Psoriatic Arthritis

Key clinical point: Cognitive abilities were altered in patients with psoriatic arthritis (PsA) compared with non-rheumatology reference individuals, with significant impairment in selective attention.

Major finding: Patients with PsA reported significant deficits in selective attention (mean difference [MD] −4.5), no effect on working memory (P = .662) and improvement in episodic short-term memory (MD 3.0; both P < .001) compared with matched reference subjects.

Study details: Findings are from a cross-sectional, exploratory study including 101 patients with axial spondyloarthritis, 117 patients with PsA, and matched non-rheumatology reference subjects without any diseases relevant to cognitive performance.

Disclosures: This study was funded by the RHADAR GbR, Germany. Some authors, including the lead author, declared receiving grants, consulting fees, speaker’s fees, travel support, honoraria, or advisory board support from several sources.

Source: Kleinert S et al. Impairment in cognitive function in patients with axial spondyloarthritis and psoriatic arthritis. Rheumatol Int. 2022 (Nov 28). Doi: 10.1007/s00296-022-05248-4

Key clinical point: Cognitive abilities were altered in patients with psoriatic arthritis (PsA) compared with non-rheumatology reference individuals, with significant impairment in selective attention.

Major finding: Patients with PsA reported significant deficits in selective attention (mean difference [MD] −4.5), no effect on working memory (P = .662) and improvement in episodic short-term memory (MD 3.0; both P < .001) compared with matched reference subjects.

Study details: Findings are from a cross-sectional, exploratory study including 101 patients with axial spondyloarthritis, 117 patients with PsA, and matched non-rheumatology reference subjects without any diseases relevant to cognitive performance.

Disclosures: This study was funded by the RHADAR GbR, Germany. Some authors, including the lead author, declared receiving grants, consulting fees, speaker’s fees, travel support, honoraria, or advisory board support from several sources.

Source: Kleinert S et al. Impairment in cognitive function in patients with axial spondyloarthritis and psoriatic arthritis. Rheumatol Int. 2022 (Nov 28). Doi: 10.1007/s00296-022-05248-4

Key clinical point: Cognitive abilities were altered in patients with psoriatic arthritis (PsA) compared with non-rheumatology reference individuals, with significant impairment in selective attention.

Major finding: Patients with PsA reported significant deficits in selective attention (mean difference [MD] −4.5), no effect on working memory (P = .662) and improvement in episodic short-term memory (MD 3.0; both P < .001) compared with matched reference subjects.

Study details: Findings are from a cross-sectional, exploratory study including 101 patients with axial spondyloarthritis, 117 patients with PsA, and matched non-rheumatology reference subjects without any diseases relevant to cognitive performance.

Disclosures: This study was funded by the RHADAR GbR, Germany. Some authors, including the lead author, declared receiving grants, consulting fees, speaker’s fees, travel support, honoraria, or advisory board support from several sources.

Source: Kleinert S et al. Impairment in cognitive function in patients with axial spondyloarthritis and psoriatic arthritis. Rheumatol Int. 2022 (Nov 28). Doi: 10.1007/s00296-022-05248-4

Key clinical point: Increasing disease activity and joint damage were significant risk factors for requiring musculoskeletal (MSK) surgery in patients with psoriatic arthritis (PsA).

Major finding: A greater number of damaged joints (hazard ratio [HR] 1.032; P < .001), presence of nail lesions (HR 2.079; P < .006), higher health assessment questionnaire scores (HR 2.012; P < .001), an elevated erythrocyte sedimentation rate (HR 2.365; P = .017), a greater number of actively inflamed joints (HR 1.037; P = .007), and human leukocyte antigen-B*27 positivity (HR 2.217; P = .048) were associated with an increased risk for surgery.

Study details: Findings are from a longitudinal, observational cohort study including 1574 patients with PsA, of which 11.8% underwent ≥1 MSK surgery attributable to PsA.

Disclosures: This study was supported by the Krembil Foundation, Toronto. The authors declared no conflicts of interest.

Source: Kwok TSH et al. Musculoskeletal surgery in psoriatic arthritis: Prevalence and risk factors. J Rheumatol. 2022 (Nov 15). Doi: 10.3899/jrheum.220908

Key clinical point: Increasing disease activity and joint damage were significant risk factors for requiring musculoskeletal (MSK) surgery in patients with psoriatic arthritis (PsA).

Major finding: A greater number of damaged joints (hazard ratio [HR] 1.032; P < .001), presence of nail lesions (HR 2.079; P < .006), higher health assessment questionnaire scores (HR 2.012; P < .001), an elevated erythrocyte sedimentation rate (HR 2.365; P = .017), a greater number of actively inflamed joints (HR 1.037; P = .007), and human leukocyte antigen-B*27 positivity (HR 2.217; P = .048) were associated with an increased risk for surgery.

Study details: Findings are from a longitudinal, observational cohort study including 1574 patients with PsA, of which 11.8% underwent ≥1 MSK surgery attributable to PsA.

Disclosures: This study was supported by the Krembil Foundation, Toronto. The authors declared no conflicts of interest.

Source: Kwok TSH et al. Musculoskeletal surgery in psoriatic arthritis: Prevalence and risk factors. J Rheumatol. 2022 (Nov 15). Doi: 10.3899/jrheum.220908

Key clinical point: Increasing disease activity and joint damage were significant risk factors for requiring musculoskeletal (MSK) surgery in patients with psoriatic arthritis (PsA).

Major finding: A greater number of damaged joints (hazard ratio [HR] 1.032; P < .001), presence of nail lesions (HR 2.079; P < .006), higher health assessment questionnaire scores (HR 2.012; P < .001), an elevated erythrocyte sedimentation rate (HR 2.365; P = .017), a greater number of actively inflamed joints (HR 1.037; P = .007), and human leukocyte antigen-B*27 positivity (HR 2.217; P = .048) were associated with an increased risk for surgery.

Study details: Findings are from a longitudinal, observational cohort study including 1574 patients with PsA, of which 11.8% underwent ≥1 MSK surgery attributable to PsA.

Disclosures: This study was supported by the Krembil Foundation, Toronto. The authors declared no conflicts of interest.

Source: Kwok TSH et al. Musculoskeletal surgery in psoriatic arthritis: Prevalence and risk factors. J Rheumatol. 2022 (Nov 15). Doi: 10.3899/jrheum.220908

Key clinical point: Psoriatic arthritis (PsA) was positively associated with Crohn’s disease and genetically predicted Crohn’s disease was associated with an increased risk for PsA, indicating a bidirectional causal relationship between the 2 diseases.

Major finding: PsA was associated with a 31.9% increased risk for Crohn’s disease (odds ratio [OR] 1.319; P < .001) and genetically predicted Crohn’s disease was linked to a 44.8% higher risk for PsA (OR 1.448; P = .001).

Study details: Findings are from a bidirectional 2-sample mendelian randomization study including 4510 patients with psoriasis, 1637 patients with PsA, and 212,242 control individuals along with 657 patients with Crohn’s disease, 2251 patients with ulcerative colitis, and 210,300 control individuals.

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

Source: Sun Y et al. The causal relationship between psoriasis, psoriatic arthritis, and inflammatory bowel diseases. Sci Rep. 2022;12:20526 (Nov 28). Doi: 10.1038/s41598-022-24872-5

Key clinical point: Psoriatic arthritis (PsA) was positively associated with Crohn’s disease and genetically predicted Crohn’s disease was associated with an increased risk for PsA, indicating a bidirectional causal relationship between the 2 diseases.

Major finding: PsA was associated with a 31.9% increased risk for Crohn’s disease (odds ratio [OR] 1.319; P < .001) and genetically predicted Crohn’s disease was linked to a 44.8% higher risk for PsA (OR 1.448; P = .001).

Study details: Findings are from a bidirectional 2-sample mendelian randomization study including 4510 patients with psoriasis, 1637 patients with PsA, and 212,242 control individuals along with 657 patients with Crohn’s disease, 2251 patients with ulcerative colitis, and 210,300 control individuals.

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

Source: Sun Y et al. The causal relationship between psoriasis, psoriatic arthritis, and inflammatory bowel diseases. Sci Rep. 2022;12:20526 (Nov 28). Doi: 10.1038/s41598-022-24872-5

Key clinical point: Psoriatic arthritis (PsA) was positively associated with Crohn’s disease and genetically predicted Crohn’s disease was associated with an increased risk for PsA, indicating a bidirectional causal relationship between the 2 diseases.

Major finding: PsA was associated with a 31.9% increased risk for Crohn’s disease (odds ratio [OR] 1.319; P < .001) and genetically predicted Crohn’s disease was linked to a 44.8% higher risk for PsA (OR 1.448; P = .001).

