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Filgotinib safe and effective in patients with RA who are methotrexate-IR with high risk for poor prognosis

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Key clinical point: Filgotinib vs placebo, both with background methotrexate, significantly improved disease activity and suppressed radiographic progression in patients with rheumatoid arthritis (RA) who were methotrexate inadequate responders (IR) and had ≤4 poor prognostic factors (PPF).

 

Major finding: Doses of 100 and 200 mg filgotinib vs placebo led to higher American College of Rheumatology 20, 50, and 70 response rates among patients with 4 PPF at week 12 (all P < .05) and significantly reduced the change from baseline in modified total Sharp score at week 24 among patients with 4 PPF (both P < .01) along with similar tolerability.

 

Study details: This post hoc analysis of FINCH 1 included 1755 patients with RA who were methotrexate-IR and were randomly assigned to receive filgotinib, adalimumab, or placebo, all with background methotrexate.

 

Disclosures: This study was funded by Gilead Sciences, Inc., with support from Eisai Co., Ltd., and Gilead Sciences K.K. Seven authors declared being current or former employees of Gilead Sciences/Galapagos BV or shareholders of various sources. Several authors reported ties with various sources.

 

Source: Combe BG et al. Efficacy and safety of filgotinib in patients with high risk of poor prognosis who showed inadequate response to MTX: A post hoc analysis of the FINCH 1 study. Rheumatol Ther. 2022 (Oct 9). Doi: 10.1007/s40744-022-00498-x

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Key clinical point: Filgotinib vs placebo, both with background methotrexate, significantly improved disease activity and suppressed radiographic progression in patients with rheumatoid arthritis (RA) who were methotrexate inadequate responders (IR) and had ≤4 poor prognostic factors (PPF).

 

Major finding: Doses of 100 and 200 mg filgotinib vs placebo led to higher American College of Rheumatology 20, 50, and 70 response rates among patients with 4 PPF at week 12 (all P < .05) and significantly reduced the change from baseline in modified total Sharp score at week 24 among patients with 4 PPF (both P < .01) along with similar tolerability.

 

Study details: This post hoc analysis of FINCH 1 included 1755 patients with RA who were methotrexate-IR and were randomly assigned to receive filgotinib, adalimumab, or placebo, all with background methotrexate.

 

Disclosures: This study was funded by Gilead Sciences, Inc., with support from Eisai Co., Ltd., and Gilead Sciences K.K. Seven authors declared being current or former employees of Gilead Sciences/Galapagos BV or shareholders of various sources. Several authors reported ties with various sources.

 

Source: Combe BG et al. Efficacy and safety of filgotinib in patients with high risk of poor prognosis who showed inadequate response to MTX: A post hoc analysis of the FINCH 1 study. Rheumatol Ther. 2022 (Oct 9). Doi: 10.1007/s40744-022-00498-x

Key clinical point: Filgotinib vs placebo, both with background methotrexate, significantly improved disease activity and suppressed radiographic progression in patients with rheumatoid arthritis (RA) who were methotrexate inadequate responders (IR) and had ≤4 poor prognostic factors (PPF).

 

Major finding: Doses of 100 and 200 mg filgotinib vs placebo led to higher American College of Rheumatology 20, 50, and 70 response rates among patients with 4 PPF at week 12 (all P < .05) and significantly reduced the change from baseline in modified total Sharp score at week 24 among patients with 4 PPF (both P < .01) along with similar tolerability.

 

Study details: This post hoc analysis of FINCH 1 included 1755 patients with RA who were methotrexate-IR and were randomly assigned to receive filgotinib, adalimumab, or placebo, all with background methotrexate.

 

Disclosures: This study was funded by Gilead Sciences, Inc., with support from Eisai Co., Ltd., and Gilead Sciences K.K. Seven authors declared being current or former employees of Gilead Sciences/Galapagos BV or shareholders of various sources. Several authors reported ties with various sources.

 

Source: Combe BG et al. Efficacy and safety of filgotinib in patients with high risk of poor prognosis who showed inadequate response to MTX: A post hoc analysis of the FINCH 1 study. Rheumatol Ther. 2022 (Oct 9). Doi: 10.1007/s40744-022-00498-x

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Positivity for autoantibodies at RA diagnosis ups risk for incident VTE

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Key clinical point: Presence of autoantibodies for cyclic citrullinated peptide (anti-CCP2), load of anticitrullinated protein antibody (ACPA) fine-specificities, and immunoglobulin M (IgM) rheumatoid factor (RF) at diagnosis of rheumatoid arthritis (RA) increased the risk for incident venous thromboembolic events (VTE) in patients with RA.

 

Major finding: Positivity for IgG anti-CCP2 (hazard ratio [HR] 1.33; 95% CI 1.00-1.78) and IgM RF (HR 1.38; 95% CI 1.04-1.83) increased the risk for incident VTE. Additionally, the risk increased with the number of ACPA fine-specificities expressed (Ptrend = .033).

 

Study details: This prospective cohort study analyzed 2782 patients with newly diagnosed RA who reported 213 first-ever VTE.

 

Disclosures: This study was supported by the Swedish Research Council, NordForsk, and others. Four authors declared being employees or part-time employees, paid advisors, or founders of different companies. Two authors reported owning patents for peptides and their use for diagnostic purpose.

 

Source: Westerlind H et al. The association between autoantibodies and risk for venous thromboembolic events among patients with rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 18). Doi: 10.1093/rheumatology/keac601

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Key clinical point: Presence of autoantibodies for cyclic citrullinated peptide (anti-CCP2), load of anticitrullinated protein antibody (ACPA) fine-specificities, and immunoglobulin M (IgM) rheumatoid factor (RF) at diagnosis of rheumatoid arthritis (RA) increased the risk for incident venous thromboembolic events (VTE) in patients with RA.

 

Major finding: Positivity for IgG anti-CCP2 (hazard ratio [HR] 1.33; 95% CI 1.00-1.78) and IgM RF (HR 1.38; 95% CI 1.04-1.83) increased the risk for incident VTE. Additionally, the risk increased with the number of ACPA fine-specificities expressed (Ptrend = .033).

 

Study details: This prospective cohort study analyzed 2782 patients with newly diagnosed RA who reported 213 first-ever VTE.

 

Disclosures: This study was supported by the Swedish Research Council, NordForsk, and others. Four authors declared being employees or part-time employees, paid advisors, or founders of different companies. Two authors reported owning patents for peptides and their use for diagnostic purpose.

 

Source: Westerlind H et al. The association between autoantibodies and risk for venous thromboembolic events among patients with rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 18). Doi: 10.1093/rheumatology/keac601

Key clinical point: Presence of autoantibodies for cyclic citrullinated peptide (anti-CCP2), load of anticitrullinated protein antibody (ACPA) fine-specificities, and immunoglobulin M (IgM) rheumatoid factor (RF) at diagnosis of rheumatoid arthritis (RA) increased the risk for incident venous thromboembolic events (VTE) in patients with RA.

