Psoriatic Arthritis

Key clinical point: In patients with psoriatic arthritis (PsA), disease activity was significantly lower in winter than in summer; however, the correlation between patient-reported outcomes (PROs) and weather-related factors lacked clinical significance.

Major finding: Disease activity scores, including the Clinical Disease Activity Index (mean, 8.2 vs 8.8; P < .001) and Simplified Disease Activity Index (mean, 8.6 vs 9.5; P < .001) scores, were significantly lower in winter than in summer. However, the association between weather-related factors and various PROs, including pain and fatigue measures, was not clinically significant (Pearson correlation coefficient, < 0.7).

Study details: In this study, 2665 PROs from 858 patients with PsA were analyzed and hourly measurements of temperature, relative humidity, and pressure were matched with disease activity and PROs in winter and summer.

Disclosures: The lead author received funding through the Canadian Association of Psoriasis Patients and the Canadian Institute of Health Research Institute of Musculoskeletal Health and Arthritis for this study. Some authors declared having ties with various sources.

Source: Joly-Chevrier M, Coupal L, Sauvageau LC, Movahedi M, Choquette D. A real-world analysis on weather variation disease activity and patient reported outcomes in psoriatic arthritis. J Rheumatol. Published online September 15, 2024. Source

Key clinical point: In patients with psoriatic arthritis (PsA), disease activity was significantly lower in winter than in summer; however, the correlation between patient-reported outcomes (PROs) and weather-related factors lacked clinical significance.

Major finding: Disease activity scores, including the Clinical Disease Activity Index (mean, 8.2 vs 8.8; P < .001) and Simplified Disease Activity Index (mean, 8.6 vs 9.5; P < .001) scores, were significantly lower in winter than in summer. However, the association between weather-related factors and various PROs, including pain and fatigue measures, was not clinically significant (Pearson correlation coefficient, < 0.7).

Study details: In this study, 2665 PROs from 858 patients with PsA were analyzed and hourly measurements of temperature, relative humidity, and pressure were matched with disease activity and PROs in winter and summer.

Disclosures: The lead author received funding through the Canadian Association of Psoriasis Patients and the Canadian Institute of Health Research Institute of Musculoskeletal Health and Arthritis for this study. Some authors declared having ties with various sources.

Source: Joly-Chevrier M, Coupal L, Sauvageau LC, Movahedi M, Choquette D. A real-world analysis on weather variation disease activity and patient reported outcomes in psoriatic arthritis. J Rheumatol. Published online September 15, 2024. Source

Key clinical point: In patients with psoriatic arthritis (PsA), disease activity was significantly lower in winter than in summer; however, the correlation between patient-reported outcomes (PROs) and weather-related factors lacked clinical significance.

Major finding: Disease activity scores, including the Clinical Disease Activity Index (mean, 8.2 vs 8.8; P < .001) and Simplified Disease Activity Index (mean, 8.6 vs 9.5; P < .001) scores, were significantly lower in winter than in summer. However, the association between weather-related factors and various PROs, including pain and fatigue measures, was not clinically significant (Pearson correlation coefficient, < 0.7).

Study details: In this study, 2665 PROs from 858 patients with PsA were analyzed and hourly measurements of temperature, relative humidity, and pressure were matched with disease activity and PROs in winter and summer.

Disclosures: The lead author received funding through the Canadian Association of Psoriasis Patients and the Canadian Institute of Health Research Institute of Musculoskeletal Health and Arthritis for this study. Some authors declared having ties with various sources.

Source: Joly-Chevrier M, Coupal L, Sauvageau LC, Movahedi M, Choquette D. A real-world analysis on weather variation disease activity and patient reported outcomes in psoriatic arthritis. J Rheumatol. Published online September 15, 2024. Source

Key clinical point: Bimekizumab rapidly improved patient-reported outcomes after the first dose in patients with active psoriatic arthritis (PsA) who were biologic-naive or inadequately responsive to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: At week 4, bimekizumab vs placebo alleviated pain (mean change in Visual Analog Scale score from baseline, −16.0 vs −3.5) and fatigue (mean change in Functional Assessment of Chronic Illness Therapy score from baseline, 3.0 vs 1.0; both P < .001). These outcomes, along with improvements in physical function and health-related quality of life, were sustained through week 16 (all P < .001).

Study details: In this post hoc analysis of the phase 3 trials BE OPTIMAL and BE COMPLETE, 1112 patients with PsA who were biologic-naive or TNFi-IR were randomly assigned to receive bimekizumab (n = 698) or placebo (n = 414).

Disclosures: This study was sponsored by UCB. Five authors declared being employees or shareholders of UCB. Other authors declared having ties with various sources, including UCB.

Source: Husni ME, Mease PJ, Merola JF, et al. Bimekizumab provided rapid improvements in patient-reported symptoms and health-related quality of life in patients with active psoriatic arthritis: Pooled 16-week results from two phase 3 studies. RMD Open. 2024;10:e004464. Source

Key clinical point: Bimekizumab rapidly improved patient-reported outcomes after the first dose in patients with active psoriatic arthritis (PsA) who were biologic-naive or inadequately responsive to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: At week 4, bimekizumab vs placebo alleviated pain (mean change in Visual Analog Scale score from baseline, −16.0 vs −3.5) and fatigue (mean change in Functional Assessment of Chronic Illness Therapy score from baseline, 3.0 vs 1.0; both P < .001). These outcomes, along with improvements in physical function and health-related quality of life, were sustained through week 16 (all P < .001).

Study details: In this post hoc analysis of the phase 3 trials BE OPTIMAL and BE COMPLETE, 1112 patients with PsA who were biologic-naive or TNFi-IR were randomly assigned to receive bimekizumab (n = 698) or placebo (n = 414).

Disclosures: This study was sponsored by UCB. Five authors declared being employees or shareholders of UCB. Other authors declared having ties with various sources, including UCB.

Source: Husni ME, Mease PJ, Merola JF, et al. Bimekizumab provided rapid improvements in patient-reported symptoms and health-related quality of life in patients with active psoriatic arthritis: Pooled 16-week results from two phase 3 studies. RMD Open. 2024;10:e004464. Source

Key clinical point: Bimekizumab rapidly improved patient-reported outcomes after the first dose in patients with active psoriatic arthritis (PsA) who were biologic-naive or inadequately responsive to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: At week 4, bimekizumab vs placebo alleviated pain (mean change in Visual Analog Scale score from baseline, −16.0 vs −3.5) and fatigue (mean change in Functional Assessment of Chronic Illness Therapy score from baseline, 3.0 vs 1.0; both P < .001). These outcomes, along with improvements in physical function and health-related quality of life, were sustained through week 16 (all P < .001).

Study details: In this post hoc analysis of the phase 3 trials BE OPTIMAL and BE COMPLETE, 1112 patients with PsA who were biologic-naive or TNFi-IR were randomly assigned to receive bimekizumab (n = 698) or placebo (n = 414).

Disclosures: This study was sponsored by UCB. Five authors declared being employees or shareholders of UCB. Other authors declared having ties with various sources, including UCB.

Source: Husni ME, Mease PJ, Merola JF, et al. Bimekizumab provided rapid improvements in patient-reported symptoms and health-related quality of life in patients with active psoriatic arthritis: Pooled 16-week results from two phase 3 studies. RMD Open. 2024;10:e004464. Source

Key clinical point: In patients with psoriatic arthritis (PsA), clinical disease activity improved rapidly with ixekizumab vs interleukin-12/23 inhibitors (IL-12/23i) and IL-23i; the improvements were similar to those with tumor necrosis factor inhibitors (TNFi) and Janus kinase inhibitors (JAKi).

Major finding: At 3 months, ixekizumab significantly improved clinical disease activity in patients with PsA compared with IL-12/23i and IL-23i (least square mean difference [LSMD], −8.4; 95% CI, −12.7 to −4.1). However, the improvements were similar to those with TNFi (LSMD, −0.2; 95% CI, −2.0 to 1.5) and JAKi (LSMD, 0.6; 95% CI, −2.3 to 3.5).

Study details: This 3-month interim analysis of the PRO-SPIRIT real-world study included 1192 patients with PsA (age, 18-80 years) across six countries who initiated or switched to a new biologic or targeted synthetic disease-modifying antirheumatic drug.

Disclosures: This study was sponsored by Eli Lilly and Company. Eight authors declared being employees and minor shareholders of Eli Lilly and Company. Several authors declared having ties with various sources, including Eli Lilly and Company.

Source: Kristensen LE, Ng KJ, Ngantcha M, et al. Comparative early effectiveness across 14 PsA drugs and 5 classes of PsA treatment: 3-month results from the PRO-SPIRIT study. RMD Open. 2024;10:e004318. Source

Key clinical point: In patients with psoriatic arthritis (PsA), clinical disease activity improved rapidly with ixekizumab vs interleukin-12/23 inhibitors (IL-12/23i) and IL-23i; the improvements were similar to those with tumor necrosis factor inhibitors (TNFi) and Janus kinase inhibitors (JAKi).

Major finding: At 3 months, ixekizumab significantly improved clinical disease activity in patients with PsA compared with IL-12/23i and IL-23i (least square mean difference [LSMD], −8.4; 95% CI, −12.7 to −4.1). However, the improvements were similar to those with TNFi (LSMD, −0.2; 95% CI, −2.0 to 1.5) and JAKi (LSMD, 0.6; 95% CI, −2.3 to 3.5).

Study details: This 3-month interim analysis of the PRO-SPIRIT real-world study included 1192 patients with PsA (age, 18-80 years) across six countries who initiated or switched to a new biologic or targeted synthetic disease-modifying antirheumatic drug.

Disclosures: This study was sponsored by Eli Lilly and Company. Eight authors declared being employees and minor shareholders of Eli Lilly and Company. Several authors declared having ties with various sources, including Eli Lilly and Company.

Source: Kristensen LE, Ng KJ, Ngantcha M, et al. Comparative early effectiveness across 14 PsA drugs and 5 classes of PsA treatment: 3-month results from the PRO-SPIRIT study. RMD Open. 2024;10:e004318. Source

Key clinical point: In patients with psoriatic arthritis (PsA), clinical disease activity improved rapidly with ixekizumab vs interleukin-12/23 inhibitors (IL-12/23i) and IL-23i; the improvements were similar to those with tumor necrosis factor inhibitors (TNFi) and Janus kinase inhibitors (JAKi).

Major finding: At 3 months, ixekizumab significantly improved clinical disease activity in patients with PsA compared with IL-12/23i and IL-23i (least square mean difference [LSMD], −8.4; 95% CI, −12.7 to −4.1). However, the improvements were similar to those with TNFi (LSMD, −0.2; 95% CI, −2.0 to 1.5) and JAKi (LSMD, 0.6; 95% CI, −2.3 to 3.5).

Study details: This 3-month interim analysis of the PRO-SPIRIT real-world study included 1192 patients with PsA (age, 18-80 years) across six countries who initiated or switched to a new biologic or targeted synthetic disease-modifying antirheumatic drug.

Disclosures: This study was sponsored by Eli Lilly and Company. Eight authors declared being employees and minor shareholders of Eli Lilly and Company. Several authors declared having ties with various sources, including Eli Lilly and Company.

Source: Kristensen LE, Ng KJ, Ngantcha M, et al. Comparative early effectiveness across 14 PsA drugs and 5 classes of PsA treatment: 3-month results from the PRO-SPIRIT study. RMD Open. 2024;10:e004318. Source

The Food and Drug Administration has approved ustekinumab-aauz (Otulfi), a biosimilar that references Johnson & Johnson’s ustekinumab (Stelara).

This is the fourth ustekinumab biosimilar approved in the United States. Like the reference product, ustekinumab-aauz is indicated for:

• Patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
• Patients 6 years or older with active psoriatic arthritis
• Adult patients with moderately to severely active Crohn’s disease
• Adult patients with moderately to severely active ulcerative colitis

Ustekinumab-aauz, produced by a partnership between Fresenius Kabi and Formycon, has two formulations: subcutaneous injection (45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe) or intravenous infusion (130 mg/26 mL solution in a single-dose vial).

The biosimilar will launch in the United States “no later than February 22, 2025,” according to the press release, “in accordance with the patent settlement between Fresenius Kabi, Formycon, and Johnson & Johnson.”

Ustekinumab-aauz is Fresenius Kabi’s fourth biosimilar granted US approval, behind adalimumab-aacf (Idacio), tocilizumab-aazg (Tyenne), and pegfilgrastim-fpgk (Stimufend).

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

The Food and Drug Administration has approved ustekinumab-aauz (Otulfi), a biosimilar that references Johnson & Johnson’s ustekinumab (Stelara).

This is the fourth ustekinumab biosimilar approved in the United States. Like the reference product, ustekinumab-aauz is indicated for:

• Patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
• Patients 6 years or older with active psoriatic arthritis
• Adult patients with moderately to severely active Crohn’s disease
• Adult patients with moderately to severely active ulcerative colitis

Ustekinumab-aauz, produced by a partnership between Fresenius Kabi and Formycon, has two formulations: subcutaneous injection (45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe) or intravenous infusion (130 mg/26 mL solution in a single-dose vial).

The biosimilar will launch in the United States “no later than February 22, 2025,” according to the press release, “in accordance with the patent settlement between Fresenius Kabi, Formycon, and Johnson & Johnson.”

Ustekinumab-aauz is Fresenius Kabi’s fourth biosimilar granted US approval, behind adalimumab-aacf (Idacio), tocilizumab-aazg (Tyenne), and pegfilgrastim-fpgk (Stimufend).

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

The Food and Drug Administration has approved ustekinumab-aauz (Otulfi), a biosimilar that references Johnson & Johnson’s ustekinumab (Stelara).