Study details: Findings are from a bidirectional 2-sample mendelian randomization study including 4510 patients with psoriasis, 1637 patients with PsA, and 212,242 control individuals along with 657 patients with Crohn’s disease, 2251 patients with ulcerative colitis, and 210,300 control individuals.

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

Source: Sun Y et al. The causal relationship between psoriasis, psoriatic arthritis, and inflammatory bowel diseases. Sci Rep. 2022;12:20526 (Nov 28). Doi: 10.1038/s41598-022-24872-5

Key clinical point: Nailfold capillary abnormalities were more prevalent in patients with psoriatic arthritis (PsA) than in patients with psoriasis vulgaris (PsV) and predicted the development of PsA in patients with psoriasis.

Major finding: Nailfold bleeding (NFB; 84.5% vs 34.7%) and enlarged capillaries (100.0% vs 25.4%; both P < .0001) were more prevalent in patients with PsA vs PsV, with both NFB (hazard ratio [HR] 2.75; P = .004) and enlarged capillaries (HR 4.49; P < .0001) predicting the development of PsA in patients with PsV.

Study details: Findings are from a prospective cohort study including 236 patients with PsV and 213 patients with PsA.

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

Source: Fukasawa T et al. Utility of nailfold capillary assessment for predicting psoriatic arthritis based on a prospective observational cohort study. Rheumatology (Oxford). 2022 (Nov 28). Doi: 10.1093/rheumatology/keac664

Key clinical point: Nailfold capillary abnormalities were more prevalent in patients with psoriatic arthritis (PsA) than in patients with psoriasis vulgaris (PsV) and predicted the development of PsA in patients with psoriasis.

Major finding: Nailfold bleeding (NFB; 84.5% vs 34.7%) and enlarged capillaries (100.0% vs 25.4%; both P < .0001) were more prevalent in patients with PsA vs PsV, with both NFB (hazard ratio [HR] 2.75; P = .004) and enlarged capillaries (HR 4.49; P < .0001) predicting the development of PsA in patients with PsV.

Study details: Findings are from a prospective cohort study including 236 patients with PsV and 213 patients with PsA.

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

Source: Fukasawa T et al. Utility of nailfold capillary assessment for predicting psoriatic arthritis based on a prospective observational cohort study. Rheumatology (Oxford). 2022 (Nov 28). Doi: 10.1093/rheumatology/keac664

Key clinical point: Nailfold capillary abnormalities were more prevalent in patients with psoriatic arthritis (PsA) than in patients with psoriasis vulgaris (PsV) and predicted the development of PsA in patients with psoriasis.

Major finding: Nailfold bleeding (NFB; 84.5% vs 34.7%) and enlarged capillaries (100.0% vs 25.4%; both P < .0001) were more prevalent in patients with PsA vs PsV, with both NFB (hazard ratio [HR] 2.75; P = .004) and enlarged capillaries (HR 4.49; P < .0001) predicting the development of PsA in patients with PsV.

Study details: Findings are from a prospective cohort study including 236 patients with PsV and 213 patients with PsA.

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

Source: Fukasawa T et al. Utility of nailfold capillary assessment for predicting psoriatic arthritis based on a prospective observational cohort study. Rheumatology (Oxford). 2022 (Nov 28). Doi: 10.1093/rheumatology/keac664

Key clinical point: Bimekizumab improved the signs and symptoms of psoriatic arthritis (PsA) in patients with previous inadequate response to or intolerance of tumor necrosis factor-alpha (TNFα) inhibitors without causing any unprecedented adverse events (AE).

Major finding: At week 16, a significantly higher proportion of patients receiving bimekizumab vs placebo achieved ≥50% improvement in American College of Rheumatology response (43% vs 7%; odds ratio 11.1; P < .0001), with treatment-emergent AE being reported by 40% of patients receiving bimekizumab and 33% of patients receiving placebo.

Study details: Findings are from the multicenter, phase 3 BE COMPLETE study including 400 patients with active PsA and previous inadequate response to or intolerance of TNFα inhibitors who were randomly assigned to receive 160 mg subcutaneous bimekizumab every 4 weeks or placebo.

Disclosures: This study was funded by UCB Pharma. Five authors declared being employees and shareholders of UCB Pharma, and the other authors reported ties with several sources, including UCB Pharma.

Source: Merola JF et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: A randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2022 (Dec 6). Doi: 10.1016/S0140-6736(22)02303-0

Key clinical point: Bimekizumab improved the signs and symptoms of psoriatic arthritis (PsA) in patients with previous inadequate response to or intolerance of tumor necrosis factor-alpha (TNFα) inhibitors without causing any unprecedented adverse events (AE).

Major finding: At week 16, a significantly higher proportion of patients receiving bimekizumab vs placebo achieved ≥50% improvement in American College of Rheumatology response (43% vs 7%; odds ratio 11.1; P < .0001), with treatment-emergent AE being reported by 40% of patients receiving bimekizumab and 33% of patients receiving placebo.

Study details: Findings are from the multicenter, phase 3 BE COMPLETE study including 400 patients with active PsA and previous inadequate response to or intolerance of TNFα inhibitors who were randomly assigned to receive 160 mg subcutaneous bimekizumab every 4 weeks or placebo.

Disclosures: This study was funded by UCB Pharma. Five authors declared being employees and shareholders of UCB Pharma, and the other authors reported ties with several sources, including UCB Pharma.

Source: Merola JF et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: A randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2022 (Dec 6). Doi: 10.1016/S0140-6736(22)02303-0

Key clinical point: Bimekizumab improved the signs and symptoms of psoriatic arthritis (PsA) in patients with previous inadequate response to or intolerance of tumor necrosis factor-alpha (TNFα) inhibitors without causing any unprecedented adverse events (AE).

Major finding: At week 16, a significantly higher proportion of patients receiving bimekizumab vs placebo achieved ≥50% improvement in American College of Rheumatology response (43% vs 7%; odds ratio 11.1; P < .0001), with treatment-emergent AE being reported by 40% of patients receiving bimekizumab and 33% of patients receiving placebo.

Study details: Findings are from the multicenter, phase 3 BE COMPLETE study including 400 patients with active PsA and previous inadequate response to or intolerance of TNFα inhibitors who were randomly assigned to receive 160 mg subcutaneous bimekizumab every 4 weeks or placebo.

Disclosures: This study was funded by UCB Pharma. Five authors declared being employees and shareholders of UCB Pharma, and the other authors reported ties with several sources, including UCB Pharma.

Source: Merola JF et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: A randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2022 (Dec 6). Doi: 10.1016/S0140-6736(22)02303-0

Key clinical point: A booster dose of BNT162b2 messenger ribonucleic acid (mRNA) SARS-CoV-2 vaccine (BioNTech-Pfizer) restored the anti-SARS-CoV-2 immunoglobulin G (IgG) levels in patients with psoriatic arthritis (PsA) who were receiving tumor necrosis factor (TNF) inhibitors.

Major finding: Although the mean anti-SARS-CoV-2 IgG levels were significantly lower in patients with PsA vs matched control individuals (2009.22 vs 6206.59 AU/mL; P = .0006) 4 months after two doses of vaccination, the mean IgG levels were similar between both groups after the booster dose (P = .20).

Study details: Findings are from a prospective study including 40 patients with PsA on TNF inhibitors and 40 matched control individuals who received two shots of the BNT162b2 mRNA vaccine.

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

Source: Venerito V et al. Anti-SARS-CoV-2 antibody decay after vaccination and immunogenicity of the booster dose of the BNT162b2 mRNA vaccine in patients with psoriatic arthritis on TNF inhibitors. Clin Exp Rheumatol. 2022 (Nov 24). Doi: 10.55563/clinexprheumatol/hptln9

Key clinical point: A booster dose of BNT162b2 messenger ribonucleic acid (mRNA) SARS-CoV-2 vaccine (BioNTech-Pfizer) restored the anti-SARS-CoV-2 immunoglobulin G (IgG) levels in patients with psoriatic arthritis (PsA) who were receiving tumor necrosis factor (TNF) inhibitors.

Major finding: Although the mean anti-SARS-CoV-2 IgG levels were significantly lower in patients with PsA vs matched control individuals (2009.22 vs 6206.59 AU/mL; P = .0006) 4 months after two doses of vaccination, the mean IgG levels were similar between both groups after the booster dose (P = .20).

Study details: Findings are from a prospective study including 40 patients with PsA on TNF inhibitors and 40 matched control individuals who received two shots of the BNT162b2 mRNA vaccine.

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

Source: Venerito V et al. Anti-SARS-CoV-2 antibody decay after vaccination and immunogenicity of the booster dose of the BNT162b2 mRNA vaccine in patients with psoriatic arthritis on TNF inhibitors. Clin Exp Rheumatol. 2022 (Nov 24). Doi: 10.55563/clinexprheumatol/hptln9

Key clinical point: A booster dose of BNT162b2 messenger ribonucleic acid (mRNA) SARS-CoV-2 vaccine (BioNTech-Pfizer) restored the anti-SARS-CoV-2 immunoglobulin G (IgG) levels in patients with psoriatic arthritis (PsA) who were receiving tumor necrosis factor (TNF) inhibitors.