 

Major finding: Positivity for IgG anti-CCP2 (hazard ratio [HR] 1.33; 95% CI 1.00-1.78) and IgM RF (HR 1.38; 95% CI 1.04-1.83) increased the risk for incident VTE. Additionally, the risk increased with the number of ACPA fine-specificities expressed (Ptrend = .033).

 

Study details: This prospective cohort study analyzed 2782 patients with newly diagnosed RA who reported 213 first-ever VTE.

 

Disclosures: This study was supported by the Swedish Research Council, NordForsk, and others. Four authors declared being employees or part-time employees, paid advisors, or founders of different companies. Two authors reported owning patents for peptides and their use for diagnostic purpose.

 

Source: Westerlind H et al. The association between autoantibodies and risk for venous thromboembolic events among patients with rheumatoid arthritis. Rheumatology (Oxford). 2022 (Oct 18). Doi: 10.1093/rheumatology/keac601

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Concomitant methotrexate hampers third SARS-CoV-2 vaccine response in elderly patients with RA

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Key clinical point: Concomitant methotrexate significantly reduced humoral response to the third SARS-CoV-2 mRNA vaccine in older (age ≥ 64.5 years) but not younger (age < 64.5 years) patients with rheumatoid arthritis (RA).

 

Major finding: Patients aged ≥ 64.5 years receiving methotrexate plus biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) vs methotrexate monotherapy or b/tsDMARD monotherapy had significantly lower serum levels of immunoglobulin G antibody for SARS-CoV-2 spike protein receptor binding domain (64.8 vs 1743.8 or 1106.0 binding antibody units/mL, respectively; Kruskal-Wallis Test, P < .001), whereas patients aged < 64.5 years showed no significant difference (Kruskal-Wallis Test, P = .334).

 

Study details: Findings are from a retrospective analysis including 136 patients with RA treated with conventional synthetic DMARD or b/ts DMARD with or without methotrexate who received the third dose of SARS-CoV-2 mRNA vaccines BNT162b2 (Pfizer/BioNTech) or mRNA-1273 (Moderna).

 

Disclosures: This study did not declare any specific source of funding. No conflict of interests was declared.

 

Source: Stahl D et al. Reduced humoral response to a third dose (booster) of SARS-CoV-2 mRNA vaccines by concomitant methotrexate therapy in elderly patients with rheumatoid arthritis. RMD Open. 2022;8(2):e002632 (Oct 10). Doi: 10.1136/rmdopen-2022-002632

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Key clinical point: Concomitant methotrexate significantly reduced humoral response to the third SARS-CoV-2 mRNA vaccine in older (age ≥ 64.5 years) but not younger (age < 64.5 years) patients with rheumatoid arthritis (RA).

 

Major finding: Patients aged ≥ 64.5 years receiving methotrexate plus biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) vs methotrexate monotherapy or b/tsDMARD monotherapy had significantly lower serum levels of immunoglobulin G antibody for SARS-CoV-2 spike protein receptor binding domain (64.8 vs 1743.8 or 1106.0 binding antibody units/mL, respectively; Kruskal-Wallis Test, P < .001), whereas patients aged < 64.5 years showed no significant difference (Kruskal-Wallis Test, P = .334).

 

Study details: Findings are from a retrospective analysis including 136 patients with RA treated with conventional synthetic DMARD or b/ts DMARD with or without methotrexate who received the third dose of SARS-CoV-2 mRNA vaccines BNT162b2 (Pfizer/BioNTech) or mRNA-1273 (Moderna).

 

Disclosures: This study did not declare any specific source of funding. No conflict of interests was declared.

 

Source: Stahl D et al. Reduced humoral response to a third dose (booster) of SARS-CoV-2 mRNA vaccines by concomitant methotrexate therapy in elderly patients with rheumatoid arthritis. RMD Open. 2022;8(2):e002632 (Oct 10). Doi: 10.1136/rmdopen-2022-002632

Key clinical point: Concomitant methotrexate significantly reduced humoral response to the third SARS-CoV-2 mRNA vaccine in older (age ≥ 64.5 years) but not younger (age < 64.5 years) patients with rheumatoid arthritis (RA).

 

Major finding: Patients aged ≥ 64.5 years receiving methotrexate plus biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) vs methotrexate monotherapy or b/tsDMARD monotherapy had significantly lower serum levels of immunoglobulin G antibody for SARS-CoV-2 spike protein receptor binding domain (64.8 vs 1743.8 or 1106.0 binding antibody units/mL, respectively; Kruskal-Wallis Test, P < .001), whereas patients aged < 64.5 years showed no significant difference (Kruskal-Wallis Test, P = .334).

 

Study details: Findings are from a retrospective analysis including 136 patients with RA treated with conventional synthetic DMARD or b/ts DMARD with or without methotrexate who received the third dose of SARS-CoV-2 mRNA vaccines BNT162b2 (Pfizer/BioNTech) or mRNA-1273 (Moderna).

 

Disclosures: This study did not declare any specific source of funding. No conflict of interests was declared.

 

Source: Stahl D et al. Reduced humoral response to a third dose (booster) of SARS-CoV-2 mRNA vaccines by concomitant methotrexate therapy in elderly patients with rheumatoid arthritis. RMD Open. 2022;8(2):e002632 (Oct 10). Doi: 10.1136/rmdopen-2022-002632

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Meta-analysis reveals increased risk for thyroid dysfunction in patients with RA

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Key clinical point: Patients with rheumatoid arthritis (RA) were at an increased risk of developing all types of thyroid dysfunctions, with the risk being the highest for hypothyroidism, followed by subclinical hypothyroidism, subclinical hyperthyroidism, and hyperthyroidism.

 

Major finding: Patients with RA vs non-RA control individuals were at a higher risk of developing thyroid dysfunctions such as hypothyroidism (pooled OR [pOR] 2.25; 95% CI 1.78-2.84), subclinical hypothyroidism (pOR 2.18; 95% CI 1.32-3.61), subclinical hyperthyroidism (pOR 2.13; 95% CI 1.25-3.63), and hyperthyroidism (OR 1.65; 95% CI 1.24-2.19).

 

Study details: Findings are from a systematic review and meta-analysis of 29 studies that evaluated thyroid dysfunction in patients with RA (n = 35,708) and non-RA control individuals (n = 149,421).

 

Disclosures: This study was supported by grants from the Science and Technology Bureau of Quanzhou and the Natural Science Foundation of Fujian Province. The authors declared no conflict of interests.

 

Source: Liu Y-j et al. Association between rheumatoid arthritis and thyroid dysfunction: A meta-analysis and systematic review. Front Endocrinol. 2022;13:1015516 (Oct 13). Doi: 10.3389/fendo.2022.1015516

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Key clinical point: Patients with rheumatoid arthritis (RA) were at an increased risk of developing all types of thyroid dysfunctions, with the risk being the highest for hypothyroidism, followed by subclinical hypothyroidism, subclinical hyperthyroidism, and hyperthyroidism.

