MDedge Rheumatology

Key clinical point: The second proximal interphalangeal (PIP) joint of the right hand and the right knee joint were the most affected in patients with psoriatic arthritis (PsA), particularly in those with older age and an earlier onset of PsA.

Major finding: The second PIP joint of the right hand had the greatest prevalence of swelling (18.9%), and the right knee joint had the highest prevalence of tenderness (24.2%). Older age was a risk factor, whereas an earlier onset of PsA was a protective factor for both swelling of the second PIP joint of the right hand and tenderness of right knee joint (P < .05 for all).

Study details: This cross-sectional study included 264 patients with PsA.

Disclosures: This study was funded by the National Key Research and Development Program of China and the National Natural Science Foundation of China. The authors did not declare any conflicts of interest.

Source: Li J, Xiao J, Xie X, et al. Individual joints involvement pattern in psoriatic arthritis: A cross-sectional study in China. J Dermatol. 2024 (Jul 12). Doi: 10.1111/1346-8138.17369 Source

Key clinical point: The second proximal interphalangeal (PIP) joint of the right hand and the right knee joint were the most affected in patients with psoriatic arthritis (PsA), particularly in those with older age and an earlier onset of PsA.

Major finding: The second PIP joint of the right hand had the greatest prevalence of swelling (18.9%), and the right knee joint had the highest prevalence of tenderness (24.2%). Older age was a risk factor, whereas an earlier onset of PsA was a protective factor for both swelling of the second PIP joint of the right hand and tenderness of right knee joint (P < .05 for all).

Study details: This cross-sectional study included 264 patients with PsA.

Disclosures: This study was funded by the National Key Research and Development Program of China and the National Natural Science Foundation of China. The authors did not declare any conflicts of interest.

Source: Li J, Xiao J, Xie X, et al. Individual joints involvement pattern in psoriatic arthritis: A cross-sectional study in China. J Dermatol. 2024 (Jul 12). Doi: 10.1111/1346-8138.17369 Source

Key clinical point: The second proximal interphalangeal (PIP) joint of the right hand and the right knee joint were the most affected in patients with psoriatic arthritis (PsA), particularly in those with older age and an earlier onset of PsA.

Major finding: The second PIP joint of the right hand had the greatest prevalence of swelling (18.9%), and the right knee joint had the highest prevalence of tenderness (24.2%). Older age was a risk factor, whereas an earlier onset of PsA was a protective factor for both swelling of the second PIP joint of the right hand and tenderness of right knee joint (P < .05 for all).

Study details: This cross-sectional study included 264 patients with PsA.

Disclosures: This study was funded by the National Key Research and Development Program of China and the National Natural Science Foundation of China. The authors did not declare any conflicts of interest.

Source: Li J, Xiao J, Xie X, et al. Individual joints involvement pattern in psoriatic arthritis: A cross-sectional study in China. J Dermatol. 2024 (Jul 12). Doi: 10.1111/1346-8138.17369 Source

Key clinical point: A dose of 160 mg bimekizumab every 4 weeks demonstrated greater long-term efficacy than 45 or 90 mg ustekinumab every 12 weeks in patients with psoriatic arthritis (PsA) who were biologic-naïve or showed inadequate response to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: At week 52, both biologic-naive (adjusted odds ratio [aOR] 3.33; P < .001) and TNFi-IR (aOR 9.85; P < .001) patients receiving bimekizumab vs 45 mg ustekinumab were more likely to achieve ≥70% improvement in the American College of Rheumatology response, with similar effect observed for bimekizumab vs 90 mg ustekinumab.

Study details: This was matching-adjusted indirect comparison of data from several phase 3 trials of bimekizumab (BE OPTIMAL, BE COMPLETE, and BE VITAL) and ustekinumab (PSUMMIT1 and PSUMMIT2). The trials involved patients with PsA who received bimekizumab (n = 698) or ustekinumab (45 mg: n = 265; 90 mg: n = 262).

Disclosures: This study was sponsored by UCB Pharma and supported by the NIHR Manchester Biomedical Research Centre, UK. Three authors declared being employees and shareholders of UCB Pharma. Several authors declared having ties with various sources, including UCB Pharma.

Source: Mease PJ, Warren RB, Nash P, et al. Comparative effectiveness of bimekizumab and ustekinumab in patients with psoriatic arthritis at 52 weeks assessed using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 (Aug 9). Doi: 10.1007/s40744-024-00705-x Source

Key clinical point: A dose of 160 mg bimekizumab every 4 weeks demonstrated greater long-term efficacy than 45 or 90 mg ustekinumab every 12 weeks in patients with psoriatic arthritis (PsA) who were biologic-naïve or showed inadequate response to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: At week 52, both biologic-naive (adjusted odds ratio [aOR] 3.33; P < .001) and TNFi-IR (aOR 9.85; P < .001) patients receiving bimekizumab vs 45 mg ustekinumab were more likely to achieve ≥70% improvement in the American College of Rheumatology response, with similar effect observed for bimekizumab vs 90 mg ustekinumab.

Study details: This was matching-adjusted indirect comparison of data from several phase 3 trials of bimekizumab (BE OPTIMAL, BE COMPLETE, and BE VITAL) and ustekinumab (PSUMMIT1 and PSUMMIT2). The trials involved patients with PsA who received bimekizumab (n = 698) or ustekinumab (45 mg: n = 265; 90 mg: n = 262).

Disclosures: This study was sponsored by UCB Pharma and supported by the NIHR Manchester Biomedical Research Centre, UK. Three authors declared being employees and shareholders of UCB Pharma. Several authors declared having ties with various sources, including UCB Pharma.

Source: Mease PJ, Warren RB, Nash P, et al. Comparative effectiveness of bimekizumab and ustekinumab in patients with psoriatic arthritis at 52 weeks assessed using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 (Aug 9). Doi: 10.1007/s40744-024-00705-x Source

Key clinical point: A dose of 160 mg bimekizumab every 4 weeks demonstrated greater long-term efficacy than 45 or 90 mg ustekinumab every 12 weeks in patients with psoriatic arthritis (PsA) who were biologic-naïve or showed inadequate response to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: At week 52, both biologic-naive (adjusted odds ratio [aOR] 3.33; P < .001) and TNFi-IR (aOR 9.85; P < .001) patients receiving bimekizumab vs 45 mg ustekinumab were more likely to achieve ≥70% improvement in the American College of Rheumatology response, with similar effect observed for bimekizumab vs 90 mg ustekinumab.