Major finding: Although the mean anti-SARS-CoV-2 IgG levels were significantly lower in patients with PsA vs matched control individuals (2009.22 vs 6206.59 AU/mL; P = .0006) 4 months after two doses of vaccination, the mean IgG levels were similar between both groups after the booster dose (P = .20).

Study details: Findings are from a prospective study including 40 patients with PsA on TNF inhibitors and 40 matched control individuals who received two shots of the BNT162b2 mRNA vaccine.

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

Source: Venerito V et al. Anti-SARS-CoV-2 antibody decay after vaccination and immunogenicity of the booster dose of the BNT162b2 mRNA vaccine in patients with psoriatic arthritis on TNF inhibitors. Clin Exp Rheumatol. 2022 (Nov 24). Doi: 10.55563/clinexprheumatol/hptln9

Key clinical point: Bimekizumab demonstrated superior efficacy outcomes compared with placebo and was well-tolerated with a consistent safety profile in patients with active psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs (bDMARD).

Major finding: At week 16, a significantly higher proportion of patients receiving bimekizumab vs placebo achieved ≥50% improvement in American College of Rheumatology response (44% vs 10%; odds ratio 7.1; P < .0001). Treatment-emergent adverse events were reported by 60% vs 49% of patients in the bimekizumab vs placebo arm, respectively, and no deaths occurred.

Study details: Findings are from the phase 3 BE OPTIMAL study including 852 patients with active PsA who were naive to bDMARD and were randomly assigned to receive bimekizumab, placebo, or adalimumab.

Disclosures: This study was funded by UCB Pharma. Five authors declared being employees and shareholders of UCB Pharma, and the other authors declared receiving grants, fees, honoraria, or having other ties with several sources, including UCB Pharma.

Source: McInnes IB et al. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: A randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. 2022 (Dec 5). Doi: 10.1016/S0140-6736(22)02302-9

Key clinical point: Bimekizumab demonstrated superior efficacy outcomes compared with placebo and was well-tolerated with a consistent safety profile in patients with active psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs (bDMARD).

Major finding: At week 16, a significantly higher proportion of patients receiving bimekizumab vs placebo achieved ≥50% improvement in American College of Rheumatology response (44% vs 10%; odds ratio 7.1; P < .0001). Treatment-emergent adverse events were reported by 60% vs 49% of patients in the bimekizumab vs placebo arm, respectively, and no deaths occurred.

Study details: Findings are from the phase 3 BE OPTIMAL study including 852 patients with active PsA who were naive to bDMARD and were randomly assigned to receive bimekizumab, placebo, or adalimumab.

Disclosures: This study was funded by UCB Pharma. Five authors declared being employees and shareholders of UCB Pharma, and the other authors declared receiving grants, fees, honoraria, or having other ties with several sources, including UCB Pharma.

Source: McInnes IB et al. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: A randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. 2022 (Dec 5). Doi: 10.1016/S0140-6736(22)02302-9

Key clinical point: Bimekizumab demonstrated superior efficacy outcomes compared with placebo and was well-tolerated with a consistent safety profile in patients with active psoriatic arthritis (PsA) who were naive to biologic disease-modifying antirheumatic drugs (bDMARD).

Major finding: At week 16, a significantly higher proportion of patients receiving bimekizumab vs placebo achieved ≥50% improvement in American College of Rheumatology response (44% vs 10%; odds ratio 7.1; P < .0001). Treatment-emergent adverse events were reported by 60% vs 49% of patients in the bimekizumab vs placebo arm, respectively, and no deaths occurred.

Study details: Findings are from the phase 3 BE OPTIMAL study including 852 patients with active PsA who were naive to bDMARD and were randomly assigned to receive bimekizumab, placebo, or adalimumab.

Disclosures: This study was funded by UCB Pharma. Five authors declared being employees and shareholders of UCB Pharma, and the other authors declared receiving grants, fees, honoraria, or having other ties with several sources, including UCB Pharma.

Source: McInnes IB et al. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: A randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. 2022 (Dec 5). Doi: 10.1016/S0140-6736(22)02302-9

Patients with rheumatic disease are at least half as likely to develop long COVID after a SARS-CoV-2 infection if they have been fully vaccinated against COVID-19, according to research published in Annals of the Rheumatic Diseases (2022 Nov 28. doi: 10.1136/ard-2022-223439).

“Moreover, those who were vaccinated prior to getting COVID-19 had less pain and fatigue after their infection,” Zachary S. Wallace, MD, MSc, an assistant professor of medicine at Harvard Medical School, Boston, and a study author, said in an interview. “These findings reinforce the importance of vaccination in this population.”

Messaging around the value of COVID vaccination has been confusing for some with rheumatic disease “because our concern regarding a blunted response to vaccination has led many patients to think that they do not provide much benefit if they are on immunosuppression,” Dr. Wallace said. “In our cohort, which included many patients on immunosuppression of varying degrees, being vaccinated was quite beneficial.”

Leonard H. Calabrese, DO, director of the R.J. Fasenmyer Center for Clinical Immunology and a professor of medicine at the Cleveland Clinic, said in an interview that the study is an “extremely important contribution to our understanding of COVID-19 and its pattern of recovery in patients with immune-mediated inflammatory diseases [IMIDs].” Remaining unanswered questions are “whether patients with IMIDs develop more frequent PASC [post–acute sequelae of COVID-19] from COVID-19 and, if so, is it milder or more severe, and does it differ in its clinical phenotype?”
 

Long COVID risk assessed at 4 weeks and 3 months after infection

The researchers prospectively tracked 280 adult patients in the Mass General Brigham health care system in the greater Boston area who had systemic autoimmune rheumatic diseases and had an acute COVID-19 infection between March 2020 and July 2022. Patients were an average 53 years old, and most were White (82%) and female (80%). More than half (59%) had inflammatory arthritis, a quarter (24%) had connective tissue disease, and most others had a vasculitis condition or multiple conditions.

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A total of 11% of patients were unvaccinated, 28% were partially vaccinated with one mRNA COVID-19 vaccine dose, and 41% were fully vaccinated with two mRNA vaccine doses or one Johnson & Johnson dose. The 116 fully vaccinated patients were considered to have a breakthrough infection while the other 164 were considered to have a nonbreakthrough infection. The breakthrough and nonbreakthrough groups were similar in terms of age, sex, race, ethnicity, smoking status, and type of rheumatic disease. Comorbidities were also similar, except obesity, which was more common in the non–breakthrough infection group (25%) than the breakthrough infection group (10%).

The researchers queried patients on their COVID-19 symptoms, how long symptoms lasted, treatments they received, and hospitalization details. COVID-19 symptoms assessed included fever, sore throat, new cough, nasal congestion/rhinorrhea, dyspnea, chest pain, rash, myalgia, fatigue/malaise, headache, nausea/vomiting, diarrhea, anosmia, dysgeusia, and joint pain.

Patients completed surveys about symptoms at 4 weeks and 3 months after infection. Long COVID, or PASC, was defined as any persistent symptom at the times assessed.
 

Vaccinated patients fared better across outcomes

At 4 weeks after infection, 41% of fully vaccinated patients had at least one persistent symptom, compared with 54% of unvaccinated or partially vaccinated patients (P = .04). At 3 months after infection, 21% of fully vaccinated patients had at least one persistent symptom, compared with 41% of unvaccinated or partially vaccinated patients (P < .0001).

Vaccinated patients were half as likely to have long COVID at 4 weeks after infection (adjusted odds ratio, 0.49) and 90% less likely to have long COVID 3 months after infection (aOR, 0.1), after adjustment for age, sex, race, comorbidities, and use of any of four immune-suppressing medications (anti-CD20 monoclonal antibodies, methotrexate, mycophenolate, or glucocorticoids).

Fully vaccinated patients with breakthrough infections had an average 21 additional days without symptoms during follow-up, compared with unvaccinated and partially vaccinated patients (P = .04).

Reduced risk of long COVID did not change for vaccinated patients after sensitivity analyses for those who did not receive nirmatrelvir/ritonavir (Paxlovid) or monoclonal antibodies, those who didn’t receive any COVID-19-related treatment, those who completed their questionnaires within 6 months after infection, and those who were not hospitalized.

“One important message is that among those who did get PASC, the severity appears similar among those with and without a breakthrough infection,” Dr. Wallace said. “This highlights the need for ongoing research to improve recognition, diagnosis, and treatment of PASC.”