 

Major finding: Patients with RA vs non-RA control individuals were at a higher risk of developing thyroid dysfunctions such as hypothyroidism (pooled OR [pOR] 2.25; 95% CI 1.78-2.84), subclinical hypothyroidism (pOR 2.18; 95% CI 1.32-3.61), subclinical hyperthyroidism (pOR 2.13; 95% CI 1.25-3.63), and hyperthyroidism (OR 1.65; 95% CI 1.24-2.19).

 

Study details: Findings are from a systematic review and meta-analysis of 29 studies that evaluated thyroid dysfunction in patients with RA (n = 35,708) and non-RA control individuals (n = 149,421).

 

Disclosures: This study was supported by grants from the Science and Technology Bureau of Quanzhou and the Natural Science Foundation of Fujian Province. The authors declared no conflict of interests.

 

Source: Liu Y-j et al. Association between rheumatoid arthritis and thyroid dysfunction: A meta-analysis and systematic review. Front Endocrinol. 2022;13:1015516 (Oct 13). Doi: 10.3389/fendo.2022.1015516

Key clinical point: Patients with rheumatoid arthritis (RA) were at an increased risk of developing all types of thyroid dysfunctions, with the risk being the highest for hypothyroidism, followed by subclinical hypothyroidism, subclinical hyperthyroidism, and hyperthyroidism.

 

Major finding: Patients with RA vs non-RA control individuals were at a higher risk of developing thyroid dysfunctions such as hypothyroidism (pooled OR [pOR] 2.25; 95% CI 1.78-2.84), subclinical hypothyroidism (pOR 2.18; 95% CI 1.32-3.61), subclinical hyperthyroidism (pOR 2.13; 95% CI 1.25-3.63), and hyperthyroidism (OR 1.65; 95% CI 1.24-2.19).

 

Study details: Findings are from a systematic review and meta-analysis of 29 studies that evaluated thyroid dysfunction in patients with RA (n = 35,708) and non-RA control individuals (n = 149,421).

 

Disclosures: This study was supported by grants from the Science and Technology Bureau of Quanzhou and the Natural Science Foundation of Fujian Province. The authors declared no conflict of interests.

 

Source: Liu Y-j et al. Association between rheumatoid arthritis and thyroid dysfunction: A meta-analysis and systematic review. Front Endocrinol. 2022;13:1015516 (Oct 13). Doi: 10.3389/fendo.2022.1015516

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Red blood cell distribution width: An effective diagnostic biomarker for RA

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Key clinical point: Red blood cell distribution width could serve as a useful biomarker and successfully differentiate between patients with rheumatoid arthritis (RA) and control individuals.

 

Major finding: Patients with RA vs. control individuals had significantly higher values for red blood cell distribution width (standardized mean difference, 0.96; P < .001); however, the mean platelet volume (P = .515) and platelet distribution width (P = .222) were not significantly different between the 2 groups.

 

Study details: This was a systematic review and meta-analysis of 23 studies, of which 11 studies reported data on red blood cell distribution width and included 1,221 patients with RA and 983 control individuals.

 

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

 

Source: Zinellu A and Mangoni AA et al. Platelet and red blood cell volume indices in patients with rheumatoid arthritis: A systematic review and meta-analysis. Diagnostics. 2022;12(11):2633 (Oct 30). Doi: 10.3390/diagnostics12112633.

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Key clinical point: Red blood cell distribution width could serve as a useful biomarker and successfully differentiate between patients with rheumatoid arthritis (RA) and control individuals.

 

Major finding: Patients with RA vs. control individuals had significantly higher values for red blood cell distribution width (standardized mean difference, 0.96; P < .001); however, the mean platelet volume (P = .515) and platelet distribution width (P = .222) were not significantly different between the 2 groups.

 

Study details: This was a systematic review and meta-analysis of 23 studies, of which 11 studies reported data on red blood cell distribution width and included 1,221 patients with RA and 983 control individuals.

 

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

 

Source: Zinellu A and Mangoni AA et al. Platelet and red blood cell volume indices in patients with rheumatoid arthritis: A systematic review and meta-analysis. Diagnostics. 2022;12(11):2633 (Oct 30). Doi: 10.3390/diagnostics12112633.

Key clinical point: Red blood cell distribution width could serve as a useful biomarker and successfully differentiate between patients with rheumatoid arthritis (RA) and control individuals.

 

Major finding: Patients with RA vs. control individuals had significantly higher values for red blood cell distribution width (standardized mean difference, 0.96; P < .001); however, the mean platelet volume (P = .515) and platelet distribution width (P = .222) were not significantly different between the 2 groups.

 

Study details: This was a systematic review and meta-analysis of 23 studies, of which 11 studies reported data on red blood cell distribution width and included 1,221 patients with RA and 983 control individuals.

 

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

 

Source: Zinellu A and Mangoni AA et al. Platelet and red blood cell volume indices in patients with rheumatoid arthritis: A systematic review and meta-analysis. Diagnostics. 2022;12(11):2633 (Oct 30). Doi: 10.3390/diagnostics12112633.

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Aging associated with seronegative RA in women

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Key clinical point: Age is an independent contributor to seronegative rheumatoid arthritis (RA), with the effect being prominent in females but not in males.

 

Major finding: Rates of rheumatoid factor (RF) and anticyclic citrullinated peptide (anti-CCP) positivity and RF/anti-CCP double positivity declined significantly with an increase in age at RA diagnosis (all P < .001). The age at disease onset was independently associated with RF (odds ratio [OR] 0.980; P < .001) and anti-CCP (OR 0.976; P < .001) positivity in patients with RA, with both the associations being significant in women (RF positivity: OR 0.979; P < .001; anti-CCP positivity: OR 0.970; P < .001) but not in men.

 

Study details: This was a cohort study including 1685 patients with RA (mean age at diagnosis, 51.9 years), of which 83.4% were women.

 

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

 

Source: Takanashi S et al. Impacts of ageing on rheumatoid factor and anti-cyclic citrullinated peptide antibody positivity in patients with rheumatoid arthritis. J Rheumatol. 2022 (Nov 1). Doi: 10.3899/jrheum.220526

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Key clinical point: Age is an independent contributor to seronegative rheumatoid arthritis (RA), with the effect being prominent in females but not in males.

 

Major finding: Rates of rheumatoid factor (RF) and anticyclic citrullinated peptide (anti-CCP) positivity and RF/anti-CCP double positivity declined significantly with an increase in age at RA diagnosis (all P < .001). The age at disease onset was independently associated with RF (odds ratio [OR] 0.980; P < .001) and anti-CCP (OR 0.976; P < .001) positivity in patients with RA, with both the associations being significant in women (RF positivity: OR 0.979; P < .001; anti-CCP positivity: OR 0.970; P < .001) but not in men.

 

Study details: This was a cohort study including 1685 patients with RA (mean age at diagnosis, 51.9 years), of which 83.4% were women.

 

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

 

Source: Takanashi S et al. Impacts of ageing on rheumatoid factor and anti-cyclic citrullinated peptide antibody positivity in patients with rheumatoid arthritis. J Rheumatol. 2022 (Nov 1). Doi: 10.3899/jrheum.220526

Key clinical point: Age is an independent contributor to seronegative rheumatoid arthritis (RA), with the effect being prominent in females but not in males.

