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Biologics Better Than Methotrexate for Preventing PsA in Psoriasis

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

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

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

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

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

 

 

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

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

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

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

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

 

 

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

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

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

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

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

 

 

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Achilles Tendon Pain Severely Impairs Function in PsA

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Fri, 07/26/2024 - 11:51

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

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

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

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

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

 

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

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

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

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

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

 

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

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

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

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

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

 

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Varied Psoriasis Manifestations Pose Differential Risk for Psoriatic Arthritis

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Fri, 07/26/2024 - 14:07

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Psoriasis Onset at an Older Age Can Hasten PsA Development

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Fri, 07/26/2024 - 13:40

Key clinical point: Patients diagnosed with psoriasis at an older vs younger age had a significantly shorter interval between psoriasis and psoriatic arthritis (PsA) diagnoses and also showed a higher likelihood of developing PsA within 6 months of having psoriasis.

Major finding: Patients with psoriasis onset at the age of 42.6 vs 18.9 years had a 62% shorter time interval between psoriasis and PsA diagnoses (exponentiated estimate 0.38; P < .001) and were ~4.6 times more likely to have a concurrent onset of PsA within 6 months of having psoriasis (odds ratio 4.56; P < .001).

Study details: This registry-based study included 384 patients diagnosed with PsA either after or concurrently with their psoriasis diagnosis.

Disclosures: This study was supported in part by a grant from the US National Institutes of Health. One author declared receiving payment or honoraria from and holding leadership or fiduciary roles with various sources.

Source: Cheemalavagu S, Jin Y, Husni ME. What clinical factors affect length of transition to psoriatic arthritis in patients with psoriasis? ACR Open Rheumatol. 2024 (June 28). Doi: 10.1002/acr2.11703 Source

 

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Key clinical point: Patients diagnosed with psoriasis at an older vs younger age had a significantly shorter interval between psoriasis and psoriatic arthritis (PsA) diagnoses and also showed a higher likelihood of developing PsA within 6 months of having psoriasis.

Major finding: Patients with psoriasis onset at the age of 42.6 vs 18.9 years had a 62% shorter time interval between psoriasis and PsA diagnoses (exponentiated estimate 0.38; P < .001) and were ~4.6 times more likely to have a concurrent onset of PsA within 6 months of having psoriasis (odds ratio 4.56; P < .001).

Study details: This registry-based study included 384 patients diagnosed with PsA either after or concurrently with their psoriasis diagnosis.

Disclosures: This study was supported in part by a grant from the US National Institutes of Health. One author declared receiving payment or honoraria from and holding leadership or fiduciary roles with various sources.

Source: Cheemalavagu S, Jin Y, Husni ME. What clinical factors affect length of transition to psoriatic arthritis in patients with psoriasis? ACR Open Rheumatol. 2024 (June 28). Doi: 10.1002/acr2.11703 Source

 

Key clinical point: Patients diagnosed with psoriasis at an older vs younger age had a significantly shorter interval between psoriasis and psoriatic arthritis (PsA) diagnoses and also showed a higher likelihood of developing PsA within 6 months of having psoriasis.

Major finding: Patients with psoriasis onset at the age of 42.6 vs 18.9 years had a 62% shorter time interval between psoriasis and PsA diagnoses (exponentiated estimate 0.38; P < .001) and were ~4.6 times more likely to have a concurrent onset of PsA within 6 months of having psoriasis (odds ratio 4.56; P < .001).

Study details: This registry-based study included 384 patients diagnosed with PsA either after or concurrently with their psoriasis diagnosis.

Disclosures: This study was supported in part by a grant from the US National Institutes of Health. One author declared receiving payment or honoraria from and holding leadership or fiduciary roles with various sources.

Source: Cheemalavagu S, Jin Y, Husni ME. What clinical factors affect length of transition to psoriatic arthritis in patients with psoriasis? ACR Open Rheumatol. 2024 (June 28). Doi: 10.1002/acr2.11703 Source

 

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Financial Hardship Common With Rheumatologic Disease: How Can Doctors Help?

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Tue, 07/23/2024 - 16:20

Many patients struggle with healthcare costs and basic expenses, according to new research.

People with rheumatologic diseases often experience a hidden symptom: financial toxicity or significant economic strain from out-of-pocket costs. A new study of 41,502 patients published in JCR: Journal of Clinical Rheumatology showed that 20% of those with rheumatologic diseases faced financial hardship from medical expenses, with 55% of those unable to pay their bills. 

Compared with patients who do not have rheumatologic diseases, and after clinical and sociodemographic factors were controlled for, patients with rheumatologic diseases were:

  • 29% more likely to have high levels of financial hardship — difficulty paying; needing to pay over time; or inability to pay bills for doctors, dentists, hospitals, therapists, medication, equipment, nursing homes, or home care.
  • 53% more likely to have high levels of financial distress — significant worry about having enough money for retirement, paying medical costs in the event of a serious illness or accident, maintaining their standard of living, paying their usual healthcare costs, and affording their normal monthly bills and housing costs.
  • 29% more likely to experience food insecurity, defined as limited or uncertain access to adequate food.
  • 58% more likely to report cost-related medication nonadherence — skipping doses, taking less medication, or delaying filling a prescription to save money.

People who were younger than 64 years, male, Black, or uninsured had higher odds of experiencing financial hardship, financial distress, food insecurity, and cost-related medication nonadherence. 

This study highlights “just how costly everyday rheumatologic conditions can be for your average American,” said lead study author Troy Amen, MD, MBA, an orthopedic surgery resident at the Hospital for Special Surgery in New York City. These diseases can be disabling, limiting a patient’s ability to work at the very time when expensive medications are needed. 

“It’s critical for clinicians to recognize how common the financial burden from healthcare costs can be, and only then can they take steps to better support patients,” said G. Caleb Alexander, MD, MS, professor of epidemiology at Johns Hopkins University in Baltimore, who was not involved in the study. 

Here’s how healthcare providers can help. 

Consider skipped medication a red flag. It’s often the first sign of a financial concern. “Sometimes with these problems, it looks like simple medication noncompliance, but it’s really a more complex form of nonadherence,” said Susan M. Goodman, MD, professor of clinical medicine at Weill Cornell Medicine in New York City and a coauthor of the study. “And I think if someone’s not taking the medication that had been very helpful, it does behoove the physician to try and figure out why that is.”

Normalize the issue to help patients open up. “I will often say, ‘You know, many, many patients don’t take their medicines exactly as prescribed. About how many days a week do you take this medicine?’” said Dr. Alexander. “If you ask in a nonconfrontational, supportive manner, I’ve found that patients are quite candid.” 

Don’t assume insurance has it covered. If patients are uninsured, help them enroll in (or renew) insurance coverage. But don’t assume insurance will solve the whole problem. “There are many people who, although they do have coverage, still can’t afford their medications,” said Dr. Goodman.

For products on high formulary tiers, the patient’s monthly cost can be hundreds to thousands of dollars. “Over the past 10-20 years, we’ve seen remarkable technological innovation in the types of medicines being brought to market, and here, I’m referring primarily to biologics and medicines made from living cells,” said Dr. Alexander, “but many of these have a price tag that is simply astronomical, and insurers aren’t going to bear the brunt of these costs alone.” 

Biosimilars can be a bit more affordable, but “the dirty little secret of biosimilars is that they’re not really very much less expensive,” said Dr. Goodman. “If your patient is doing well on a drug that gets dropped from their insurance plan’s formulary, or if they switch to a plan that doesn’t cover it, try calling and advocating for an exception. It’s an uphill battle, but it sometimes works,” she said.

If not? Help your patients apply for a patient assistance program. Many drug manufacturers offer copay assistance through their websites, and nonprofit patient assistance organizations such as the PAN Foundation, the Patient Advocate Foundation’s Co-Pay Relief Program, or The Assistance Fund can also help fill the gaps. One study published in the Journal of Managed Care and Specialty Pharmacy showed that in patients with rheumatoid arthritis, copay assistance was associated with 79% lower odds of prescription abandonment (failure to fill within 30 days of health plan approval).

Beware of “shiny penny syndrome.” It’s easy to get excited about new, innovative medications, especially when sales reps provide plenty of free samples. “There is a tendency to treat every new medicine as if it’s a bright shiny object in the streambed, and you know that’s not always the case,” said Dr. Alexander. “So, I think we have to be careful, especially in settings when we’re talking about ultra–high-cost medicines, that we’re aware of the burden these medicines may place on patients and that we’re navigating that with patients together, and not simply leaving that as a conversation that never happens in the exam room.”

Maybe there’s an older, time-tested drug that works just as well as the newer, more expensive one. Perhaps there is a slightly less effective medicine that costs a lot less. “These are cost–quality trade-offs that clinicians and patients should be navigating together,” said Dr. Alexander. For example, in a patient with rheumatoid arthritis, a tumor necrosis factor alpha inhibitor might work similarly to or almost as well as an interleukin inhibitor, the newer and typically more expensive choice. 

“Some clinicians may find it quite unpalatable to be potentially compromising on safety or efficacy in the interest of reducing the cost of therapies, but as former Surgeon General C. Everett Koop said, ‘Drugs don’t work in patients who don’t take them,’ ” said Dr. Alexander. “So, if the choice is for someone not to be taking a treatment, or to be taking one that may be a little bit less good, I’ll take the latter.”

Consider the patient’s broader care team. Encourage patients to discuss costs with their other healthcare providers. For patients taking multiple medications, a few adjustments could make a big impact on their wallets. Primary care providers or other specialists might recommend some older and less expensive, but still effective, drugs, such as thiazides for hypertension or metformin for type 2 diabetes. Another option might be to simplify the patient’s regimen or include some fixed-dose combination pills in place of two others.

And if no one has referred the patient to a medical social worker, make the connection. A social worker can put patients in touch with local agencies that can help them with food, housing, and other nonmedical costs. 

Talk about this problem with anyone who will listen. One of the best ways to help patients with rheumatologic diseases is to ensure that decision-makers don’t overlook them. Professional societies such as the American College of Rheumatology can be great resources for advocacy in Washington, DC. Political movements can make drugs more affordable — for example, insulin prices have dropped in recent years because of political pressure, said Dr. Goodman.

“A lot of our national policy now focuses on aiding patients with single high-cost events, but we hope studies like these can really get policymakers to think through how to better support patients with chronic conditions that may have been historically ignored, such as patients with rheumatologic disease,” said Dr. Amen. 