This is the fourth ustekinumab biosimilar approved in the United States. Like the reference product, ustekinumab-aauz is indicated for:

• Patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
• Patients 6 years or older with active psoriatic arthritis
• Adult patients with moderately to severely active Crohn’s disease
• Adult patients with moderately to severely active ulcerative colitis

Ustekinumab-aauz, produced by a partnership between Fresenius Kabi and Formycon, has two formulations: subcutaneous injection (45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe) or intravenous infusion (130 mg/26 mL solution in a single-dose vial).

The biosimilar will launch in the United States “no later than February 22, 2025,” according to the press release, “in accordance with the patent settlement between Fresenius Kabi, Formycon, and Johnson & Johnson.”

Ustekinumab-aauz is Fresenius Kabi’s fourth biosimilar granted US approval, behind adalimumab-aacf (Idacio), tocilizumab-aazg (Tyenne), and pegfilgrastim-fpgk (Stimufend).

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

TOPLINE:

Home-based phototherapy for plaque and guttate psoriasis is as effective as office-based phototherapy, according to results of the randomized Light Treatment Effectiveness study.

METHODOLOGY:

• The pragmatic, investigator-initiated, open-label, noninferiority, randomized trial compared the effectiveness of 12 weeks of treatment with narrow-band ultraviolet B phototherapy administered at home (n = 393) vs at the doctor’s office (n = 390).
• Overall, 783 patients with plaque or guttate psoriasis (mean age, 48 years; 48% women) were enrolled at 42 academic and private clinical dermatology practices in the United States from March 1, 2019, to December 4, 2023, and were followed up through June 2024. At baseline, the mean Physician Global Assessment (PGA) and the mean Dermatology Life Quality Index (DLQI) scores were 2.7 and 12.2, respectively.
• The two co-primary endpoints were a PGA score ≤ 1 indicating clear or almost clear skin and a DLQI score ≤ 5.

TAKEAWAY:

• At 12 weeks, a PGA score ≤ 1 was achieved in 32.8% of patients using home-based phototherapy and in 25.6% of those who received office-based phototherapy (P < .001).
• At 12 weeks, a DLQI score ≤ 5 was achieved in 52.4% and 33.6% of home- and office-treated patients, respectively (P < .001).
• Similar benefits were seen across all Fitzpatrick skin types.
• A higher percentage of patients were adherent to home-based (51.4%) vs office-based (15.9%) phototherapy (P < .001).

IN PRACTICE:

“These data support the use of home phototherapy as a first-line treatment option for psoriasis,” and “efforts are needed to make home and office phototherapy more available to patients,” said the study’s lead author.

SOURCE:

Joel M. Gelfand, MD, director of the Psoriasis and Phototherapy Treatment Center at the University of Pennsylvania, Philadelphia, presented the findings at the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis meeting during the annual meeting of the European Academy of Dermatology and Venereology, with simultaneous publication in JAMA Dermatology.

LIMITATIONS:

This was an open-label trial and because of its pragmatic design, outcome data were missing. The cost of the home-based phototherapy equipment used in the study was $6040.88, which was mostly covered by Medicare, but direct costs to patients may have varied depending on their insurance plan.

DISCLOSURES:

The Patient-Centered Outcomes Research Institute funded the study. Daavlin provided and shipped machines for home-based phototherapy to patients at no cost. Dr. Gelfand disclosed serving as a consultant for AbbVie, Artax, Bristol-Myers Squibb, Boehringer Ingelheim, Celldex, and other companies. The full list of author disclosures can be found in the published study.

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

TOPLINE:

Home-based phototherapy for plaque and guttate psoriasis is as effective as office-based phototherapy, according to results of the randomized Light Treatment Effectiveness study.

METHODOLOGY:

• The pragmatic, investigator-initiated, open-label, noninferiority, randomized trial compared the effectiveness of 12 weeks of treatment with narrow-band ultraviolet B phototherapy administered at home (n = 393) vs at the doctor’s office (n = 390).
• Overall, 783 patients with plaque or guttate psoriasis (mean age, 48 years; 48% women) were enrolled at 42 academic and private clinical dermatology practices in the United States from March 1, 2019, to December 4, 2023, and were followed up through June 2024. At baseline, the mean Physician Global Assessment (PGA) and the mean Dermatology Life Quality Index (DLQI) scores were 2.7 and 12.2, respectively.
• The two co-primary endpoints were a PGA score ≤ 1 indicating clear or almost clear skin and a DLQI score ≤ 5.

TAKEAWAY:

• At 12 weeks, a PGA score ≤ 1 was achieved in 32.8% of patients using home-based phototherapy and in 25.6% of those who received office-based phototherapy (P < .001).
• At 12 weeks, a DLQI score ≤ 5 was achieved in 52.4% and 33.6% of home- and office-treated patients, respectively (P < .001).
• Similar benefits were seen across all Fitzpatrick skin types.
• A higher percentage of patients were adherent to home-based (51.4%) vs office-based (15.9%) phototherapy (P < .001).

IN PRACTICE:

“These data support the use of home phototherapy as a first-line treatment option for psoriasis,” and “efforts are needed to make home and office phototherapy more available to patients,” said the study’s lead author.

SOURCE:

Joel M. Gelfand, MD, director of the Psoriasis and Phototherapy Treatment Center at the University of Pennsylvania, Philadelphia, presented the findings at the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis meeting during the annual meeting of the European Academy of Dermatology and Venereology, with simultaneous publication in JAMA Dermatology.

LIMITATIONS:

This was an open-label trial and because of its pragmatic design, outcome data were missing. The cost of the home-based phototherapy equipment used in the study was $6040.88, which was mostly covered by Medicare, but direct costs to patients may have varied depending on their insurance plan.

DISCLOSURES:

The Patient-Centered Outcomes Research Institute funded the study. Daavlin provided and shipped machines for home-based phototherapy to patients at no cost. Dr. Gelfand disclosed serving as a consultant for AbbVie, Artax, Bristol-Myers Squibb, Boehringer Ingelheim, Celldex, and other companies. The full list of author disclosures can be found in the published study.

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

TOPLINE:

Home-based phototherapy for plaque and guttate psoriasis is as effective as office-based phototherapy, according to results of the randomized Light Treatment Effectiveness study.

METHODOLOGY:

• The pragmatic, investigator-initiated, open-label, noninferiority, randomized trial compared the effectiveness of 12 weeks of treatment with narrow-band ultraviolet B phototherapy administered at home (n = 393) vs at the doctor’s office (n = 390).
• Overall, 783 patients with plaque or guttate psoriasis (mean age, 48 years; 48% women) were enrolled at 42 academic and private clinical dermatology practices in the United States from March 1, 2019, to December 4, 2023, and were followed up through June 2024. At baseline, the mean Physician Global Assessment (PGA) and the mean Dermatology Life Quality Index (DLQI) scores were 2.7 and 12.2, respectively.
• The two co-primary endpoints were a PGA score ≤ 1 indicating clear or almost clear skin and a DLQI score ≤ 5.

TAKEAWAY:

• At 12 weeks, a PGA score ≤ 1 was achieved in 32.8% of patients using home-based phototherapy and in 25.6% of those who received office-based phototherapy (P < .001).
• At 12 weeks, a DLQI score ≤ 5 was achieved in 52.4% and 33.6% of home- and office-treated patients, respectively (P < .001).
• Similar benefits were seen across all Fitzpatrick skin types.
• A higher percentage of patients were adherent to home-based (51.4%) vs office-based (15.9%) phototherapy (P < .001).

IN PRACTICE:

“These data support the use of home phototherapy as a first-line treatment option for psoriasis,” and “efforts are needed to make home and office phototherapy more available to patients,” said the study’s lead author.

SOURCE:

Joel M. Gelfand, MD, director of the Psoriasis and Phototherapy Treatment Center at the University of Pennsylvania, Philadelphia, presented the findings at the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis meeting during the annual meeting of the European Academy of Dermatology and Venereology, with simultaneous publication in JAMA Dermatology.

LIMITATIONS:

This was an open-label trial and because of its pragmatic design, outcome data were missing. The cost of the home-based phototherapy equipment used in the study was $6040.88, which was mostly covered by Medicare, but direct costs to patients may have varied depending on their insurance plan.

DISCLOSURES:

The Patient-Centered Outcomes Research Institute funded the study. Daavlin provided and shipped machines for home-based phototherapy to patients at no cost. Dr. Gelfand disclosed serving as a consultant for AbbVie, Artax, Bristol-Myers Squibb, Boehringer Ingelheim, Celldex, and other companies. The full list of author disclosures can be found in the published study.

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

When Jennifer Welsh, a 40-year-old from New Britain, Connecticut, visited her doctor about pain in her joints and neck, her doctor sent her to the emergency department (ED) to rule out meningitis. The ED did rule that out, as well as strep, so Ms. Welsh went to her follow-up appointment a few days later, hoping for answers or at least more tests to get those answers.

Instead, the doctor — a different one from the same practice as her primary care physician (PCP) — wouldn’t even talk to Ms. Welsh about her symptoms because she couldn’t see the ED’s results and refused to view the results that Ms. Welsh could pull up online.

“She just completely shut me down,” Ms. Welsh recalled. “It was a really awful appointment, and I left in tears. I was in physical pain, I had just been to the ER, nothing is really resolved, I’m stressed out about it, and this woman is completely dismissing me.”

She had been able to schedule an appointment with her regular PCP later that week, but after the harrowing experience with this doctor, she wondered if her PCP would order the rheumatoid arthritis (RA) test that Ms. Welsh suspected she needed. So, she took matters into her own hands.

“I was searching for what test to ask for from my doctor,” she said, and she found that she could order it on her own from a major lab company she was already familiar with. For around $100, “I could get it done and see what it says on my own,” she said.

But that’s not how it worked out. Her regular PCP apologized for the other doctor’s behavior and ordered the RA test as well as additional tests — and got results while Ms. Welsh still waited for the one she ordered to arrive over a week later.

At first, Ms. Welsh was grateful she could order the RA test without her doctor’s referral. “I felt it gave me a sense of control over the situation that I felt really not in control of, until the system failed me, and I didn’t get the results,” she said. But then, “not having someone I could call and get an answer about why my tests were delayed, why I wasn’t able to access them, why it was taking so long — it was definitely anxiety-inducing.”
 

A Growing Market

Ms. Welsh is one of a growing number of patients who are ordering direct-to-consumer (DTC) lab tests without the recommendation or guidance of a doctor. They’re offered online by labs ranging from well-established giants like Quest and Labcorp to smaller, potentially less vetted companies, although some smaller companies contract with larger companies like Quest. Combined, the DTC market is projected to be worth $2 billion by 2025.

Yet the burgeoning industry has also drawn critiques from both bioethicists and privacy experts. A research letter in JAMA in 2023, for example, found that less than half of the 21 companies identified in an online search declared Health Insurance Portability and Accountability Act compliance, while more than half “indicated the potential use of consumer data for research purposes either internally or through third-party sharing.” That study found the most commonly offered tests were related to diabetes, the thyroid, and vitamin levels, and hormone tests for men and women, such as testosterone or estradiol.

But a number of companies also offer tests related to rheumatologic conditions. A handful of tests offered by Labcorp, for example, could be used in rheumatology, such as tests for celiac antibodies or high-sensitivity C-reactive protein. Quest similarly offers a handful of autoimmune-related tests. But other companies offer a long slate of autoimmune or antibody tests.

The antinuclear antibody (ANA) test and RA panel offered by Quest are the same tests, run and analyzed in the same labs, as those ordered by physicians and hospitals, according to James Faix, MD, the medical director of immunology at Quest Diagnostics. Their RA panel includes rheumatoid factor and anti-cyclic citrullinated peptide as well as antibody to mutated citrullinated vimentin, “which may detect approximately 10%-15%” of patients who test negative to the first two.

Quest’s ANA test with reflex costs $112, and its RA panel costs $110, price points that are similar across other companies’ offerings. Labcorp declined to respond to questions about its DTC tests, and several smaller companies did not respond to queries about their offerings. It can therefore be hard to assess what’s included or what the quality is of many DTC tests, particularly from smaller, less established companies.
 

Oversight and Quality Control

Anthony Killeen, MD, PhD, president of the Association for Diagnostics & Laboratory Medicine (ADLM) and director of Clinical Laboratories at the University of Minnesota Medical Center in Minneapolis, said via email that the ADLM supports “expanding consumer access to direct-to-consumer laboratory testing services that have demonstrated analytical and clinical validity and clinical utility,” given the importance of individuals learning about their health status and becoming more involved in health decisions. But the ADLM also recommends “that only CLIA-certified laboratories perform direct-to-consumer testing,” he said.

Association for Diagnostics &amp; Laboratory Medicine

“There are direct-to-consumer tests on the market that are not medical-grade laboratory tests and that may be performed in nonaccredited laboratories,” Dr. Killeen said. “We advise consumers to steer clear of such tests.” The ADLM also encourages consumers to “work with qualified healthcare providers when making decisions based off the results they receive from any direct-to-consumer tests” and recommends that DTC test companies “provide consumers with sufficient information and/or access to expert help to assist them in ordering tests and interpreting the results.”

Yet it’s unclear how much support, if any, consumers can receive in terms of understanding what their tests mean. Most of the companies in the 2023 study offered optional follow-up with a healthcare professional, but these professionals ranged from physicians to “health coaches,” and all the companies had disclaimers that “test results did not constitute medical advice.”

At Quest, the only company to respond to this news organization’s request for comment, consumer-initiated tests ordered online are first reviewed by a physician at PWNHealth, an independent, third-party physician network, to determine that it’s appropriate before the lab order is actually placed.