 

Major finding: Rates of rheumatoid factor (RF) and anticyclic citrullinated peptide (anti-CCP) positivity and RF/anti-CCP double positivity declined significantly with an increase in age at RA diagnosis (all P < .001). The age at disease onset was independently associated with RF (odds ratio [OR] 0.980; P < .001) and anti-CCP (OR 0.976; P < .001) positivity in patients with RA, with both the associations being significant in women (RF positivity: OR 0.979; P < .001; anti-CCP positivity: OR 0.970; P < .001) but not in men.

 

Study details: This was a cohort study including 1685 patients with RA (mean age at diagnosis, 51.9 years), of which 83.4% were women.

 

Disclosures: This study did not receive any funding. The authors declared no conflict of interests.

 

Source: Takanashi S et al. Impacts of ageing on rheumatoid factor and anti-cyclic citrullinated peptide antibody positivity in patients with rheumatoid arthritis. J Rheumatol. 2022 (Nov 1). Doi: 10.3899/jrheum.220526

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Seropositive RA: A strong risk factor for lung cancer

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Key clinical point: Patients with rheumatoid arthritis (RA) were at an increased risk for lung cancer compared with the general population, with seropositivity being a strong and independent risk factor above what can be explained by smoking.

 

Major finding: Patients with RA vs. general population were at increased risk for lung cancer (adjusted hazard ratio [aHR] 1.70; 95% CI 1.54-1.87), with the risk being even higher among ever smokers (aHR 1.82; 95% CI 1.06-3.17) or current smokers (aHR 2.73; 95% CI 1.21-6.16) and double seropositivity being a strong and independent risk factor (aHR 6.21; 95% CI 1.47-26.33).

 

Study details: This was a population-based matched cohort study including 44,101 patients with RA who were individually matched with 216,495 control individuals from the general population and prospectively followed for the occurrence of lung cancer.

 

Disclosures: This study was funded by the Swedish Research Council and other sources. K Chatzidionysiou declared receiving consulting fees from various sources. J Askling declared serving as principal investigator and having ties with various sources.

 

Source: Chatzidionysiou K et al. Risk of lung cancer in rheumatoid arthritis and in relation to autoantibody positivity and smoking. RMD Open. 2022;8(2):e002465 (Oct 21). Doi: 10.1136/rmdopen-2022-002465

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Key clinical point: Patients with rheumatoid arthritis (RA) were at an increased risk for lung cancer compared with the general population, with seropositivity being a strong and independent risk factor above what can be explained by smoking.

 

Major finding: Patients with RA vs. general population were at increased risk for lung cancer (adjusted hazard ratio [aHR] 1.70; 95% CI 1.54-1.87), with the risk being even higher among ever smokers (aHR 1.82; 95% CI 1.06-3.17) or current smokers (aHR 2.73; 95% CI 1.21-6.16) and double seropositivity being a strong and independent risk factor (aHR 6.21; 95% CI 1.47-26.33).

 

Study details: This was a population-based matched cohort study including 44,101 patients with RA who were individually matched with 216,495 control individuals from the general population and prospectively followed for the occurrence of lung cancer.

 

Disclosures: This study was funded by the Swedish Research Council and other sources. K Chatzidionysiou declared receiving consulting fees from various sources. J Askling declared serving as principal investigator and having ties with various sources.

 

Source: Chatzidionysiou K et al. Risk of lung cancer in rheumatoid arthritis and in relation to autoantibody positivity and smoking. RMD Open. 2022;8(2):e002465 (Oct 21). Doi: 10.1136/rmdopen-2022-002465

Key clinical point: Patients with rheumatoid arthritis (RA) were at an increased risk for lung cancer compared with the general population, with seropositivity being a strong and independent risk factor above what can be explained by smoking.

 

Major finding: Patients with RA vs. general population were at increased risk for lung cancer (adjusted hazard ratio [aHR] 1.70; 95% CI 1.54-1.87), with the risk being even higher among ever smokers (aHR 1.82; 95% CI 1.06-3.17) or current smokers (aHR 2.73; 95% CI 1.21-6.16) and double seropositivity being a strong and independent risk factor (aHR 6.21; 95% CI 1.47-26.33).

 

Study details: This was a population-based matched cohort study including 44,101 patients with RA who were individually matched with 216,495 control individuals from the general population and prospectively followed for the occurrence of lung cancer.

 

Disclosures: This study was funded by the Swedish Research Council and other sources. K Chatzidionysiou declared receiving consulting fees from various sources. J Askling declared serving as principal investigator and having ties with various sources.

 

Source: Chatzidionysiou K et al. Risk of lung cancer in rheumatoid arthritis and in relation to autoantibody positivity and smoking. RMD Open. 2022;8(2):e002465 (Oct 21). Doi: 10.1136/rmdopen-2022-002465

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Tocilizumab more effective than etanercept in suppressing progression of joint erosion in RA

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Key clinical point: Tocilizumab was more effective than etanercept in inhibiting the radiographic progression of joint erosion in rheumatoid arthritis (RA), with joint damage progression being significantly associated with the baseline clinical disease activity index (CDAI) score.

 

Major finding: At 12 months, a significantly higher proportion of patients showed no radiographic progression of joint erosion with tocilizumab vs etanercept (change in total Sharp/van der Heijde score [erosion] ≤0%; 86.8% vs 63.2%; P = .032). The progression of radiographic joint erosion was significantly correlated with the baseline CDAI score (odds ratio 1.05; P = .037).

 

Study details: This was a retrospective cohort study including 187 patients with RA who received tocilizumab or etanercept for at least 12 months.

 

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

 

Source: Hayashi S et al. Comparison of the inhibitory effect of tocilizumab and etanercept on the progression of joint erosion in rheumatoid arthritis treatment. Sci Rep. 2022;12(1):17524 (Oct 20). Doi: 10.1038/s41598-022-22152-w

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Key clinical point: Tocilizumab was more effective than etanercept in inhibiting the radiographic progression of joint erosion in rheumatoid arthritis (RA), with joint damage progression being significantly associated with the baseline clinical disease activity index (CDAI) score.

 

Major finding: At 12 months, a significantly higher proportion of patients showed no radiographic progression of joint erosion with tocilizumab vs etanercept (change in total Sharp/van der Heijde score [erosion] ≤0%; 86.8% vs 63.2%; P = .032). The progression of radiographic joint erosion was significantly correlated with the baseline CDAI score (odds ratio 1.05; P = .037).

 

Study details: This was a retrospective cohort study including 187 patients with RA who received tocilizumab or etanercept for at least 12 months.

 

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

 

Source: Hayashi S et al. Comparison of the inhibitory effect of tocilizumab and etanercept on the progression of joint erosion in rheumatoid arthritis treatment. Sci Rep. 2022;12(1):17524 (Oct 20). Doi: 10.1038/s41598-022-22152-w

Key clinical point: Tocilizumab was more effective than etanercept in inhibiting the radiographic progression of joint erosion in rheumatoid arthritis (RA), with joint damage progression being significantly associated with the baseline clinical disease activity index (CDAI) score.