Study details: This was matching-adjusted indirect comparison of data from several phase 3 trials of bimekizumab (BE OPTIMAL, BE COMPLETE, and BE VITAL) and ustekinumab (PSUMMIT1 and PSUMMIT2). The trials involved patients with PsA who received bimekizumab (n = 698) or ustekinumab (45 mg: n = 265; 90 mg: n = 262).

Disclosures: This study was sponsored by UCB Pharma and supported by the NIHR Manchester Biomedical Research Centre, UK. Three authors declared being employees and shareholders of UCB Pharma. Several authors declared having ties with various sources, including UCB Pharma.

Source: Mease PJ, Warren RB, Nash P, et al. Comparative effectiveness of bimekizumab and ustekinumab in patients with psoriatic arthritis at 52 weeks assessed using a matching-adjusted indirect comparison. Rheumatol Ther. 2024 (Aug 9). Doi: 10.1007/s40744-024-00705-x Source

Key clinical point: First-line targeted therapy, particularly use of tumor necrosis factor inhibitors (TNFi), reduced the use of symptomatic treatments, methotrexate, mood disorder treatments, hospitalizations, and sick leave in patients with psoriatic arthritis (PsA).

Major finding: First-line targeted therapy significantly reduced the use of non-steroidal anti-inflammatory drugs (NSAID; −15%), prednisone (−9%), methotrexate (−15%), mood disorder treatments (−2%), and rate of hospitalizations (−12%) and sick leave (−4%; all P < 10^-4). TNFi showed greater reductions in NSAID (adjusted odds ratio [aOR] 1.04; 95% CI 1.01-1.07) and prednisone use (aOR 1.04; 95% CI 1.02-1.06) compared with interleukin 17 inhibitors (IL17i), with similar outcomes for IL12/23i.

Study details: This cohort study included 9793 patients with PsA age ≥18 years who had initiated targeted therapies for at least 9 months.

Disclosures: The authors did not declare any specific funding. Two authors declared receiving a subsidy to attend a congress or receiving consulting fees and serving as investigators for various sources.

Source: Pina Vegas L, Iggui S, Sbidian E, Claudepierre P. Impact of initiation of targeted therapy on the use of psoriatic arthritis-related treatments and healthcare consumption: A cohort study of 9793 patients from the French health insurance database (SNDS). RMD Open. 2024;10:e004631 (Aug 7). Doi: 10.1136/rmdopen-2024-004631 Source

Key clinical point: First-line targeted therapy, particularly use of tumor necrosis factor inhibitors (TNFi), reduced the use of symptomatic treatments, methotrexate, mood disorder treatments, hospitalizations, and sick leave in patients with psoriatic arthritis (PsA).

Major finding: First-line targeted therapy significantly reduced the use of non-steroidal anti-inflammatory drugs (NSAID; −15%), prednisone (−9%), methotrexate (−15%), mood disorder treatments (−2%), and rate of hospitalizations (−12%) and sick leave (−4%; all P < 10^-4). TNFi showed greater reductions in NSAID (adjusted odds ratio [aOR] 1.04; 95% CI 1.01-1.07) and prednisone use (aOR 1.04; 95% CI 1.02-1.06) compared with interleukin 17 inhibitors (IL17i), with similar outcomes for IL12/23i.

Study details: This cohort study included 9793 patients with PsA age ≥18 years who had initiated targeted therapies for at least 9 months.

Disclosures: The authors did not declare any specific funding. Two authors declared receiving a subsidy to attend a congress or receiving consulting fees and serving as investigators for various sources.

Source: Pina Vegas L, Iggui S, Sbidian E, Claudepierre P. Impact of initiation of targeted therapy on the use of psoriatic arthritis-related treatments and healthcare consumption: A cohort study of 9793 patients from the French health insurance database (SNDS). RMD Open. 2024;10:e004631 (Aug 7). Doi: 10.1136/rmdopen-2024-004631 Source

Key clinical point: First-line targeted therapy, particularly use of tumor necrosis factor inhibitors (TNFi), reduced the use of symptomatic treatments, methotrexate, mood disorder treatments, hospitalizations, and sick leave in patients with psoriatic arthritis (PsA).

Major finding: First-line targeted therapy significantly reduced the use of non-steroidal anti-inflammatory drugs (NSAID; −15%), prednisone (−9%), methotrexate (−15%), mood disorder treatments (−2%), and rate of hospitalizations (−12%) and sick leave (−4%; all P < 10^-4). TNFi showed greater reductions in NSAID (adjusted odds ratio [aOR] 1.04; 95% CI 1.01-1.07) and prednisone use (aOR 1.04; 95% CI 1.02-1.06) compared with interleukin 17 inhibitors (IL17i), with similar outcomes for IL12/23i.

Study details: This cohort study included 9793 patients with PsA age ≥18 years who had initiated targeted therapies for at least 9 months.

Disclosures: The authors did not declare any specific funding. Two authors declared receiving a subsidy to attend a congress or receiving consulting fees and serving as investigators for various sources.

Source: Pina Vegas L, Iggui S, Sbidian E, Claudepierre P. Impact of initiation of targeted therapy on the use of psoriatic arthritis-related treatments and healthcare consumption: A cohort study of 9793 patients from the French health insurance database (SNDS). RMD Open. 2024;10:e004631 (Aug 7). Doi: 10.1136/rmdopen-2024-004631 Source

Key clinical point: Patients with psoriatic arthritis (PsA) who achieved disease control despite having an inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs (cs/bDMARD) showed improved patient-reported outcomes (PRO).

Major finding: At week 104, patients who did vs did not achieve minimal disease activity had significant improvements in the Health Assessment Questionnaire–Disability Index (least squares mean change from baseline [Δ] −0.82 vs −0.17; P ≤ .0001), pain (Δ −4.75 vs −1.77; P ≤ .0001), and other investigated PRO.

Study details: This post hoc analysis of two phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2, included 1069 and 317 patients with PsA and inadequate response to ≥1 csDMARD or bDMARD, respectively, who were randomly assigned to receive upadacitinib, placebo with crossover to upadacitinib, or adalimumab.

Disclosures: This study was funded by AbbVie, and AbbVie participated in the design of the trial and the publication of its results. Seven authors declared being employees of AbbVie and may own its stock or stock options. Several authors declared having ties with AbbVie and other sources.