Many more breakthrough infections (72%) than nonbreakthrough infections (2%) occurred during Omicron. The authors acknowledged that different variants might play a role in different long COVID risks but said such potential confounding is unlikely to fully explain the results.

“Even with data suggesting that the Omicron variants may be intrinsically less severe, vaccination still has an impact on severity of infection, rates of hospitalization, and other outcomes and thus may play a role in the risk of PASC,” lead author Naomi Patel, MD, an instructor at Harvard Medical School and a rheumatologist at Massachusetts General Hospital, said in an interview. “A study evaluating the proportions with PASC by vaccination status during the time in which a single variant is predominant, such as the early Omicron era, could help to better assess the more isolated impact of vaccination on PASC.”

Dr. Calabrese said he is convinced that Omicron infections are less likely to result in more severe forms of acute COVID than pre-Omicron infections, and he suspects Omicron infections are also less likely to result in long COVID, although less evidence currently supports this hypothesis.

Hospitalization was more common in unvaccinated/partly vaccinated patients than in vaccinated patients (27% vs. 5%; P = .001). Although pain and fatigue were lower in those with breakthrough infections, functional scores and health-related quality of life were similar in both groups.

Some symptoms significantly differed between vaccinated and unvaccinated/partly vaccinated groups, possibly caused partly by different variants. Nasal congestion was more common (73%) in those with breakthrough infections than in those with nonbreakthrough infections (46%; P < .0001). Those who were unvaccinated/partly vaccinated were significantly more likely to have loss of smell (46% vs. 22%) or taste (45% vs. 28%) or to have joint pain (11% vs. 4%).

Treatment with nirmatrelvir/ritonavir was also more common in vaccinated patients (12%) than in unvaccinated/partly vaccinated patients (1%; P < .0001), as was treatment with monoclonal antibodies (34% vs. 8%; P < .0001).

The study was limited by its low diversity and being at a single health care system, the authors said. Study coauthor Jeffrey A. Sparks, MD, MMSc, an assistant professor of medicine at Brigham and Women’s Hospital and Harvard Medical School, said in an interview that the group is planning additional studies as their cohort grows, including “investigating the relationships between COVID-19 and specific rheumatic diseases and immunomodulating medications, expansion of autoimmunity and systemic inflammation, and lung damage among specific patient populations.”

Dr. Calabrese said it will be important for follow-up study of the symptomatic patients to “determine how many of these patients will fit the clinical picture of long COVID or long-haul phenotypes over the months and years ahead, including documenting exertional malaise and quality of life.

This study only assessed patients who received zero, one, or two doses of a vaccine, but many patients with rheumatic disease today will likely have received booster doses. However, Dr. Calabrese said it would be difficult to quantify whether a third, fourth, or fifth dose offers additional protection from long-term COVID complications after full vaccination or hybrid vaccination.

The research was funded by the Rheumatology Research Foundation, the National Institutes of Health, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Llura Gund Award for Rheumatoid Arthritis Research and Care. Dr. Wallace has received research support from Bristol-Myers Squibb and Principia/Sanofi and consulting fees from Zenas BioPharma, Horizon, Sanofi, Shionogi, Viela Bio, and Medpace. Dr. Sparks has received research support from Bristol-Myers Squibb and consulting fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer. Dr. Patel has received consulting fees from FVC Health. Calabrese has consulted for Genentech, Sanofi-Regeneron, AstraZeneca, and GlaxoSmithKline.

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

Patients with rheumatic disease are at least half as likely to develop long COVID after a SARS-CoV-2 infection if they have been fully vaccinated against COVID-19, according to research published in Annals of the Rheumatic Diseases (2022 Nov 28. doi: 10.1136/ard-2022-223439).

“Moreover, those who were vaccinated prior to getting COVID-19 had less pain and fatigue after their infection,” Zachary S. Wallace, MD, MSc, an assistant professor of medicine at Harvard Medical School, Boston, and a study author, said in an interview. “These findings reinforce the importance of vaccination in this population.”

Messaging around the value of COVID vaccination has been confusing for some with rheumatic disease “because our concern regarding a blunted response to vaccination has led many patients to think that they do not provide much benefit if they are on immunosuppression,” Dr. Wallace said. “In our cohort, which included many patients on immunosuppression of varying degrees, being vaccinated was quite beneficial.”

Leonard H. Calabrese, DO, director of the R.J. Fasenmyer Center for Clinical Immunology and a professor of medicine at the Cleveland Clinic, said in an interview that the study is an “extremely important contribution to our understanding of COVID-19 and its pattern of recovery in patients with immune-mediated inflammatory diseases [IMIDs].” Remaining unanswered questions are “whether patients with IMIDs develop more frequent PASC [post–acute sequelae of COVID-19] from COVID-19 and, if so, is it milder or more severe, and does it differ in its clinical phenotype?”
 

Long COVID risk assessed at 4 weeks and 3 months after infection

The researchers prospectively tracked 280 adult patients in the Mass General Brigham health care system in the greater Boston area who had systemic autoimmune rheumatic diseases and had an acute COVID-19 infection between March 2020 and July 2022. Patients were an average 53 years old, and most were White (82%) and female (80%). More than half (59%) had inflammatory arthritis, a quarter (24%) had connective tissue disease, and most others had a vasculitis condition or multiple conditions.

filadendron/E+/Getty Images

A total of 11% of patients were unvaccinated, 28% were partially vaccinated with one mRNA COVID-19 vaccine dose, and 41% were fully vaccinated with two mRNA vaccine doses or one Johnson & Johnson dose. The 116 fully vaccinated patients were considered to have a breakthrough infection while the other 164 were considered to have a nonbreakthrough infection. The breakthrough and nonbreakthrough groups were similar in terms of age, sex, race, ethnicity, smoking status, and type of rheumatic disease. Comorbidities were also similar, except obesity, which was more common in the non–breakthrough infection group (25%) than the breakthrough infection group (10%).

The researchers queried patients on their COVID-19 symptoms, how long symptoms lasted, treatments they received, and hospitalization details. COVID-19 symptoms assessed included fever, sore throat, new cough, nasal congestion/rhinorrhea, dyspnea, chest pain, rash, myalgia, fatigue/malaise, headache, nausea/vomiting, diarrhea, anosmia, dysgeusia, and joint pain.

Patients completed surveys about symptoms at 4 weeks and 3 months after infection. Long COVID, or PASC, was defined as any persistent symptom at the times assessed.
 

Vaccinated patients fared better across outcomes

At 4 weeks after infection, 41% of fully vaccinated patients had at least one persistent symptom, compared with 54% of unvaccinated or partially vaccinated patients (P = .04). At 3 months after infection, 21% of fully vaccinated patients had at least one persistent symptom, compared with 41% of unvaccinated or partially vaccinated patients (P < .0001).

Vaccinated patients were half as likely to have long COVID at 4 weeks after infection (adjusted odds ratio, 0.49) and 90% less likely to have long COVID 3 months after infection (aOR, 0.1), after adjustment for age, sex, race, comorbidities, and use of any of four immune-suppressing medications (anti-CD20 monoclonal antibodies, methotrexate, mycophenolate, or glucocorticoids).

Fully vaccinated patients with breakthrough infections had an average 21 additional days without symptoms during follow-up, compared with unvaccinated and partially vaccinated patients (P = .04).

Reduced risk of long COVID did not change for vaccinated patients after sensitivity analyses for those who did not receive nirmatrelvir/ritonavir (Paxlovid) or monoclonal antibodies, those who didn’t receive any COVID-19-related treatment, those who completed their questionnaires within 6 months after infection, and those who were not hospitalized.

“One important message is that among those who did get PASC, the severity appears similar among those with and without a breakthrough infection,” Dr. Wallace said. “This highlights the need for ongoing research to improve recognition, diagnosis, and treatment of PASC.”

Many more breakthrough infections (72%) than nonbreakthrough infections (2%) occurred during Omicron. The authors acknowledged that different variants might play a role in different long COVID risks but said such potential confounding is unlikely to fully explain the results.

“Even with data suggesting that the Omicron variants may be intrinsically less severe, vaccination still has an impact on severity of infection, rates of hospitalization, and other outcomes and thus may play a role in the risk of PASC,” lead author Naomi Patel, MD, an instructor at Harvard Medical School and a rheumatologist at Massachusetts General Hospital, said in an interview. “A study evaluating the proportions with PASC by vaccination status during the time in which a single variant is predominant, such as the early Omicron era, could help to better assess the more isolated impact of vaccination on PASC.”

Dr. Calabrese said he is convinced that Omicron infections are less likely to result in more severe forms of acute COVID than pre-Omicron infections, and he suspects Omicron infections are also less likely to result in long COVID, although less evidence currently supports this hypothesis.

Hospitalization was more common in unvaccinated/partly vaccinated patients than in vaccinated patients (27% vs. 5%; P = .001). Although pain and fatigue were lower in those with breakthrough infections, functional scores and health-related quality of life were similar in both groups.