 

Major finding: At 12 months, a significantly higher proportion of patients showed no radiographic progression of joint erosion with tocilizumab vs etanercept (change in total Sharp/van der Heijde score [erosion] ≤0%; 86.8% vs 63.2%; P = .032). The progression of radiographic joint erosion was significantly correlated with the baseline CDAI score (odds ratio 1.05; P = .037).

 

Study details: This was a retrospective cohort study including 187 patients with RA who received tocilizumab or etanercept for at least 12 months.

 

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

 

Source: Hayashi S et al. Comparison of the inhibitory effect of tocilizumab and etanercept on the progression of joint erosion in rheumatoid arthritis treatment. Sci Rep. 2022;12(1):17524 (Oct 20). Doi: 10.1038/s41598-022-22152-w

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Treatment intensification benefits early RA nonresponders in COBRA treat-to-target trial

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Key clinical point: Significant proportion of patients with high-risk early rheumatoid arthritis (RA) achieved the treatment target with a combination of methotrexate and step-down prednisolone, whereas nonresponders benefited from treatment intensification albeit with more adverse events.

 

Major finding: Overall, 73% of patients at high risk achieved the treatment target at 13 weeks. A significant proportion of nonresponders who were at high risk achieved the treatment target with treatment intensification vs continuation (80% vs 44%; difference 36%; P = .04), but experienced more adverse events (P < .01).

 

Study details: This study included 190 patients with early RA from the COBRA treat-to-target trial, of which high-risk patients received prednisolone (30 mg/day tapered to 7.5 mg/day) and methotrexate (increased from 10 to 25 mg/week). At 13 weeks, nonresponders were randomly assigned to treatment continuation or intensification (methotrexate 25 mg/week; prednisolone 60 mg/day tapered to 7.5 mg/day; sulfasalazine 2 g/day; and hydroxychloroquine 400 mg/day).

 

Disclosures: This study was supported by an unrestricted grant from Pfizer. M Boers and WF Lems reported ties with various sources.

 

Source: Hartman L et al. Favorable effect of a ‘second hit’ after 13 weeks in early RA non-responders: The Amsterdam COBRA treat-to-target randomized trial. Rheumatology (Oxford). 2022 (Oct 7). Doi: 10.1093/rheumatology/keac582

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Key clinical point: Significant proportion of patients with high-risk early rheumatoid arthritis (RA) achieved the treatment target with a combination of methotrexate and step-down prednisolone, whereas nonresponders benefited from treatment intensification albeit with more adverse events.

 

Major finding: Overall, 73% of patients at high risk achieved the treatment target at 13 weeks. A significant proportion of nonresponders who were at high risk achieved the treatment target with treatment intensification vs continuation (80% vs 44%; difference 36%; P = .04), but experienced more adverse events (P < .01).

 

Study details: This study included 190 patients with early RA from the COBRA treat-to-target trial, of which high-risk patients received prednisolone (30 mg/day tapered to 7.5 mg/day) and methotrexate (increased from 10 to 25 mg/week). At 13 weeks, nonresponders were randomly assigned to treatment continuation or intensification (methotrexate 25 mg/week; prednisolone 60 mg/day tapered to 7.5 mg/day; sulfasalazine 2 g/day; and hydroxychloroquine 400 mg/day).

 

Disclosures: This study was supported by an unrestricted grant from Pfizer. M Boers and WF Lems reported ties with various sources.

 

Source: Hartman L et al. Favorable effect of a ‘second hit’ after 13 weeks in early RA non-responders: The Amsterdam COBRA treat-to-target randomized trial. Rheumatology (Oxford). 2022 (Oct 7). Doi: 10.1093/rheumatology/keac582

Key clinical point: Significant proportion of patients with high-risk early rheumatoid arthritis (RA) achieved the treatment target with a combination of methotrexate and step-down prednisolone, whereas nonresponders benefited from treatment intensification albeit with more adverse events.

 

Major finding: Overall, 73% of patients at high risk achieved the treatment target at 13 weeks. A significant proportion of nonresponders who were at high risk achieved the treatment target with treatment intensification vs continuation (80% vs 44%; difference 36%; P = .04), but experienced more adverse events (P < .01).

 

Study details: This study included 190 patients with early RA from the COBRA treat-to-target trial, of which high-risk patients received prednisolone (30 mg/day tapered to 7.5 mg/day) and methotrexate (increased from 10 to 25 mg/week). At 13 weeks, nonresponders were randomly assigned to treatment continuation or intensification (methotrexate 25 mg/week; prednisolone 60 mg/day tapered to 7.5 mg/day; sulfasalazine 2 g/day; and hydroxychloroquine 400 mg/day).

 

Disclosures: This study was supported by an unrestricted grant from Pfizer. M Boers and WF Lems reported ties with various sources.

 

Source: Hartman L et al. Favorable effect of a ‘second hit’ after 13 weeks in early RA non-responders: The Amsterdam COBRA treat-to-target randomized trial. Rheumatology (Oxford). 2022 (Oct 7). Doi: 10.1093/rheumatology/keac582

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New ACR vaccination guideline: Take your best shot

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The new American College of Rheumatology Guideline for Vaccinations in Patients with Rheumatic and Musculoskeletal Diseases (RMDs) emphasizes that both adult and pediatric patients should receive recommended vaccinations whenever possible.

But the guideline, currently in press, also offers recommendations about whether and when to withhold vaccines from patients with RMDs, such as avoiding the use of live attenuated virus vaccines in patients who are on immunosuppressive drug regimens, such as conventional synthetic disease-modifying antirheumatic drugs (DMARDs), biologic DMARDs, or targeted synthetic DMARDs.

Dr. Anne R. Bass

The new consensus guideline was formulated with the understanding that patients with RMDs are at increased risk for vaccine-preventable infections and more serious complications from infections, compared with the general population.

However, the guideline also acknowledges that the immunogenicity and safety of vaccines may differ among patients with RMDs, and that, depending on the patient age and disease state, individuals may benefit from modified vaccine indications, schedules, or modified medication schedules, said guideline panel member Anne Bass, MD, a rheumatologist at Hospital for Special Surgery and a professor of clinical medicine at Weill Cornell Medicine in New York, who presented the guideline with other panel members in a session outlining the recommendations at the annual meeting of the ACR.

“In addition, vaccination recommendations – since much of it relates to medications – really applies across diseases, and so the ACR felt that, rather than having vaccine recommendations tacked onto the end of treatment guidelines for each individual disease, that the topic should be discussed or tackled as a whole,” she said.

The guideline does not cover vaccinations in patients taking nonsteroidal anti-inflammatory drugs because this class of agents has minimal or no impact on antibody responses to vaccines. The guideline also does not address vaccinations against COVID-19 infections since the rapidly changing formulations would make the recommendations obsolete before they were even published, and because the U.S. Centers for Disease Control and Prevention provides up-to-date guidance on COVID-19 vaccinations in patients with compromised immunity, she said.
 