Source: Kavanaugh A, Mease P, Gossec L, et al. Association between achievement of clinical disease control and improvement in patient-reported outcomes and quality of life in patients with psoriatic arthritis in the phase 3 SELECT-PsA 1 and 2 randomized controlled trials. ACR Open Rheumatol. 2024 (Aug 1). Doi: 10.1002/acr2.11714 Source

Key clinical point: Patients with psoriatic arthritis (PsA) who achieved disease control despite having an inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs (cs/bDMARD) showed improved patient-reported outcomes (PRO).

Major finding: At week 104, patients who did vs did not achieve minimal disease activity had significant improvements in the Health Assessment Questionnaire–Disability Index (least squares mean change from baseline [Δ] −0.82 vs −0.17; P ≤ .0001), pain (Δ −4.75 vs −1.77; P ≤ .0001), and other investigated PRO.

Study details: This post hoc analysis of two phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2, included 1069 and 317 patients with PsA and inadequate response to ≥1 csDMARD or bDMARD, respectively, who were randomly assigned to receive upadacitinib, placebo with crossover to upadacitinib, or adalimumab.

Disclosures: This study was funded by AbbVie, and AbbVie participated in the design of the trial and the publication of its results. Seven authors declared being employees of AbbVie and may own its stock or stock options. Several authors declared having ties with AbbVie and other sources.

Source: Kavanaugh A, Mease P, Gossec L, et al. Association between achievement of clinical disease control and improvement in patient-reported outcomes and quality of life in patients with psoriatic arthritis in the phase 3 SELECT-PsA 1 and 2 randomized controlled trials. ACR Open Rheumatol. 2024 (Aug 1). Doi: 10.1002/acr2.11714 Source

Key clinical point: Patients with psoriatic arthritis (PsA) who achieved disease control despite having an inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs (cs/bDMARD) showed improved patient-reported outcomes (PRO).

Major finding: At week 104, patients who did vs did not achieve minimal disease activity had significant improvements in the Health Assessment Questionnaire–Disability Index (least squares mean change from baseline [Δ] −0.82 vs −0.17; P ≤ .0001), pain (Δ −4.75 vs −1.77; P ≤ .0001), and other investigated PRO.

Study details: This post hoc analysis of two phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2, included 1069 and 317 patients with PsA and inadequate response to ≥1 csDMARD or bDMARD, respectively, who were randomly assigned to receive upadacitinib, placebo with crossover to upadacitinib, or adalimumab.

Disclosures: This study was funded by AbbVie, and AbbVie participated in the design of the trial and the publication of its results. Seven authors declared being employees of AbbVie and may own its stock or stock options. Several authors declared having ties with AbbVie and other sources.

Source: Kavanaugh A, Mease P, Gossec L, et al. Association between achievement of clinical disease control and improvement in patient-reported outcomes and quality of life in patients with psoriatic arthritis in the phase 3 SELECT-PsA 1 and 2 randomized controlled trials. ACR Open Rheumatol. 2024 (Aug 1). Doi: 10.1002/acr2.11714 Source

Key clinical point: Patients who received interleukin-23 inhibitors (IL-23i) and interleukin-12/23 inhibitors (IL-12/23i) for the management of psoriasis had a comparable risk for incident psoriatic arthritis (PsA).

Major finding: Patients treated with IL-23i vs IL-12/23i demonstrated no significant difference in the risk for PsA (hazard ratio 0.96; P = .812) and cumulative incidence of PsA (P = .812).

Study details: This retrospective cohort study included the propensity score–matched data of patients with psoriasis age 18 years or older from the TriNetX database who were treated with either IL-23i (n = 2142) or IL-12/23i (n = 2142).

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

Source: Tsai SHL, Yang C-Y, Huo A-P, Wei JC-C. Interleukin 23 versus interleukin 12/23 inhibitors on preventing incidental psoriatic arthritis in patients with psoriasis? A real-world comparison from the TriNetX Global Collaborative Network. J Am Acad Dermatol. 2024 (Jul 27). Doi: 0.1016/j.jaad.2024.07.1473 Source

Key clinical point: Patients who received interleukin-23 inhibitors (IL-23i) and interleukin-12/23 inhibitors (IL-12/23i) for the management of psoriasis had a comparable risk for incident psoriatic arthritis (PsA).

Major finding: Patients treated with IL-23i vs IL-12/23i demonstrated no significant difference in the risk for PsA (hazard ratio 0.96; P = .812) and cumulative incidence of PsA (P = .812).

Study details: This retrospective cohort study included the propensity score–matched data of patients with psoriasis age 18 years or older from the TriNetX database who were treated with either IL-23i (n = 2142) or IL-12/23i (n = 2142).

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

Source: Tsai SHL, Yang C-Y, Huo A-P, Wei JC-C. Interleukin 23 versus interleukin 12/23 inhibitors on preventing incidental psoriatic arthritis in patients with psoriasis? A real-world comparison from the TriNetX Global Collaborative Network. J Am Acad Dermatol. 2024 (Jul 27). Doi: 0.1016/j.jaad.2024.07.1473 Source

Key clinical point: Patients who received interleukin-23 inhibitors (IL-23i) and interleukin-12/23 inhibitors (IL-12/23i) for the management of psoriasis had a comparable risk for incident psoriatic arthritis (PsA).

Major finding: Patients treated with IL-23i vs IL-12/23i demonstrated no significant difference in the risk for PsA (hazard ratio 0.96; P = .812) and cumulative incidence of PsA (P = .812).

Study details: This retrospective cohort study included the propensity score–matched data of patients with psoriasis age 18 years or older from the TriNetX database who were treated with either IL-23i (n = 2142) or IL-12/23i (n = 2142).

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

Source: Tsai SHL, Yang C-Y, Huo A-P, Wei JC-C. Interleukin 23 versus interleukin 12/23 inhibitors on preventing incidental psoriatic arthritis in patients with psoriasis? A real-world comparison from the TriNetX Global Collaborative Network. J Am Acad Dermatol. 2024 (Jul 27). Doi: 0.1016/j.jaad.2024.07.1473 Source

Key clinical point: Bimekizumab demonstrated sustained efficacy and was well tolerated for 52 weeks, regardless of concomitant methotrexate use, in patients with psoriatic arthritis (PsA) who were biologic-naive or intolerant to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: Through week 52, nearly half of the patients receiving bimekizumab with or without methotrexate achieved a ≥50% improvement in American College of Rheumatology response (biologic-naive ~55%; TNFi-IR ~48-56%) and minimal disease activity (biologic-naive ~55%; TNFi-IR ~47%). The rates of experiencing at least one treatment emergent adverse event were similar across the subgroups.