“Once results are available, individuals have the option to discuss their results with an independent physician at no extra cost,” Dr. Faix said. ANA or RA results outside the normal ranges may trigger a “call from a PWNHealth healthcare coordinator, who can help provide information, suggestions on next steps, and set up time for the individual to speak with an independent physician to discuss questions or concerns regarding the results,” he said.

“Our goal is not to replace the role of a healthcare provider,” Dr. Faix said. “We are providing an alternate way for people to engage with the healthcare system that offers convenience, gives people more control over their own healthcare journeys, and meets them where they are, supporting both consumers and their care teams.” The company has expanded its offerings from an initial 30 tests made available in 2018 to over 130 today, deciding which to offer “based on consumer research and expertise of clinical experts.” The company has also “seen steady interest in our two consumer rheumatology offerings,” Dr. Faix said.
 

The DTC Landscape in Rheumatology

Within rheumatology, among the most popular tests is for ANA, based on the experience of Alfred Kim, MD, PhD, associate professor of medicine at Washington University School of Medicine in St Louis, Missouri.

Dr. Kim

“For a lot of people, losing control over their health is maybe the most frightening experience they can have, so I think a lot of patients use this as a way to kind of have ownership over their health,” Dr. Kim said. “Let’s say they’ve been to four doctors. No one can explain what’s going on. They’re getting frustrated, and so they just turn to solutions where they feel like they have ownership over the situation.”

Though the market is undoubtedly growing, the growth appears uneven across geography and institution types. Kim has seen a “fair number of referrals,” with patients coming in with results from a DTC test. Michael Putman, MD, MSci, assistant professor of medicine at the Medical College of Wisconsin in Milwaukee, hasn’t seen it much. “I know that patients can get testing done themselves independently, but I don’t have people routinely coming in with tests they’ve ordered in advance of our appointment,” Dr. Putman said, but, like Dr. Kim, he recognizes why patients might seek them out.

Dr. Putman

Ron Hester Photography

Risks vs Benefits

DTC testing is not an answer to the national shortage of rheumatologists, however, especially given the risks that Dr. Niewold, Dr. Putman, and Dr. Kim worry outweigh potential benefits. On the one hand, getting online test results may help expedite a referral to a specialist, Dr. Niewold said. But a long wait for that appointment could then easily become a bigger source of anxiety than comfort, Dr. Putman said.

“It’s a trade-off where you are accepting a lot more people getting false-positive diagnoses and spending months thinking they have some disease where they might not, in exchange for a couple people who would have had a delayed diagnosis,” Dr. Putman said. “There’s an enormous amount of existential suffering,” that’s familiar to rheumatologists because some patients may dread the diagnosis of a rheumatic disease the way they might fear a cancer diagnosis, especially if they have lost a family member to a condition that they suspect they share, he said. “To put yourself into an existential catastrophe — that’s not a small harm.”

Dr. Niewold agreed, pointing out that patients with a positive ANA test may “get unnecessarily worried and stay up all night reading about lupus, getting scared for weeks on end before seeing a specialist.” And there are financial harms as well for patients who may order the same test multiple times, or a whole slate of tests, that they don’t need for hundreds or thousands of dollars. There’s also the lost time and effort of researching a condition or even seeking out support groups that patients may pursue, Dr. Niewold said.

The likely biggest risk to individuals, however, is the potential for overdiagnosis or misdiagnosis.

“If someone comes in and they’ve read the textbook on lupus and they have a positive ANA, it’s really hard as a rheumatologist to walk that back,” Dr. Putman said. “The human mind is a powerful thing,” he added, and people who get a positive test will likely start to notice things like joint pain or a rash on their cheeks and begin attributing it to a diagnosis they risk convincing themselves they have. “When people come into your clinic not knowing what a disease would look like and they just tell you how they’re feeling, it’s a much cleaner and more honest way to approach diagnosis.”

Most patients likely don’t realize, for example, that none of the tests rheumatologists usually order are diagnostic in and of themselves, Dr. Niewold said. “They’re all kind of like stars in the constellation of a diagnosis,” he said. “They’re helpful, but none of them is sufficient by itself.”

Dr. Killeen agreed, noting that “consumers might not understand the nuances of these tests well enough to know whether it is appropriate to order them or how to interpret the results correctly.” Given the long-term implications of a diagnosis for a rheumatologic disease, “I would have concerns about consumers ordering and interpreting rheumatologic tests without working closely with their physicians,” Dr. Killeen said. “The main concern that lab experts have about direct-to-consumer tests is the potential for people to get misleading results and/or to misinterpret their results, which in turn could lead to people not getting the treatment they need or getting treatment when they don’t need any at all.”

It’s one thing for patients to come in asking for a particular treatment they may not need but which a doctor may be able to dissuade them from seeking. But Dr. Kim also pointed out the risk that patients may decide to treat themselves with therapies that haven’t undergone rigorous testing or haven’t been recommended by a physician.

“We tend to have people who come in with a pretty clear idea of what they want done, but the problem is, we don’t know if their reasoning is correct from a clinical perspective,” Dr. Kim said. Companies offer these tests with the belief that they’re “providing patients a choice, an option to take ownership,” he said, “but the potential harm can be realized very quickly because there are going to be people who are misdiagnosing themselves and, worse yet, may then pursue their own treatment plan that’s going in the opposite direction of where we think it needs to go.”

Or, on the flip side, if a patient erroneously believes they have the answer to what ails them, it may delay diagnosis of a more serious condition that’s rarer or harder to detect. Kim pointed to, for example, intravascular lymphoma, which is notoriously as difficult to identify as it is rare and aggressive. If a patient’s confirmation bias has led them to believe they have an autoimmune condition, they may not receive the more serious diagnosis until it’s advanced too far to treat.
 

Patient-Provider Relationship Friction

Another concern is how these tests may lead to confusion and frustration that can erode the patient-provider relationship, particularly because most patients don’t know how to interpret the results or understand the bigger context in which the results have to be interpreted. Many patients may think a test can come back with a binary answer, a positive or negative, and that means they do or don’t have a condition. That’s generally true for pregnancy tests, COVID tests, and sexually transmitted infection tests — the kinds of tests that have long been available to consumers and which have fairly straightforward answers.

But physicians know that’s not the case for many conditions, particularly those in rheumatology.

“In rheumatic diseases, because the tests have such marginal value in terms of diagnosis, almost always we develop a suspicion before we even think about ordering the tests, and then that dictates whether or not we cross that threshold,” Dr. Kim said. “A negative test doesn’t exclude the fact that you may have disease X, but a positive test also doesn’t mean you have disease X. All they provide is an idea of the risk.”

But some patients who come in with DTC test results have “already made the decision in their mind that they have a certain condition,” Dr. Kim said. “This is obviously dangerous because the majority of these patients do not have the condition they think they have, and it leaves a very uncomfortable feeling after the visit because they feel like they’ve been either betrayed by me or by the test, and they leave more confused.”

Patients may also come in with tests that a doctor isn’t familiar with or isn’t sure how to interpret on its own, at least for that particular patient.

“For ANA testing, we have a pretty good idea of its positive and negative predictive value because it’s ordered so much, but for many of these tests being offered, there are specific autoantibodies, and we tend to only get them in people where there’s a clinical suspicion,” Dr. Kim said. “Within that very specific context, we kind of understand what that value means, but if you give it to the general public, then those numbers aren’t as applicable and most likely overestimate the risk of disease.”

Even if providers consider the results of a DTC test in their differential, they may want to be sure it’s from a trustworthy source. “If a provider is uncertain about whether a direct-to-consumer testing company is reputable or about whether a direct-to-consumer test result is reliable, I would encourage them to consult with their laboratory medicine colleagues,” Dr. Killeen said.
 

Responding to Patients

Like any other patient coming to a clinical visit, the most common reason patients are likely ordering these tests is that they’re seeking answers. Kim doesn’t typically see patients doing their own monitoring for diagnosed conditions between visits — the expense would add up too quickly — or testing for genetic markers, which likely wouldn’t be very helpful either.

“Even though most of our diseases probably have a genetic underpinning, how much it contributes is always unclear,” Dr. Kim said. Even conditions with clear genetic variants, such as familial Mediterranean fever, spondyloarthritis, and Behçet disease, can only support a diagnosis, not diagnose it on its own, Dr. Killeen said. And these are not among the tests currently available on most DTC company sites.

While there are also tests that can offer information about genetic risks for certain medications, such as a thiopurine methyltransferase test to find out if a patient lacks the enzyme needed to break down the immunosuppressant drug azathioprine, Kim hasn’t seen patients seeking these out either.

“The more global and more compassionate way to think about this is that we have a lot of people who are struggling to understand what’s going on with their bodies, and most physicians really don’t know what the next steps are for these people,” Dr. Kim said. “They’re desperate, and their quality of life is so poor that they’re going to take extreme steps to try to manage their own frustration with this condition.”

That means clinicians’ most powerful tools when patients come in with DTC test results are their listening skills.

“Empathy is the most important thing, just being able to share the patient’s frustration to the point where they had to take matters into their own hands,” Dr. Kim said. “I think a lot of rheumatologists are actually pretty comfortable being in this position.”

Additionally, doctors should know that some patients may be engaging in attempts to self-diagnose, self-treat, or otherwise self-manage their symptoms or perceived condition. “They just need to be aware and try to make sure there’s no harm being done,” Dr. Kim said.

Ms. Welsh didn’t seek treatment or diagnosis on her own, but getting her test also did not give her the control she was seeking. “Looking back, it was kind of a waste of money, but it felt good in the moment,” Ms. Welsh said. “I was so upset, and I wanted that control, and in the end, it didn’t get me results any sooner, and it didn’t give me peace of mind.”

It was Ms. Welsh’s primary care doctor listening to her concerns, ordering the same test she had ordered with several others, and working with her to seek answers that reassured her that her provider cared about her well-being.

“A lot of what I do in my business is reassure people that you know what they have is treatable or not going to end their life as they know it,” Dr. Putman said. “And you certainly can’t reassure them if they’re not in your clinic yet.”

Dr. Putman has participated in clinical trials with AbbVie, consulting with Novartis and GSK, and clinical trials and consulting with Amgen and AstraZeneca. Dr. Niewold reported receiving research grants from EMD Serono and Zenas BioPharma and consulting for Thermo Fisher Scientific, Progentec Diagnostics, Roivant Sciences, AstraZeneca, S3 Connected Health, Flagship Pioneering, and Guidepoint. Dr. Kim reported sponsored research agreements with AstraZeneca, Bristol-Myers Squibb, Novartis, and CRISPR Therapeutics; royalties from Kypha; and consulting/speaking for Amgen, ANI Pharmaceuticals, Atara Biotherapeutics, Aurinia Pharmaceuticals, CARGO Therapeutics, Exagen Diagnostics, GSK, Hinge Bio, Kypha, Progentec Diagnostics, Synthekine, and UpToDate. Dr. Killeen had no relevant financial relationships to disclose.
 

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

When Jennifer Welsh, a 40-year-old from New Britain, Connecticut, visited her doctor about pain in her joints and neck, her doctor sent her to the emergency department (ED) to rule out meningitis. The ED did rule that out, as well as strep, so Ms. Welsh went to her follow-up appointment a few days later, hoping for answers or at least more tests to get those answers.

Instead, the doctor — a different one from the same practice as her primary care physician (PCP) — wouldn’t even talk to Ms. Welsh about her symptoms because she couldn’t see the ED’s results and refused to view the results that Ms. Welsh could pull up online.

“She just completely shut me down,” Ms. Welsh recalled. “It was a really awful appointment, and I left in tears. I was in physical pain, I had just been to the ER, nothing is really resolved, I’m stressed out about it, and this woman is completely dismissing me.”

She had been able to schedule an appointment with her regular PCP later that week, but after the harrowing experience with this doctor, she wondered if her PCP would order the rheumatoid arthritis (RA) test that Ms. Welsh suspected she needed. So, she took matters into her own hands.

“I was searching for what test to ask for from my doctor,” she said, and she found that she could order it on her own from a major lab company she was already familiar with. For around $100, “I could get it done and see what it says on my own,” she said.

But that’s not how it worked out. Her regular PCP apologized for the other doctor’s behavior and ordered the RA test as well as additional tests — and got results while Ms. Welsh still waited for the one she ordered to arrive over a week later.

At first, Ms. Welsh was grateful she could order the RA test without her doctor’s referral. “I felt it gave me a sense of control over the situation that I felt really not in control of, until the system failed me, and I didn’t get the results,” she said. But then, “not having someone I could call and get an answer about why my tests were delayed, why I wasn’t able to access them, why it was taking so long — it was definitely anxiety-inducing.”
 

A Growing Market

Ms. Welsh is one of a growing number of patients who are ordering direct-to-consumer (DTC) lab tests without the recommendation or guidance of a doctor. They’re offered online by labs ranging from well-established giants like Quest and Labcorp to smaller, potentially less vetted companies, although some smaller companies contract with larger companies like Quest. Combined, the DTC market is projected to be worth $2 billion by 2025.

Yet the burgeoning industry has also drawn critiques from both bioethicists and privacy experts. A research letter in JAMA in 2023, for example, found that less than half of the 21 companies identified in an online search declared Health Insurance Portability and Accountability Act compliance, while more than half “indicated the potential use of consumer data for research purposes either internally or through third-party sharing.” That study found the most commonly offered tests were related to diabetes, the thyroid, and vitamin levels, and hormone tests for men and women, such as testosterone or estradiol.

But a number of companies also offer tests related to rheumatologic conditions. A handful of tests offered by Labcorp, for example, could be used in rheumatology, such as tests for celiac antibodies or high-sensitivity C-reactive protein. Quest similarly offers a handful of autoimmune-related tests. But other companies offer a long slate of autoimmune or antibody tests.