Guiding principles

The overarching principles of the guideline are to give indicated vaccines to patients with RMD whenever possible and that any decision to hold medications before or after vaccination consider the dosage used, RMD disease activity, and the patient’s risk for vaccine-preventable infection.

Dr. Clifton O. Bingham III

The guideline also states that “shared decision-making with patients is a key component of any vaccination strategy.”

Panel member Clifton O. Bingham III, MD, professor of medicine at Johns Hopkins University in Baltimore, outlined expanded indications for vaccinations against influenza, pneumococcal infections, varicella zoster virus (VZV) and human papillomavirus (HPV).
 

Influenza

The guideline conditionally recommends that patients with RMD aged 65 years and older and adults older than age 18 years who are on immunosuppressive medications should receive either high-dose or adjuvanted influenza vaccination rather than regular-dose vaccines.

“It’s recognized that the high-dose or adjuvanted vaccinations may be unavailable for patients when they’re seen in your practice,” Dr. Bingham said,” and we came out with two additional statements within the guidelines that said that any flu vaccine is recommended over no flu vaccinations, because we do know that responses are elicited, and a flu vaccination today is preferred over a flu vaccination delay.”
 

Pneumococcal vaccination

The panelists strongly recommended that patients with RMD younger than age 65 years who are on immunosuppressive medication receive pneumococcal vaccinations.

The ACR guideline is in sync with those issued by the CDC’s Advisory Committee on Immunization Practices, Dr. Bingham said. He urged audience members to visit a CDC-ACIP web page for more information on who should receive pneumococcal vaccination and when.
 

Recombinant varicella zoster

The recommendations strongly support that patients aged 18 years and over who are on immunosuppressive therapies should receive the recombinant VZV vaccine (Shingrix).

HPV

A less robust, conditional recommendation is for patients with RMDs who are between the ages of 26 and 45 years and on immunosuppressive medications to receive the HPV vaccine (if they have not already received the vaccine).

Non-live attenuated vaccines

Kevin Winthrop, MD, MPH, professor of infectious diseases and public health at Oregon Health & Science University, Portland, summarized the recommendations for managing immunosuppressive therapies in patients scheduled to receive vaccinations using killed or nonactive antigens.

Dr. Kevin Winthrop

“In influenza season, don’t pass up the opportunity to vaccinate,” he said, adding, “if you can wait on rituximab dosing, do it, and if you can’t, go ahead and vaccinate.”

The guidelines also recommend a 2-week methotrexate hold at the time of influenza vaccination; other DMARD dosing changes are likely not necessary at the time of vaccination, “but this is an area of fervent study, and I think in a year or two we’ll have more experimental hold data with regard to other DMARDs,” Dr. Winthrop said.

For other nonlive attenuated vaccinations, recommendations are similar to those for influenza, except with more flexible timing because these vaccinations are not seasonal. When and how to hold methotrexate is still up in the air, he said.

Additionally, it’s recommended that vaccinations be delayed in patients on high-dose prednisone until the drug is tapered to below 20 mg per day, and ideally to less than 10 mg per day, he said.
 

Live-attenuated vaccines

The guideline conditionally recommends deferring live-attenuated vaccines in patients on immunosuppressive drugs. It also recommends holding these medications “for an appropriate period before” vaccination and for 4 weeks afterward.

“Although the evidence around conventional synthetic DMARDs and TNF inhibitors is reassuring in terms of their safety at the time of live attenuated vaccines, as you can see the number of studies is quite small, and so the voting panel conditionally recommend against administering live-attenuated virus vaccines to patients who are on conventional synthetics, biologic, or targeted DMARDs,” Dr. Bass said.
 

 

 

In utero exposures

Most women with RMD who have recently given birth will consult their general pediatricians rather than rheumatologists for infant vaccinations, but pediatricians may not be aware of the affect that in utero exposures to biologic DMARDs can have on vaccine safety and immunogenicity in infants, Dr, Bass said.

“It’s important that you, as a provider, give your recommendations regarding infant rotavirus vaccination after in utero exposure to the pregnant rheumatic disease patient prior to delivery, and let that patient know that this is something that they should share with their pediatrician to be,” she advised audience members.
 

Getting the message out

In an interview, session moderator and guidelines panelist Lisa F. Imundo, MD, director of the center for adolescent rheumatology at Columbia University in New York, noted that rheumatologists don’t usually have the full schedule of pediatric vaccinations in stock and often leave the decisions about what to give – and when – to general practitioners.

Dr. Lisa F. Imundo

“Pediatric rheumatologists sometimes will give patients flu vaccinations because they’re a high-risk population of patients, and we want to make sure that they’re getting it in a timely manner,” she said.

In addition, because pneumococcal polysaccharide vaccines are not indicated in the general pediatric population, children on biologic DMARDs who have completed their standard series of pneumococcal conjugate vaccines (PCV13 or PVC15) are recommended to get a 23-valent pneumococcal polysaccharide vaccine, Dr. Imundo said.

She also noted that communication between pediatric rheumatologists and general practitioners about vaccine recommendations can be challenging.

“It’s a huge issue, figuring out how we’re going to communicate all of this information to our pediatric colleagues,” she said. “With individual patients, we may sometimes remind doctors, especially with our younger patients who haven’t gotten their live vaccines, that they really shouldn’t get live vaccines until they’re off medication or until we arrange holding medication for some period of time.”

She said that ACR vaccine committee members are working with infectious disease specialists and guideline developers for the American Academy of Pediatrics to ensure guidelines include the most important vaccination recommendations for pediatric patients with RMDs.

The development process for the guidelines was supported by the ACR. Dr. Bass reported no relevant disclosures, Dr. Bingham disclosed consulting activities, grant/research support, and royalties from various corporate entities. Dr. Winthrop disclosed consulting activities for and research funding from various companies. Dr. Imundo reported no relevant financial relationships.

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The new American College of Rheumatology Guideline for Vaccinations in Patients with Rheumatic and Musculoskeletal Diseases (RMDs) emphasizes that both adult and pediatric patients should receive recommended vaccinations whenever possible.

But the guideline, currently in press, also offers recommendations about whether and when to withhold vaccines from patients with RMDs, such as avoiding the use of live attenuated virus vaccines in patients who are on immunosuppressive drug regimens, such as conventional synthetic disease-modifying antirheumatic drugs (DMARDs), biologic DMARDs, or targeted synthetic DMARDs.

Dr. Anne R. Bass

The new consensus guideline was formulated with the understanding that patients with RMDs are at increased risk for vaccine-preventable infections and more serious complications from infections, compared with the general population.

However, the guideline also acknowledges that the immunogenicity and safety of vaccines may differ among patients with RMDs, and that, depending on the patient age and disease state, individuals may benefit from modified vaccine indications, schedules, or modified medication schedules, said guideline panel member Anne Bass, MD, a rheumatologist at Hospital for Special Surgery and a professor of clinical medicine at Weill Cornell Medicine in New York, who presented the guideline with other panel members in a session outlining the recommendations at the annual meeting of the ACR.