Some symptoms significantly differed between vaccinated and unvaccinated/partly vaccinated groups, possibly caused partly by different variants. Nasal congestion was more common (73%) in those with breakthrough infections than in those with nonbreakthrough infections (46%; P < .0001). Those who were unvaccinated/partly vaccinated were significantly more likely to have loss of smell (46% vs. 22%) or taste (45% vs. 28%) or to have joint pain (11% vs. 4%).

Treatment with nirmatrelvir/ritonavir was also more common in vaccinated patients (12%) than in unvaccinated/partly vaccinated patients (1%; P < .0001), as was treatment with monoclonal antibodies (34% vs. 8%; P < .0001).

The study was limited by its low diversity and being at a single health care system, the authors said. Study coauthor Jeffrey A. Sparks, MD, MMSc, an assistant professor of medicine at Brigham and Women’s Hospital and Harvard Medical School, said in an interview that the group is planning additional studies as their cohort grows, including “investigating the relationships between COVID-19 and specific rheumatic diseases and immunomodulating medications, expansion of autoimmunity and systemic inflammation, and lung damage among specific patient populations.”

Dr. Calabrese said it will be important for follow-up study of the symptomatic patients to “determine how many of these patients will fit the clinical picture of long COVID or long-haul phenotypes over the months and years ahead, including documenting exertional malaise and quality of life.

This study only assessed patients who received zero, one, or two doses of a vaccine, but many patients with rheumatic disease today will likely have received booster doses. However, Dr. Calabrese said it would be difficult to quantify whether a third, fourth, or fifth dose offers additional protection from long-term COVID complications after full vaccination or hybrid vaccination.

The research was funded by the Rheumatology Research Foundation, the National Institutes of Health, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Llura Gund Award for Rheumatoid Arthritis Research and Care. Dr. Wallace has received research support from Bristol-Myers Squibb and Principia/Sanofi and consulting fees from Zenas BioPharma, Horizon, Sanofi, Shionogi, Viela Bio, and Medpace. Dr. Sparks has received research support from Bristol-Myers Squibb and consulting fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer. Dr. Patel has received consulting fees from FVC Health. Calabrese has consulted for Genentech, Sanofi-Regeneron, AstraZeneca, and GlaxoSmithKline.

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

Patients with rheumatic disease are at least half as likely to develop long COVID after a SARS-CoV-2 infection if they have been fully vaccinated against COVID-19, according to research published in Annals of the Rheumatic Diseases (2022 Nov 28. doi: 10.1136/ard-2022-223439).

“Moreover, those who were vaccinated prior to getting COVID-19 had less pain and fatigue after their infection,” Zachary S. Wallace, MD, MSc, an assistant professor of medicine at Harvard Medical School, Boston, and a study author, said in an interview. “These findings reinforce the importance of vaccination in this population.”

Messaging around the value of COVID vaccination has been confusing for some with rheumatic disease “because our concern regarding a blunted response to vaccination has led many patients to think that they do not provide much benefit if they are on immunosuppression,” Dr. Wallace said. “In our cohort, which included many patients on immunosuppression of varying degrees, being vaccinated was quite beneficial.”

Leonard H. Calabrese, DO, director of the R.J. Fasenmyer Center for Clinical Immunology and a professor of medicine at the Cleveland Clinic, said in an interview that the study is an “extremely important contribution to our understanding of COVID-19 and its pattern of recovery in patients with immune-mediated inflammatory diseases [IMIDs].” Remaining unanswered questions are “whether patients with IMIDs develop more frequent PASC [post–acute sequelae of COVID-19] from COVID-19 and, if so, is it milder or more severe, and does it differ in its clinical phenotype?”
 

Long COVID risk assessed at 4 weeks and 3 months after infection

The researchers prospectively tracked 280 adult patients in the Mass General Brigham health care system in the greater Boston area who had systemic autoimmune rheumatic diseases and had an acute COVID-19 infection between March 2020 and July 2022. Patients were an average 53 years old, and most were White (82%) and female (80%). More than half (59%) had inflammatory arthritis, a quarter (24%) had connective tissue disease, and most others had a vasculitis condition or multiple conditions.

filadendron/E+/Getty Images

A total of 11% of patients were unvaccinated, 28% were partially vaccinated with one mRNA COVID-19 vaccine dose, and 41% were fully vaccinated with two mRNA vaccine doses or one Johnson & Johnson dose. The 116 fully vaccinated patients were considered to have a breakthrough infection while the other 164 were considered to have a nonbreakthrough infection. The breakthrough and nonbreakthrough groups were similar in terms of age, sex, race, ethnicity, smoking status, and type of rheumatic disease. Comorbidities were also similar, except obesity, which was more common in the non–breakthrough infection group (25%) than the breakthrough infection group (10%).

The researchers queried patients on their COVID-19 symptoms, how long symptoms lasted, treatments they received, and hospitalization details. COVID-19 symptoms assessed included fever, sore throat, new cough, nasal congestion/rhinorrhea, dyspnea, chest pain, rash, myalgia, fatigue/malaise, headache, nausea/vomiting, diarrhea, anosmia, dysgeusia, and joint pain.

Patients completed surveys about symptoms at 4 weeks and 3 months after infection. Long COVID, or PASC, was defined as any persistent symptom at the times assessed.
 

Vaccinated patients fared better across outcomes

At 4 weeks after infection, 41% of fully vaccinated patients had at least one persistent symptom, compared with 54% of unvaccinated or partially vaccinated patients (P = .04). At 3 months after infection, 21% of fully vaccinated patients had at least one persistent symptom, compared with 41% of unvaccinated or partially vaccinated patients (P < .0001).

Vaccinated patients were half as likely to have long COVID at 4 weeks after infection (adjusted odds ratio, 0.49) and 90% less likely to have long COVID 3 months after infection (aOR, 0.1), after adjustment for age, sex, race, comorbidities, and use of any of four immune-suppressing medications (anti-CD20 monoclonal antibodies, methotrexate, mycophenolate, or glucocorticoids).

Fully vaccinated patients with breakthrough infections had an average 21 additional days without symptoms during follow-up, compared with unvaccinated and partially vaccinated patients (P = .04).

Reduced risk of long COVID did not change for vaccinated patients after sensitivity analyses for those who did not receive nirmatrelvir/ritonavir (Paxlovid) or monoclonal antibodies, those who didn’t receive any COVID-19-related treatment, those who completed their questionnaires within 6 months after infection, and those who were not hospitalized.

“One important message is that among those who did get PASC, the severity appears similar among those with and without a breakthrough infection,” Dr. Wallace said. “This highlights the need for ongoing research to improve recognition, diagnosis, and treatment of PASC.”

Many more breakthrough infections (72%) than nonbreakthrough infections (2%) occurred during Omicron. The authors acknowledged that different variants might play a role in different long COVID risks but said such potential confounding is unlikely to fully explain the results.

“Even with data suggesting that the Omicron variants may be intrinsically less severe, vaccination still has an impact on severity of infection, rates of hospitalization, and other outcomes and thus may play a role in the risk of PASC,” lead author Naomi Patel, MD, an instructor at Harvard Medical School and a rheumatologist at Massachusetts General Hospital, said in an interview. “A study evaluating the proportions with PASC by vaccination status during the time in which a single variant is predominant, such as the early Omicron era, could help to better assess the more isolated impact of vaccination on PASC.”

Dr. Calabrese said he is convinced that Omicron infections are less likely to result in more severe forms of acute COVID than pre-Omicron infections, and he suspects Omicron infections are also less likely to result in long COVID, although less evidence currently supports this hypothesis.

Hospitalization was more common in unvaccinated/partly vaccinated patients than in vaccinated patients (27% vs. 5%; P = .001). Although pain and fatigue were lower in those with breakthrough infections, functional scores and health-related quality of life were similar in both groups.

Some symptoms significantly differed between vaccinated and unvaccinated/partly vaccinated groups, possibly caused partly by different variants. Nasal congestion was more common (73%) in those with breakthrough infections than in those with nonbreakthrough infections (46%; P < .0001). Those who were unvaccinated/partly vaccinated were significantly more likely to have loss of smell (46% vs. 22%) or taste (45% vs. 28%) or to have joint pain (11% vs. 4%).

Treatment with nirmatrelvir/ritonavir was also more common in vaccinated patients (12%) than in unvaccinated/partly vaccinated patients (1%; P < .0001), as was treatment with monoclonal antibodies (34% vs. 8%; P < .0001).

The study was limited by its low diversity and being at a single health care system, the authors said. Study coauthor Jeffrey A. Sparks, MD, MMSc, an assistant professor of medicine at Brigham and Women’s Hospital and Harvard Medical School, said in an interview that the group is planning additional studies as their cohort grows, including “investigating the relationships between COVID-19 and specific rheumatic diseases and immunomodulating medications, expansion of autoimmunity and systemic inflammation, and lung damage among specific patient populations.”