The antinuclear antibody (ANA) test and RA panel offered by Quest are the same tests, run and analyzed in the same labs, as those ordered by physicians and hospitals, according to James Faix, MD, the medical director of immunology at Quest Diagnostics. Their RA panel includes rheumatoid factor and anti-cyclic citrullinated peptide as well as antibody to mutated citrullinated vimentin, “which may detect approximately 10%-15%” of patients who test negative to the first two.

Quest’s ANA test with reflex costs $112, and its RA panel costs $110, price points that are similar across other companies’ offerings. Labcorp declined to respond to questions about its DTC tests, and several smaller companies did not respond to queries about their offerings. It can therefore be hard to assess what’s included or what the quality is of many DTC tests, particularly from smaller, less established companies.
 

Oversight and Quality Control

Anthony Killeen, MD, PhD, president of the Association for Diagnostics & Laboratory Medicine (ADLM) and director of Clinical Laboratories at the University of Minnesota Medical Center in Minneapolis, said via email that the ADLM supports “expanding consumer access to direct-to-consumer laboratory testing services that have demonstrated analytical and clinical validity and clinical utility,” given the importance of individuals learning about their health status and becoming more involved in health decisions. But the ADLM also recommends “that only CLIA-certified laboratories perform direct-to-consumer testing,” he said.

Association for Diagnostics &amp; Laboratory Medicine

“There are direct-to-consumer tests on the market that are not medical-grade laboratory tests and that may be performed in nonaccredited laboratories,” Dr. Killeen said. “We advise consumers to steer clear of such tests.” The ADLM also encourages consumers to “work with qualified healthcare providers when making decisions based off the results they receive from any direct-to-consumer tests” and recommends that DTC test companies “provide consumers with sufficient information and/or access to expert help to assist them in ordering tests and interpreting the results.”

Yet it’s unclear how much support, if any, consumers can receive in terms of understanding what their tests mean. Most of the companies in the 2023 study offered optional follow-up with a healthcare professional, but these professionals ranged from physicians to “health coaches,” and all the companies had disclaimers that “test results did not constitute medical advice.”

At Quest, the only company to respond to this news organization’s request for comment, consumer-initiated tests ordered online are first reviewed by a physician at PWNHealth, an independent, third-party physician network, to determine that it’s appropriate before the lab order is actually placed.

“Once results are available, individuals have the option to discuss their results with an independent physician at no extra cost,” Dr. Faix said. ANA or RA results outside the normal ranges may trigger a “call from a PWNHealth healthcare coordinator, who can help provide information, suggestions on next steps, and set up time for the individual to speak with an independent physician to discuss questions or concerns regarding the results,” he said.

“Our goal is not to replace the role of a healthcare provider,” Dr. Faix said. “We are providing an alternate way for people to engage with the healthcare system that offers convenience, gives people more control over their own healthcare journeys, and meets them where they are, supporting both consumers and their care teams.” The company has expanded its offerings from an initial 30 tests made available in 2018 to over 130 today, deciding which to offer “based on consumer research and expertise of clinical experts.” The company has also “seen steady interest in our two consumer rheumatology offerings,” Dr. Faix said.
 

The DTC Landscape in Rheumatology

Within rheumatology, among the most popular tests is for ANA, based on the experience of Alfred Kim, MD, PhD, associate professor of medicine at Washington University School of Medicine in St Louis, Missouri.

Dr. Kim

“For a lot of people, losing control over their health is maybe the most frightening experience they can have, so I think a lot of patients use this as a way to kind of have ownership over their health,” Dr. Kim said. “Let’s say they’ve been to four doctors. No one can explain what’s going on. They’re getting frustrated, and so they just turn to solutions where they feel like they have ownership over the situation.”

Though the market is undoubtedly growing, the growth appears uneven across geography and institution types. Kim has seen a “fair number of referrals,” with patients coming in with results from a DTC test. Michael Putman, MD, MSci, assistant professor of medicine at the Medical College of Wisconsin in Milwaukee, hasn’t seen it much. “I know that patients can get testing done themselves independently, but I don’t have people routinely coming in with tests they’ve ordered in advance of our appointment,” Dr. Putman said, but, like Dr. Kim, he recognizes why patients might seek them out.

Dr. Putman

Ron Hester Photography

Risks vs Benefits

DTC testing is not an answer to the national shortage of rheumatologists, however, especially given the risks that Dr. Niewold, Dr. Putman, and Dr. Kim worry outweigh potential benefits. On the one hand, getting online test results may help expedite a referral to a specialist, Dr. Niewold said. But a long wait for that appointment could then easily become a bigger source of anxiety than comfort, Dr. Putman said.

“It’s a trade-off where you are accepting a lot more people getting false-positive diagnoses and spending months thinking they have some disease where they might not, in exchange for a couple people who would have had a delayed diagnosis,” Dr. Putman said. “There’s an enormous amount of existential suffering,” that’s familiar to rheumatologists because some patients may dread the diagnosis of a rheumatic disease the way they might fear a cancer diagnosis, especially if they have lost a family member to a condition that they suspect they share, he said. “To put yourself into an existential catastrophe — that’s not a small harm.”

Dr. Niewold agreed, pointing out that patients with a positive ANA test may “get unnecessarily worried and stay up all night reading about lupus, getting scared for weeks on end before seeing a specialist.” And there are financial harms as well for patients who may order the same test multiple times, or a whole slate of tests, that they don’t need for hundreds or thousands of dollars. There’s also the lost time and effort of researching a condition or even seeking out support groups that patients may pursue, Dr. Niewold said.

The likely biggest risk to individuals, however, is the potential for overdiagnosis or misdiagnosis.

“If someone comes in and they’ve read the textbook on lupus and they have a positive ANA, it’s really hard as a rheumatologist to walk that back,” Dr. Putman said. “The human mind is a powerful thing,” he added, and people who get a positive test will likely start to notice things like joint pain or a rash on their cheeks and begin attributing it to a diagnosis they risk convincing themselves they have. “When people come into your clinic not knowing what a disease would look like and they just tell you how they’re feeling, it’s a much cleaner and more honest way to approach diagnosis.”

Most patients likely don’t realize, for example, that none of the tests rheumatologists usually order are diagnostic in and of themselves, Dr. Niewold said. “They’re all kind of like stars in the constellation of a diagnosis,” he said. “They’re helpful, but none of them is sufficient by itself.”

Dr. Killeen agreed, noting that “consumers might not understand the nuances of these tests well enough to know whether it is appropriate to order them or how to interpret the results correctly.” Given the long-term implications of a diagnosis for a rheumatologic disease, “I would have concerns about consumers ordering and interpreting rheumatologic tests without working closely with their physicians,” Dr. Killeen said. “The main concern that lab experts have about direct-to-consumer tests is the potential for people to get misleading results and/or to misinterpret their results, which in turn could lead to people not getting the treatment they need or getting treatment when they don’t need any at all.”

It’s one thing for patients to come in asking for a particular treatment they may not need but which a doctor may be able to dissuade them from seeking. But Dr. Kim also pointed out the risk that patients may decide to treat themselves with therapies that haven’t undergone rigorous testing or haven’t been recommended by a physician.

“We tend to have people who come in with a pretty clear idea of what they want done, but the problem is, we don’t know if their reasoning is correct from a clinical perspective,” Dr. Kim said. Companies offer these tests with the belief that they’re “providing patients a choice, an option to take ownership,” he said, “but the potential harm can be realized very quickly because there are going to be people who are misdiagnosing themselves and, worse yet, may then pursue their own treatment plan that’s going in the opposite direction of where we think it needs to go.”

Or, on the flip side, if a patient erroneously believes they have the answer to what ails them, it may delay diagnosis of a more serious condition that’s rarer or harder to detect. Kim pointed to, for example, intravascular lymphoma, which is notoriously as difficult to identify as it is rare and aggressive. If a patient’s confirmation bias has led them to believe they have an autoimmune condition, they may not receive the more serious diagnosis until it’s advanced too far to treat.
 

Patient-Provider Relationship Friction

Another concern is how these tests may lead to confusion and frustration that can erode the patient-provider relationship, particularly because most patients don’t know how to interpret the results or understand the bigger context in which the results have to be interpreted. Many patients may think a test can come back with a binary answer, a positive or negative, and that means they do or don’t have a condition. That’s generally true for pregnancy tests, COVID tests, and sexually transmitted infection tests — the kinds of tests that have long been available to consumers and which have fairly straightforward answers.

But physicians know that’s not the case for many conditions, particularly those in rheumatology.

“In rheumatic diseases, because the tests have such marginal value in terms of diagnosis, almost always we develop a suspicion before we even think about ordering the tests, and then that dictates whether or not we cross that threshold,” Dr. Kim said. “A negative test doesn’t exclude the fact that you may have disease X, but a positive test also doesn’t mean you have disease X. All they provide is an idea of the risk.”

But some patients who come in with DTC test results have “already made the decision in their mind that they have a certain condition,” Dr. Kim said. “This is obviously dangerous because the majority of these patients do not have the condition they think they have, and it leaves a very uncomfortable feeling after the visit because they feel like they’ve been either betrayed by me or by the test, and they leave more confused.”

Patients may also come in with tests that a doctor isn’t familiar with or isn’t sure how to interpret on its own, at least for that particular patient.

“For ANA testing, we have a pretty good idea of its positive and negative predictive value because it’s ordered so much, but for many of these tests being offered, there are specific autoantibodies, and we tend to only get them in people where there’s a clinical suspicion,” Dr. Kim said. “Within that very specific context, we kind of understand what that value means, but if you give it to the general public, then those numbers aren’t as applicable and most likely overestimate the risk of disease.”

Even if providers consider the results of a DTC test in their differential, they may want to be sure it’s from a trustworthy source. “If a provider is uncertain about whether a direct-to-consumer testing company is reputable or about whether a direct-to-consumer test result is reliable, I would encourage them to consult with their laboratory medicine colleagues,” Dr. Killeen said.
 

Responding to Patients

Like any other patient coming to a clinical visit, the most common reason patients are likely ordering these tests is that they’re seeking answers. Kim doesn’t typically see patients doing their own monitoring for diagnosed conditions between visits — the expense would add up too quickly — or testing for genetic markers, which likely wouldn’t be very helpful either.

“Even though most of our diseases probably have a genetic underpinning, how much it contributes is always unclear,” Dr. Kim said. Even conditions with clear genetic variants, such as familial Mediterranean fever, spondyloarthritis, and Behçet disease, can only support a diagnosis, not diagnose it on its own, Dr. Killeen said. And these are not among the tests currently available on most DTC company sites.

While there are also tests that can offer information about genetic risks for certain medications, such as a thiopurine methyltransferase test to find out if a patient lacks the enzyme needed to break down the immunosuppressant drug azathioprine, Kim hasn’t seen patients seeking these out either.

“The more global and more compassionate way to think about this is that we have a lot of people who are struggling to understand what’s going on with their bodies, and most physicians really don’t know what the next steps are for these people,” Dr. Kim said. “They’re desperate, and their quality of life is so poor that they’re going to take extreme steps to try to manage their own frustration with this condition.”

That means clinicians’ most powerful tools when patients come in with DTC test results are their listening skills.

“Empathy is the most important thing, just being able to share the patient’s frustration to the point where they had to take matters into their own hands,” Dr. Kim said. “I think a lot of rheumatologists are actually pretty comfortable being in this position.”

Additionally, doctors should know that some patients may be engaging in attempts to self-diagnose, self-treat, or otherwise self-manage their symptoms or perceived condition. “They just need to be aware and try to make sure there’s no harm being done,” Dr. Kim said.

Ms. Welsh didn’t seek treatment or diagnosis on her own, but getting her test also did not give her the control she was seeking. “Looking back, it was kind of a waste of money, but it felt good in the moment,” Ms. Welsh said. “I was so upset, and I wanted that control, and in the end, it didn’t get me results any sooner, and it didn’t give me peace of mind.”

It was Ms. Welsh’s primary care doctor listening to her concerns, ordering the same test she had ordered with several others, and working with her to seek answers that reassured her that her provider cared about her well-being.

“A lot of what I do in my business is reassure people that you know what they have is treatable or not going to end their life as they know it,” Dr. Putman said. “And you certainly can’t reassure them if they’re not in your clinic yet.”

Dr. Putman has participated in clinical trials with AbbVie, consulting with Novartis and GSK, and clinical trials and consulting with Amgen and AstraZeneca. Dr. Niewold reported receiving research grants from EMD Serono and Zenas BioPharma and consulting for Thermo Fisher Scientific, Progentec Diagnostics, Roivant Sciences, AstraZeneca, S3 Connected Health, Flagship Pioneering, and Guidepoint. Dr. Kim reported sponsored research agreements with AstraZeneca, Bristol-Myers Squibb, Novartis, and CRISPR Therapeutics; royalties from Kypha; and consulting/speaking for Amgen, ANI Pharmaceuticals, Atara Biotherapeutics, Aurinia Pharmaceuticals, CARGO Therapeutics, Exagen Diagnostics, GSK, Hinge Bio, Kypha, Progentec Diagnostics, Synthekine, and UpToDate. Dr. Killeen had no relevant financial relationships to disclose.
 

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

When Jennifer Welsh, a 40-year-old from New Britain, Connecticut, visited her doctor about pain in her joints and neck, her doctor sent her to the emergency department (ED) to rule out meningitis. The ED did rule that out, as well as strep, so Ms. Welsh went to her follow-up appointment a few days later, hoping for answers or at least more tests to get those answers.

Instead, the doctor — a different one from the same practice as her primary care physician (PCP) — wouldn’t even talk to Ms. Welsh about her symptoms because she couldn’t see the ED’s results and refused to view the results that Ms. Welsh could pull up online.

“She just completely shut me down,” Ms. Welsh recalled. “It was a really awful appointment, and I left in tears. I was in physical pain, I had just been to the ER, nothing is really resolved, I’m stressed out about it, and this woman is completely dismissing me.”