The first step is raising awareness and telling your story. “As providers, we are often [at the] forefront in witnessing how chronic conditions and their associated costs can negatively affect patients’ lives and even alter clinical outcomes,” Dr. Amen added. “By publishing data and sharing meaningful patient stories and clinical vignettes, we can begin to advocate and humanize these patients to policymakers.” 

Information on study funding was not available. All authors reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

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Many patients struggle with healthcare costs and basic expenses, according to new research.

People with rheumatologic diseases often experience a hidden symptom: financial toxicity or significant economic strain from out-of-pocket costs. A new study of 41,502 patients published in JCR: Journal of Clinical Rheumatology showed that 20% of those with rheumatologic diseases faced financial hardship from medical expenses, with 55% of those unable to pay their bills. 

Compared with patients who do not have rheumatologic diseases, and after clinical and sociodemographic factors were controlled for, patients with rheumatologic diseases were:

  • 29% more likely to have high levels of financial hardship — difficulty paying; needing to pay over time; or inability to pay bills for doctors, dentists, hospitals, therapists, medication, equipment, nursing homes, or home care.
  • 53% more likely to have high levels of financial distress — significant worry about having enough money for retirement, paying medical costs in the event of a serious illness or accident, maintaining their standard of living, paying their usual healthcare costs, and affording their normal monthly bills and housing costs.
  • 29% more likely to experience food insecurity, defined as limited or uncertain access to adequate food.
  • 58% more likely to report cost-related medication nonadherence — skipping doses, taking less medication, or delaying filling a prescription to save money.

People who were younger than 64 years, male, Black, or uninsured had higher odds of experiencing financial hardship, financial distress, food insecurity, and cost-related medication nonadherence. 

This study highlights “just how costly everyday rheumatologic conditions can be for your average American,” said lead study author Troy Amen, MD, MBA, an orthopedic surgery resident at the Hospital for Special Surgery in New York City. These diseases can be disabling, limiting a patient’s ability to work at the very time when expensive medications are needed. 

“It’s critical for clinicians to recognize how common the financial burden from healthcare costs can be, and only then can they take steps to better support patients,” said G. Caleb Alexander, MD, MS, professor of epidemiology at Johns Hopkins University in Baltimore, who was not involved in the study. 

Here’s how healthcare providers can help. 

Consider skipped medication a red flag. It’s often the first sign of a financial concern. “Sometimes with these problems, it looks like simple medication noncompliance, but it’s really a more complex form of nonadherence,” said Susan M. Goodman, MD, professor of clinical medicine at Weill Cornell Medicine in New York City and a coauthor of the study. “And I think if someone’s not taking the medication that had been very helpful, it does behoove the physician to try and figure out why that is.”

Normalize the issue to help patients open up. “I will often say, ‘You know, many, many patients don’t take their medicines exactly as prescribed. About how many days a week do you take this medicine?’” said Dr. Alexander. “If you ask in a nonconfrontational, supportive manner, I’ve found that patients are quite candid.” 

Don’t assume insurance has it covered. If patients are uninsured, help them enroll in (or renew) insurance coverage. But don’t assume insurance will solve the whole problem. “There are many people who, although they do have coverage, still can’t afford their medications,” said Dr. Goodman.

For products on high formulary tiers, the patient’s monthly cost can be hundreds to thousands of dollars. “Over the past 10-20 years, we’ve seen remarkable technological innovation in the types of medicines being brought to market, and here, I’m referring primarily to biologics and medicines made from living cells,” said Dr. Alexander, “but many of these have a price tag that is simply astronomical, and insurers aren’t going to bear the brunt of these costs alone.” 

Biosimilars can be a bit more affordable, but “the dirty little secret of biosimilars is that they’re not really very much less expensive,” said Dr. Goodman. “If your patient is doing well on a drug that gets dropped from their insurance plan’s formulary, or if they switch to a plan that doesn’t cover it, try calling and advocating for an exception. It’s an uphill battle, but it sometimes works,” she said.

If not? Help your patients apply for a patient assistance program. Many drug manufacturers offer copay assistance through their websites, and nonprofit patient assistance organizations such as the PAN Foundation, the Patient Advocate Foundation’s Co-Pay Relief Program, or The Assistance Fund can also help fill the gaps. One study published in the Journal of Managed Care and Specialty Pharmacy showed that in patients with rheumatoid arthritis, copay assistance was associated with 79% lower odds of prescription abandonment (failure to fill within 30 days of health plan approval).

Beware of “shiny penny syndrome.” It’s easy to get excited about new, innovative medications, especially when sales reps provide plenty of free samples. “There is a tendency to treat every new medicine as if it’s a bright shiny object in the streambed, and you know that’s not always the case,” said Dr. Alexander. “So, I think we have to be careful, especially in settings when we’re talking about ultra–high-cost medicines, that we’re aware of the burden these medicines may place on patients and that we’re navigating that with patients together, and not simply leaving that as a conversation that never happens in the exam room.”

Maybe there’s an older, time-tested drug that works just as well as the newer, more expensive one. Perhaps there is a slightly less effective medicine that costs a lot less. “These are cost–quality trade-offs that clinicians and patients should be navigating together,” said Dr. Alexander. For example, in a patient with rheumatoid arthritis, a tumor necrosis factor alpha inhibitor might work similarly to or almost as well as an interleukin inhibitor, the newer and typically more expensive choice. 

“Some clinicians may find it quite unpalatable to be potentially compromising on safety or efficacy in the interest of reducing the cost of therapies, but as former Surgeon General C. Everett Koop said, ‘Drugs don’t work in patients who don’t take them,’ ” said Dr. Alexander. “So, if the choice is for someone not to be taking a treatment, or to be taking one that may be a little bit less good, I’ll take the latter.”

Consider the patient’s broader care team. Encourage patients to discuss costs with their other healthcare providers. For patients taking multiple medications, a few adjustments could make a big impact on their wallets. Primary care providers or other specialists might recommend some older and less expensive, but still effective, drugs, such as thiazides for hypertension or metformin for type 2 diabetes. Another option might be to simplify the patient’s regimen or include some fixed-dose combination pills in place of two others.

And if no one has referred the patient to a medical social worker, make the connection. A social worker can put patients in touch with local agencies that can help them with food, housing, and other nonmedical costs. 

Talk about this problem with anyone who will listen. One of the best ways to help patients with rheumatologic diseases is to ensure that decision-makers don’t overlook them. Professional societies such as the American College of Rheumatology can be great resources for advocacy in Washington, DC. Political movements can make drugs more affordable — for example, insulin prices have dropped in recent years because of political pressure, said Dr. Goodman.

“A lot of our national policy now focuses on aiding patients with single high-cost events, but we hope studies like these can really get policymakers to think through how to better support patients with chronic conditions that may have been historically ignored, such as patients with rheumatologic disease,” said Dr. Amen. 

The first step is raising awareness and telling your story. “As providers, we are often [at the] forefront in witnessing how chronic conditions and their associated costs can negatively affect patients’ lives and even alter clinical outcomes,” Dr. Amen added. “By publishing data and sharing meaningful patient stories and clinical vignettes, we can begin to advocate and humanize these patients to policymakers.” 

Information on study funding was not available. All authors reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

Many patients struggle with healthcare costs and basic expenses, according to new research.

People with rheumatologic diseases often experience a hidden symptom: financial toxicity or significant economic strain from out-of-pocket costs. A new study of 41,502 patients published in JCR: Journal of Clinical Rheumatology showed that 20% of those with rheumatologic diseases faced financial hardship from medical expenses, with 55% of those unable to pay their bills. 

Compared with patients who do not have rheumatologic diseases, and after clinical and sociodemographic factors were controlled for, patients with rheumatologic diseases were:

  • 29% more likely to have high levels of financial hardship — difficulty paying; needing to pay over time; or inability to pay bills for doctors, dentists, hospitals, therapists, medication, equipment, nursing homes, or home care.
  • 53% more likely to have high levels of financial distress — significant worry about having enough money for retirement, paying medical costs in the event of a serious illness or accident, maintaining their standard of living, paying their usual healthcare costs, and affording their normal monthly bills and housing costs.
  • 29% more likely to experience food insecurity, defined as limited or uncertain access to adequate food.
  • 58% more likely to report cost-related medication nonadherence — skipping doses, taking less medication, or delaying filling a prescription to save money.

People who were younger than 64 years, male, Black, or uninsured had higher odds of experiencing financial hardship, financial distress, food insecurity, and cost-related medication nonadherence. 

This study highlights “just how costly everyday rheumatologic conditions can be for your average American,” said lead study author Troy Amen, MD, MBA, an orthopedic surgery resident at the Hospital for Special Surgery in New York City. These diseases can be disabling, limiting a patient’s ability to work at the very time when expensive medications are needed. 

“It’s critical for clinicians to recognize how common the financial burden from healthcare costs can be, and only then can they take steps to better support patients,” said G. Caleb Alexander, MD, MS, professor of epidemiology at Johns Hopkins University in Baltimore, who was not involved in the study. 

Here’s how healthcare providers can help. 

Consider skipped medication a red flag. It’s often the first sign of a financial concern. “Sometimes with these problems, it looks like simple medication noncompliance, but it’s really a more complex form of nonadherence,” said Susan M. Goodman, MD, professor of clinical medicine at Weill Cornell Medicine in New York City and a coauthor of the study. “And I think if someone’s not taking the medication that had been very helpful, it does behoove the physician to try and figure out why that is.”

Normalize the issue to help patients open up. “I will often say, ‘You know, many, many patients don’t take their medicines exactly as prescribed. About how many days a week do you take this medicine?’” said Dr. Alexander. “If you ask in a nonconfrontational, supportive manner, I’ve found that patients are quite candid.” 

Don’t assume insurance has it covered. If patients are uninsured, help them enroll in (or renew) insurance coverage. But don’t assume insurance will solve the whole problem. “There are many people who, although they do have coverage, still can’t afford their medications,” said Dr. Goodman.

For products on high formulary tiers, the patient’s monthly cost can be hundreds to thousands of dollars. “Over the past 10-20 years, we’ve seen remarkable technological innovation in the types of medicines being brought to market, and here, I’m referring primarily to biologics and medicines made from living cells,” said Dr. Alexander, “but many of these have a price tag that is simply astronomical, and insurers aren’t going to bear the brunt of these costs alone.” 