“In addition, vaccination recommendations – since much of it relates to medications – really applies across diseases, and so the ACR felt that, rather than having vaccine recommendations tacked onto the end of treatment guidelines for each individual disease, that the topic should be discussed or tackled as a whole,” she said.

The guideline does not cover vaccinations in patients taking nonsteroidal anti-inflammatory drugs because this class of agents has minimal or no impact on antibody responses to vaccines. The guideline also does not address vaccinations against COVID-19 infections since the rapidly changing formulations would make the recommendations obsolete before they were even published, and because the U.S. Centers for Disease Control and Prevention provides up-to-date guidance on COVID-19 vaccinations in patients with compromised immunity, she said.
 

Guiding principles

The overarching principles of the guideline are to give indicated vaccines to patients with RMD whenever possible and that any decision to hold medications before or after vaccination consider the dosage used, RMD disease activity, and the patient’s risk for vaccine-preventable infection.

Dr. Clifton O. Bingham III

The guideline also states that “shared decision-making with patients is a key component of any vaccination strategy.”

Panel member Clifton O. Bingham III, MD, professor of medicine at Johns Hopkins University in Baltimore, outlined expanded indications for vaccinations against influenza, pneumococcal infections, varicella zoster virus (VZV) and human papillomavirus (HPV).
 

Influenza

The guideline conditionally recommends that patients with RMD aged 65 years and older and adults older than age 18 years who are on immunosuppressive medications should receive either high-dose or adjuvanted influenza vaccination rather than regular-dose vaccines.

“It’s recognized that the high-dose or adjuvanted vaccinations may be unavailable for patients when they’re seen in your practice,” Dr. Bingham said,” and we came out with two additional statements within the guidelines that said that any flu vaccine is recommended over no flu vaccinations, because we do know that responses are elicited, and a flu vaccination today is preferred over a flu vaccination delay.”
 

Pneumococcal vaccination

The panelists strongly recommended that patients with RMD younger than age 65 years who are on immunosuppressive medication receive pneumococcal vaccinations.

The ACR guideline is in sync with those issued by the CDC’s Advisory Committee on Immunization Practices, Dr. Bingham said. He urged audience members to visit a CDC-ACIP web page for more information on who should receive pneumococcal vaccination and when.
 

Recombinant varicella zoster

The recommendations strongly support that patients aged 18 years and over who are on immunosuppressive therapies should receive the recombinant VZV vaccine (Shingrix).

HPV

A less robust, conditional recommendation is for patients with RMDs who are between the ages of 26 and 45 years and on immunosuppressive medications to receive the HPV vaccine (if they have not already received the vaccine).

Non-live attenuated vaccines

Kevin Winthrop, MD, MPH, professor of infectious diseases and public health at Oregon Health & Science University, Portland, summarized the recommendations for managing immunosuppressive therapies in patients scheduled to receive vaccinations using killed or nonactive antigens.

Dr. Kevin Winthrop

“In influenza season, don’t pass up the opportunity to vaccinate,” he said, adding, “if you can wait on rituximab dosing, do it, and if you can’t, go ahead and vaccinate.”

The guidelines also recommend a 2-week methotrexate hold at the time of influenza vaccination; other DMARD dosing changes are likely not necessary at the time of vaccination, “but this is an area of fervent study, and I think in a year or two we’ll have more experimental hold data with regard to other DMARDs,” Dr. Winthrop said.

For other nonlive attenuated vaccinations, recommendations are similar to those for influenza, except with more flexible timing because these vaccinations are not seasonal. When and how to hold methotrexate is still up in the air, he said.

Additionally, it’s recommended that vaccinations be delayed in patients on high-dose prednisone until the drug is tapered to below 20 mg per day, and ideally to less than 10 mg per day, he said.
 

Live-attenuated vaccines

The guideline conditionally recommends deferring live-attenuated vaccines in patients on immunosuppressive drugs. It also recommends holding these medications “for an appropriate period before” vaccination and for 4 weeks afterward.

“Although the evidence around conventional synthetic DMARDs and TNF inhibitors is reassuring in terms of their safety at the time of live attenuated vaccines, as you can see the number of studies is quite small, and so the voting panel conditionally recommend against administering live-attenuated virus vaccines to patients who are on conventional synthetics, biologic, or targeted DMARDs,” Dr. Bass said.
 

 

 

In utero exposures

Most women with RMD who have recently given birth will consult their general pediatricians rather than rheumatologists for infant vaccinations, but pediatricians may not be aware of the affect that in utero exposures to biologic DMARDs can have on vaccine safety and immunogenicity in infants, Dr, Bass said.

“It’s important that you, as a provider, give your recommendations regarding infant rotavirus vaccination after in utero exposure to the pregnant rheumatic disease patient prior to delivery, and let that patient know that this is something that they should share with their pediatrician to be,” she advised audience members.
 

Getting the message out

In an interview, session moderator and guidelines panelist Lisa F. Imundo, MD, director of the center for adolescent rheumatology at Columbia University in New York, noted that rheumatologists don’t usually have the full schedule of pediatric vaccinations in stock and often leave the decisions about what to give – and when – to general practitioners.

Dr. Lisa F. Imundo

“Pediatric rheumatologists sometimes will give patients flu vaccinations because they’re a high-risk population of patients, and we want to make sure that they’re getting it in a timely manner,” she said.

In addition, because pneumococcal polysaccharide vaccines are not indicated in the general pediatric population, children on biologic DMARDs who have completed their standard series of pneumococcal conjugate vaccines (PCV13 or PVC15) are recommended to get a 23-valent pneumococcal polysaccharide vaccine, Dr. Imundo said.

She also noted that communication between pediatric rheumatologists and general practitioners about vaccine recommendations can be challenging.

“It’s a huge issue, figuring out how we’re going to communicate all of this information to our pediatric colleagues,” she said. “With individual patients, we may sometimes remind doctors, especially with our younger patients who haven’t gotten their live vaccines, that they really shouldn’t get live vaccines until they’re off medication or until we arrange holding medication for some period of time.”

She said that ACR vaccine committee members are working with infectious disease specialists and guideline developers for the American Academy of Pediatrics to ensure guidelines include the most important vaccination recommendations for pediatric patients with RMDs.

The development process for the guidelines was supported by the ACR. Dr. Bass reported no relevant disclosures, Dr. Bingham disclosed consulting activities, grant/research support, and royalties from various corporate entities. Dr. Winthrop disclosed consulting activities for and research funding from various companies. Dr. Imundo reported no relevant financial relationships.

The new American College of Rheumatology Guideline for Vaccinations in Patients with Rheumatic and Musculoskeletal Diseases (RMDs) emphasizes that both adult and pediatric patients should receive recommended vaccinations whenever possible.

But the guideline, currently in press, also offers recommendations about whether and when to withhold vaccines from patients with RMDs, such as avoiding the use of live attenuated virus vaccines in patients who are on immunosuppressive drug regimens, such as conventional synthetic disease-modifying antirheumatic drugs (DMARDs), biologic DMARDs, or targeted synthetic DMARDs.