Study details: This post hoc analysis of phase 3 trials (BE OPTIMAL, BE COMPLETE, and BE VITAL) included biologic-naive (n = 852) or TNFi-IR (n = 400) patients with PsA who received bimekizumab, placebo with crossover to bimekizumab at week 16, or adalimumab, with or without methotrexate.

Disclosures: This study was funded by UCB Pharma and supported by the NIHR Manchester Biomedical Research Centre, UK. Two authors declared being employees of or holding stocks in UCB. Several authors declared having other ties with UCB and other sources.

Source: McInnes IB, Mease PJ, Tanaka Y, et al. Efficacy and safety of bimekizumab in patients with psoriatic arthritis with or without methotrexate: 52-week results from two phase 3 studies. ACR Open Rheumatol. 2024 (Jul 30). Doi: 10.1002/acr2.11727 Source

Key clinical point: Bimekizumab demonstrated sustained efficacy and was well tolerated for 52 weeks, regardless of concomitant methotrexate use, in patients with psoriatic arthritis (PsA) who were biologic-naive or intolerant to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: Through week 52, nearly half of the patients receiving bimekizumab with or without methotrexate achieved a ≥50% improvement in American College of Rheumatology response (biologic-naive ~55%; TNFi-IR ~48-56%) and minimal disease activity (biologic-naive ~55%; TNFi-IR ~47%). The rates of experiencing at least one treatment emergent adverse event were similar across the subgroups.

Study details: This post hoc analysis of phase 3 trials (BE OPTIMAL, BE COMPLETE, and BE VITAL) included biologic-naive (n = 852) or TNFi-IR (n = 400) patients with PsA who received bimekizumab, placebo with crossover to bimekizumab at week 16, or adalimumab, with or without methotrexate.

Disclosures: This study was funded by UCB Pharma and supported by the NIHR Manchester Biomedical Research Centre, UK. Two authors declared being employees of or holding stocks in UCB. Several authors declared having other ties with UCB and other sources.

Source: McInnes IB, Mease PJ, Tanaka Y, et al. Efficacy and safety of bimekizumab in patients with psoriatic arthritis with or without methotrexate: 52-week results from two phase 3 studies. ACR Open Rheumatol. 2024 (Jul 30). Doi: 10.1002/acr2.11727 Source

Key clinical point: Bimekizumab demonstrated sustained efficacy and was well tolerated for 52 weeks, regardless of concomitant methotrexate use, in patients with psoriatic arthritis (PsA) who were biologic-naive or intolerant to tumor necrosis factor inhibitors (TNFi-IR).

Major finding: Through week 52, nearly half of the patients receiving bimekizumab with or without methotrexate achieved a ≥50% improvement in American College of Rheumatology response (biologic-naive ~55%; TNFi-IR ~48-56%) and minimal disease activity (biologic-naive ~55%; TNFi-IR ~47%). The rates of experiencing at least one treatment emergent adverse event were similar across the subgroups.

Study details: This post hoc analysis of phase 3 trials (BE OPTIMAL, BE COMPLETE, and BE VITAL) included biologic-naive (n = 852) or TNFi-IR (n = 400) patients with PsA who received bimekizumab, placebo with crossover to bimekizumab at week 16, or adalimumab, with or without methotrexate.

Disclosures: This study was funded by UCB Pharma and supported by the NIHR Manchester Biomedical Research Centre, UK. Two authors declared being employees of or holding stocks in UCB. Several authors declared having other ties with UCB and other sources.

Source: McInnes IB, Mease PJ, Tanaka Y, et al. Efficacy and safety of bimekizumab in patients with psoriatic arthritis with or without methotrexate: 52-week results from two phase 3 studies. ACR Open Rheumatol. 2024 (Jul 30). Doi: 10.1002/acr2.11727 Source

TOPLINE: 

Patients with psoriasis, uveitis, or colitis who present with undiagnosed chronic back pain should be referred to a rheumatologist for the assessment of axial spondyloarthritis (axSpA), with MRI being a more accurate diagnostic method than clinical features.

METHODOLOGY:

• Researchers assessed the prevalence of axSpA according to the extra-articular presentation and human leukocyte antigen B27 (HLA-B27) status in two Canadian cohorts (SASPIC 1 and 2).
• Overall, 363 adult patients aged ≤ 45 years with psoriasis, uveitis, or colitis who presented with chronic undiagnosed back and/or buttock pain lasting 3 months or more were included.
• Participants were referred to rheumatologists with expertise in axSpA for structured diagnostic evaluations, including history, physical exam, levels of C-reactive protein, HLA-B27 status, and imaging studies.
• An MRI of the sacroiliac joints was conducted in all patients in the SASPIC-2 cohort and in 62.3% of those in the SASPIC-1 cohort.
• The primary outcome was the proportion of patients diagnosed with axSpA after final global evaluation, and the secondary outcome was the impact of MRI on diagnosis and classification.

TAKEAWAY:

• AxSpA diagnoses were made in 46.7% with psoriasis, 61.6% with uveitis, and 46.8% with colitis in the SASPIC-1 cohort and in 23.5%, 57.9%, and 23.3%, respectively, in the SASPIC-2 cohort.
• Being positive for HLA-B27 was linked to the presence of axSpA in 56%-88% of those in both the cohorts.
• Musculoskeletal clinical features were not helpful in differentiating between patients with and without axSpA.
• In both the cohorts, the MRI of the sacroiliac joints was indicative of axSpA in a significantly greater number of patients with psoriasis, uveitis, or colitis who were diagnosed with axSpA than in those not diagnosed with axSpA (P < .05 for all).

IN PRACTICE:

“Our data supports the benefit of recent referral recommendations that advocate referral to a rheumatologist of patients with chronic back pain and extra-articular features related to axSpA,” the authors wrote.

SOURCE:

The study was led by Walter P. Maksymowych, MB ChB, University of Alberta, Edmonton, Alberta, Canada. It was published online in Arthritis & Rheumatology.

LIMITATIONS: 

MRI readers had to rely on their own expertise to decide if an MRI was indeed positive and thus indicative of axSpA. This study included only patients with undiagnosed back pain, and a longer follow-up duration could have led to a higher number of patients being diagnosed with axial inflammation. In SASPIC-1, local rheumatologists conducted MRI evaluations of the spinal lesions only when necessary, while in SASPIC-2, MRI of only the sacroiliac joints was required.