Biosimilars can be a bit more affordable, but “the dirty little secret of biosimilars is that they’re not really very much less expensive,” said Dr. Goodman. “If your patient is doing well on a drug that gets dropped from their insurance plan’s formulary, or if they switch to a plan that doesn’t cover it, try calling and advocating for an exception. It’s an uphill battle, but it sometimes works,” she said.

If not? Help your patients apply for a patient assistance program. Many drug manufacturers offer copay assistance through their websites, and nonprofit patient assistance organizations such as the PAN Foundation, the Patient Advocate Foundation’s Co-Pay Relief Program, or The Assistance Fund can also help fill the gaps. One study published in the Journal of Managed Care and Specialty Pharmacy showed that in patients with rheumatoid arthritis, copay assistance was associated with 79% lower odds of prescription abandonment (failure to fill within 30 days of health plan approval).

Beware of “shiny penny syndrome.” It’s easy to get excited about new, innovative medications, especially when sales reps provide plenty of free samples. “There is a tendency to treat every new medicine as if it’s a bright shiny object in the streambed, and you know that’s not always the case,” said Dr. Alexander. “So, I think we have to be careful, especially in settings when we’re talking about ultra–high-cost medicines, that we’re aware of the burden these medicines may place on patients and that we’re navigating that with patients together, and not simply leaving that as a conversation that never happens in the exam room.”

Maybe there’s an older, time-tested drug that works just as well as the newer, more expensive one. Perhaps there is a slightly less effective medicine that costs a lot less. “These are cost–quality trade-offs that clinicians and patients should be navigating together,” said Dr. Alexander. For example, in a patient with rheumatoid arthritis, a tumor necrosis factor alpha inhibitor might work similarly to or almost as well as an interleukin inhibitor, the newer and typically more expensive choice. 

“Some clinicians may find it quite unpalatable to be potentially compromising on safety or efficacy in the interest of reducing the cost of therapies, but as former Surgeon General C. Everett Koop said, ‘Drugs don’t work in patients who don’t take them,’ ” said Dr. Alexander. “So, if the choice is for someone not to be taking a treatment, or to be taking one that may be a little bit less good, I’ll take the latter.”

Consider the patient’s broader care team. Encourage patients to discuss costs with their other healthcare providers. For patients taking multiple medications, a few adjustments could make a big impact on their wallets. Primary care providers or other specialists might recommend some older and less expensive, but still effective, drugs, such as thiazides for hypertension or metformin for type 2 diabetes. Another option might be to simplify the patient’s regimen or include some fixed-dose combination pills in place of two others.

And if no one has referred the patient to a medical social worker, make the connection. A social worker can put patients in touch with local agencies that can help them with food, housing, and other nonmedical costs. 

Talk about this problem with anyone who will listen. One of the best ways to help patients with rheumatologic diseases is to ensure that decision-makers don’t overlook them. Professional societies such as the American College of Rheumatology can be great resources for advocacy in Washington, DC. Political movements can make drugs more affordable — for example, insulin prices have dropped in recent years because of political pressure, said Dr. Goodman.

“A lot of our national policy now focuses on aiding patients with single high-cost events, but we hope studies like these can really get policymakers to think through how to better support patients with chronic conditions that may have been historically ignored, such as patients with rheumatologic disease,” said Dr. Amen. 

The first step is raising awareness and telling your story. “As providers, we are often [at the] forefront in witnessing how chronic conditions and their associated costs can negatively affect patients’ lives and even alter clinical outcomes,” Dr. Amen added. “By publishing data and sharing meaningful patient stories and clinical vignettes, we can begin to advocate and humanize these patients to policymakers.” 

Information on study funding was not available. All authors reported no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

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Recurrent Monoarthritis: Does Microwave Ablation Help?

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Tue, 07/23/2024 - 16:16

 

TOPLINE:

Microwave ablation reduces synovial hypertrophy, the number of monoarthritis attacks, and the need for intra-articular aspiration (IAA) in patients with recurrent monoarthritis, significantly improving functional disability and pain scores.

METHODOLOGY:

  • Researchers conducted a prospective study to assess the long-term effects of microwave ablation as adjunct therapy in patients with various rheumatic diseases and recurrent monoarthritis resistant to medical treatment.
  • Overall, 24 knee joints of 22 patients (10 women; 12 men; median age, 37 years) with recurrent monoarthritis were included.
  • Microwave ablation (15 or 20 W) was performed until microbubbles indicating coagulation necrosis were observed.
  • Patients underwent clinical and radiologic follow-up at 2 weeks and at 1, 3, 6, and 12 months post procedure.
  • Clinical follow-up included monitoring for remission or recurrence of monoarthritis and any complications.

TAKEAWAY:

  • Microwave ablation significantly reduced the IAA count in the last 6 months before ablation from 129 (144 months total) to 7 in a total of 226 months post ablation (P < .001).
  • Functional disability and pain scores improved significantly after microwave ablation, with median scores dropping from 9 to 1 (both P < .0001).
  • No complications were observed during the procedure or follow-up, indicating the safety of microwave ablation.
  • MRI findings showed a significant regression in synovial hypertrophy at 6 months post microwave ablation.

IN PRACTICE:

“Reducing the volume of intractable synovial hypertrophy by shrinking and inactivating with heat-based degradation by MWA [microwave ablation] makes it possible to avoid more systemic treatments or invasive approach and their possible side effects,” the authors wrote.

SOURCE:

The study was led by Rabia Deniz, MD, Department of Rheumatology, University of Health Sciences Başakşehir Çam and Sakura City Hospital in Istanbul, Turkey. It was published online in Rheumatology.

LIMITATIONS:

The relatively small sample size and enrollment of patients with heterogeneous severity and diagnosis of rheumatic diseases may limit the generalizability of the findings. Patient noncompliance with medical treatment and additional mechanical trauma to the targeted joints may have resulted in follow-up problems. The semiobjective evaluation of the ultrasonography and MRI findings with regard to the synovial hypertrophy volume was another limitation.

DISCLOSURES:

The study did not receive any specific funding. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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TOPLINE:

Microwave ablation reduces synovial hypertrophy, the number of monoarthritis attacks, and the need for intra-articular aspiration (IAA) in patients with recurrent monoarthritis, significantly improving functional disability and pain scores.

METHODOLOGY:

  • Researchers conducted a prospective study to assess the long-term effects of microwave ablation as adjunct therapy in patients with various rheumatic diseases and recurrent monoarthritis resistant to medical treatment.
  • Overall, 24 knee joints of 22 patients (10 women; 12 men; median age, 37 years) with recurrent monoarthritis were included.
  • Microwave ablation (15 or 20 W) was performed until microbubbles indicating coagulation necrosis were observed.
  • Patients underwent clinical and radiologic follow-up at 2 weeks and at 1, 3, 6, and 12 months post procedure.
  • Clinical follow-up included monitoring for remission or recurrence of monoarthritis and any complications.

TAKEAWAY:

  • Microwave ablation significantly reduced the IAA count in the last 6 months before ablation from 129 (144 months total) to 7 in a total of 226 months post ablation (P < .001).
  • Functional disability and pain scores improved significantly after microwave ablation, with median scores dropping from 9 to 1 (both P < .0001).
  • No complications were observed during the procedure or follow-up, indicating the safety of microwave ablation.
  • MRI findings showed a significant regression in synovial hypertrophy at 6 months post microwave ablation.

IN PRACTICE:

“Reducing the volume of intractable synovial hypertrophy by shrinking and inactivating with heat-based degradation by MWA [microwave ablation] makes it possible to avoid more systemic treatments or invasive approach and their possible side effects,” the authors wrote.

SOURCE:

The study was led by Rabia Deniz, MD, Department of Rheumatology, University of Health Sciences Başakşehir Çam and Sakura City Hospital in Istanbul, Turkey. It was published online in Rheumatology.

LIMITATIONS:

The relatively small sample size and enrollment of patients with heterogeneous severity and diagnosis of rheumatic diseases may limit the generalizability of the findings. Patient noncompliance with medical treatment and additional mechanical trauma to the targeted joints may have resulted in follow-up problems. The semiobjective evaluation of the ultrasonography and MRI findings with regard to the synovial hypertrophy volume was another limitation.

DISCLOSURES:

The study did not receive any specific funding. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

 

TOPLINE:

Microwave ablation reduces synovial hypertrophy, the number of monoarthritis attacks, and the need for intra-articular aspiration (IAA) in patients with recurrent monoarthritis, significantly improving functional disability and pain scores.

METHODOLOGY:

  • Researchers conducted a prospective study to assess the long-term effects of microwave ablation as adjunct therapy in patients with various rheumatic diseases and recurrent monoarthritis resistant to medical treatment.
  • Overall, 24 knee joints of 22 patients (10 women; 12 men; median age, 37 years) with recurrent monoarthritis were included.
  • Microwave ablation (15 or 20 W) was performed until microbubbles indicating coagulation necrosis were observed.
  • Patients underwent clinical and radiologic follow-up at 2 weeks and at 1, 3, 6, and 12 months post procedure.
  • Clinical follow-up included monitoring for remission or recurrence of monoarthritis and any complications.

TAKEAWAY:

  • Microwave ablation significantly reduced the IAA count in the last 6 months before ablation from 129 (144 months total) to 7 in a total of 226 months post ablation (P < .001).
  • Functional disability and pain scores improved significantly after microwave ablation, with median scores dropping from 9 to 1 (both P < .0001).
  • No complications were observed during the procedure or follow-up, indicating the safety of microwave ablation.
  • MRI findings showed a significant regression in synovial hypertrophy at 6 months post microwave ablation.

IN PRACTICE:

“Reducing the volume of intractable synovial hypertrophy by shrinking and inactivating with heat-based degradation by MWA [microwave ablation] makes it possible to avoid more systemic treatments or invasive approach and their possible side effects,” the authors wrote.

SOURCE:

The study was led by Rabia Deniz, MD, Department of Rheumatology, University of Health Sciences Başakşehir Çam and Sakura City Hospital in Istanbul, Turkey. It was published online in Rheumatology.