She had been able to schedule an appointment with her regular PCP later that week, but after the harrowing experience with this doctor, she wondered if her PCP would order the rheumatoid arthritis (RA) test that Ms. Welsh suspected she needed. So, she took matters into her own hands.

“I was searching for what test to ask for from my doctor,” she said, and she found that she could order it on her own from a major lab company she was already familiar with. For around $100, “I could get it done and see what it says on my own,” she said.

But that’s not how it worked out. Her regular PCP apologized for the other doctor’s behavior and ordered the RA test as well as additional tests — and got results while Ms. Welsh still waited for the one she ordered to arrive over a week later.

At first, Ms. Welsh was grateful she could order the RA test without her doctor’s referral. “I felt it gave me a sense of control over the situation that I felt really not in control of, until the system failed me, and I didn’t get the results,” she said. But then, “not having someone I could call and get an answer about why my tests were delayed, why I wasn’t able to access them, why it was taking so long — it was definitely anxiety-inducing.”
 

A Growing Market

Ms. Welsh is one of a growing number of patients who are ordering direct-to-consumer (DTC) lab tests without the recommendation or guidance of a doctor. They’re offered online by labs ranging from well-established giants like Quest and Labcorp to smaller, potentially less vetted companies, although some smaller companies contract with larger companies like Quest. Combined, the DTC market is projected to be worth $2 billion by 2025.

Yet the burgeoning industry has also drawn critiques from both bioethicists and privacy experts. A research letter in JAMA in 2023, for example, found that less than half of the 21 companies identified in an online search declared Health Insurance Portability and Accountability Act compliance, while more than half “indicated the potential use of consumer data for research purposes either internally or through third-party sharing.” That study found the most commonly offered tests were related to diabetes, the thyroid, and vitamin levels, and hormone tests for men and women, such as testosterone or estradiol.

But a number of companies also offer tests related to rheumatologic conditions. A handful of tests offered by Labcorp, for example, could be used in rheumatology, such as tests for celiac antibodies or high-sensitivity C-reactive protein. Quest similarly offers a handful of autoimmune-related tests. But other companies offer a long slate of autoimmune or antibody tests.

The antinuclear antibody (ANA) test and RA panel offered by Quest are the same tests, run and analyzed in the same labs, as those ordered by physicians and hospitals, according to James Faix, MD, the medical director of immunology at Quest Diagnostics. Their RA panel includes rheumatoid factor and anti-cyclic citrullinated peptide as well as antibody to mutated citrullinated vimentin, “which may detect approximately 10%-15%” of patients who test negative to the first two.

Quest’s ANA test with reflex costs $112, and its RA panel costs $110, price points that are similar across other companies’ offerings. Labcorp declined to respond to questions about its DTC tests, and several smaller companies did not respond to queries about their offerings. It can therefore be hard to assess what’s included or what the quality is of many DTC tests, particularly from smaller, less established companies.
 

Oversight and Quality Control

Anthony Killeen, MD, PhD, president of the Association for Diagnostics & Laboratory Medicine (ADLM) and director of Clinical Laboratories at the University of Minnesota Medical Center in Minneapolis, said via email that the ADLM supports “expanding consumer access to direct-to-consumer laboratory testing services that have demonstrated analytical and clinical validity and clinical utility,” given the importance of individuals learning about their health status and becoming more involved in health decisions. But the ADLM also recommends “that only CLIA-certified laboratories perform direct-to-consumer testing,” he said.

Association for Diagnostics &amp; Laboratory Medicine

“There are direct-to-consumer tests on the market that are not medical-grade laboratory tests and that may be performed in nonaccredited laboratories,” Dr. Killeen said. “We advise consumers to steer clear of such tests.” The ADLM also encourages consumers to “work with qualified healthcare providers when making decisions based off the results they receive from any direct-to-consumer tests” and recommends that DTC test companies “provide consumers with sufficient information and/or access to expert help to assist them in ordering tests and interpreting the results.”

Yet it’s unclear how much support, if any, consumers can receive in terms of understanding what their tests mean. Most of the companies in the 2023 study offered optional follow-up with a healthcare professional, but these professionals ranged from physicians to “health coaches,” and all the companies had disclaimers that “test results did not constitute medical advice.”

At Quest, the only company to respond to this news organization’s request for comment, consumer-initiated tests ordered online are first reviewed by a physician at PWNHealth, an independent, third-party physician network, to determine that it’s appropriate before the lab order is actually placed.

“Once results are available, individuals have the option to discuss their results with an independent physician at no extra cost,” Dr. Faix said. ANA or RA results outside the normal ranges may trigger a “call from a PWNHealth healthcare coordinator, who can help provide information, suggestions on next steps, and set up time for the individual to speak with an independent physician to discuss questions or concerns regarding the results,” he said.

“Our goal is not to replace the role of a healthcare provider,” Dr. Faix said. “We are providing an alternate way for people to engage with the healthcare system that offers convenience, gives people more control over their own healthcare journeys, and meets them where they are, supporting both consumers and their care teams.” The company has expanded its offerings from an initial 30 tests made available in 2018 to over 130 today, deciding which to offer “based on consumer research and expertise of clinical experts.” The company has also “seen steady interest in our two consumer rheumatology offerings,” Dr. Faix said.
 

The DTC Landscape in Rheumatology

Within rheumatology, among the most popular tests is for ANA, based on the experience of Alfred Kim, MD, PhD, associate professor of medicine at Washington University School of Medicine in St Louis, Missouri.

Dr. Kim

“For a lot of people, losing control over their health is maybe the most frightening experience they can have, so I think a lot of patients use this as a way to kind of have ownership over their health,” Dr. Kim said. “Let’s say they’ve been to four doctors. No one can explain what’s going on. They’re getting frustrated, and so they just turn to solutions where they feel like they have ownership over the situation.”

Though the market is undoubtedly growing, the growth appears uneven across geography and institution types. Kim has seen a “fair number of referrals,” with patients coming in with results from a DTC test. Michael Putman, MD, MSci, assistant professor of medicine at the Medical College of Wisconsin in Milwaukee, hasn’t seen it much. “I know that patients can get testing done themselves independently, but I don’t have people routinely coming in with tests they’ve ordered in advance of our appointment,” Dr. Putman said, but, like Dr. Kim, he recognizes why patients might seek them out.

Dr. Putman

Ron Hester Photography

Risks vs Benefits

DTC testing is not an answer to the national shortage of rheumatologists, however, especially given the risks that Dr. Niewold, Dr. Putman, and Dr. Kim worry outweigh potential benefits. On the one hand, getting online test results may help expedite a referral to a specialist, Dr. Niewold said. But a long wait for that appointment could then easily become a bigger source of anxiety than comfort, Dr. Putman said.

“It’s a trade-off where you are accepting a lot more people getting false-positive diagnoses and spending months thinking they have some disease where they might not, in exchange for a couple people who would have had a delayed diagnosis,” Dr. Putman said. “There’s an enormous amount of existential suffering,” that’s familiar to rheumatologists because some patients may dread the diagnosis of a rheumatic disease the way they might fear a cancer diagnosis, especially if they have lost a family member to a condition that they suspect they share, he said. “To put yourself into an existential catastrophe — that’s not a small harm.”

Dr. Niewold agreed, pointing out that patients with a positive ANA test may “get unnecessarily worried and stay up all night reading about lupus, getting scared for weeks on end before seeing a specialist.” And there are financial harms as well for patients who may order the same test multiple times, or a whole slate of tests, that they don’t need for hundreds or thousands of dollars. There’s also the lost time and effort of researching a condition or even seeking out support groups that patients may pursue, Dr. Niewold said.

The likely biggest risk to individuals, however, is the potential for overdiagnosis or misdiagnosis.

“If someone comes in and they’ve read the textbook on lupus and they have a positive ANA, it’s really hard as a rheumatologist to walk that back,” Dr. Putman said. “The human mind is a powerful thing,” he added, and people who get a positive test will likely start to notice things like joint pain or a rash on their cheeks and begin attributing it to a diagnosis they risk convincing themselves they have. “When people come into your clinic not knowing what a disease would look like and they just tell you how they’re feeling, it’s a much cleaner and more honest way to approach diagnosis.”

Most patients likely don’t realize, for example, that none of the tests rheumatologists usually order are diagnostic in and of themselves, Dr. Niewold said. “They’re all kind of like stars in the constellation of a diagnosis,” he said. “They’re helpful, but none of them is sufficient by itself.”

Dr. Killeen agreed, noting that “consumers might not understand the nuances of these tests well enough to know whether it is appropriate to order them or how to interpret the results correctly.” Given the long-term implications of a diagnosis for a rheumatologic disease, “I would have concerns about consumers ordering and interpreting rheumatologic tests without working closely with their physicians,” Dr. Killeen said. “The main concern that lab experts have about direct-to-consumer tests is the potential for people to get misleading results and/or to misinterpret their results, which in turn could lead to people not getting the treatment they need or getting treatment when they don’t need any at all.”

It’s one thing for patients to come in asking for a particular treatment they may not need but which a doctor may be able to dissuade them from seeking. But Dr. Kim also pointed out the risk that patients may decide to treat themselves with therapies that haven’t undergone rigorous testing or haven’t been recommended by a physician.

“We tend to have people who come in with a pretty clear idea of what they want done, but the problem is, we don’t know if their reasoning is correct from a clinical perspective,” Dr. Kim said. Companies offer these tests with the belief that they’re “providing patients a choice, an option to take ownership,” he said, “but the potential harm can be realized very quickly because there are going to be people who are misdiagnosing themselves and, worse yet, may then pursue their own treatment plan that’s going in the opposite direction of where we think it needs to go.”

Or, on the flip side, if a patient erroneously believes they have the answer to what ails them, it may delay diagnosis of a more serious condition that’s rarer or harder to detect. Kim pointed to, for example, intravascular lymphoma, which is notoriously as difficult to identify as it is rare and aggressive. If a patient’s confirmation bias has led them to believe they have an autoimmune condition, they may not receive the more serious diagnosis until it’s advanced too far to treat.
 

Patient-Provider Relationship Friction

Another concern is how these tests may lead to confusion and frustration that can erode the patient-provider relationship, particularly because most patients don’t know how to interpret the results or understand the bigger context in which the results have to be interpreted. Many patients may think a test can come back with a binary answer, a positive or negative, and that means they do or don’t have a condition. That’s generally true for pregnancy tests, COVID tests, and sexually transmitted infection tests — the kinds of tests that have long been available to consumers and which have fairly straightforward answers.

But physicians know that’s not the case for many conditions, particularly those in rheumatology.

“In rheumatic diseases, because the tests have such marginal value in terms of diagnosis, almost always we develop a suspicion before we even think about ordering the tests, and then that dictates whether or not we cross that threshold,” Dr. Kim said. “A negative test doesn’t exclude the fact that you may have disease X, but a positive test also doesn’t mean you have disease X. All they provide is an idea of the risk.”

But some patients who come in with DTC test results have “already made the decision in their mind that they have a certain condition,” Dr. Kim said. “This is obviously dangerous because the majority of these patients do not have the condition they think they have, and it leaves a very uncomfortable feeling after the visit because they feel like they’ve been either betrayed by me or by the test, and they leave more confused.”

Patients may also come in with tests that a doctor isn’t familiar with or isn’t sure how to interpret on its own, at least for that particular patient.

“For ANA testing, we have a pretty good idea of its positive and negative predictive value because it’s ordered so much, but for many of these tests being offered, there are specific autoantibodies, and we tend to only get them in people where there’s a clinical suspicion,” Dr. Kim said. “Within that very specific context, we kind of understand what that value means, but if you give it to the general public, then those numbers aren’t as applicable and most likely overestimate the risk of disease.”

Even if providers consider the results of a DTC test in their differential, they may want to be sure it’s from a trustworthy source. “If a provider is uncertain about whether a direct-to-consumer testing company is reputable or about whether a direct-to-consumer test result is reliable, I would encourage them to consult with their laboratory medicine colleagues,” Dr. Killeen said.
 

Responding to Patients

Like any other patient coming to a clinical visit, the most common reason patients are likely ordering these tests is that they’re seeking answers. Kim doesn’t typically see patients doing their own monitoring for diagnosed conditions between visits — the expense would add up too quickly — or testing for genetic markers, which likely wouldn’t be very helpful either.

“Even though most of our diseases probably have a genetic underpinning, how much it contributes is always unclear,” Dr. Kim said. Even conditions with clear genetic variants, such as familial Mediterranean fever, spondyloarthritis, and Behçet disease, can only support a diagnosis, not diagnose it on its own, Dr. Killeen said. And these are not among the tests currently available on most DTC company sites.

While there are also tests that can offer information about genetic risks for certain medications, such as a thiopurine methyltransferase test to find out if a patient lacks the enzyme needed to break down the immunosuppressant drug azathioprine, Kim hasn’t seen patients seeking these out either.

“The more global and more compassionate way to think about this is that we have a lot of people who are struggling to understand what’s going on with their bodies, and most physicians really don’t know what the next steps are for these people,” Dr. Kim said. “They’re desperate, and their quality of life is so poor that they’re going to take extreme steps to try to manage their own frustration with this condition.”

That means clinicians’ most powerful tools when patients come in with DTC test results are their listening skills.

“Empathy is the most important thing, just being able to share the patient’s frustration to the point where they had to take matters into their own hands,” Dr. Kim said. “I think a lot of rheumatologists are actually pretty comfortable being in this position.”

Additionally, doctors should know that some patients may be engaging in attempts to self-diagnose, self-treat, or otherwise self-manage their symptoms or perceived condition. “They just need to be aware and try to make sure there’s no harm being done,” Dr. Kim said.