DISCLOSURES:

SASPIC-1 was supported by AbbVie Canada and Janssen Canada, and SASPIC-2 was supported by AbbVie Canada. The authors disclosed receiving grants, consulting fees, speaking fees, and/or honoraria and having other ties with AbbVie and several other pharmaceutical companies.

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

TOPLINE: 

Patients with psoriasis, uveitis, or colitis who present with undiagnosed chronic back pain should be referred to a rheumatologist for the assessment of axial spondyloarthritis (axSpA), with MRI being a more accurate diagnostic method than clinical features.

METHODOLOGY:

• Researchers assessed the prevalence of axSpA according to the extra-articular presentation and human leukocyte antigen B27 (HLA-B27) status in two Canadian cohorts (SASPIC 1 and 2).
• Overall, 363 adult patients aged ≤ 45 years with psoriasis, uveitis, or colitis who presented with chronic undiagnosed back and/or buttock pain lasting 3 months or more were included.
• Participants were referred to rheumatologists with expertise in axSpA for structured diagnostic evaluations, including history, physical exam, levels of C-reactive protein, HLA-B27 status, and imaging studies.
• An MRI of the sacroiliac joints was conducted in all patients in the SASPIC-2 cohort and in 62.3% of those in the SASPIC-1 cohort.
• The primary outcome was the proportion of patients diagnosed with axSpA after final global evaluation, and the secondary outcome was the impact of MRI on diagnosis and classification.

TAKEAWAY:

• AxSpA diagnoses were made in 46.7% with psoriasis, 61.6% with uveitis, and 46.8% with colitis in the SASPIC-1 cohort and in 23.5%, 57.9%, and 23.3%, respectively, in the SASPIC-2 cohort.
• Being positive for HLA-B27 was linked to the presence of axSpA in 56%-88% of those in both the cohorts.
• Musculoskeletal clinical features were not helpful in differentiating between patients with and without axSpA.
• In both the cohorts, the MRI of the sacroiliac joints was indicative of axSpA in a significantly greater number of patients with psoriasis, uveitis, or colitis who were diagnosed with axSpA than in those not diagnosed with axSpA (P < .05 for all).

IN PRACTICE:

“Our data supports the benefit of recent referral recommendations that advocate referral to a rheumatologist of patients with chronic back pain and extra-articular features related to axSpA,” the authors wrote.

SOURCE:

The study was led by Walter P. Maksymowych, MB ChB, University of Alberta, Edmonton, Alberta, Canada. It was published online in Arthritis & Rheumatology.

LIMITATIONS: 

MRI readers had to rely on their own expertise to decide if an MRI was indeed positive and thus indicative of axSpA. This study included only patients with undiagnosed back pain, and a longer follow-up duration could have led to a higher number of patients being diagnosed with axial inflammation. In SASPIC-1, local rheumatologists conducted MRI evaluations of the spinal lesions only when necessary, while in SASPIC-2, MRI of only the sacroiliac joints was required.

DISCLOSURES:

SASPIC-1 was supported by AbbVie Canada and Janssen Canada, and SASPIC-2 was supported by AbbVie Canada. The authors disclosed receiving grants, consulting fees, speaking fees, and/or honoraria and having other ties with AbbVie and several other pharmaceutical companies.

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

TOPLINE: 

Patients with psoriasis, uveitis, or colitis who present with undiagnosed chronic back pain should be referred to a rheumatologist for the assessment of axial spondyloarthritis (axSpA), with MRI being a more accurate diagnostic method than clinical features.

METHODOLOGY:

• Researchers assessed the prevalence of axSpA according to the extra-articular presentation and human leukocyte antigen B27 (HLA-B27) status in two Canadian cohorts (SASPIC 1 and 2).
• Overall, 363 adult patients aged ≤ 45 years with psoriasis, uveitis, or colitis who presented with chronic undiagnosed back and/or buttock pain lasting 3 months or more were included.
• Participants were referred to rheumatologists with expertise in axSpA for structured diagnostic evaluations, including history, physical exam, levels of C-reactive protein, HLA-B27 status, and imaging studies.
• An MRI of the sacroiliac joints was conducted in all patients in the SASPIC-2 cohort and in 62.3% of those in the SASPIC-1 cohort.
• The primary outcome was the proportion of patients diagnosed with axSpA after final global evaluation, and the secondary outcome was the impact of MRI on diagnosis and classification.

TAKEAWAY:

• AxSpA diagnoses were made in 46.7% with psoriasis, 61.6% with uveitis, and 46.8% with colitis in the SASPIC-1 cohort and in 23.5%, 57.9%, and 23.3%, respectively, in the SASPIC-2 cohort.
• Being positive for HLA-B27 was linked to the presence of axSpA in 56%-88% of those in both the cohorts.
• Musculoskeletal clinical features were not helpful in differentiating between patients with and without axSpA.
• In both the cohorts, the MRI of the sacroiliac joints was indicative of axSpA in a significantly greater number of patients with psoriasis, uveitis, or colitis who were diagnosed with axSpA than in those not diagnosed with axSpA (P < .05 for all).

IN PRACTICE:

“Our data supports the benefit of recent referral recommendations that advocate referral to a rheumatologist of patients with chronic back pain and extra-articular features related to axSpA,” the authors wrote.

SOURCE:

The study was led by Walter P. Maksymowych, MB ChB, University of Alberta, Edmonton, Alberta, Canada. It was published online in Arthritis & Rheumatology.

LIMITATIONS: 

MRI readers had to rely on their own expertise to decide if an MRI was indeed positive and thus indicative of axSpA. This study included only patients with undiagnosed back pain, and a longer follow-up duration could have led to a higher number of patients being diagnosed with axial inflammation. In SASPIC-1, local rheumatologists conducted MRI evaluations of the spinal lesions only when necessary, while in SASPIC-2, MRI of only the sacroiliac joints was required.

DISCLOSURES:

SASPIC-1 was supported by AbbVie Canada and Janssen Canada, and SASPIC-2 was supported by AbbVie Canada. The authors disclosed receiving grants, consulting fees, speaking fees, and/or honoraria and having other ties with AbbVie and several other pharmaceutical companies.

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

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs. 

Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.

PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.

The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.

Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana. 

Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines. 

For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said. 

One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.

This Q&A has been edited for length and clarity.

What would you want federal and state policymakers to do in response to the FTC’s report?