LIMITATIONS:

The relatively small sample size and enrollment of patients with heterogeneous severity and diagnosis of rheumatic diseases may limit the generalizability of the findings. Patient noncompliance with medical treatment and additional mechanical trauma to the targeted joints may have resulted in follow-up problems. The semiobjective evaluation of the ultrasonography and MRI findings with regard to the synovial hypertrophy volume was another limitation.

DISCLOSURES:

The study did not receive any specific funding. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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Debate: Should Dermatologists or Rheumatologists Manage Musculoskeletal Symptoms in Patients With Psoriasis?

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Changed
Tue, 07/23/2024 - 09:27

Musculoskeletal (MSK) symptoms are common in patients with psoriasis, but should they be primarily handled by dermatologists or should rheumatologists be “in the driver’s seat?” That was the subject of a debate between a dermatologist and a rheumatologist at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

Fabian Proft, MD, the rheumatologist, spoke first and emphasized the potential that MSK symptoms are a sign of psoriatic arthritis (PsA) and therefore should be managed by a rheumatologist.

“Obviously, the rheumatologist perspective [is that] I should be in the driver’s seat when taking care of patient with psoriasis and MSK symptoms, but I will still need to have a copilot there: [The dermatologist] will have a slot,” said Dr. Proft, who is a rheumatologist at Charité — Universitätsmedizin Berlin.

“It’s so important that we make the correct and early diagnosis of [psoriatic arthritis and psoriasis] symptoms,” said Dr. Proft. He specifically called out cases where patients have symptoms that are difficult to determine, whether the cause is inflammatory, and when experience with imaging can be a key factor in the diagnosis.

It’s important not to overdiagnose or overtreat patients, he said, providing an example of a patient with psoriasis who had been training for a marathon. The MRI image suggested that his Achilles tendonitis pain was related to his athletic training, not PsA-associated inflammation. “So I think this is very important that you have the knowledge to read MRIs, and especially also carefully assessing them so as not to overdiagnose patients,” said Dr. Proft.

Dermatologist Rebuttal

In her rebuttal, Laura Savage, MD, PhD, emphasized the need for more of a coequal partnership between the two specialties because of the ability of dermatologists to intervene early in the treatment and prevention of PsA.

“Traditionally, I agree rheumatologists would solely be responsible for the assessment and the management of psoriatic arthritis, but I think that paradigm has shifted in part due to the increased recognition of the need for earlier intervention to limit disease progression and to reduce or even prevent functional limitation,” said Dr. Savage, who is a consultant dermatologist at Leeds Teaching Hospitals NHS Trust and a senior lecturer at the University of Leeds, Leeds, England.

Ideally, molecular biomarkers would be available to predict the development of PsA, but there aren’t any. Still, “we have a huge biomarker in the form of the skin, and it’s recognized that the majority of patients who will develop psoriatic arthritis will have antecedent psoriasis in about 70% of cases,” Dr. Savage said. “There’s a typical time delay of around 7-12 years between the onset of the skin [disease] and the patients developing psoriatic arthritis, and so many of them are going to be into the care of other healthcare practitioners, and particularly the care of dermatologists.”

Dermatologists may also be able to play a role in the prevention of PsA, according to Dr. Savage. In one retrospective study, treatment of skin lesions with biologics was associated with a reduced frequency of progression to PsA (11.1% vs 16.4%) over 10 years (P = .0006). Studies with tumor necrosis factor inhibitors and other interventions have shown similar results.

Such findings have led to the treat intercept strategy, which targets patients with psoriasis who have risk factors for transition to PsA — such as nail pitting, gluteal cleft disease, scalp disease, type 2 diabetes, obesity, and a first-degree relative with PsA — as well as symptoms of prodromal PSA, such as arthralgia and fatigue.

“I think dermatologists are aware of the need to not leave our patients languishing on these therapies and actually escalating them onto effective treatments that may also be able to treat early psoriatic arthritis. We could be more mindful about our choice of treatments for these patients, going on to thinking about their increased risk of PSA and trying to intercept,” Dr. Savage said. “What we don’t want is our patients to be developing these musculoskeletal symptoms of pain and stiffness and functional limitation and disability. We want to be treating the patients with musculoskeletal symptoms of that earlier prodromal phase when they’re developing arthralgia and fatigue.”

She conceded that more complicated patients are good candidates for care by the rheumatologist. “You can do your fancy imaging, and we’ll leave that to you, and the difficult-to-treat patients to [the rheumatologist], but actually we need to just get on and treat them,” she said. “One could argue as well that as a dermatologist, I’m likely to broaden my horizons in terms of choice of therapy and treat all of the domains of the patient. So I would argue that actually it should be the dermatologist who is in that driving seat, particularly when it comes to the management of early psoriatic arthritis, and actually what we should be doing is driving our patients and steering them to earlier intervention and better control for all domains of disease.”
 

 

 

Collaborative Care

During the follow-up discussion, both Dr. Proft and Dr. Savage agreed that dermatologists and rheumatologists should be working together in managing patients. “What we need to do is steer our patients toward collaborative care with our rheumatologists by trying to minimize delays to treatment, by working together in parallel clinics, combined clinics, and on virtual [multidisciplinary teams],” said Dr. Savage.

Dr. Proft agreed. “We should join forces and make decisions together.”

Dr. Savage and Dr. Proft did not provide any financial disclosures.

A version of this article appeared on Medscape.com.

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Musculoskeletal (MSK) symptoms are common in patients with psoriasis, but should they be primarily handled by dermatologists or should rheumatologists be “in the driver’s seat?” That was the subject of a debate between a dermatologist and a rheumatologist at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

Fabian Proft, MD, the rheumatologist, spoke first and emphasized the potential that MSK symptoms are a sign of psoriatic arthritis (PsA) and therefore should be managed by a rheumatologist.

“Obviously, the rheumatologist perspective [is that] I should be in the driver’s seat when taking care of patient with psoriasis and MSK symptoms, but I will still need to have a copilot there: [The dermatologist] will have a slot,” said Dr. Proft, who is a rheumatologist at Charité — Universitätsmedizin Berlin.

“It’s so important that we make the correct and early diagnosis of [psoriatic arthritis and psoriasis] symptoms,” said Dr. Proft. He specifically called out cases where patients have symptoms that are difficult to determine, whether the cause is inflammatory, and when experience with imaging can be a key factor in the diagnosis.

It’s important not to overdiagnose or overtreat patients, he said, providing an example of a patient with psoriasis who had been training for a marathon. The MRI image suggested that his Achilles tendonitis pain was related to his athletic training, not PsA-associated inflammation. “So I think this is very important that you have the knowledge to read MRIs, and especially also carefully assessing them so as not to overdiagnose patients,” said Dr. Proft.

Dermatologist Rebuttal

In her rebuttal, Laura Savage, MD, PhD, emphasized the need for more of a coequal partnership between the two specialties because of the ability of dermatologists to intervene early in the treatment and prevention of PsA.

“Traditionally, I agree rheumatologists would solely be responsible for the assessment and the management of psoriatic arthritis, but I think that paradigm has shifted in part due to the increased recognition of the need for earlier intervention to limit disease progression and to reduce or even prevent functional limitation,” said Dr. Savage, who is a consultant dermatologist at Leeds Teaching Hospitals NHS Trust and a senior lecturer at the University of Leeds, Leeds, England.

Ideally, molecular biomarkers would be available to predict the development of PsA, but there aren’t any. Still, “we have a huge biomarker in the form of the skin, and it’s recognized that the majority of patients who will develop psoriatic arthritis will have antecedent psoriasis in about 70% of cases,” Dr. Savage said. “There’s a typical time delay of around 7-12 years between the onset of the skin [disease] and the patients developing psoriatic arthritis, and so many of them are going to be into the care of other healthcare practitioners, and particularly the care of dermatologists.”

Dermatologists may also be able to play a role in the prevention of PsA, according to Dr. Savage. In one retrospective study, treatment of skin lesions with biologics was associated with a reduced frequency of progression to PsA (11.1% vs 16.4%) over 10 years (P = .0006). Studies with tumor necrosis factor inhibitors and other interventions have shown similar results.

Such findings have led to the treat intercept strategy, which targets patients with psoriasis who have risk factors for transition to PsA — such as nail pitting, gluteal cleft disease, scalp disease, type 2 diabetes, obesity, and a first-degree relative with PsA — as well as symptoms of prodromal PSA, such as arthralgia and fatigue.

“I think dermatologists are aware of the need to not leave our patients languishing on these therapies and actually escalating them onto effective treatments that may also be able to treat early psoriatic arthritis. We could be more mindful about our choice of treatments for these patients, going on to thinking about their increased risk of PSA and trying to intercept,” Dr. Savage said. “What we don’t want is our patients to be developing these musculoskeletal symptoms of pain and stiffness and functional limitation and disability. We want to be treating the patients with musculoskeletal symptoms of that earlier prodromal phase when they’re developing arthralgia and fatigue.”

She conceded that more complicated patients are good candidates for care by the rheumatologist. “You can do your fancy imaging, and we’ll leave that to you, and the difficult-to-treat patients to [the rheumatologist], but actually we need to just get on and treat them,” she said. “One could argue as well that as a dermatologist, I’m likely to broaden my horizons in terms of choice of therapy and treat all of the domains of the patient. So I would argue that actually it should be the dermatologist who is in that driving seat, particularly when it comes to the management of early psoriatic arthritis, and actually what we should be doing is driving our patients and steering them to earlier intervention and better control for all domains of disease.”
 

 

 

Collaborative Care

During the follow-up discussion, both Dr. Proft and Dr. Savage agreed that dermatologists and rheumatologists should be working together in managing patients. “What we need to do is steer our patients toward collaborative care with our rheumatologists by trying to minimize delays to treatment, by working together in parallel clinics, combined clinics, and on virtual [multidisciplinary teams],” said Dr. Savage.

Dr. Proft agreed. “We should join forces and make decisions together.”

Dr. Savage and Dr. Proft did not provide any financial disclosures.

A version of this article appeared on Medscape.com.

Musculoskeletal (MSK) symptoms are common in patients with psoriasis, but should they be primarily handled by dermatologists or should rheumatologists be “in the driver’s seat?” That was the subject of a debate between a dermatologist and a rheumatologist at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.

Fabian Proft, MD, the rheumatologist, spoke first and emphasized the potential that MSK symptoms are a sign of psoriatic arthritis (PsA) and therefore should be managed by a rheumatologist.

