset, indicating site of infection being associated with the increased PsA risk rather than the pathogen.
Major finding: Among all samples sent for culture, a pharyngeal sample was associated with a higher risk for PsA onset within first 50 days compared with a urine (hazard ratio [HR] 8.78; 95% CI 3.23-23.91), nasopharyngeal (HR 8.26; 95% CI 2.23-30.63), or blood (HR 25.22; 95% CI 3.12-204.13) sample; however, streptococcal infections in the pharynx or at any other site were not associated with an increased risk for PsA.
Study details: Findings are from a population-based cohort study including 313,235 bacterial cultures from 128,982 individuals.
Disclosures: The study was supported by the Landspitali University Hospital, Iceland. A Ogdie and T Love declared serving as consultants and receiving grants and reimbursement from several sources.
Source: Thrastardottir T et al. Strong site-specific association of pharyngeal cultures with the onset of psoriatic arthritis and psoriasis, regardless of pathogen. Rheumatology (Oxford). 2022 (Apr 23). Doi: 10.1093/rheumatology/keac253
Key clinical point: Having sent a pharyngeal sample for culture was associated with an increased risk for psoriatic arthritis (PsA) onset, indicating site of infection being associated with the increased PsA risk rather than the pathogen.
Major finding: Among all samples sent for culture, a pharyngeal sample was associated with a higher risk for PsA onset within first 50 days compared with a urine (hazard ratio [HR] 8.78; 95% CI 3.23-23.91), nasopharyngeal (HR 8.26; 95% CI 2.23-30.63), or blood (HR 25.22; 95% CI 3.12-204.13) sample; however, streptococcal infections in the pharynx or at any other site were not associated with an increased risk for PsA.
Study details: Findings are from a population-based cohort study including 313,235 bacterial cultures from 128,982 individuals.
Disclosures: The study was supported by the Landspitali University Hospital, Iceland. A Ogdie and T Love declared serving as consultants and receiving grants and reimbursement from several sources.
Source: Thrastardottir T et al. Strong site-specific association of pharyngeal cultures with the onset of psoriatic arthritis and psoriasis, regardless of pathogen. Rheumatology (Oxford). 2022 (Apr 23). Doi: 10.1093/rheumatology/keac253
PsA: Real-world efficacy, safety, and retention rate of secukinumab
Key clinical point: Both first- and second-line secukinumab therapies demonstrated substantial improvement in disease activity, adequate retention rates, and a satisfactory safety profile in a real-world population of patients with psoriatic arthritis (PsA).
Major finding: Mean Disease Activity Score 28 using C-reactive protein decreased from 3.0 to 2.0 and 1.9 at the first and third years of follow-up, whereas the proportion of patients in remission/low disease activity increased from 52.1% and 71.4% to 100% after 2 years of the first- and second-line secukinumab treatments, respectively. The overall retention rates of secukinumab were 74.1%, 59.1%, and 54.2% in the first, second, and third years of treatment, respectively, with no new adverse events being reported.
Study details: This observational, retrospective analysis included 639 patients with PsA or axial spondyloarthritis from the BIOBADASER registry who had received secukinumab for >12 months. Of these patients, 350 had PsA.
Disclosures: This study was sponsored by Novartis Spain. C Sastré is an employee of Novartis. The other authors reported no conflicts of interest.
Source: Moreno-Ramos MJ et al. Real-world effectiveness and treatment retention of secukinumab in patients with psoriatic arthritis and axial spondyloarthritis: A descriptive observational analysis of the Spanish BIOBADASER Registry. Rheumatol Ther. 2022 (Apr 25). Doi: 10.1007/s40744-022-00446-9
Key clinical point: Both first- and second-line secukinumab therapies demonstrated substantial improvement in disease activity, adequate retention rates, and a satisfactory safety profile in a real-world population of patients with psoriatic arthritis (PsA).
Major finding: Mean Disease Activity Score 28 using C-reactive protein decreased from 3.0 to 2.0 and 1.9 at the first and third years of follow-up, whereas the proportion of patients in remission/low disease activity increased from 52.1% and 71.4% to 100% after 2 years of the first- and second-line secukinumab treatments, respectively. The overall retention rates of secukinumab were 74.1%, 59.1%, and 54.2% in the first, second, and third years of treatment, respectively, with no new adverse events being reported.
Study details: This observational, retrospective analysis included 639 patients with PsA or axial spondyloarthritis from the BIOBADASER registry who had received secukinumab for >12 months. Of these patients, 350 had PsA.
Disclosures: This study was sponsored by Novartis Spain. C Sastré is an employee of Novartis. The other authors reported no conflicts of interest.
Source: Moreno-Ramos MJ et al. Real-world effectiveness and treatment retention of secukinumab in patients with psoriatic arthritis and axial spondyloarthritis: A descriptive observational analysis of the Spanish BIOBADASER Registry. Rheumatol Ther. 2022 (Apr 25). Doi: 10.1007/s40744-022-00446-9
Key clinical point: Both first- and second-line secukinumab therapies demonstrated substantial improvement in disease activity, adequate retention rates, and a satisfactory safety profile in a real-world population of patients with psoriatic arthritis (PsA).
Major finding: Mean Disease Activity Score 28 using C-reactive protein decreased from 3.0 to 2.0 and 1.9 at the first and third years of follow-up, whereas the proportion of patients in remission/low disease activity increased from 52.1% and 71.4% to 100% after 2 years of the first- and second-line secukinumab treatments, respectively. The overall retention rates of secukinumab were 74.1%, 59.1%, and 54.2% in the first, second, and third years of treatment, respectively, with no new adverse events being reported.
Study details: This observational, retrospective analysis included 639 patients with PsA or axial spondyloarthritis from the BIOBADASER registry who had received secukinumab for >12 months. Of these patients, 350 had PsA.
Disclosures: This study was sponsored by Novartis Spain. C Sastré is an employee of Novartis. The other authors reported no conflicts of interest.
Source: Moreno-Ramos MJ et al. Real-world effectiveness and treatment retention of secukinumab in patients with psoriatic arthritis and axial spondyloarthritis: A descriptive observational analysis of the Spanish BIOBADASER Registry. Rheumatol Ther. 2022 (Apr 25). Doi: 10.1007/s40744-022-00446-9