Dr. Calabrese said it will be important for follow-up study of the symptomatic patients to “determine how many of these patients will fit the clinical picture of long COVID or long-haul phenotypes over the months and years ahead, including documenting exertional malaise and quality of life.

This study only assessed patients who received zero, one, or two doses of a vaccine, but many patients with rheumatic disease today will likely have received booster doses. However, Dr. Calabrese said it would be difficult to quantify whether a third, fourth, or fifth dose offers additional protection from long-term COVID complications after full vaccination or hybrid vaccination.

The research was funded by the Rheumatology Research Foundation, the National Institutes of Health, the R. Bruce and Joan M. Mickey Research Scholar Fund, and the Llura Gund Award for Rheumatoid Arthritis Research and Care. Dr. Wallace has received research support from Bristol-Myers Squibb and Principia/Sanofi and consulting fees from Zenas BioPharma, Horizon, Sanofi, Shionogi, Viela Bio, and Medpace. Dr. Sparks has received research support from Bristol-Myers Squibb and consulting fees from AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead, Inova Diagnostics, Janssen, Optum, and Pfizer. Dr. Patel has received consulting fees from FVC Health. Calabrese has consulted for Genentech, Sanofi-Regeneron, AstraZeneca, and GlaxoSmithKline.

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

Research published during the past month focused mostly on sex differences, biomarkers, and treatment. Sex differences in psoriatic arthritis (PsA) are a significant focus of current research. One major question is how clinical features differ between men and women. Furer and colleagues investigated differences in musculoskeletal ultrasonographic features between men and women with PsA. In a prospective study including 70 men and 88 women, they demonstrated that although the total synovitis and tenosynovitis scores were similar between the two sexes, compared with women, men had higher total ultrasound and gray scale enthesitis scores (both P = .01) and sonographic active inflammatory score (P = .005). Given the uncertainty associated with the clinical diagnosis of enthesitis, this study emphasizes the importance of careful ultrasonographic evaluation when evaluating enthesitis patients, especially women.

It is important to investigate pregnancy outcomes in women with inflammatory arthritis, including PsA, to appropriately counsel and manage patients in the reproductive-age group. Preeclampsia is an important pregnancy outcome that is less well studied in PsA. Secher and colleagues analyzed data from registries in Sweden and Denmark that included singleton pregnant women with rheumatoid arthritis (n = 1739), axial spondyloarthritis (n = 819), and PsA (n = 489) who were matched with 17,390, 8190, and 4890 control pregnant women, respectively. They found that compared with the control women, the risk for preeclampsia was much higher in women with PsA (adjusted odds ratio [aOR; adjusted for country, maternal age, parity, year of delivery, body mass index (BMI), smoking, and education] 1.85; 95% CI 1.10-3.12), with the risk being primarily driven by the receipt of monotherapy for PsA before pregnancy (aOR 2.72; 95% CI 1.44-5.13), probably reflecting the presence of more severe disease. Women with PsA who tend to have higher BMI and active disease need to be counseled about the risk for preeclampsia and be carefully monitored.

The Disease Activity index for PsA (DAPSA) is a validated instrument used in clinical practice to assess PsA disease activity. One drawback of this instrument is that it requires testing for C-reactive protein (CRP), the results of which may not be available immediately, making it difficult to use DAPSA for implementing treating-to-target strategies during a clinic visit. To alleviate this issue, a quick quantitative CRP (qCRP) assay was developed. In a multicenter, cross-sectional study including 104 patients with PsA and available CRP values (measured by routine laboratory and qCRP assays), Proft and colleagues demonstrated that 98.1% of patients were similarly categorized into disease activity groups (remission and low, moderate, and high disease activity) using DAPSA based on qCRP (Q-DAPSA) and DAPSA. The agreement between the two instruments was excellent (weighted Cohen kappa 0.980; 95% CI 0.952-1.000). Thus, the Q-DAPSA may be used in place of DAPSA when evaluating PsA disease activity.

Regarding treatment, in an exploratory analysis of SELECT-PsA 1, McInnes and colleagues demonstrated that, at week 104, a similar proportion of patients receiving 15/30 mg upadacitinib vs adalimumab achieved ≥ 20% improvement in the American College of Rheumatology (ACR20) criteria (69.0%/69.5% vs 63.4%), whereas significantly more patients receiving 30 mg upadacitinib vs adalimumab achieved minimal disease activity (45.9% vs 37.8%; P < .05). The safety profiles of upadacitinib and adalimumab were comparable. Moreover, analyses of 52-week outcome data from the ongoing phase 3 KEEPsAKE 1 study of risankizumab (IL-23 inhibitor) by Kristensen and colleagues showed that among patients who received risankizumab continuously, the ACR20 response increased from 57.3% at week 24 to 70.0% at week 52. No new safety signals were identified. Thus, upadacitinib and risankizumab are newer, safe, and effective disease-modifying antirheumatic drugs for PsA.

Research published during the past month focused mostly on sex differences, biomarkers, and treatment. Sex differences in psoriatic arthritis (PsA) are a significant focus of current research. One major question is how clinical features differ between men and women. Furer and colleagues investigated differences in musculoskeletal ultrasonographic features between men and women with PsA. In a prospective study including 70 men and 88 women, they demonstrated that although the total synovitis and tenosynovitis scores were similar between the two sexes, compared with women, men had higher total ultrasound and gray scale enthesitis scores (both P = .01) and sonographic active inflammatory score (P = .005). Given the uncertainty associated with the clinical diagnosis of enthesitis, this study emphasizes the importance of careful ultrasonographic evaluation when evaluating enthesitis patients, especially women.

It is important to investigate pregnancy outcomes in women with inflammatory arthritis, including PsA, to appropriately counsel and manage patients in the reproductive-age group. Preeclampsia is an important pregnancy outcome that is less well studied in PsA. Secher and colleagues analyzed data from registries in Sweden and Denmark that included singleton pregnant women with rheumatoid arthritis (n = 1739), axial spondyloarthritis (n = 819), and PsA (n = 489) who were matched with 17,390, 8190, and 4890 control pregnant women, respectively. They found that compared with the control women, the risk for preeclampsia was much higher in women with PsA (adjusted odds ratio [aOR; adjusted for country, maternal age, parity, year of delivery, body mass index (BMI), smoking, and education] 1.85; 95% CI 1.10-3.12), with the risk being primarily driven by the receipt of monotherapy for PsA before pregnancy (aOR 2.72; 95% CI 1.44-5.13), probably reflecting the presence of more severe disease. Women with PsA who tend to have higher BMI and active disease need to be counseled about the risk for preeclampsia and be carefully monitored.

The Disease Activity index for PsA (DAPSA) is a validated instrument used in clinical practice to assess PsA disease activity. One drawback of this instrument is that it requires testing for C-reactive protein (CRP), the results of which may not be available immediately, making it difficult to use DAPSA for implementing treating-to-target strategies during a clinic visit. To alleviate this issue, a quick quantitative CRP (qCRP) assay was developed. In a multicenter, cross-sectional study including 104 patients with PsA and available CRP values (measured by routine laboratory and qCRP assays), Proft and colleagues demonstrated that 98.1% of patients were similarly categorized into disease activity groups (remission and low, moderate, and high disease activity) using DAPSA based on qCRP (Q-DAPSA) and DAPSA. The agreement between the two instruments was excellent (weighted Cohen kappa 0.980; 95% CI 0.952-1.000). Thus, the Q-DAPSA may be used in place of DAPSA when evaluating PsA disease activity.

Regarding treatment, in an exploratory analysis of SELECT-PsA 1, McInnes and colleagues demonstrated that, at week 104, a similar proportion of patients receiving 15/30 mg upadacitinib vs adalimumab achieved ≥ 20% improvement in the American College of Rheumatology (ACR20) criteria (69.0%/69.5% vs 63.4%), whereas significantly more patients receiving 30 mg upadacitinib vs adalimumab achieved minimal disease activity (45.9% vs 37.8%; P < .05). The safety profiles of upadacitinib and adalimumab were comparable. Moreover, analyses of 52-week outcome data from the ongoing phase 3 KEEPsAKE 1 study of risankizumab (IL-23 inhibitor) by Kristensen and colleagues showed that among patients who received risankizumab continuously, the ACR20 response increased from 57.3% at week 24 to 70.0% at week 52. No new safety signals were identified. Thus, upadacitinib and risankizumab are newer, safe, and effective disease-modifying antirheumatic drugs for PsA.