I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.

Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies. 

That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.

You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?

Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report. 

Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.

What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies. 

They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well. 

I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.

In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed. 

The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective? 

Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.

The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?

Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.” 

I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.

Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.” 

That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.

Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response. 

I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
 

A version of this article appeared on Medscape.com.

The American Board of Internal Medicine (ABIM) has revoked certification for two physicians known for leading an organization that promotes ivermectin as a treatment for COVID-19.

Pierre Kory, MD, is no longer certified in critical care medicine, pulmonary disease, and internal medicine, according to the ABIM website. Paul Ellis Marik, MD, is no longer certified in critical care medicine or internal medicine. 

Dr. Marik is the chief scientific officer and Dr. Kory is president emeritus of the Front Line COVID-19 Critical Care Alliance, a group they founded in March 2020. The FLCCC gained notoriety during the height of the pandemic for advocating ivermectin as a treatment for COVID. It now espouses regimens of supplements to treat “vaccine injury” and also offers treatments for Lyme disease.

Ivermectin was proven to not be of use in treating COVID. Studies purporting to show a benefit were later linked to errors, and some were found to have been based on potentially fraudulent research.

The ABIM declined to comment when asked by this news organization about its action. Its website indicates that “revoked” indicates “loss of certification due to disciplinary action for which ABIM has determined that the conduct underlying the sanction does not warrant a defined pathway for restoration of certification at the time of disciplinary sanction.”

In a statement emailed to this news organization, Dr. Kory and Dr. Marik said, “we believe this decision represents a dangerous shift away from the foundation principles of medical discourse and scientific debate that have historically been the bedrock of medical education associations.”

The FLCCC said in the statement that it, along with Dr. Kory and Dr. Marik, are “evaluating options to challenge these decisions.”

Dr. Kory and Dr. Marik said they were notified in May 2022 that they were facing a potential ABIM disciplinary action. An ABIM committee recommended the revocation in July 2023, saying the two men were spreading “false or inaccurate medical information,” according to FLCCC. Dr. Kory and Dr. Marik lost an appeal. 

In a 2023 statement, Dr. Kory and Dr. Marik called the ABIM action an “attack on freedom of speech.”

“This isn’t a free speech question,” said Arthur L. Caplan, PhD, the Drs. William F. and Virginia Connolly Mitty Professor of Bioethics at NYU Grossman School of Medicine’s Department of Population Health, New York City. “You do have the right to free speech, but you don’t have the right to practice outside of the standard of care boundaries,” he told this news organization.

The ABIM action “is the field standing up and saying, ‘These are the limits of what you can do,’” said Dr. Caplan. It means the profession is rejecting those “who are involved in things that harm patients or delay them getting accepted treatments,” he said. Caplan noted that a disciplinary action had been a long time in coming — 3 years since the first battles over ivermectin. 

Wendy Parmet, JD, Matthews Distinguished University Professor of Law at Northeastern University School of Public Policy and Urban Affairs, Boston, said that misinformation spread by physicians is especially harmful because it comes with an air of credibility.

“We certainly want people to be able to dissent,” Ms. Parmet told this news organization. To engender trust, any sanctions by a professional board should be done in a deliberative process with a strong evidentiary base, she said. 

“You want to leave sufficient room for discourse and discussion within the profession, and you don’t want the board to enforce a narrow, rigid orthodoxy,” she said. But in cases where people are “peddling information that is way outside the consensus” or are “profiting off of it, for the profession to take no action, that is, I think, detrimental also to the trust in the profession,” she said.

She was not surprised that Dr. Kory and Dr. Marik would fight to retain certification. “Board certification is an important, very worthwhile thing to have,” she said. “Losing it is not trivial.”

Dr. Kory, who is licensed in California, New York, and Wisconsin, “does not require this certification for his independent practice but is evaluating next steps with attorneys,” according to the statement from FLCCC.

Dr. Marik, whose Virginia medical license expired in 2022, “is no longer treating patients and has dedicated his time and efforts to the FLCCC Alliance,” the statement said.

Dr. Caplan served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position) and is a contributing author and advisor for this news organization. Ms. Parmet reports no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

The American Board of Internal Medicine (ABIM) has revoked certification for two physicians known for leading an organization that promotes ivermectin as a treatment for COVID-19.

Pierre Kory, MD, is no longer certified in critical care medicine, pulmonary disease, and internal medicine, according to the ABIM website. Paul Ellis Marik, MD, is no longer certified in critical care medicine or internal medicine. 

Dr. Marik is the chief scientific officer and Dr. Kory is president emeritus of the Front Line COVID-19 Critical Care Alliance, a group they founded in March 2020. The FLCCC gained notoriety during the height of the pandemic for advocating ivermectin as a treatment for COVID. It now espouses regimens of supplements to treat “vaccine injury” and also offers treatments for Lyme disease.

Ivermectin was proven to not be of use in treating COVID. Studies purporting to show a benefit were later linked to errors, and some were found to have been based on potentially fraudulent research.

The ABIM declined to comment when asked by this news organization about its action. Its website indicates that “revoked” indicates “loss of certification due to disciplinary action for which ABIM has determined that the conduct underlying the sanction does not warrant a defined pathway for restoration of certification at the time of disciplinary sanction.”

In a statement emailed to this news organization, Dr. Kory and Dr. Marik said, “we believe this decision represents a dangerous shift away from the foundation principles of medical discourse and scientific debate that have historically been the bedrock of medical education associations.”

The FLCCC said in the statement that it, along with Dr. Kory and Dr. Marik, are “evaluating options to challenge these decisions.”

Dr. Kory and Dr. Marik said they were notified in May 2022 that they were facing a potential ABIM disciplinary action. An ABIM committee recommended the revocation in July 2023, saying the two men were spreading “false or inaccurate medical information,” according to FLCCC. Dr. Kory and Dr. Marik lost an appeal. 

In a 2023 statement, Dr. Kory and Dr. Marik called the ABIM action an “attack on freedom of speech.”

“This isn’t a free speech question,” said Arthur L. Caplan, PhD, the Drs. William F. and Virginia Connolly Mitty Professor of Bioethics at NYU Grossman School of Medicine’s Department of Population Health, New York City. “You do have the right to free speech, but you don’t have the right to practice outside of the standard of care boundaries,” he told this news organization.