Ms. Welsh didn’t seek treatment or diagnosis on her own, but getting her test also did not give her the control she was seeking. “Looking back, it was kind of a waste of money, but it felt good in the moment,” Ms. Welsh said. “I was so upset, and I wanted that control, and in the end, it didn’t get me results any sooner, and it didn’t give me peace of mind.”

It was Ms. Welsh’s primary care doctor listening to her concerns, ordering the same test she had ordered with several others, and working with her to seek answers that reassured her that her provider cared about her well-being.

“A lot of what I do in my business is reassure people that you know what they have is treatable or not going to end their life as they know it,” Dr. Putman said. “And you certainly can’t reassure them if they’re not in your clinic yet.”

Dr. Putman has participated in clinical trials with AbbVie, consulting with Novartis and GSK, and clinical trials and consulting with Amgen and AstraZeneca. Dr. Niewold reported receiving research grants from EMD Serono and Zenas BioPharma and consulting for Thermo Fisher Scientific, Progentec Diagnostics, Roivant Sciences, AstraZeneca, S3 Connected Health, Flagship Pioneering, and Guidepoint. Dr. Kim reported sponsored research agreements with AstraZeneca, Bristol-Myers Squibb, Novartis, and CRISPR Therapeutics; royalties from Kypha; and consulting/speaking for Amgen, ANI Pharmaceuticals, Atara Biotherapeutics, Aurinia Pharmaceuticals, CARGO Therapeutics, Exagen Diagnostics, GSK, Hinge Bio, Kypha, Progentec Diagnostics, Synthekine, and UpToDate. Dr. Killeen had no relevant financial relationships to disclose.
 

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

Matching adjusted indirect comparison is one method of evaluating comparative effectiveness. To compare the efficacy between bimekizumab, an interleukin (IL) 17A/F inhibitor and risankizumab, an IL-23 inhibitor, Mease et al conducted such a study using data from four phase 3 trials (BE OPTIMAL, BE COMPLETE, KEEPsAKE-1, and KEEPsAKE-2) involving patients who were biologic-naive or inadequate responders to tumour necrosis factor (TNF) inhibitors  who received bimekizumab (n = 698) or risankizumab (n = 589).¹
 

At week 52, bimekizumab led to a higher likelihood of achieving a ≥ 70% improvement in the American College of Rheumatology (ACR) response in patients who were biologic-naive and TNF inhibitor inadequate responders (TNFi-IR), compared with risankizumab. Bimekizumab also had greater odds of achieving minimal disease activity in patients who were TNFi-IR. Thus, bimekizumab may be superior to risankizumab for treating those with PsA. Randomized controlled head-to-head clinical trials are required to confirm these findings.

In regard to long-term safety and efficacy of bimekizumab, Mease et al reported that bimekizumab demonstrated consistent safety and sustained efficacy for up to 2 years in patients with PsA.² In this open-label extension (BE VITAL) of two phase 3 trials that included biologic-naive (n = 852) and TNFi-IR (n = 400) patients with PsA who were randomly assigned to receive bimekizumab, placebo with crossover to bimekizumab at week 16, or adalimumab followed by bimekizumab at week 52, no new safety signals were noted from weeks 52 to 104,. SARS-CoV-2 infection was the most common treatment-emergent adverse event. Approximately 50% of biologic-naive and TNFi-IR patients maintained a 50% or greater improvement in the ACR response.

Guselkumab, another IL-23 inhibitor, has proven efficacy in treating PsA. Curtis et al investigated the impact of early achievement of improvement with guselkumab and longer-term outcomes.³ This was a post hoc analysis of two phase 3 trials, DISCOVER-1 and DISCOVER-2, which included 1120 patients with active PsA who received guselkumab every 4 or 8 weeks (Q4W) or placebo with a crossover to guselkumab Q4W at week 24. The study demonstrated that guselkumab led to early achievement of minimal clinically important improvement (MCII) in clinical disease activity index for PsA (cDAPSA), with higher response rates at week 4 compared with placebo. Moreover, achieving early MCII in cDAPSA was associated with sustained disease control at weeks 24 and 52. Thus, guselkumab treatment achieved MCII in cDAPSA after the first dose and sustained disease control for up to 1 year. Early treatment response and a proven safety record make guselkumab an attractive treatment option for PsA.

PsA clinical trials mostly include patients with polyarthritis. Little is known about treatment efficacy for oligoarticular PsA. To address this gap in knowledge, Gossec et al reported the results of the phase 4 FOREMOST trial that included 308 patients with early (symptom duration 5 years or less) targeted therapy–naive oligoarticular PsA and were randomly assigned to receive apremilast (n = 203) or placebo (n = 105).⁴ At week 16, a higher proportion of patients receiving apremilast achieved minimal disease activity (joints response) compared with those receiving placebo. No new safety signals were reported. Apremilast is thus efficacious in treating early oligoarticular PsA as well as polyarticular PsA and psoriasis. Similar studies with other targeted therapies will help clinicians better manage early oligoarticular PsA.

References

1. Mease PJ, Warren RB, Nash P, et al. Comparative effectiveness of bimekizumab and risankizumab in patients with psoriatic arthritis at 52 weeks assessed using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 Aug 9. Source
2. Mease PJ, Merola JF, Tanaka Y, et al. Safety and efficacy of bimekizumab in patients with psoriatic arthritis: 2-year results from two phase 3 studies. Rheumatol Ther. 2024 Aug 31. Source
3. Curtis JR, et al. Early improvements with guselkumab associate with sustained control of psoriatic arthritis: post hoc analyses of two phase 3 trials. Rheumatol Ther. 2024 Sep 11. Source
4. Gossec L, Coates LC, Gladman DD, et al. Treatment of early oligoarticular psoriatic arthritis with apremilast: primary outcomes at week 16 from the FOREMOST randomised controlled trial. Ann Rheum Dis. 2024 Sep 16:ard-2024-225833. Source

Matching adjusted indirect comparison is one method of evaluating comparative effectiveness. To compare the efficacy between bimekizumab, an interleukin (IL) 17A/F inhibitor and risankizumab, an IL-23 inhibitor, Mease et al conducted such a study using data from four phase 3 trials (BE OPTIMAL, BE COMPLETE, KEEPsAKE-1, and KEEPsAKE-2) involving patients who were biologic-naive or inadequate responders to tumour necrosis factor (TNF) inhibitors  who received bimekizumab (n = 698) or risankizumab (n = 589).¹
 

At week 52, bimekizumab led to a higher likelihood of achieving a ≥ 70% improvement in the American College of Rheumatology (ACR) response in patients who were biologic-naive and TNF inhibitor inadequate responders (TNFi-IR), compared with risankizumab. Bimekizumab also had greater odds of achieving minimal disease activity in patients who were TNFi-IR. Thus, bimekizumab may be superior to risankizumab for treating those with PsA. Randomized controlled head-to-head clinical trials are required to confirm these findings.

In regard to long-term safety and efficacy of bimekizumab, Mease et al reported that bimekizumab demonstrated consistent safety and sustained efficacy for up to 2 years in patients with PsA.² In this open-label extension (BE VITAL) of two phase 3 trials that included biologic-naive (n = 852) and TNFi-IR (n = 400) patients with PsA who were randomly assigned to receive bimekizumab, placebo with crossover to bimekizumab at week 16, or adalimumab followed by bimekizumab at week 52, no new safety signals were noted from weeks 52 to 104,. SARS-CoV-2 infection was the most common treatment-emergent adverse event. Approximately 50% of biologic-naive and TNFi-IR patients maintained a 50% or greater improvement in the ACR response.

Guselkumab, another IL-23 inhibitor, has proven efficacy in treating PsA. Curtis et al investigated the impact of early achievement of improvement with guselkumab and longer-term outcomes.³ This was a post hoc analysis of two phase 3 trials, DISCOVER-1 and DISCOVER-2, which included 1120 patients with active PsA who received guselkumab every 4 or 8 weeks (Q4W) or placebo with a crossover to guselkumab Q4W at week 24. The study demonstrated that guselkumab led to early achievement of minimal clinically important improvement (MCII) in clinical disease activity index for PsA (cDAPSA), with higher response rates at week 4 compared with placebo. Moreover, achieving early MCII in cDAPSA was associated with sustained disease control at weeks 24 and 52. Thus, guselkumab treatment achieved MCII in cDAPSA after the first dose and sustained disease control for up to 1 year. Early treatment response and a proven safety record make guselkumab an attractive treatment option for PsA.

PsA clinical trials mostly include patients with polyarthritis. Little is known about treatment efficacy for oligoarticular PsA. To address this gap in knowledge, Gossec et al reported the results of the phase 4 FOREMOST trial that included 308 patients with early (symptom duration 5 years or less) targeted therapy–naive oligoarticular PsA and were randomly assigned to receive apremilast (n = 203) or placebo (n = 105).⁴ At week 16, a higher proportion of patients receiving apremilast achieved minimal disease activity (joints response) compared with those receiving placebo. No new safety signals were reported. Apremilast is thus efficacious in treating early oligoarticular PsA as well as polyarticular PsA and psoriasis. Similar studies with other targeted therapies will help clinicians better manage early oligoarticular PsA.

References

1. Mease PJ, Warren RB, Nash P, et al. Comparative effectiveness of bimekizumab and risankizumab in patients with psoriatic arthritis at 52 weeks assessed using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 Aug 9. Source
2. Mease PJ, Merola JF, Tanaka Y, et al. Safety and efficacy of bimekizumab in patients with psoriatic arthritis: 2-year results from two phase 3 studies. Rheumatol Ther. 2024 Aug 31. Source
3. Curtis JR, et al. Early improvements with guselkumab associate with sustained control of psoriatic arthritis: post hoc analyses of two phase 3 trials. Rheumatol Ther. 2024 Sep 11. Source
4. Gossec L, Coates LC, Gladman DD, et al. Treatment of early oligoarticular psoriatic arthritis with apremilast: primary outcomes at week 16 from the FOREMOST randomised controlled trial. Ann Rheum Dis. 2024 Sep 16:ard-2024-225833. Source

Matching adjusted indirect comparison is one method of evaluating comparative effectiveness. To compare the efficacy between bimekizumab, an interleukin (IL) 17A/F inhibitor and risankizumab, an IL-23 inhibitor, Mease et al conducted such a study using data from four phase 3 trials (BE OPTIMAL, BE COMPLETE, KEEPsAKE-1, and KEEPsAKE-2) involving patients who were biologic-naive or inadequate responders to tumour necrosis factor (TNF) inhibitors  who received bimekizumab (n = 698) or risankizumab (n = 589).¹
 

At week 52, bimekizumab led to a higher likelihood of achieving a ≥ 70% improvement in the American College of Rheumatology (ACR) response in patients who were biologic-naive and TNF inhibitor inadequate responders (TNFi-IR), compared with risankizumab. Bimekizumab also had greater odds of achieving minimal disease activity in patients who were TNFi-IR. Thus, bimekizumab may be superior to risankizumab for treating those with PsA. Randomized controlled head-to-head clinical trials are required to confirm these findings.

In regard to long-term safety and efficacy of bimekizumab, Mease et al reported that bimekizumab demonstrated consistent safety and sustained efficacy for up to 2 years in patients with PsA.² In this open-label extension (BE VITAL) of two phase 3 trials that included biologic-naive (n = 852) and TNFi-IR (n = 400) patients with PsA who were randomly assigned to receive bimekizumab, placebo with crossover to bimekizumab at week 16, or adalimumab followed by bimekizumab at week 52, no new safety signals were noted from weeks 52 to 104,. SARS-CoV-2 infection was the most common treatment-emergent adverse event. Approximately 50% of biologic-naive and TNFi-IR patients maintained a 50% or greater improvement in the ACR response.

Guselkumab, another IL-23 inhibitor, has proven efficacy in treating PsA. Curtis et al investigated the impact of early achievement of improvement with guselkumab and longer-term outcomes.³ This was a post hoc analysis of two phase 3 trials, DISCOVER-1 and DISCOVER-2, which included 1120 patients with active PsA who received guselkumab every 4 or 8 weeks (Q4W) or placebo with a crossover to guselkumab Q4W at week 24. The study demonstrated that guselkumab led to early achievement of minimal clinically important improvement (MCII) in clinical disease activity index for PsA (cDAPSA), with higher response rates at week 4 compared with placebo. Moreover, achieving early MCII in cDAPSA was associated with sustained disease control at weeks 24 and 52. Thus, guselkumab treatment achieved MCII in cDAPSA after the first dose and sustained disease control for up to 1 year. Early treatment response and a proven safety record make guselkumab an attractive treatment option for PsA.

PsA clinical trials mostly include patients with polyarthritis. Little is known about treatment efficacy for oligoarticular PsA. To address this gap in knowledge, Gossec et al reported the results of the phase 4 FOREMOST trial that included 308 patients with early (symptom duration 5 years or less) targeted therapy–naive oligoarticular PsA and were randomly assigned to receive apremilast (n = 203) or placebo (n = 105).⁴ At week 16, a higher proportion of patients receiving apremilast achieved minimal disease activity (joints response) compared with those receiving placebo. No new safety signals were reported. Apremilast is thus efficacious in treating early oligoarticular PsA as well as polyarticular PsA and psoriasis. Similar studies with other targeted therapies will help clinicians better manage early oligoarticular PsA.