Research published during the past month focused mostly on sex differences, biomarkers, and treatment. Sex differences in psoriatic arthritis (PsA) are a significant focus of current research. One major question is how clinical features differ between men and women. Furer and colleagues investigated differences in musculoskeletal ultrasonographic features between men and women with PsA. In a prospective study including 70 men and 88 women, they demonstrated that although the total synovitis and tenosynovitis scores were similar between the two sexes, compared with women, men had higher total ultrasound and gray scale enthesitis scores (both P = .01) and sonographic active inflammatory score (P = .005). Given the uncertainty associated with the clinical diagnosis of enthesitis, this study emphasizes the importance of careful ultrasonographic evaluation when evaluating enthesitis patients, especially women.

It is important to investigate pregnancy outcomes in women with inflammatory arthritis, including PsA, to appropriately counsel and manage patients in the reproductive-age group. Preeclampsia is an important pregnancy outcome that is less well studied in PsA. Secher and colleagues analyzed data from registries in Sweden and Denmark that included singleton pregnant women with rheumatoid arthritis (n = 1739), axial spondyloarthritis (n = 819), and PsA (n = 489) who were matched with 17,390, 8190, and 4890 control pregnant women, respectively. They found that compared with the control women, the risk for preeclampsia was much higher in women with PsA (adjusted odds ratio [aOR; adjusted for country, maternal age, parity, year of delivery, body mass index (BMI), smoking, and education] 1.85; 95% CI 1.10-3.12), with the risk being primarily driven by the receipt of monotherapy for PsA before pregnancy (aOR 2.72; 95% CI 1.44-5.13), probably reflecting the presence of more severe disease. Women with PsA who tend to have higher BMI and active disease need to be counseled about the risk for preeclampsia and be carefully monitored.

The Disease Activity index for PsA (DAPSA) is a validated instrument used in clinical practice to assess PsA disease activity. One drawback of this instrument is that it requires testing for C-reactive protein (CRP), the results of which may not be available immediately, making it difficult to use DAPSA for implementing treating-to-target strategies during a clinic visit. To alleviate this issue, a quick quantitative CRP (qCRP) assay was developed. In a multicenter, cross-sectional study including 104 patients with PsA and available CRP values (measured by routine laboratory and qCRP assays), Proft and colleagues demonstrated that 98.1% of patients were similarly categorized into disease activity groups (remission and low, moderate, and high disease activity) using DAPSA based on qCRP (Q-DAPSA) and DAPSA. The agreement between the two instruments was excellent (weighted Cohen kappa 0.980; 95% CI 0.952-1.000). Thus, the Q-DAPSA may be used in place of DAPSA when evaluating PsA disease activity.

Regarding treatment, in an exploratory analysis of SELECT-PsA 1, McInnes and colleagues demonstrated that, at week 104, a similar proportion of patients receiving 15/30 mg upadacitinib vs adalimumab achieved ≥ 20% improvement in the American College of Rheumatology (ACR20) criteria (69.0%/69.5% vs 63.4%), whereas significantly more patients receiving 30 mg upadacitinib vs adalimumab achieved minimal disease activity (45.9% vs 37.8%; P < .05). The safety profiles of upadacitinib and adalimumab were comparable. Moreover, analyses of 52-week outcome data from the ongoing phase 3 KEEPsAKE 1 study of risankizumab (IL-23 inhibitor) by Kristensen and colleagues showed that among patients who received risankizumab continuously, the ACR20 response increased from 57.3% at week 24 to 70.0% at week 52. No new safety signals were identified. Thus, upadacitinib and risankizumab are newer, safe, and effective disease-modifying antirheumatic drugs for PsA.

Competition between five biologic drugs and their skinny-label biosimilars saved Medicare an estimated $1.5 billion during 2015-2020. But these savings accruing to Medicare and the availability of those and other biosimilars through skinny labeling is under threat from recent court rulings, according to a research letter published online in JAMA Internal Medicine.

The authors highlighted the need for such savings by noting that, while biologics comprise less than 5% of prescription drug use, their price tag amounts to about 40% of U.S. drug spending, Biologic manufacturers often delay the availability of biosimilars for additional years beyond the original patent expiration through further patents for supplemental indications. To provide a counterbalance, federal law allows the Food and Drug Administration to approve “skinny-label” generics and biosimilars that carve out patent-protected indications or regulatory exclusivities. But once a generic drug reaches the market through this process with a skinny label, it may often be substituted for indications that go beyond the ones listed on the skinny label. In fact, some state laws mandate that pharmacists substitute interchangeable generics for brand-name drugs, helping to decrease drug prices. In response to legal threats to the skinny-label pathway, Alexander C. Egilman and colleagues at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, assessed the frequency of approval and marketing of skinny-label biosimilars from 2015 to 2021 and the resultant savings to Medicare.

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The authors estimated annual Part B (clinician-administered) savings from skinny-label biosimilars through 2020 by comparing actual biologic and skinny-label biosimilar spending with estimated biologic spending without competition using the Medicare Dashboard. They assumed that the unit price of the biologic would increase at its 5-year compound annual growth rate prior to competition.

In that period, the FDA approved 33 biosimilars linked to 11 biologics. Among them, 22 (66.7%) had a skinny label. Of 21 biosimilars marketed before 2022, 13 (61.9%) were launched with a skinny label. Of the 8 biologics linked to these 21 biosimilars, 5 of the first-to-market biosimilars had skinny labels (bevacizumab, filgrastim, infliximab, pegfilgrastim, and rituximab), leading to earlier competition through 2021.

The estimated $1.5 billion in savings to Medicare from these skinny-label biosimilars over the 2015-2020 span represents 4.9% of the $30.2 billion that Medicare spent on the five biologics during this period. The researchers pointed out that once adalimumab (Humira) faces skinny-label biosimilar competition in 2023, savings will likely grow substantially.

In response to the research letter, an editor’s note by JAMA Internal Medicine Editorial Fellow Eric Ward, MD, and JAMA Internal Medicine Editor at Large and Online Editor Robert Steinbrook, MD, stated that, between 2015 and 2019, 24 (43%) of 56 brand-name drugs had competition from skinny-labeled generic formulations after first becoming available as generics.

The editors also referenced a JAMA Viewpoints article from 2021 that reviewed the most recent case challenging the skinny-label pathway in which GlaxoSmithKline sued Teva for its marketing of a skinny-label generic of the brand-name beta-blocker carvedilol (Coreg) that the plaintive claimed “induced physicians to prescribe carvedilol for indications that had been carved out by Teva’s skinny label, thus infringing GlaxoSmithKline’s patents.” A $235 million judgment against Teva was overturned by a district court and then reversed again by a Federal Circuit court that, after receiving criticism, reconsidered the case, and a panel affirmed the judgment against Teva.

“The Federal Circuit panel’s decision has the potential to put generic drugs that fail to adequately carve out indications from the brand name labeling at risk for damages related to infringement,” the authors wrote. Similar claims of infringement are being heard in other courts, they wrote, and they urged careful targeting of skinny-label carveouts, and suggest also that challenges to the arguments used against Teva focus on preservation of First Amendment rights as protection for lawful and accurate speech in drug labels.

“The legal uncertainties are likely to continue, as manufacturers pursue novel and complex strategies to protect the patents and regulatory exclusivities of brand-name drugs and biologics,” Dr. Ward and Dr. Steinbrook wrote, adding that “the path forward is for Congress to enact additional legislation that reaffirms and strengthens the permissibility of skinny labeling.”

The research letter’s corresponding author, Ameet Sarpatwari, PhD, JD, assistant professor at Harvard Medical School, and assistant director for the Harvard Program On Regulation, Therapeutics, And Law, echoed concerns over the Teva case in an interview. “There has certainly been concern that should the appellate decision stand, there will be a chilling effect. As the lone dissenter in that case noted, ‘no skinny-label generic is safe.’ I think many generic and biosimilar manufacturers are awaiting to see whether the Supreme Court will take the case.”

He added: “I do not believe the likelihood of skinny-label-supportive legislation making it through Congress will be greatly diminished in a divided Congress. Democrats and Republicans alike should seek to promote competition in the marketplace, which is what the skinny-labeling pathway accomplishes.”

The authors reported no relevant conflicts of interest. The research was funded by a grant from Arnold Ventures.

Competition between five biologic drugs and their skinny-label biosimilars saved Medicare an estimated $1.5 billion during 2015-2020. But these savings accruing to Medicare and the availability of those and other biosimilars through skinny labeling is under threat from recent court rulings, according to a research letter published online in JAMA Internal Medicine.