The ABIM action “is the field standing up and saying, ‘These are the limits of what you can do,’” said Dr. Caplan. It means the profession is rejecting those “who are involved in things that harm patients or delay them getting accepted treatments,” he said. Caplan noted that a disciplinary action had been a long time in coming — 3 years since the first battles over ivermectin. 

Wendy Parmet, JD, Matthews Distinguished University Professor of Law at Northeastern University School of Public Policy and Urban Affairs, Boston, said that misinformation spread by physicians is especially harmful because it comes with an air of credibility.

“We certainly want people to be able to dissent,” Ms. Parmet told this news organization. To engender trust, any sanctions by a professional board should be done in a deliberative process with a strong evidentiary base, she said. 

“You want to leave sufficient room for discourse and discussion within the profession, and you don’t want the board to enforce a narrow, rigid orthodoxy,” she said. But in cases where people are “peddling information that is way outside the consensus” or are “profiting off of it, for the profession to take no action, that is, I think, detrimental also to the trust in the profession,” she said.

She was not surprised that Dr. Kory and Dr. Marik would fight to retain certification. “Board certification is an important, very worthwhile thing to have,” she said. “Losing it is not trivial.”

Dr. Kory, who is licensed in California, New York, and Wisconsin, “does not require this certification for his independent practice but is evaluating next steps with attorneys,” according to the statement from FLCCC.

Dr. Marik, whose Virginia medical license expired in 2022, “is no longer treating patients and has dedicated his time and efforts to the FLCCC Alliance,” the statement said.

Dr. Caplan served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position) and is a contributing author and advisor for this news organization. Ms. Parmet reports no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

The American Board of Internal Medicine (ABIM) has revoked certification for two physicians known for leading an organization that promotes ivermectin as a treatment for COVID-19.

Pierre Kory, MD, is no longer certified in critical care medicine, pulmonary disease, and internal medicine, according to the ABIM website. Paul Ellis Marik, MD, is no longer certified in critical care medicine or internal medicine. 

Dr. Marik is the chief scientific officer and Dr. Kory is president emeritus of the Front Line COVID-19 Critical Care Alliance, a group they founded in March 2020. The FLCCC gained notoriety during the height of the pandemic for advocating ivermectin as a treatment for COVID. It now espouses regimens of supplements to treat “vaccine injury” and also offers treatments for Lyme disease.

Ivermectin was proven to not be of use in treating COVID. Studies purporting to show a benefit were later linked to errors, and some were found to have been based on potentially fraudulent research.

The ABIM declined to comment when asked by this news organization about its action. Its website indicates that “revoked” indicates “loss of certification due to disciplinary action for which ABIM has determined that the conduct underlying the sanction does not warrant a defined pathway for restoration of certification at the time of disciplinary sanction.”

In a statement emailed to this news organization, Dr. Kory and Dr. Marik said, “we believe this decision represents a dangerous shift away from the foundation principles of medical discourse and scientific debate that have historically been the bedrock of medical education associations.”

The FLCCC said in the statement that it, along with Dr. Kory and Dr. Marik, are “evaluating options to challenge these decisions.”

Dr. Kory and Dr. Marik said they were notified in May 2022 that they were facing a potential ABIM disciplinary action. An ABIM committee recommended the revocation in July 2023, saying the two men were spreading “false or inaccurate medical information,” according to FLCCC. Dr. Kory and Dr. Marik lost an appeal. 

In a 2023 statement, Dr. Kory and Dr. Marik called the ABIM action an “attack on freedom of speech.”

“This isn’t a free speech question,” said Arthur L. Caplan, PhD, the Drs. William F. and Virginia Connolly Mitty Professor of Bioethics at NYU Grossman School of Medicine’s Department of Population Health, New York City. “You do have the right to free speech, but you don’t have the right to practice outside of the standard of care boundaries,” he told this news organization.

The ABIM action “is the field standing up and saying, ‘These are the limits of what you can do,’” said Dr. Caplan. It means the profession is rejecting those “who are involved in things that harm patients or delay them getting accepted treatments,” he said. Caplan noted that a disciplinary action had been a long time in coming — 3 years since the first battles over ivermectin. 

Wendy Parmet, JD, Matthews Distinguished University Professor of Law at Northeastern University School of Public Policy and Urban Affairs, Boston, said that misinformation spread by physicians is especially harmful because it comes with an air of credibility.

“We certainly want people to be able to dissent,” Ms. Parmet told this news organization. To engender trust, any sanctions by a professional board should be done in a deliberative process with a strong evidentiary base, she said. 

“You want to leave sufficient room for discourse and discussion within the profession, and you don’t want the board to enforce a narrow, rigid orthodoxy,” she said. But in cases where people are “peddling information that is way outside the consensus” or are “profiting off of it, for the profession to take no action, that is, I think, detrimental also to the trust in the profession,” she said.

She was not surprised that Dr. Kory and Dr. Marik would fight to retain certification. “Board certification is an important, very worthwhile thing to have,” she said. “Losing it is not trivial.”

Dr. Kory, who is licensed in California, New York, and Wisconsin, “does not require this certification for his independent practice but is evaluating next steps with attorneys,” according to the statement from FLCCC.

Dr. Marik, whose Virginia medical license expired in 2022, “is no longer treating patients and has dedicated his time and efforts to the FLCCC Alliance,” the statement said.

Dr. Caplan served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position) and is a contributing author and advisor for this news organization. Ms. Parmet reports no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Nearly 10% of patients with chronic pain treated with opioids develop opioid use disorder, whereas 30% show signs and symptoms of dependence, highlighting the need for monitoring and alternative pain management strategies. 

METHODOLOGY:

• Researchers conducted a systematic review and meta-analysis using MEDLINE, Embase, and PsycINFO databases from inception to January 27, 2021.
• The studies analyzed were predominantly from the United States (n = 115) as well as high-income countries such as the United Kingdom (n = 5), France (n = 3), Spain (n = 4), Germany (n = 4), and Australia (n = 2).
• A total of 148 studies from various settings with over 4.3 million participants were included, focusing on patients aged ≥ 12 years with chronic non-cancer pain of ≥ 3 months duration, treated with opioid analgesics.
• Problematic opioid use was categorized into four categories: dependence and opioid use disorder, signs and symptoms of dependence and opioid use disorder, aberrant behavior, and at risk for dependence and opioid use disorder.