“Obviously, the rheumatologist perspective [is that] I should be in the driver’s seat when taking care of patient with psoriasis and MSK symptoms, but I will still need to have a copilot there: [The dermatologist] will have a slot,” said Dr. Proft, who is a rheumatologist at Charité — Universitätsmedizin Berlin.

“It’s so important that we make the correct and early diagnosis of [psoriatic arthritis and psoriasis] symptoms,” said Dr. Proft. He specifically called out cases where patients have symptoms that are difficult to determine, whether the cause is inflammatory, and when experience with imaging can be a key factor in the diagnosis.

It’s important not to overdiagnose or overtreat patients, he said, providing an example of a patient with psoriasis who had been training for a marathon. The MRI image suggested that his Achilles tendonitis pain was related to his athletic training, not PsA-associated inflammation. “So I think this is very important that you have the knowledge to read MRIs, and especially also carefully assessing them so as not to overdiagnose patients,” said Dr. Proft.

Dermatologist Rebuttal

In her rebuttal, Laura Savage, MD, PhD, emphasized the need for more of a coequal partnership between the two specialties because of the ability of dermatologists to intervene early in the treatment and prevention of PsA.

“Traditionally, I agree rheumatologists would solely be responsible for the assessment and the management of psoriatic arthritis, but I think that paradigm has shifted in part due to the increased recognition of the need for earlier intervention to limit disease progression and to reduce or even prevent functional limitation,” said Dr. Savage, who is a consultant dermatologist at Leeds Teaching Hospitals NHS Trust and a senior lecturer at the University of Leeds, Leeds, England.

Ideally, molecular biomarkers would be available to predict the development of PsA, but there aren’t any. Still, “we have a huge biomarker in the form of the skin, and it’s recognized that the majority of patients who will develop psoriatic arthritis will have antecedent psoriasis in about 70% of cases,” Dr. Savage said. “There’s a typical time delay of around 7-12 years between the onset of the skin [disease] and the patients developing psoriatic arthritis, and so many of them are going to be into the care of other healthcare practitioners, and particularly the care of dermatologists.”

Dermatologists may also be able to play a role in the prevention of PsA, according to Dr. Savage. In one retrospective study, treatment of skin lesions with biologics was associated with a reduced frequency of progression to PsA (11.1% vs 16.4%) over 10 years (P = .0006). Studies with tumor necrosis factor inhibitors and other interventions have shown similar results.

Such findings have led to the treat intercept strategy, which targets patients with psoriasis who have risk factors for transition to PsA — such as nail pitting, gluteal cleft disease, scalp disease, type 2 diabetes, obesity, and a first-degree relative with PsA — as well as symptoms of prodromal PSA, such as arthralgia and fatigue.

“I think dermatologists are aware of the need to not leave our patients languishing on these therapies and actually escalating them onto effective treatments that may also be able to treat early psoriatic arthritis. We could be more mindful about our choice of treatments for these patients, going on to thinking about their increased risk of PSA and trying to intercept,” Dr. Savage said. “What we don’t want is our patients to be developing these musculoskeletal symptoms of pain and stiffness and functional limitation and disability. We want to be treating the patients with musculoskeletal symptoms of that earlier prodromal phase when they’re developing arthralgia and fatigue.”

She conceded that more complicated patients are good candidates for care by the rheumatologist. “You can do your fancy imaging, and we’ll leave that to you, and the difficult-to-treat patients to [the rheumatologist], but actually we need to just get on and treat them,” she said. “One could argue as well that as a dermatologist, I’m likely to broaden my horizons in terms of choice of therapy and treat all of the domains of the patient. So I would argue that actually it should be the dermatologist who is in that driving seat, particularly when it comes to the management of early psoriatic arthritis, and actually what we should be doing is driving our patients and steering them to earlier intervention and better control for all domains of disease.”
 

 

 

Collaborative Care

During the follow-up discussion, both Dr. Proft and Dr. Savage agreed that dermatologists and rheumatologists should be working together in managing patients. “What we need to do is steer our patients toward collaborative care with our rheumatologists by trying to minimize delays to treatment, by working together in parallel clinics, combined clinics, and on virtual [multidisciplinary teams],” said Dr. Savage.

Dr. Proft agreed. “We should join forces and make decisions together.”

Dr. Savage and Dr. Proft did not provide any financial disclosures.

A version of this article appeared on Medscape.com.

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Debate Over Axial Involvement in Psoriatic Arthritis Still Unresolved Despite New Studies

Article Type
Changed
Tue, 07/02/2024 - 13:45

— While there is no doubt that some people with psoriatic arthritis (PsA) have axial symptoms, data presented at the annual European Congress of Rheumatology do not appear to add much to what is already known about axial PsA or to further the cause of differentiating it from axial spondyloarthritis (axSpA).

In both the AXIS study and Reuma.pt, around one in three patients with PsA were found to have axial involvement. Notably, the percentage of people with axial PsA was found to vary according to how imaging information was interpreted in the AXIS study. Both studies were discussed during the Axial Involvement in PsA and SpA session at EULAR 2024.
 

The One-Million-Dollar Question

“So, the one-million-dollar question: What is it, really?” Philippe Carron, MD, PhD, Ghent University Hospital, Ghent, Belgium, said in the presentation that started the session. Despite PsA being described more than 60 years ago, “we still have no internationally accepted definition or a consensus on how we should define these patients and how we should screen them,” he said.

“There are some believers that it is just a form of axial SpA with concomitant psoriasis, but also some people that think that the axial PsA is a typical disease, with typical characteristics which are different from axial disease,” Dr. Carron said.

The lack of consensus makes it difficult to estimate just how many people have axial PsA. Reported prevalences range from 5% to 70%, “all caused by which criteria that you’re using to define axial involvement,” Dr. Carron added.

There are, however, two things that can be agreed upon, according to Dr. Carron. First, the prevalence of axial involvement in people with early PsA is “much, much lower” than that of more established disease. Second, exclusive axial involvement is seen in “just a minority of PsA patients.” Most people with axial disease also have peripheral disease, he added.

Imaging findings in axial PsA “are quite similar to those seen in axial SpA,” although Dr. Carron also said that there were some distinct differences. Radiographic sacroiliitis occurs in around 25%-50% of people with axial PsA, and atypical syndesmophytes are more often found in people with axial PsA than in those with axSpA.
 

Shared Characteristics

But are axial PsA and axSpA separate diseases or part of the same disease continuum? That’s a question that is still very much open for debate, said Sofia Ramiro, MD, PhD, a senior researcher at Leiden University Medical Center, Leiden, the Netherlands, and rheumatology consultant at Zuyderland Medical Center in Heerlen, the Netherlands.

While many studies have looked to answer this question, there is a big methodological problem — the studies largely cannot be compared as they have used different definitions of axSpA.

Take a patient with inflammatory back pain, psoriasis, and oligoarthritis, Dr. Ramiro said. If the patient goes to one rheumatologist, they may get a diagnosis of axSpA, but if they go to a different rheumatologist, they may get a diagnosis of axial PsA.

“This is influenced by training, expertise, by beliefs, and by belonging to ASAS [Assessment of Spondyloarthritis International Society] or to GRAPPA [Group for Research and Assessment of Psoriasis and Psoriatic Arthritis],” Dr. Ramiro suggested. It’s “a diagnostic bias” that is very difficult to overcome and makes direct comparisons between patient populations recruited into clinical studies “extremely challenging.”

To confuse matters more, axial PsA and axSpA share common characteristics: Inflammatory back pain, HLA-B27 positivity, elevated levels of C-reactive protein (CRP) or a higher erythrocyte sedimentation rate, and structural lesions in the sacroiliac joints and spine.
 

 

 

AXIS Study ‘Gives Answers’

More research into factors associated with axial PsA need to be performed to try to help define the condition and enable classification and ultimately treatment guidelines. This is where the AXIS study comes in.

The AXIS study is a joint project of ASAS and GRAPPA that was started in January 2019 with the aim of defining a homogeneous subgroup of patients who could be studied.

“The objectives of the AXIS study are to determine the frequency of axial involvement in patients with PsA; to identify the frequency of active inflammatory and structural changes on imaging; and to identify factors associated with the presence of axial involvement in PsA,” Murat Torgutalp, MD, of Charité – Universitätsmedizin Berlin, Berlin, Germany, said at EULAR 2024.

The study population consisted of 409 consecutively recruited patients diagnosed with PsA according to CASPAR (Classification for Psoriatic Arthritis) criteria; all have had PsA for up to 10 years and were untreated with biologic or targeted synthetic disease modifying drugs at the time of inclusion.

Dr. Torgutalp, who is the study’s primary research coordinator, reported that a diagnosis of PsA was made in 37% of the population when local investigators considered available clinical, laboratory, and imaging data. However, patients’ imaging data were also centrally assessed, and when the local investigators were party to the expert imaging interpretations, the percentage of people diagnosed with PsA dropped to 27%.

“When we looked at the clinical characteristics, the presence of the back pain, particularly inflammatory back pain, HLA-B27 positivity, elevated CRP, and presence of active, inflammatory and structural changes in the sacroiliac joints and spine were associated with the final conclusion on the presence of axial involvement,” Dr. Torgutalp said.

Despite the title of his presentation being “The Axis Study Gives Answers,” Dr. Torgutalp presented lots of data without giving much insight into how they might be used. He concluded that “overall, there was a trend toward overestimation of the presence of imaging changes indicative of axial involvement across all imaging modalities” by the local investigators.

Dennis McGonagle, MB, MCH, BAO, PhD, of the University of Leeds, Leeds, England,said in an interview that the AXIS study “is a noble, international effort across multiple countries to try and better understand axial PsA.”

Dr. McGonagle, who was not involved in the study, added: “A lot of data are being generated, and a lot of analysis needs to be done to drill down to get a clear message that could influence practice.”
 

Axial PsA in the Portuguese Population

Separately, Catarina Abreu, a rheumatology intern at Hospital Garcia de Orta, Almada, Portugal, presented some real-world data on axial PsA from Reuma.pt.

Of 2304 patients, 854 (37.1%) reportedly had axial PsA, which had been defined as physician-reported spondylitis or the presence of imaging findings suggestive of axial involvement. This included radiographic- or MRI-detected sacroiliitis or syndesmophytes seen on axial x-rays.