The authors highlighted the need for such savings by noting that, while biologics comprise less than 5% of prescription drug use, their price tag amounts to about 40% of U.S. drug spending, Biologic manufacturers often delay the availability of biosimilars for additional years beyond the original patent expiration through further patents for supplemental indications. To provide a counterbalance, federal law allows the Food and Drug Administration to approve “skinny-label” generics and biosimilars that carve out patent-protected indications or regulatory exclusivities. But once a generic drug reaches the market through this process with a skinny label, it may often be substituted for indications that go beyond the ones listed on the skinny label. In fact, some state laws mandate that pharmacists substitute interchangeable generics for brand-name drugs, helping to decrease drug prices. In response to legal threats to the skinny-label pathway, Alexander C. Egilman and colleagues at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, assessed the frequency of approval and marketing of skinny-label biosimilars from 2015 to 2021 and the resultant savings to Medicare.

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The authors estimated annual Part B (clinician-administered) savings from skinny-label biosimilars through 2020 by comparing actual biologic and skinny-label biosimilar spending with estimated biologic spending without competition using the Medicare Dashboard. They assumed that the unit price of the biologic would increase at its 5-year compound annual growth rate prior to competition.

In that period, the FDA approved 33 biosimilars linked to 11 biologics. Among them, 22 (66.7%) had a skinny label. Of 21 biosimilars marketed before 2022, 13 (61.9%) were launched with a skinny label. Of the 8 biologics linked to these 21 biosimilars, 5 of the first-to-market biosimilars had skinny labels (bevacizumab, filgrastim, infliximab, pegfilgrastim, and rituximab), leading to earlier competition through 2021.

The estimated $1.5 billion in savings to Medicare from these skinny-label biosimilars over the 2015-2020 span represents 4.9% of the $30.2 billion that Medicare spent on the five biologics during this period. The researchers pointed out that once adalimumab (Humira) faces skinny-label biosimilar competition in 2023, savings will likely grow substantially.

In response to the research letter, an editor’s note by JAMA Internal Medicine Editorial Fellow Eric Ward, MD, and JAMA Internal Medicine Editor at Large and Online Editor Robert Steinbrook, MD, stated that, between 2015 and 2019, 24 (43%) of 56 brand-name drugs had competition from skinny-labeled generic formulations after first becoming available as generics.

The editors also referenced a JAMA Viewpoints article from 2021 that reviewed the most recent case challenging the skinny-label pathway in which GlaxoSmithKline sued Teva for its marketing of a skinny-label generic of the brand-name beta-blocker carvedilol (Coreg) that the plaintive claimed “induced physicians to prescribe carvedilol for indications that had been carved out by Teva’s skinny label, thus infringing GlaxoSmithKline’s patents.” A $235 million judgment against Teva was overturned by a district court and then reversed again by a Federal Circuit court that, after receiving criticism, reconsidered the case, and a panel affirmed the judgment against Teva.

“The Federal Circuit panel’s decision has the potential to put generic drugs that fail to adequately carve out indications from the brand name labeling at risk for damages related to infringement,” the authors wrote. Similar claims of infringement are being heard in other courts, they wrote, and they urged careful targeting of skinny-label carveouts, and suggest also that challenges to the arguments used against Teva focus on preservation of First Amendment rights as protection for lawful and accurate speech in drug labels.

“The legal uncertainties are likely to continue, as manufacturers pursue novel and complex strategies to protect the patents and regulatory exclusivities of brand-name drugs and biologics,” Dr. Ward and Dr. Steinbrook wrote, adding that “the path forward is for Congress to enact additional legislation that reaffirms and strengthens the permissibility of skinny labeling.”

The research letter’s corresponding author, Ameet Sarpatwari, PhD, JD, assistant professor at Harvard Medical School, and assistant director for the Harvard Program On Regulation, Therapeutics, And Law, echoed concerns over the Teva case in an interview. “There has certainly been concern that should the appellate decision stand, there will be a chilling effect. As the lone dissenter in that case noted, ‘no skinny-label generic is safe.’ I think many generic and biosimilar manufacturers are awaiting to see whether the Supreme Court will take the case.”

He added: “I do not believe the likelihood of skinny-label-supportive legislation making it through Congress will be greatly diminished in a divided Congress. Democrats and Republicans alike should seek to promote competition in the marketplace, which is what the skinny-labeling pathway accomplishes.”

The authors reported no relevant conflicts of interest. The research was funded by a grant from Arnold Ventures.

Competition between five biologic drugs and their skinny-label biosimilars saved Medicare an estimated $1.5 billion during 2015-2020. But these savings accruing to Medicare and the availability of those and other biosimilars through skinny labeling is under threat from recent court rulings, according to a research letter published online in JAMA Internal Medicine.

The authors highlighted the need for such savings by noting that, while biologics comprise less than 5% of prescription drug use, their price tag amounts to about 40% of U.S. drug spending, Biologic manufacturers often delay the availability of biosimilars for additional years beyond the original patent expiration through further patents for supplemental indications. To provide a counterbalance, federal law allows the Food and Drug Administration to approve “skinny-label” generics and biosimilars that carve out patent-protected indications or regulatory exclusivities. But once a generic drug reaches the market through this process with a skinny label, it may often be substituted for indications that go beyond the ones listed on the skinny label. In fact, some state laws mandate that pharmacists substitute interchangeable generics for brand-name drugs, helping to decrease drug prices. In response to legal threats to the skinny-label pathway, Alexander C. Egilman and colleagues at Brigham and Women’s Hospital and Harvard Medical School, both in Boston, assessed the frequency of approval and marketing of skinny-label biosimilars from 2015 to 2021 and the resultant savings to Medicare.

TheaDesign/Thinkstock

The authors estimated annual Part B (clinician-administered) savings from skinny-label biosimilars through 2020 by comparing actual biologic and skinny-label biosimilar spending with estimated biologic spending without competition using the Medicare Dashboard. They assumed that the unit price of the biologic would increase at its 5-year compound annual growth rate prior to competition.

In that period, the FDA approved 33 biosimilars linked to 11 biologics. Among them, 22 (66.7%) had a skinny label. Of 21 biosimilars marketed before 2022, 13 (61.9%) were launched with a skinny label. Of the 8 biologics linked to these 21 biosimilars, 5 of the first-to-market biosimilars had skinny labels (bevacizumab, filgrastim, infliximab, pegfilgrastim, and rituximab), leading to earlier competition through 2021.

The estimated $1.5 billion in savings to Medicare from these skinny-label biosimilars over the 2015-2020 span represents 4.9% of the $30.2 billion that Medicare spent on the five biologics during this period. The researchers pointed out that once adalimumab (Humira) faces skinny-label biosimilar competition in 2023, savings will likely grow substantially.

In response to the research letter, an editor’s note by JAMA Internal Medicine Editorial Fellow Eric Ward, MD, and JAMA Internal Medicine Editor at Large and Online Editor Robert Steinbrook, MD, stated that, between 2015 and 2019, 24 (43%) of 56 brand-name drugs had competition from skinny-labeled generic formulations after first becoming available as generics.

The editors also referenced a JAMA Viewpoints article from 2021 that reviewed the most recent case challenging the skinny-label pathway in which GlaxoSmithKline sued Teva for its marketing of a skinny-label generic of the brand-name beta-blocker carvedilol (Coreg) that the plaintive claimed “induced physicians to prescribe carvedilol for indications that had been carved out by Teva’s skinny label, thus infringing GlaxoSmithKline’s patents.” A $235 million judgment against Teva was overturned by a district court and then reversed again by a Federal Circuit court that, after receiving criticism, reconsidered the case, and a panel affirmed the judgment against Teva.

“The Federal Circuit panel’s decision has the potential to put generic drugs that fail to adequately carve out indications from the brand name labeling at risk for damages related to infringement,” the authors wrote. Similar claims of infringement are being heard in other courts, they wrote, and they urged careful targeting of skinny-label carveouts, and suggest also that challenges to the arguments used against Teva focus on preservation of First Amendment rights as protection for lawful and accurate speech in drug labels.

“The legal uncertainties are likely to continue, as manufacturers pursue novel and complex strategies to protect the patents and regulatory exclusivities of brand-name drugs and biologics,” Dr. Ward and Dr. Steinbrook wrote, adding that “the path forward is for Congress to enact additional legislation that reaffirms and strengthens the permissibility of skinny labeling.”

The research letter’s corresponding author, Ameet Sarpatwari, PhD, JD, assistant professor at Harvard Medical School, and assistant director for the Harvard Program On Regulation, Therapeutics, And Law, echoed concerns over the Teva case in an interview. “There has certainly been concern that should the appellate decision stand, there will be a chilling effect. As the lone dissenter in that case noted, ‘no skinny-label generic is safe.’ I think many generic and biosimilar manufacturers are awaiting to see whether the Supreme Court will take the case.”

He added: “I do not believe the likelihood of skinny-label-supportive legislation making it through Congress will be greatly diminished in a divided Congress. Democrats and Republicans alike should seek to promote competition in the marketplace, which is what the skinny-labeling pathway accomplishes.”

The authors reported no relevant conflicts of interest. The research was funded by a grant from Arnold Ventures.