TAKEAWAY:

• The pooled prevalence of dependence and opioid use disorder was 9.3% (95% CI, 5.7%-14.8%), with significant heterogeneity across studies.
• Signs and symptoms of dependence were observed in 29.6% (95% CI, 22.1%-38.3%) of patients, indicating a high prevalence of problematic opioid use.
• Aberrant behavior was reported in 22% (95% CI, 17.4%-27.3%) of patients, highlighting the need for careful monitoring and intervention.
• The prevalence of patients at risk of developing dependence was 12.4% (95% CI, 4.3%-30.7%), suggesting the importance of early identification and prevention strategies.

IN PRACTICE:

“Clinicians and policymakers need a more accurate estimate of the prevalence of problematic opioid use in pain patients so that they can gauge the true extent of the problem, change prescribing guidance if necessary, and develop and implement effective interventions to manage the problem,” Kyla H. Thomas, PhD, the lead author, noted in a press release. Knowing the size of the problem is a necessary step to managing it, she added.

SOURCE:

The study was led by Dr. Thomas, Population Health Sciences, Bristol Medical School, University of Bristol in England. It was published online, in Addiction. 

LIMITATIONS:

The study’s high heterogeneity across included studies suggests caution in interpreting the findings. The reliance on self-reported data and varying definitions of problematic opioid use may affect the accuracy of prevalence estimates. Most studies were conducted in high-income countries, limiting the generalizability to other settings. 

DISCLOSURES: 

The study was funded by the National Institute for Health and Care Research (NIHR). Dr. Thomas reported receiving financial support from the NIHR for this study.

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

TOPLINE:

Nearly 10% of patients with chronic pain treated with opioids develop opioid use disorder, whereas 30% show signs and symptoms of dependence, highlighting the need for monitoring and alternative pain management strategies. 

METHODOLOGY:

• Researchers conducted a systematic review and meta-analysis using MEDLINE, Embase, and PsycINFO databases from inception to January 27, 2021.
• The studies analyzed were predominantly from the United States (n = 115) as well as high-income countries such as the United Kingdom (n = 5), France (n = 3), Spain (n = 4), Germany (n = 4), and Australia (n = 2).
• A total of 148 studies from various settings with over 4.3 million participants were included, focusing on patients aged ≥ 12 years with chronic non-cancer pain of ≥ 3 months duration, treated with opioid analgesics.
• Problematic opioid use was categorized into four categories: dependence and opioid use disorder, signs and symptoms of dependence and opioid use disorder, aberrant behavior, and at risk for dependence and opioid use disorder.

TAKEAWAY:

• The pooled prevalence of dependence and opioid use disorder was 9.3% (95% CI, 5.7%-14.8%), with significant heterogeneity across studies.
• Signs and symptoms of dependence were observed in 29.6% (95% CI, 22.1%-38.3%) of patients, indicating a high prevalence of problematic opioid use.
• Aberrant behavior was reported in 22% (95% CI, 17.4%-27.3%) of patients, highlighting the need for careful monitoring and intervention.
• The prevalence of patients at risk of developing dependence was 12.4% (95% CI, 4.3%-30.7%), suggesting the importance of early identification and prevention strategies.

IN PRACTICE:

“Clinicians and policymakers need a more accurate estimate of the prevalence of problematic opioid use in pain patients so that they can gauge the true extent of the problem, change prescribing guidance if necessary, and develop and implement effective interventions to manage the problem,” Kyla H. Thomas, PhD, the lead author, noted in a press release. Knowing the size of the problem is a necessary step to managing it, she added.

SOURCE:

The study was led by Dr. Thomas, Population Health Sciences, Bristol Medical School, University of Bristol in England. It was published online, in Addiction. 

LIMITATIONS:

The study’s high heterogeneity across included studies suggests caution in interpreting the findings. The reliance on self-reported data and varying definitions of problematic opioid use may affect the accuracy of prevalence estimates. Most studies were conducted in high-income countries, limiting the generalizability to other settings. 

DISCLOSURES: 

The study was funded by the National Institute for Health and Care Research (NIHR). Dr. Thomas reported receiving financial support from the NIHR for this study.

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

TOPLINE:

Nearly 10% of patients with chronic pain treated with opioids develop opioid use disorder, whereas 30% show signs and symptoms of dependence, highlighting the need for monitoring and alternative pain management strategies. 

METHODOLOGY:

• Researchers conducted a systematic review and meta-analysis using MEDLINE, Embase, and PsycINFO databases from inception to January 27, 2021.
• The studies analyzed were predominantly from the United States (n = 115) as well as high-income countries such as the United Kingdom (n = 5), France (n = 3), Spain (n = 4), Germany (n = 4), and Australia (n = 2).
• A total of 148 studies from various settings with over 4.3 million participants were included, focusing on patients aged ≥ 12 years with chronic non-cancer pain of ≥ 3 months duration, treated with opioid analgesics.
• Problematic opioid use was categorized into four categories: dependence and opioid use disorder, signs and symptoms of dependence and opioid use disorder, aberrant behavior, and at risk for dependence and opioid use disorder.

TAKEAWAY:

• The pooled prevalence of dependence and opioid use disorder was 9.3% (95% CI, 5.7%-14.8%), with significant heterogeneity across studies.
• Signs and symptoms of dependence were observed in 29.6% (95% CI, 22.1%-38.3%) of patients, indicating a high prevalence of problematic opioid use.
• Aberrant behavior was reported in 22% (95% CI, 17.4%-27.3%) of patients, highlighting the need for careful monitoring and intervention.
• The prevalence of patients at risk of developing dependence was 12.4% (95% CI, 4.3%-30.7%), suggesting the importance of early identification and prevention strategies.

IN PRACTICE:

“Clinicians and policymakers need a more accurate estimate of the prevalence of problematic opioid use in pain patients so that they can gauge the true extent of the problem, change prescribing guidance if necessary, and develop and implement effective interventions to manage the problem,” Kyla H. Thomas, PhD, the lead author, noted in a press release. Knowing the size of the problem is a necessary step to managing it, she added.

SOURCE:

The study was led by Dr. Thomas, Population Health Sciences, Bristol Medical School, University of Bristol in England. It was published online, in Addiction. 

LIMITATIONS:

The study’s high heterogeneity across included studies suggests caution in interpreting the findings. The reliance on self-reported data and varying definitions of problematic opioid use may affect the accuracy of prevalence estimates. Most studies were conducted in high-income countries, limiting the generalizability to other settings. 

DISCLOSURES: 

The study was funded by the National Institute for Health and Care Research (NIHR). Dr. Thomas reported receiving financial support from the NIHR for this study.

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