The majority (78.2%) of those with an axial PsA diagnosis had concomitant peripheral involvement, with 8.1% having exclusive axial disease.

About 70% of the axial PsA diagnoses had been made using clinical or laboratory findings alone, and 30% of diagnoses was based on imaging results. Of the latter, Ms. Abreu noted that patients who had imaging data available were more likely to be HLA-B27 positive and less likely to have dactylitis, with respective odds ratios (ORs) of 3.10 and 2.42.

Individuals with axial PsA were more likely to have enthesitis (OR, 1.92), although no data were available on whether this was axial or peripheral enthesitis. Tobacco exposure was also linked to an increased chance of having axial PsA (OR, 1.66).

Ms. Abreu noted that the “scarce number of available imaging exams” and other missing data in Reuma.pt may have led to an underdiagnosis of axial PsA.

“The difference that we found between axial and peripheral [PsA] are similar to the differences found in other studies that compared axial psoriatic arthritis with axial spondyloarthritis,” Ms. Abreu said.

“So, we leave with the question that was already left before here: If these are different diseases or just different phenotypes of the same disease, and what implications will this have in the future?” Ms. Abreu concluded.

Dr. Carron received educational grants, speaker fees, or honoraria for other consultancy work from AbbVie, UCB, Pfizer, Eli Lilly, Novartis, Janssen, and Galapagos/Alfasigma. Dr. Ramiro is an ASAS executive committee member and received research grants or consulting/speaker fees from AbbVie, Eli Lilly, Galapagos, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Sanofi, and UCB. AXIS is supported by unrestricted research grants from AbbVie, Galapagos, Janssen, Eli Lilly, Novartis, Pfizer, and UCB. Dr. Torgutalp is the primary research coordinator for the study; he reported no financial conflicts of interest. The Reuma.pt registry was developed with the financial support of the pharmaceutical industry and is currently supported by AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Merck Sharp and Dohme, Novartis, Pfizer, and Sobi. Ms. Abreu reported no financial conflicts of interest.

A version of this article appeared on Medscape.com.

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— While there is no doubt that some people with psoriatic arthritis (PsA) have axial symptoms, data presented at the annual European Congress of Rheumatology do not appear to add much to what is already known about axial PsA or to further the cause of differentiating it from axial spondyloarthritis (axSpA).

In both the AXIS study and Reuma.pt, around one in three patients with PsA were found to have axial involvement. Notably, the percentage of people with axial PsA was found to vary according to how imaging information was interpreted in the AXIS study. Both studies were discussed during the Axial Involvement in PsA and SpA session at EULAR 2024.
 

The One-Million-Dollar Question

“So, the one-million-dollar question: What is it, really?” Philippe Carron, MD, PhD, Ghent University Hospital, Ghent, Belgium, said in the presentation that started the session. Despite PsA being described more than 60 years ago, “we still have no internationally accepted definition or a consensus on how we should define these patients and how we should screen them,” he said.

“There are some believers that it is just a form of axial SpA with concomitant psoriasis, but also some people that think that the axial PsA is a typical disease, with typical characteristics which are different from axial disease,” Dr. Carron said.

The lack of consensus makes it difficult to estimate just how many people have axial PsA. Reported prevalences range from 5% to 70%, “all caused by which criteria that you’re using to define axial involvement,” Dr. Carron added.

There are, however, two things that can be agreed upon, according to Dr. Carron. First, the prevalence of axial involvement in people with early PsA is “much, much lower” than that of more established disease. Second, exclusive axial involvement is seen in “just a minority of PsA patients.” Most people with axial disease also have peripheral disease, he added.

Imaging findings in axial PsA “are quite similar to those seen in axial SpA,” although Dr. Carron also said that there were some distinct differences. Radiographic sacroiliitis occurs in around 25%-50% of people with axial PsA, and atypical syndesmophytes are more often found in people with axial PsA than in those with axSpA.
 

Shared Characteristics

But are axial PsA and axSpA separate diseases or part of the same disease continuum? That’s a question that is still very much open for debate, said Sofia Ramiro, MD, PhD, a senior researcher at Leiden University Medical Center, Leiden, the Netherlands, and rheumatology consultant at Zuyderland Medical Center in Heerlen, the Netherlands.

While many studies have looked to answer this question, there is a big methodological problem — the studies largely cannot be compared as they have used different definitions of axSpA.

Take a patient with inflammatory back pain, psoriasis, and oligoarthritis, Dr. Ramiro said. If the patient goes to one rheumatologist, they may get a diagnosis of axSpA, but if they go to a different rheumatologist, they may get a diagnosis of axial PsA.

“This is influenced by training, expertise, by beliefs, and by belonging to ASAS [Assessment of Spondyloarthritis International Society] or to GRAPPA [Group for Research and Assessment of Psoriasis and Psoriatic Arthritis],” Dr. Ramiro suggested. It’s “a diagnostic bias” that is very difficult to overcome and makes direct comparisons between patient populations recruited into clinical studies “extremely challenging.”

To confuse matters more, axial PsA and axSpA share common characteristics: Inflammatory back pain, HLA-B27 positivity, elevated levels of C-reactive protein (CRP) or a higher erythrocyte sedimentation rate, and structural lesions in the sacroiliac joints and spine.
 

 

 

AXIS Study ‘Gives Answers’

More research into factors associated with axial PsA need to be performed to try to help define the condition and enable classification and ultimately treatment guidelines. This is where the AXIS study comes in.

The AXIS study is a joint project of ASAS and GRAPPA that was started in January 2019 with the aim of defining a homogeneous subgroup of patients who could be studied.

“The objectives of the AXIS study are to determine the frequency of axial involvement in patients with PsA; to identify the frequency of active inflammatory and structural changes on imaging; and to identify factors associated with the presence of axial involvement in PsA,” Murat Torgutalp, MD, of Charité – Universitätsmedizin Berlin, Berlin, Germany, said at EULAR 2024.

The study population consisted of 409 consecutively recruited patients diagnosed with PsA according to CASPAR (Classification for Psoriatic Arthritis) criteria; all have had PsA for up to 10 years and were untreated with biologic or targeted synthetic disease modifying drugs at the time of inclusion.

Dr. Torgutalp, who is the study’s primary research coordinator, reported that a diagnosis of PsA was made in 37% of the population when local investigators considered available clinical, laboratory, and imaging data. However, patients’ imaging data were also centrally assessed, and when the local investigators were party to the expert imaging interpretations, the percentage of people diagnosed with PsA dropped to 27%.

“When we looked at the clinical characteristics, the presence of the back pain, particularly inflammatory back pain, HLA-B27 positivity, elevated CRP, and presence of active, inflammatory and structural changes in the sacroiliac joints and spine were associated with the final conclusion on the presence of axial involvement,” Dr. Torgutalp said.

Despite the title of his presentation being “The Axis Study Gives Answers,” Dr. Torgutalp presented lots of data without giving much insight into how they might be used. He concluded that “overall, there was a trend toward overestimation of the presence of imaging changes indicative of axial involvement across all imaging modalities” by the local investigators.

Dennis McGonagle, MB, MCH, BAO, PhD, of the University of Leeds, Leeds, England,said in an interview that the AXIS study “is a noble, international effort across multiple countries to try and better understand axial PsA.”

Dr. McGonagle, who was not involved in the study, added: “A lot of data are being generated, and a lot of analysis needs to be done to drill down to get a clear message that could influence practice.”
 

Axial PsA in the Portuguese Population

Separately, Catarina Abreu, a rheumatology intern at Hospital Garcia de Orta, Almada, Portugal, presented some real-world data on axial PsA from Reuma.pt.

Of 2304 patients, 854 (37.1%) reportedly had axial PsA, which had been defined as physician-reported spondylitis or the presence of imaging findings suggestive of axial involvement. This included radiographic- or MRI-detected sacroiliitis or syndesmophytes seen on axial x-rays.

The majority (78.2%) of those with an axial PsA diagnosis had concomitant peripheral involvement, with 8.1% having exclusive axial disease.

About 70% of the axial PsA diagnoses had been made using clinical or laboratory findings alone, and 30% of diagnoses was based on imaging results. Of the latter, Ms. Abreu noted that patients who had imaging data available were more likely to be HLA-B27 positive and less likely to have dactylitis, with respective odds ratios (ORs) of 3.10 and 2.42.

Individuals with axial PsA were more likely to have enthesitis (OR, 1.92), although no data were available on whether this was axial or peripheral enthesitis. Tobacco exposure was also linked to an increased chance of having axial PsA (OR, 1.66).

Ms. Abreu noted that the “scarce number of available imaging exams” and other missing data in Reuma.pt may have led to an underdiagnosis of axial PsA.

“The difference that we found between axial and peripheral [PsA] are similar to the differences found in other studies that compared axial psoriatic arthritis with axial spondyloarthritis,” Ms. Abreu said.

“So, we leave with the question that was already left before here: If these are different diseases or just different phenotypes of the same disease, and what implications will this have in the future?” Ms. Abreu concluded.

Dr. Carron received educational grants, speaker fees, or honoraria for other consultancy work from AbbVie, UCB, Pfizer, Eli Lilly, Novartis, Janssen, and Galapagos/Alfasigma. Dr. Ramiro is an ASAS executive committee member and received research grants or consulting/speaker fees from AbbVie, Eli Lilly, Galapagos, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Sanofi, and UCB. AXIS is supported by unrestricted research grants from AbbVie, Galapagos, Janssen, Eli Lilly, Novartis, Pfizer, and UCB. Dr. Torgutalp is the primary research coordinator for the study; he reported no financial conflicts of interest. The Reuma.pt registry was developed with the financial support of the pharmaceutical industry and is currently supported by AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Merck Sharp and Dohme, Novartis, Pfizer, and Sobi. Ms. Abreu reported no financial conflicts of interest.

A version of this article appeared on Medscape.com.

— While there is no doubt that some people with psoriatic arthritis (PsA) have axial symptoms, data presented at the annual European Congress of Rheumatology do not appear to add much to what is already known about axial PsA or to further the cause of differentiating it from axial spondyloarthritis (axSpA).

In both the AXIS study and Reuma.pt, around one in three patients with PsA were found to have axial involvement. Notably, the percentage of people with axial PsA was found to vary according to how imaging information was interpreted in the AXIS study. Both studies were discussed during the Axial Involvement in PsA and SpA session at EULAR 2024.
 