References

1. Mease PJ, Warren RB, Nash P, et al. Comparative effectiveness of bimekizumab and risankizumab in patients with psoriatic arthritis at 52 weeks assessed using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 Aug 9. Source
2. Mease PJ, Merola JF, Tanaka Y, et al. Safety and efficacy of bimekizumab in patients with psoriatic arthritis: 2-year results from two phase 3 studies. Rheumatol Ther. 2024 Aug 31. Source
3. Curtis JR, et al. Early improvements with guselkumab associate with sustained control of psoriatic arthritis: post hoc analyses of two phase 3 trials. Rheumatol Ther. 2024 Sep 11. Source
4. Gossec L, Coates LC, Gladman DD, et al. Treatment of early oligoarticular psoriatic arthritis with apremilast: primary outcomes at week 16 from the FOREMOST randomised controlled trial. Ann Rheum Dis. 2024 Sep 16:ard-2024-225833. Source

The Food and Drug Administration has approved bimekizumab-bkzx (Bimzelx; UCB) for adult patients with active psoriatic arthritis (PsA), active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS).

The drug, an interleukin (IL)–17A and IL-17F inhibitor, was first approved in October 2023 for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Wikimedia Commons/FitzColinGerald/Creative Commons License

“In psoriatic arthritis and across the spectrum of axSpA, clinical study results and real-world experience outside the US have highlighted that Bimzelx can help patients achieve high thresholds of clinical response that are rapid in onset and sustained up to 2 years,” said Emmanuel Caeymaex, executive vice president, head of patient impact, and chief commercial officer of UCB in a press release. 

The recommended dosage of bimekizumab for adult patients with active PsA, nr-axSpA, or AS is 160 mg by subcutaneous injection every 4 weeks. For patients with PsA and coexistent moderate to severe plaque psoriasis, the dosage is the same as for patients with plaque psoriasis. The dosing for plaque psoriasis is to administer 320 mg (two 160-mg injections) by subcutaneous injection at weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing ≥ 120 kg, consider a dose of 320 mg every 4 weeks after week 16.
 

PsA Clinical Trials

The approval for PsA was based on data from two phase 3 clinical trials, including 852 participants naive to biologics (BE OPTIMAL) and 400 participants with inadequate response to treatment with one or two tumor necrosis factor (TNF) inhibitors (BE COMPLETE). Both studies met their primary endpoint, 50% improvement in American College of Rheumatology response criteria (ACR50) at 16 weeks, as well as ranked secondary endpoints. Secondary endpoints included minimal disease activity (MDA) and Psoriasis Area and Severity Index 100 (complete skin clearance) at week 16.

At 16 weeks:

• About 44% of both the biologic-naive (189 of 431) and TNF inhibitor–resistant (116 of 267) groups receiving bimekizumab achieved ACR50 response, compared with 10% (28 of 281) and 7% (9 of 133) receiving placebo, respectively.
• About 45% of all patients treated with bimekizumab achieved MDA.
• Nearly 60% of TNF inhibitor–resistant patients had complete skin clearance.

These responses generally were sustained for 1 year. The most common adverse reactions are upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infection.
 

NR-axSpA and AS Clinical Trials

The approval for active nr-axSpA and active AS was based on data from two clinical studies, BE MOBILE 1 (nr-axSpA) and BE MOBILE 2 (AS). Both studies met their primary endpoint, 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS40) at 16 weeks.

Key findings included:

• In nr-axSpA patients, 47.7% (61 of 128) receiving bimekizumab achieved ASAS40 at week 16, compared with 21.4% (27 of 126) receiving placebo.
• In AS patients, 44.8% (99 of 221) in the bimekizumab group achieved ASAS40 response at week 16 vs 22.5% (25 of 111) receiving placebo.
• At 1 year in both groups, 60% treated with bimekizumab achieved an Ankylosing Spondylitis Disease Activity Score < 2.1.

In nr-axSpA, the most common adverse reactions are upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, increase in transaminase, and urinary tract infection. In AS, the most common adverse reactions are upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection-site pain, rash, and vulvovaginal mycotic infection.

Bimekizumab was approved by the European Commission for the same rheumatologic indications in June 2023.

Bimekizumab is currently available to eligible patients in the United States, according to the press release.

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

The Food and Drug Administration has approved bimekizumab-bkzx (Bimzelx; UCB) for adult patients with active psoriatic arthritis (PsA), active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS).

The drug, an interleukin (IL)–17A and IL-17F inhibitor, was first approved in October 2023 for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Wikimedia Commons/FitzColinGerald/Creative Commons License

“In psoriatic arthritis and across the spectrum of axSpA, clinical study results and real-world experience outside the US have highlighted that Bimzelx can help patients achieve high thresholds of clinical response that are rapid in onset and sustained up to 2 years,” said Emmanuel Caeymaex, executive vice president, head of patient impact, and chief commercial officer of UCB in a press release. 

The recommended dosage of bimekizumab for adult patients with active PsA, nr-axSpA, or AS is 160 mg by subcutaneous injection every 4 weeks. For patients with PsA and coexistent moderate to severe plaque psoriasis, the dosage is the same as for patients with plaque psoriasis. The dosing for plaque psoriasis is to administer 320 mg (two 160-mg injections) by subcutaneous injection at weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing ≥ 120 kg, consider a dose of 320 mg every 4 weeks after week 16.
 

PsA Clinical Trials

The approval for PsA was based on data from two phase 3 clinical trials, including 852 participants naive to biologics (BE OPTIMAL) and 400 participants with inadequate response to treatment with one or two tumor necrosis factor (TNF) inhibitors (BE COMPLETE). Both studies met their primary endpoint, 50% improvement in American College of Rheumatology response criteria (ACR50) at 16 weeks, as well as ranked secondary endpoints. Secondary endpoints included minimal disease activity (MDA) and Psoriasis Area and Severity Index 100 (complete skin clearance) at week 16.

At 16 weeks:

• About 44% of both the biologic-naive (189 of 431) and TNF inhibitor–resistant (116 of 267) groups receiving bimekizumab achieved ACR50 response, compared with 10% (28 of 281) and 7% (9 of 133) receiving placebo, respectively.
• About 45% of all patients treated with bimekizumab achieved MDA.
• Nearly 60% of TNF inhibitor–resistant patients had complete skin clearance.

These responses generally were sustained for 1 year. The most common adverse reactions are upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infection.
 

NR-axSpA and AS Clinical Trials

The approval for active nr-axSpA and active AS was based on data from two clinical studies, BE MOBILE 1 (nr-axSpA) and BE MOBILE 2 (AS). Both studies met their primary endpoint, 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS40) at 16 weeks.

Key findings included:

• In nr-axSpA patients, 47.7% (61 of 128) receiving bimekizumab achieved ASAS40 at week 16, compared with 21.4% (27 of 126) receiving placebo.
• In AS patients, 44.8% (99 of 221) in the bimekizumab group achieved ASAS40 response at week 16 vs 22.5% (25 of 111) receiving placebo.
• At 1 year in both groups, 60% treated with bimekizumab achieved an Ankylosing Spondylitis Disease Activity Score < 2.1.

In nr-axSpA, the most common adverse reactions are upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, increase in transaminase, and urinary tract infection. In AS, the most common adverse reactions are upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection-site pain, rash, and vulvovaginal mycotic infection.

Bimekizumab was approved by the European Commission for the same rheumatologic indications in June 2023.

Bimekizumab is currently available to eligible patients in the United States, according to the press release.

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

The Food and Drug Administration has approved bimekizumab-bkzx (Bimzelx; UCB) for adult patients with active psoriatic arthritis (PsA), active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS).

The drug, an interleukin (IL)–17A and IL-17F inhibitor, was first approved in October 2023 for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Wikimedia Commons/FitzColinGerald/Creative Commons License

“In psoriatic arthritis and across the spectrum of axSpA, clinical study results and real-world experience outside the US have highlighted that Bimzelx can help patients achieve high thresholds of clinical response that are rapid in onset and sustained up to 2 years,” said Emmanuel Caeymaex, executive vice president, head of patient impact, and chief commercial officer of UCB in a press release. 

The recommended dosage of bimekizumab for adult patients with active PsA, nr-axSpA, or AS is 160 mg by subcutaneous injection every 4 weeks. For patients with PsA and coexistent moderate to severe plaque psoriasis, the dosage is the same as for patients with plaque psoriasis. The dosing for plaque psoriasis is to administer 320 mg (two 160-mg injections) by subcutaneous injection at weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing ≥ 120 kg, consider a dose of 320 mg every 4 weeks after week 16.
 

PsA Clinical Trials

The approval for PsA was based on data from two phase 3 clinical trials, including 852 participants naive to biologics (BE OPTIMAL) and 400 participants with inadequate response to treatment with one or two tumor necrosis factor (TNF) inhibitors (BE COMPLETE). Both studies met their primary endpoint, 50% improvement in American College of Rheumatology response criteria (ACR50) at 16 weeks, as well as ranked secondary endpoints. Secondary endpoints included minimal disease activity (MDA) and Psoriasis Area and Severity Index 100 (complete skin clearance) at week 16.

At 16 weeks:

• About 44% of both the biologic-naive (189 of 431) and TNF inhibitor–resistant (116 of 267) groups receiving bimekizumab achieved ACR50 response, compared with 10% (28 of 281) and 7% (9 of 133) receiving placebo, respectively.
• About 45% of all patients treated with bimekizumab achieved MDA.
• Nearly 60% of TNF inhibitor–resistant patients had complete skin clearance.

These responses generally were sustained for 1 year. The most common adverse reactions are upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infection.
 

NR-axSpA and AS Clinical Trials

The approval for active nr-axSpA and active AS was based on data from two clinical studies, BE MOBILE 1 (nr-axSpA) and BE MOBILE 2 (AS). Both studies met their primary endpoint, 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS40) at 16 weeks.

Key findings included:

• In nr-axSpA patients, 47.7% (61 of 128) receiving bimekizumab achieved ASAS40 at week 16, compared with 21.4% (27 of 126) receiving placebo.
• In AS patients, 44.8% (99 of 221) in the bimekizumab group achieved ASAS40 response at week 16 vs 22.5% (25 of 111) receiving placebo.
• At 1 year in both groups, 60% treated with bimekizumab achieved an Ankylosing Spondylitis Disease Activity Score < 2.1.

In nr-axSpA, the most common adverse reactions are upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, increase in transaminase, and urinary tract infection. In AS, the most common adverse reactions are upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection-site pain, rash, and vulvovaginal mycotic infection.

Bimekizumab was approved by the European Commission for the same rheumatologic indications in June 2023.

Bimekizumab is currently available to eligible patients in the United States, according to the press release.

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

Two relatively simple interventions — addressing high blood pressure (BP) and smoking cessation — could make a huge difference for patients with rheumatic disease. Patients with autoimmune disease are up to three times more likely to develop cardiovascular disease (CVD) than the general population. In addition to compounding CVD, smoking is tied to the development of certain autoimmune conditions, as well as worse outcomes. Christie Bartels, MD, chief of the Division of Rheumatology at the University of Wisconsin School of Medicine and Public Health, Madison, has focused her research on improving cardiac health in inflammatory diseases. This news organization spoke with Bartels about two short interventions she developed that tackle hypertension and smoking cessation during regular visits, each taking less than 3 minutes.

How Do These Programs Address Cardiac Disease Prevention?

The BP and Quit Connect programs help clinics systematically address the two most modifiable risk factors for CVD: high BP and smoking. There’s also evidence that addressing these two risk factors improves outcomes in rheumatic diseases. Hypertension predicts an increase in lupus damage. Particularly in lupus nephritis, hypertension will increase the risk for CVD and kidney failure. People who use tobacco have worse outcomes in diseases like rheumatoid arthritis, psoriatic arthritis, and lupus, as well as more CVD, and antirheumatic drugs may not work as well.

University of Wisconsin School of Medicine and Public Health

In 90 seconds to 3 minutes, staff can do protocol-based care, which we’ve done across 20,000-plus visits. We showed we can improve population level rates of high BP and BP control, as well as increase smoking quitting rates across different patient settings.
 

What Is the Quit Connect Program?

The Quit Connect program is a 10- to 90-second point of care intervention. During rooming, staff (medical assistants and nurses) ask patients: “A) Do you smoke? and B) Have you thought about cutting back or quitting in the next 30 days?”

It turns out, when you ask the question that way, between a third and a half of people say that they’ve thought about cutting back or quitting. Then, we can get patients connected directly to Quitline, a free public service across all 50 states that smokers can use to get cessation support.

If patients are ready, we ask if we can arrange for them to receive a call from a Quitline coach about setting a quit date or receiving free nicotine replacement therapy. The beautiful thing is when that all happens, A) it’s free to the patient, and B) the results from the Quitline can be recorded right back to the electronic health record.

In our most recent publication in Arthritis Care & Research, we documented bringing Quit Connect to Grady Hospital in downtown Atlanta. It’s a safety net hospital, where 80% patients are Black and 70%-80% patients are on public insurance or uninsured. Using this protocol, we improved Quitline referrals 20-fold.
 

What Is the BP Connect Program?

At least half of the encounters in United States happen in specialty clinics. Unfortunately, when patients get their BP measured in a specialty clinic that’s not a cardiology or a vascular clinic, often, even if the pressure is high, the clinic doesn’t give patients feedback on that. The problem is because we haven’t said anything, that gives people the false reassurance that their BP is okay.

We’ve developed a 3-minute protocol to ask, advise, and connect. The idea is that if we measure a high BP, then we remeasure and confirm that it’s high. Then, we advise why it matters in rheumatic disease: Patients with rheumatic diseases are already at an increased risk for heart disease, and controlling BP can make a big difference. Then, we connect patients with high BP back to primary care.

Specifically, a SmartSet — an electronic medical record feature — prompts different actions based on confirmed high BP readings:

• If systolic BP ≥ 140-159, the SmartSet directs scheduling a visit to a nurse or primary care provider.
• If systolic BP ≥ 160-179, the next primary care visit anticipates the need to see a prescriber.
• If systolic BP ≥ 180, then the medical assistant or nurse at the visit is instructed to notify the provider who can arrange a provider-to-provider handoff for safety to exclude a hypertensive emergency.