Dr. Anne R. Bass

The new consensus guideline was formulated with the understanding that patients with RMDs are at increased risk for vaccine-preventable infections and more serious complications from infections, compared with the general population.

However, the guideline also acknowledges that the immunogenicity and safety of vaccines may differ among patients with RMDs, and that, depending on the patient age and disease state, individuals may benefit from modified vaccine indications, schedules, or modified medication schedules, said guideline panel member Anne Bass, MD, a rheumatologist at Hospital for Special Surgery and a professor of clinical medicine at Weill Cornell Medicine in New York, who presented the guideline with other panel members in a session outlining the recommendations at the annual meeting of the ACR.

“In addition, vaccination recommendations – since much of it relates to medications – really applies across diseases, and so the ACR felt that, rather than having vaccine recommendations tacked onto the end of treatment guidelines for each individual disease, that the topic should be discussed or tackled as a whole,” she said.

The guideline does not cover vaccinations in patients taking nonsteroidal anti-inflammatory drugs because this class of agents has minimal or no impact on antibody responses to vaccines. The guideline also does not address vaccinations against COVID-19 infections since the rapidly changing formulations would make the recommendations obsolete before they were even published, and because the U.S. Centers for Disease Control and Prevention provides up-to-date guidance on COVID-19 vaccinations in patients with compromised immunity, she said.
 

Guiding principles

The overarching principles of the guideline are to give indicated vaccines to patients with RMD whenever possible and that any decision to hold medications before or after vaccination consider the dosage used, RMD disease activity, and the patient’s risk for vaccine-preventable infection.

Dr. Clifton O. Bingham III

The guideline also states that “shared decision-making with patients is a key component of any vaccination strategy.”

Panel member Clifton O. Bingham III, MD, professor of medicine at Johns Hopkins University in Baltimore, outlined expanded indications for vaccinations against influenza, pneumococcal infections, varicella zoster virus (VZV) and human papillomavirus (HPV).
 

Influenza

The guideline conditionally recommends that patients with RMD aged 65 years and older and adults older than age 18 years who are on immunosuppressive medications should receive either high-dose or adjuvanted influenza vaccination rather than regular-dose vaccines.

“It’s recognized that the high-dose or adjuvanted vaccinations may be unavailable for patients when they’re seen in your practice,” Dr. Bingham said,” and we came out with two additional statements within the guidelines that said that any flu vaccine is recommended over no flu vaccinations, because we do know that responses are elicited, and a flu vaccination today is preferred over a flu vaccination delay.”
 

Pneumococcal vaccination

The panelists strongly recommended that patients with RMD younger than age 65 years who are on immunosuppressive medication receive pneumococcal vaccinations.

The ACR guideline is in sync with those issued by the CDC’s Advisory Committee on Immunization Practices, Dr. Bingham said. He urged audience members to visit a CDC-ACIP web page for more information on who should receive pneumococcal vaccination and when.
 

Recombinant varicella zoster

The recommendations strongly support that patients aged 18 years and over who are on immunosuppressive therapies should receive the recombinant VZV vaccine (Shingrix).

HPV

A less robust, conditional recommendation is for patients with RMDs who are between the ages of 26 and 45 years and on immunosuppressive medications to receive the HPV vaccine (if they have not already received the vaccine).

Non-live attenuated vaccines

Kevin Winthrop, MD, MPH, professor of infectious diseases and public health at Oregon Health & Science University, Portland, summarized the recommendations for managing immunosuppressive therapies in patients scheduled to receive vaccinations using killed or nonactive antigens.

Dr. Kevin Winthrop

“In influenza season, don’t pass up the opportunity to vaccinate,” he said, adding, “if you can wait on rituximab dosing, do it, and if you can’t, go ahead and vaccinate.”

The guidelines also recommend a 2-week methotrexate hold at the time of influenza vaccination; other DMARD dosing changes are likely not necessary at the time of vaccination, “but this is an area of fervent study, and I think in a year or two we’ll have more experimental hold data with regard to other DMARDs,” Dr. Winthrop said.

For other nonlive attenuated vaccinations, recommendations are similar to those for influenza, except with more flexible timing because these vaccinations are not seasonal. When and how to hold methotrexate is still up in the air, he said.

Additionally, it’s recommended that vaccinations be delayed in patients on high-dose prednisone until the drug is tapered to below 20 mg per day, and ideally to less than 10 mg per day, he said.
 

Live-attenuated vaccines

The guideline conditionally recommends deferring live-attenuated vaccines in patients on immunosuppressive drugs. It also recommends holding these medications “for an appropriate period before” vaccination and for 4 weeks afterward.

“Although the evidence around conventional synthetic DMARDs and TNF inhibitors is reassuring in terms of their safety at the time of live attenuated vaccines, as you can see the number of studies is quite small, and so the voting panel conditionally recommend against administering live-attenuated virus vaccines to patients who are on conventional synthetics, biologic, or targeted DMARDs,” Dr. Bass said.
 

 

 

In utero exposures

Most women with RMD who have recently given birth will consult their general pediatricians rather than rheumatologists for infant vaccinations, but pediatricians may not be aware of the affect that in utero exposures to biologic DMARDs can have on vaccine safety and immunogenicity in infants, Dr, Bass said.

“It’s important that you, as a provider, give your recommendations regarding infant rotavirus vaccination after in utero exposure to the pregnant rheumatic disease patient prior to delivery, and let that patient know that this is something that they should share with their pediatrician to be,” she advised audience members.
 

Getting the message out

In an interview, session moderator and guidelines panelist Lisa F. Imundo, MD, director of the center for adolescent rheumatology at Columbia University in New York, noted that rheumatologists don’t usually have the full schedule of pediatric vaccinations in stock and often leave the decisions about what to give – and when – to general practitioners.

Dr. Lisa F. Imundo

“Pediatric rheumatologists sometimes will give patients flu vaccinations because they’re a high-risk population of patients, and we want to make sure that they’re getting it in a timely manner,” she said.

In addition, because pneumococcal polysaccharide vaccines are not indicated in the general pediatric population, children on biologic DMARDs who have completed their standard series of pneumococcal conjugate vaccines (PCV13 or PVC15) are recommended to get a 23-valent pneumococcal polysaccharide vaccine, Dr. Imundo said.

She also noted that communication between pediatric rheumatologists and general practitioners about vaccine recommendations can be challenging.

“It’s a huge issue, figuring out how we’re going to communicate all of this information to our pediatric colleagues,” she said. “With individual patients, we may sometimes remind doctors, especially with our younger patients who haven’t gotten their live vaccines, that they really shouldn’t get live vaccines until they’re off medication or until we arrange holding medication for some period of time.”

She said that ACR vaccine committee members are working with infectious disease specialists and guideline developers for the American Academy of Pediatrics to ensure guidelines include the most important vaccination recommendations for pediatric patients with RMDs.

The development process for the guidelines was supported by the ACR. Dr. Bass reported no relevant disclosures, Dr. Bingham disclosed consulting activities, grant/research support, and royalties from various corporate entities. Dr. Winthrop disclosed consulting activities for and research funding from various companies. Dr. Imundo reported no relevant financial relationships.

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