The One-Million-Dollar Question

“So, the one-million-dollar question: What is it, really?” Philippe Carron, MD, PhD, Ghent University Hospital, Ghent, Belgium, said in the presentation that started the session. Despite PsA being described more than 60 years ago, “we still have no internationally accepted definition or a consensus on how we should define these patients and how we should screen them,” he said.

“There are some believers that it is just a form of axial SpA with concomitant psoriasis, but also some people that think that the axial PsA is a typical disease, with typical characteristics which are different from axial disease,” Dr. Carron said.

The lack of consensus makes it difficult to estimate just how many people have axial PsA. Reported prevalences range from 5% to 70%, “all caused by which criteria that you’re using to define axial involvement,” Dr. Carron added.

There are, however, two things that can be agreed upon, according to Dr. Carron. First, the prevalence of axial involvement in people with early PsA is “much, much lower” than that of more established disease. Second, exclusive axial involvement is seen in “just a minority of PsA patients.” Most people with axial disease also have peripheral disease, he added.

Imaging findings in axial PsA “are quite similar to those seen in axial SpA,” although Dr. Carron also said that there were some distinct differences. Radiographic sacroiliitis occurs in around 25%-50% of people with axial PsA, and atypical syndesmophytes are more often found in people with axial PsA than in those with axSpA.
 

Shared Characteristics

But are axial PsA and axSpA separate diseases or part of the same disease continuum? That’s a question that is still very much open for debate, said Sofia Ramiro, MD, PhD, a senior researcher at Leiden University Medical Center, Leiden, the Netherlands, and rheumatology consultant at Zuyderland Medical Center in Heerlen, the Netherlands.

While many studies have looked to answer this question, there is a big methodological problem — the studies largely cannot be compared as they have used different definitions of axSpA.

Take a patient with inflammatory back pain, psoriasis, and oligoarthritis, Dr. Ramiro said. If the patient goes to one rheumatologist, they may get a diagnosis of axSpA, but if they go to a different rheumatologist, they may get a diagnosis of axial PsA.

“This is influenced by training, expertise, by beliefs, and by belonging to ASAS [Assessment of Spondyloarthritis International Society] or to GRAPPA [Group for Research and Assessment of Psoriasis and Psoriatic Arthritis],” Dr. Ramiro suggested. It’s “a diagnostic bias” that is very difficult to overcome and makes direct comparisons between patient populations recruited into clinical studies “extremely challenging.”

To confuse matters more, axial PsA and axSpA share common characteristics: Inflammatory back pain, HLA-B27 positivity, elevated levels of C-reactive protein (CRP) or a higher erythrocyte sedimentation rate, and structural lesions in the sacroiliac joints and spine.
 

 

 

AXIS Study ‘Gives Answers’

More research into factors associated with axial PsA need to be performed to try to help define the condition and enable classification and ultimately treatment guidelines. This is where the AXIS study comes in.

The AXIS study is a joint project of ASAS and GRAPPA that was started in January 2019 with the aim of defining a homogeneous subgroup of patients who could be studied.

“The objectives of the AXIS study are to determine the frequency of axial involvement in patients with PsA; to identify the frequency of active inflammatory and structural changes on imaging; and to identify factors associated with the presence of axial involvement in PsA,” Murat Torgutalp, MD, of Charité – Universitätsmedizin Berlin, Berlin, Germany, said at EULAR 2024.

The study population consisted of 409 consecutively recruited patients diagnosed with PsA according to CASPAR (Classification for Psoriatic Arthritis) criteria; all have had PsA for up to 10 years and were untreated with biologic or targeted synthetic disease modifying drugs at the time of inclusion.

Dr. Torgutalp, who is the study’s primary research coordinator, reported that a diagnosis of PsA was made in 37% of the population when local investigators considered available clinical, laboratory, and imaging data. However, patients’ imaging data were also centrally assessed, and when the local investigators were party to the expert imaging interpretations, the percentage of people diagnosed with PsA dropped to 27%.

“When we looked at the clinical characteristics, the presence of the back pain, particularly inflammatory back pain, HLA-B27 positivity, elevated CRP, and presence of active, inflammatory and structural changes in the sacroiliac joints and spine were associated with the final conclusion on the presence of axial involvement,” Dr. Torgutalp said.

Despite the title of his presentation being “The Axis Study Gives Answers,” Dr. Torgutalp presented lots of data without giving much insight into how they might be used. He concluded that “overall, there was a trend toward overestimation of the presence of imaging changes indicative of axial involvement across all imaging modalities” by the local investigators.

Dennis McGonagle, MB, MCH, BAO, PhD, of the University of Leeds, Leeds, England,said in an interview that the AXIS study “is a noble, international effort across multiple countries to try and better understand axial PsA.”

Dr. McGonagle, who was not involved in the study, added: “A lot of data are being generated, and a lot of analysis needs to be done to drill down to get a clear message that could influence practice.”
 

Axial PsA in the Portuguese Population

Separately, Catarina Abreu, a rheumatology intern at Hospital Garcia de Orta, Almada, Portugal, presented some real-world data on axial PsA from Reuma.pt.

Of 2304 patients, 854 (37.1%) reportedly had axial PsA, which had been defined as physician-reported spondylitis or the presence of imaging findings suggestive of axial involvement. This included radiographic- or MRI-detected sacroiliitis or syndesmophytes seen on axial x-rays.

The majority (78.2%) of those with an axial PsA diagnosis had concomitant peripheral involvement, with 8.1% having exclusive axial disease.

About 70% of the axial PsA diagnoses had been made using clinical or laboratory findings alone, and 30% of diagnoses was based on imaging results. Of the latter, Ms. Abreu noted that patients who had imaging data available were more likely to be HLA-B27 positive and less likely to have dactylitis, with respective odds ratios (ORs) of 3.10 and 2.42.

Individuals with axial PsA were more likely to have enthesitis (OR, 1.92), although no data were available on whether this was axial or peripheral enthesitis. Tobacco exposure was also linked to an increased chance of having axial PsA (OR, 1.66).

Ms. Abreu noted that the “scarce number of available imaging exams” and other missing data in Reuma.pt may have led to an underdiagnosis of axial PsA.

“The difference that we found between axial and peripheral [PsA] are similar to the differences found in other studies that compared axial psoriatic arthritis with axial spondyloarthritis,” Ms. Abreu said.

“So, we leave with the question that was already left before here: If these are different diseases or just different phenotypes of the same disease, and what implications will this have in the future?” Ms. Abreu concluded.

Dr. Carron received educational grants, speaker fees, or honoraria for other consultancy work from AbbVie, UCB, Pfizer, Eli Lilly, Novartis, Janssen, and Galapagos/Alfasigma. Dr. Ramiro is an ASAS executive committee member and received research grants or consulting/speaker fees from AbbVie, Eli Lilly, Galapagos, Janssen, Merck Sharp and Dohme, Novartis, Pfizer, Sanofi, and UCB. AXIS is supported by unrestricted research grants from AbbVie, Galapagos, Janssen, Eli Lilly, Novartis, Pfizer, and UCB. Dr. Torgutalp is the primary research coordinator for the study; he reported no financial conflicts of interest. The Reuma.pt registry was developed with the financial support of the pharmaceutical industry and is currently supported by AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Merck Sharp and Dohme, Novartis, Pfizer, and Sobi. Ms. Abreu reported no financial conflicts of interest.

A version of this article appeared on Medscape.com.

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Pyzchiva Receives FDA Approval as Third Ustekinumab Biosimilar

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The Food and Drug Administration has approved ustekinumab-ttwe (Pyzchiva) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions.

In addition, the agency “provisionally determined” that the medication would be interchangeable with the reference product but that designation would not take hold until the interchangeability exclusivity period for the first approved biosimilar ustekinumab-auub (Wezlana) expires, according to a press release. This designation would, depending on state law, allow a pharmacist to substitute the biosimilar for the reference product without involving the prescribing clinician. It’s unclear when ustekinumab-auub’s interchangeability exclusivity ends.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Ustekinumab-ttwe, a human interleukin (IL)-12 and IL-23 antagonist, is indicated for the treatment of:

  • Moderate to severe plaque psoriasis in adults and pediatric patients aged 6 years or older who are candidates for phototherapy or systemic therapy 
  • Active psoriatic arthritis in adults and pediatric patients aged 6 years or older with moderately to severely active Crohn’s disease or ulcerative colitis

It is administered via subcutaneous injection in 45 mg/0.5 mL and 90 mg/mL prefilled syringes or via intravenous infusion in 130 mg/26 mL (5 mg/mL) single-dose vial. 

Developed by Samsung Bioepis, ustekinumab-ttwe will be commercialized by Sandoz in the United States. Besides ustekinumab-auub, the other ustekinumab biosimilar is ustekinumab-aekn (Selarsdi).

Ustekinumab-ttwe is expected to launch in February 2025 “in accordance with the settlement and license agreement with Janssen Biotech,” which manufacturers the reference product, Sandoz said. The other approved ustekinumab biosimilars will launch within a similar time frame.

A version of this article appeared on Medscape.com.

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The Food and Drug Administration has approved ustekinumab-ttwe (Pyzchiva) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions.

In addition, the agency “provisionally determined” that the medication would be interchangeable with the reference product but that designation would not take hold until the interchangeability exclusivity period for the first approved biosimilar ustekinumab-auub (Wezlana) expires, according to a press release. This designation would, depending on state law, allow a pharmacist to substitute the biosimilar for the reference product without involving the prescribing clinician. It’s unclear when ustekinumab-auub’s interchangeability exclusivity ends.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Ustekinumab-ttwe, a human interleukin (IL)-12 and IL-23 antagonist, is indicated for the treatment of:

  • Moderate to severe plaque psoriasis in adults and pediatric patients aged 6 years or older who are candidates for phototherapy or systemic therapy 
  • Active psoriatic arthritis in adults and pediatric patients aged 6 years or older with moderately to severely active Crohn’s disease or ulcerative colitis

It is administered via subcutaneous injection in 45 mg/0.5 mL and 90 mg/mL prefilled syringes or via intravenous infusion in 130 mg/26 mL (5 mg/mL) single-dose vial. 

Developed by Samsung Bioepis, ustekinumab-ttwe will be commercialized by Sandoz in the United States. Besides ustekinumab-auub, the other ustekinumab biosimilar is ustekinumab-aekn (Selarsdi).