That order goes to the scheduler to call primary care to coordinate follow-up. BP Connect doubled the likelihood of a guideline-recommended follow-up in primary care within 30 days. All patients benefited, and disparities decreased. BP Connect has had 1100 downloads, and both BP and Quit Connect programs are endorsed by the Centers for Disease Control and Prevention and Million Hearts.
 

How Do These Programs Affect Clinical Practice?

We developed these interventions with a health system engineer, and we time stamped everything. Part of the sustainability of this model is that it fits within a regular workflow. As a practicing rheumatologist, I understand that time is a precious commodity.

The interventions are in partnership with frontline staff. We’ve received feedback that they feel pride participating in these initiatives. They can say, because of me, 30 patients followed up last month for high BP, or 10 patients took a referral to the Quitline last year. We celebrate these accomplishments with the staff.
 

What Are the Next Steps for These Programs?

Public-facing toolkits for both BP and Quit Connect programs are available online. We have implemented [these programs] in a rural setting, in an urban setting, in Milwaukee and in Atlanta, and we are looking in the future to do a larger, multistate implementation study. If folks are interested, we’d love to partner with them to look at disseminating this further.

A version of this article appeared on Medscape.com.

Two relatively simple interventions — addressing high blood pressure (BP) and smoking cessation — could make a huge difference for patients with rheumatic disease. Patients with autoimmune disease are up to three times more likely to develop cardiovascular disease (CVD) than the general population. In addition to compounding CVD, smoking is tied to the development of certain autoimmune conditions, as well as worse outcomes. Christie Bartels, MD, chief of the Division of Rheumatology at the University of Wisconsin School of Medicine and Public Health, Madison, has focused her research on improving cardiac health in inflammatory diseases. This news organization spoke with Bartels about two short interventions she developed that tackle hypertension and smoking cessation during regular visits, each taking less than 3 minutes.

How Do These Programs Address Cardiac Disease Prevention?

The BP and Quit Connect programs help clinics systematically address the two most modifiable risk factors for CVD: high BP and smoking. There’s also evidence that addressing these two risk factors improves outcomes in rheumatic diseases. Hypertension predicts an increase in lupus damage. Particularly in lupus nephritis, hypertension will increase the risk for CVD and kidney failure. People who use tobacco have worse outcomes in diseases like rheumatoid arthritis, psoriatic arthritis, and lupus, as well as more CVD, and antirheumatic drugs may not work as well.

University of Wisconsin School of Medicine and Public Health

In 90 seconds to 3 minutes, staff can do protocol-based care, which we’ve done across 20,000-plus visits. We showed we can improve population level rates of high BP and BP control, as well as increase smoking quitting rates across different patient settings.
 

What Is the Quit Connect Program?

The Quit Connect program is a 10- to 90-second point of care intervention. During rooming, staff (medical assistants and nurses) ask patients: “A) Do you smoke? and B) Have you thought about cutting back or quitting in the next 30 days?”

It turns out, when you ask the question that way, between a third and a half of people say that they’ve thought about cutting back or quitting. Then, we can get patients connected directly to Quitline, a free public service across all 50 states that smokers can use to get cessation support.

If patients are ready, we ask if we can arrange for them to receive a call from a Quitline coach about setting a quit date or receiving free nicotine replacement therapy. The beautiful thing is when that all happens, A) it’s free to the patient, and B) the results from the Quitline can be recorded right back to the electronic health record.

In our most recent publication in Arthritis Care & Research, we documented bringing Quit Connect to Grady Hospital in downtown Atlanta. It’s a safety net hospital, where 80% patients are Black and 70%-80% patients are on public insurance or uninsured. Using this protocol, we improved Quitline referrals 20-fold.
 

What Is the BP Connect Program?

At least half of the encounters in United States happen in specialty clinics. Unfortunately, when patients get their BP measured in a specialty clinic that’s not a cardiology or a vascular clinic, often, even if the pressure is high, the clinic doesn’t give patients feedback on that. The problem is because we haven’t said anything, that gives people the false reassurance that their BP is okay.

We’ve developed a 3-minute protocol to ask, advise, and connect. The idea is that if we measure a high BP, then we remeasure and confirm that it’s high. Then, we advise why it matters in rheumatic disease: Patients with rheumatic diseases are already at an increased risk for heart disease, and controlling BP can make a big difference. Then, we connect patients with high BP back to primary care.

Specifically, a SmartSet — an electronic medical record feature — prompts different actions based on confirmed high BP readings:

• If systolic BP ≥ 140-159, the SmartSet directs scheduling a visit to a nurse or primary care provider.
• If systolic BP ≥ 160-179, the next primary care visit anticipates the need to see a prescriber.
• If systolic BP ≥ 180, then the medical assistant or nurse at the visit is instructed to notify the provider who can arrange a provider-to-provider handoff for safety to exclude a hypertensive emergency.

That order goes to the scheduler to call primary care to coordinate follow-up. BP Connect doubled the likelihood of a guideline-recommended follow-up in primary care within 30 days. All patients benefited, and disparities decreased. BP Connect has had 1100 downloads, and both BP and Quit Connect programs are endorsed by the Centers for Disease Control and Prevention and Million Hearts.
 

How Do These Programs Affect Clinical Practice?

We developed these interventions with a health system engineer, and we time stamped everything. Part of the sustainability of this model is that it fits within a regular workflow. As a practicing rheumatologist, I understand that time is a precious commodity.

The interventions are in partnership with frontline staff. We’ve received feedback that they feel pride participating in these initiatives. They can say, because of me, 30 patients followed up last month for high BP, or 10 patients took a referral to the Quitline last year. We celebrate these accomplishments with the staff.
 

What Are the Next Steps for These Programs?

Public-facing toolkits for both BP and Quit Connect programs are available online. We have implemented [these programs] in a rural setting, in an urban setting, in Milwaukee and in Atlanta, and we are looking in the future to do a larger, multistate implementation study. If folks are interested, we’d love to partner with them to look at disseminating this further.

A version of this article appeared on Medscape.com.

Two relatively simple interventions — addressing high blood pressure (BP) and smoking cessation — could make a huge difference for patients with rheumatic disease. Patients with autoimmune disease are up to three times more likely to develop cardiovascular disease (CVD) than the general population. In addition to compounding CVD, smoking is tied to the development of certain autoimmune conditions, as well as worse outcomes. Christie Bartels, MD, chief of the Division of Rheumatology at the University of Wisconsin School of Medicine and Public Health, Madison, has focused her research on improving cardiac health in inflammatory diseases. This news organization spoke with Bartels about two short interventions she developed that tackle hypertension and smoking cessation during regular visits, each taking less than 3 minutes.

How Do These Programs Address Cardiac Disease Prevention?

The BP and Quit Connect programs help clinics systematically address the two most modifiable risk factors for CVD: high BP and smoking. There’s also evidence that addressing these two risk factors improves outcomes in rheumatic diseases. Hypertension predicts an increase in lupus damage. Particularly in lupus nephritis, hypertension will increase the risk for CVD and kidney failure. People who use tobacco have worse outcomes in diseases like rheumatoid arthritis, psoriatic arthritis, and lupus, as well as more CVD, and antirheumatic drugs may not work as well.

University of Wisconsin School of Medicine and Public Health

In 90 seconds to 3 minutes, staff can do protocol-based care, which we’ve done across 20,000-plus visits. We showed we can improve population level rates of high BP and BP control, as well as increase smoking quitting rates across different patient settings.
 

What Is the Quit Connect Program?

The Quit Connect program is a 10- to 90-second point of care intervention. During rooming, staff (medical assistants and nurses) ask patients: “A) Do you smoke? and B) Have you thought about cutting back or quitting in the next 30 days?”

It turns out, when you ask the question that way, between a third and a half of people say that they’ve thought about cutting back or quitting. Then, we can get patients connected directly to Quitline, a free public service across all 50 states that smokers can use to get cessation support.

If patients are ready, we ask if we can arrange for them to receive a call from a Quitline coach about setting a quit date or receiving free nicotine replacement therapy. The beautiful thing is when that all happens, A) it’s free to the patient, and B) the results from the Quitline can be recorded right back to the electronic health record.

In our most recent publication in Arthritis Care & Research, we documented bringing Quit Connect to Grady Hospital in downtown Atlanta. It’s a safety net hospital, where 80% patients are Black and 70%-80% patients are on public insurance or uninsured. Using this protocol, we improved Quitline referrals 20-fold.
 

What Is the BP Connect Program?

At least half of the encounters in United States happen in specialty clinics. Unfortunately, when patients get their BP measured in a specialty clinic that’s not a cardiology or a vascular clinic, often, even if the pressure is high, the clinic doesn’t give patients feedback on that. The problem is because we haven’t said anything, that gives people the false reassurance that their BP is okay.

We’ve developed a 3-minute protocol to ask, advise, and connect. The idea is that if we measure a high BP, then we remeasure and confirm that it’s high. Then, we advise why it matters in rheumatic disease: Patients with rheumatic diseases are already at an increased risk for heart disease, and controlling BP can make a big difference. Then, we connect patients with high BP back to primary care.

Specifically, a SmartSet — an electronic medical record feature — prompts different actions based on confirmed high BP readings:

• If systolic BP ≥ 140-159, the SmartSet directs scheduling a visit to a nurse or primary care provider.
• If systolic BP ≥ 160-179, the next primary care visit anticipates the need to see a prescriber.
• If systolic BP ≥ 180, then the medical assistant or nurse at the visit is instructed to notify the provider who can arrange a provider-to-provider handoff for safety to exclude a hypertensive emergency.

That order goes to the scheduler to call primary care to coordinate follow-up. BP Connect doubled the likelihood of a guideline-recommended follow-up in primary care within 30 days. All patients benefited, and disparities decreased. BP Connect has had 1100 downloads, and both BP and Quit Connect programs are endorsed by the Centers for Disease Control and Prevention and Million Hearts.
 

How Do These Programs Affect Clinical Practice?

We developed these interventions with a health system engineer, and we time stamped everything. Part of the sustainability of this model is that it fits within a regular workflow. As a practicing rheumatologist, I understand that time is a precious commodity.

The interventions are in partnership with frontline staff. We’ve received feedback that they feel pride participating in these initiatives. They can say, because of me, 30 patients followed up last month for high BP, or 10 patients took a referral to the Quitline last year. We celebrate these accomplishments with the staff.
 

What Are the Next Steps for These Programs?

Public-facing toolkits for both BP and Quit Connect programs are available online. We have implemented [these programs] in a rural setting, in an urban setting, in Milwaukee and in Atlanta, and we are looking in the future to do a larger, multistate implementation study. If folks are interested, we’d love to partner with them to look at disseminating this further.

A version of this article appeared on Medscape.com.

Key clinical point: Nearly two out of three patients with psoriatic arthritis (PsA) had clinically significant central sensitization (CS), with the severity of psoriasis, anxiety level, and sleep quality being independent predictors of worse CS Inventory (CSI) scores.

Major finding: Overall, 65.1% patients had clinically significant CS, with a CSI score ≥ 40, with the severity of psoriasis and disease activity scores for PsA being positively associated with CSI scores (correlation coefficient 0.393-0.652; P < .001). The Psoriasis Area Severity Index (odds ratio [OR] 9.70; P = .017), General Anxiety Disorder-7 (OR 2.89; P = .014), and Insomnia Severity Index (OR 5.56; P = .041) scores were independent predictors of CS.

Study details: This cross-sectional observational study included 103 patients with PsA (age 18-75 years) with a mean CSI score of 45.4.

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

Source: Kaya MN, Tecer D, Kılıç Ö, et al. Impact of central sensitization on clinical and functional aspects of psoriatic arthritis. Medicina. 2024;60(9):1449 (Sept 4). Source

Key clinical point: Nearly two out of three patients with psoriatic arthritis (PsA) had clinically significant central sensitization (CS), with the severity of psoriasis, anxiety level, and sleep quality being independent predictors of worse CS Inventory (CSI) scores.

Major finding: Overall, 65.1% patients had clinically significant CS, with a CSI score ≥ 40, with the severity of psoriasis and disease activity scores for PsA being positively associated with CSI scores (correlation coefficient 0.393-0.652; P < .001). The Psoriasis Area Severity Index (odds ratio [OR] 9.70; P = .017), General Anxiety Disorder-7 (OR 2.89; P = .014), and Insomnia Severity Index (OR 5.56; P = .041) scores were independent predictors of CS.

Study details: This cross-sectional observational study included 103 patients with PsA (age 18-75 years) with a mean CSI score of 45.4.

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

Source: Kaya MN, Tecer D, Kılıç Ö, et al. Impact of central sensitization on clinical and functional aspects of psoriatic arthritis. Medicina. 2024;60(9):1449 (Sept 4). Source

Key clinical point: Nearly two out of three patients with psoriatic arthritis (PsA) had clinically significant central sensitization (CS), with the severity of psoriasis, anxiety level, and sleep quality being independent predictors of worse CS Inventory (CSI) scores.

Major finding: Overall, 65.1% patients had clinically significant CS, with a CSI score ≥ 40, with the severity of psoriasis and disease activity scores for PsA being positively associated with CSI scores (correlation coefficient 0.393-0.652; P < .001). The Psoriasis Area Severity Index (odds ratio [OR] 9.70; P = .017), General Anxiety Disorder-7 (OR 2.89; P = .014), and Insomnia Severity Index (OR 5.56; P = .041) scores were independent predictors of CS.

Study details: This cross-sectional observational study included 103 patients with PsA (age 18-75 years) with a mean CSI score of 45.4.

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

Source: Kaya MN, Tecer D, Kılıç Ö, et al. Impact of central sensitization on clinical and functional aspects of psoriatic arthritis. Medicina. 2024;60(9):1449 (Sept 4). Source