Ustekinumab-ttwe is expected to launch in February 2025 “in accordance with the settlement and license agreement with Janssen Biotech,” which manufacturers the reference product, Sandoz said. The other approved ustekinumab biosimilars will launch within a similar time frame.

A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved ustekinumab-ttwe (Pyzchiva) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions.

In addition, the agency “provisionally determined” that the medication would be interchangeable with the reference product but that designation would not take hold until the interchangeability exclusivity period for the first approved biosimilar ustekinumab-auub (Wezlana) expires, according to a press release. This designation would, depending on state law, allow a pharmacist to substitute the biosimilar for the reference product without involving the prescribing clinician. It’s unclear when ustekinumab-auub’s interchangeability exclusivity ends.

Wikimedia Commons/FitzColinGerald/Creative Commons License

Ustekinumab-ttwe, a human interleukin (IL)-12 and IL-23 antagonist, is indicated for the treatment of:

  • Moderate to severe plaque psoriasis in adults and pediatric patients aged 6 years or older who are candidates for phototherapy or systemic therapy 
  • Active psoriatic arthritis in adults and pediatric patients aged 6 years or older with moderately to severely active Crohn’s disease or ulcerative colitis

It is administered via subcutaneous injection in 45 mg/0.5 mL and 90 mg/mL prefilled syringes or via intravenous infusion in 130 mg/26 mL (5 mg/mL) single-dose vial. 

Developed by Samsung Bioepis, ustekinumab-ttwe will be commercialized by Sandoz in the United States. Besides ustekinumab-auub, the other ustekinumab biosimilar is ustekinumab-aekn (Selarsdi).

Ustekinumab-ttwe is expected to launch in February 2025 “in accordance with the settlement and license agreement with Janssen Biotech,” which manufacturers the reference product, Sandoz said. The other approved ustekinumab biosimilars will launch within a similar time frame.

A version of this article appeared on Medscape.com.

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Psoriatic Arthritis Symptoms Relieved with TYK2 Inhibitor in Phase 2 Trial

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Changed
Fri, 06/28/2024 - 14:43

 

TOPLINE:

The tyrosine kinase 2 (TYK2) inhibitor TAK-279 demonstrated superiority to placebo in patients with active psoriatic arthritis (PsA), according to phase 2 trial results.

METHODOLOGY:

  • Eligible patients were over 18 years old, had PsA for over 6 months, met the classification criteria for PsA, and had at least three swollen and tender joints despite prior nonsteroidal anti-inflammatory drug, disease-modifying antirheumatic drug, or biologic treatment.
  • A total of 290 patients were randomized 1:1:1:1 to receive placebo, oral TAK-279 5 mg, 15 mg, or 30 mg once daily.
  • The primary endpoint was a 20% improvement in the American College of Rheumatology response criteria (ACR20) at 12 weeks.

TAKEAWAY:

  • More than half of patients assigned to TAK-279 15 mg (53.3%) and TAK-279 30 mg (54.2%) achieved ACR20 at 12 weeks, compared with 29.2% of those assigned to placebo.
  • Psoriasis Area and Severity Index 75 response rates were also higher in patients assigned to TAK-279 30 mg (45.7%) or 15 mg (28.3%) than those in placebo (15.4%).
  • Treatment-emergent adverse events (TEAEs) of any kind were numerically higher in the 30-mg group, though serious TEAEs were similar across all treatment arms.
  • The most frequent adverse events were nasal pharyngitis, upper respiratory tract infections, headache, and rash, with rash being most common in the TAK-279 30-mg group.

IN PRACTICE:

“There are few targeted oral therapies for active PSA available currently,” said lead author Alan Kivitz, MD, Altoona Center for Clinical Research, Duncansville, Pennsylvania, “and [TAK-279], which was well tolerated and demonstrated superior efficacy versus placebo, may be a promising targeted oral therapy for patients with PsA.”
 

SOURCE:

Dr. Kivitz presented the study findings at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Meeting, held in Vienna.

LIMITATIONS:

The study was a phase 2 trial, and larger studies in active PsA are needed (and currently being planned).
 

DISCLOSURES:

The phase 2 trial was funded by Nimbus and Takeda. Dr. Kivitz has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AbbVie, Amgen, Eli Lilly, GlaxoSmithKline, Pfizer, and UCB. He has stock or stock options in Pfizer, Amgen, GlaxoSmithKline, Gilead, Novartis, and Pfizer and has received consultant fees from Fresenius Kabi, Genzyme, Gilead, Grunenthal, GlaxoSmithKline, Horizon, Janssen, Pfizer, Selecta, SynAct Pharma, and Takeda. He has been part of a board or advisory board for ChemoCentryx, Horizon, Janssen, Novartis, Princeton Biopartners, and UCB. Other authors also disclosed many relationships with pharmaceutical companies.

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

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TOPLINE:

The tyrosine kinase 2 (TYK2) inhibitor TAK-279 demonstrated superiority to placebo in patients with active psoriatic arthritis (PsA), according to phase 2 trial results.

METHODOLOGY:

  • Eligible patients were over 18 years old, had PsA for over 6 months, met the classification criteria for PsA, and had at least three swollen and tender joints despite prior nonsteroidal anti-inflammatory drug, disease-modifying antirheumatic drug, or biologic treatment.
  • A total of 290 patients were randomized 1:1:1:1 to receive placebo, oral TAK-279 5 mg, 15 mg, or 30 mg once daily.
  • The primary endpoint was a 20% improvement in the American College of Rheumatology response criteria (ACR20) at 12 weeks.

TAKEAWAY:

  • More than half of patients assigned to TAK-279 15 mg (53.3%) and TAK-279 30 mg (54.2%) achieved ACR20 at 12 weeks, compared with 29.2% of those assigned to placebo.
  • Psoriasis Area and Severity Index 75 response rates were also higher in patients assigned to TAK-279 30 mg (45.7%) or 15 mg (28.3%) than those in placebo (15.4%).
  • Treatment-emergent adverse events (TEAEs) of any kind were numerically higher in the 30-mg group, though serious TEAEs were similar across all treatment arms.
  • The most frequent adverse events were nasal pharyngitis, upper respiratory tract infections, headache, and rash, with rash being most common in the TAK-279 30-mg group.

IN PRACTICE:

“There are few targeted oral therapies for active PSA available currently,” said lead author Alan Kivitz, MD, Altoona Center for Clinical Research, Duncansville, Pennsylvania, “and [TAK-279], which was well tolerated and demonstrated superior efficacy versus placebo, may be a promising targeted oral therapy for patients with PsA.”
 

SOURCE:

Dr. Kivitz presented the study findings at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Meeting, held in Vienna.

LIMITATIONS:

The study was a phase 2 trial, and larger studies in active PsA are needed (and currently being planned).
 

DISCLOSURES:

The phase 2 trial was funded by Nimbus and Takeda. Dr. Kivitz has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AbbVie, Amgen, Eli Lilly, GlaxoSmithKline, Pfizer, and UCB. He has stock or stock options in Pfizer, Amgen, GlaxoSmithKline, Gilead, Novartis, and Pfizer and has received consultant fees from Fresenius Kabi, Genzyme, Gilead, Grunenthal, GlaxoSmithKline, Horizon, Janssen, Pfizer, Selecta, SynAct Pharma, and Takeda. He has been part of a board or advisory board for ChemoCentryx, Horizon, Janssen, Novartis, Princeton Biopartners, and UCB. Other authors also disclosed many relationships with pharmaceutical companies.

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

 

TOPLINE:

The tyrosine kinase 2 (TYK2) inhibitor TAK-279 demonstrated superiority to placebo in patients with active psoriatic arthritis (PsA), according to phase 2 trial results.

METHODOLOGY:

  • Eligible patients were over 18 years old, had PsA for over 6 months, met the classification criteria for PsA, and had at least three swollen and tender joints despite prior nonsteroidal anti-inflammatory drug, disease-modifying antirheumatic drug, or biologic treatment.
  • A total of 290 patients were randomized 1:1:1:1 to receive placebo, oral TAK-279 5 mg, 15 mg, or 30 mg once daily.
  • The primary endpoint was a 20% improvement in the American College of Rheumatology response criteria (ACR20) at 12 weeks.

TAKEAWAY:

  • More than half of patients assigned to TAK-279 15 mg (53.3%) and TAK-279 30 mg (54.2%) achieved ACR20 at 12 weeks, compared with 29.2% of those assigned to placebo.
  • Psoriasis Area and Severity Index 75 response rates were also higher in patients assigned to TAK-279 30 mg (45.7%) or 15 mg (28.3%) than those in placebo (15.4%).
  • Treatment-emergent adverse events (TEAEs) of any kind were numerically higher in the 30-mg group, though serious TEAEs were similar across all treatment arms.
  • The most frequent adverse events were nasal pharyngitis, upper respiratory tract infections, headache, and rash, with rash being most common in the TAK-279 30-mg group.

IN PRACTICE:

“There are few targeted oral therapies for active PSA available currently,” said lead author Alan Kivitz, MD, Altoona Center for Clinical Research, Duncansville, Pennsylvania, “and [TAK-279], which was well tolerated and demonstrated superior efficacy versus placebo, may be a promising targeted oral therapy for patients with PsA.”
 

SOURCE:

Dr. Kivitz presented the study findings at the European Alliance of Associations for Rheumatology (EULAR) 2024 Annual Meeting, held in Vienna.

LIMITATIONS:

The study was a phase 2 trial, and larger studies in active PsA are needed (and currently being planned).
 

DISCLOSURES:

The phase 2 trial was funded by Nimbus and Takeda. Dr. Kivitz has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AbbVie, Amgen, Eli Lilly, GlaxoSmithKline, Pfizer, and UCB. He has stock or stock options in Pfizer, Amgen, GlaxoSmithKline, Gilead, Novartis, and Pfizer and has received consultant fees from Fresenius Kabi, Genzyme, Gilead, Grunenthal, GlaxoSmithKline, Horizon, Janssen, Pfizer, Selecta, SynAct Pharma, and Takeda. He has been part of a board or advisory board for ChemoCentryx, Horizon, Janssen, Novartis, Princeton Biopartners, and UCB. Other authors also disclosed many relationships with pharmaceutical companies.

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

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