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Insights on methotrexate safety with combination therapies in early RA
Key clinical point: Patients with early rheumatoid arthritis (RA) had a higher frequency of adverse events (AE) with methotrexate + tociluzumab vs methotrexate + active conventional treatment (ACT), which restricted their ability to tolerate the target dose of 25 mg methotrexate per week.
Major finding: The risk for methotrexate-associated AE was significantly higher (hazard ratio 1.48; 95% CI 1.20-1.84) and the proportion of patients able to tolerate 25 mg methotrexate per week at 24 weeks was significantly lower (odds ratio 0.25; P < .001) in the methotrexate + tocilizumab vs methotrexate + ACT group. However, the risks for methotrexate-associated AE were comparable for methotrexate +ACT and the combinations of methotrexate with other biologics like certolizumab-pegol or abatacept.
Study details: This post hoc analysis of the phase 4 NORD-STAR trial included 812 treatment-naive patients with early RA who were randomly assigned to receive methotrexate in combination with ACT, certolizumab-pegol, abatacept, or tocilizumab.
Disclosures: This study did not receive any specific funding. Some authors declared receiving grants, contracts, payments, honoraria, or consulting fees from or having other ties with various sources.
Source: Lend K et al. Methotrexate safety and efficacy in combination therapies in patients with early rheumatoid arthritis: A post-hoc analysis of a randomized controlled trial (NORD-STAR). Arthritis Rheumatol. 2023 (Oct 17). doi: 10.1002/art.42730
Key clinical point: Patients with early rheumatoid arthritis (RA) had a higher frequency of adverse events (AE) with methotrexate + tociluzumab vs methotrexate + active conventional treatment (ACT), which restricted their ability to tolerate the target dose of 25 mg methotrexate per week.
Major finding: The risk for methotrexate-associated AE was significantly higher (hazard ratio 1.48; 95% CI 1.20-1.84) and the proportion of patients able to tolerate 25 mg methotrexate per week at 24 weeks was significantly lower (odds ratio 0.25; P < .001) in the methotrexate + tocilizumab vs methotrexate + ACT group. However, the risks for methotrexate-associated AE were comparable for methotrexate +ACT and the combinations of methotrexate with other biologics like certolizumab-pegol or abatacept.
Study details: This post hoc analysis of the phase 4 NORD-STAR trial included 812 treatment-naive patients with early RA who were randomly assigned to receive methotrexate in combination with ACT, certolizumab-pegol, abatacept, or tocilizumab.
Disclosures: This study did not receive any specific funding. Some authors declared receiving grants, contracts, payments, honoraria, or consulting fees from or having other ties with various sources.
Source: Lend K et al. Methotrexate safety and efficacy in combination therapies in patients with early rheumatoid arthritis: A post-hoc analysis of a randomized controlled trial (NORD-STAR). Arthritis Rheumatol. 2023 (Oct 17). doi: 10.1002/art.42730
Key clinical point: Patients with early rheumatoid arthritis (RA) had a higher frequency of adverse events (AE) with methotrexate + tociluzumab vs methotrexate + active conventional treatment (ACT), which restricted their ability to tolerate the target dose of 25 mg methotrexate per week.
Major finding: The risk for methotrexate-associated AE was significantly higher (hazard ratio 1.48; 95% CI 1.20-1.84) and the proportion of patients able to tolerate 25 mg methotrexate per week at 24 weeks was significantly lower (odds ratio 0.25; P < .001) in the methotrexate + tocilizumab vs methotrexate + ACT group. However, the risks for methotrexate-associated AE were comparable for methotrexate +ACT and the combinations of methotrexate with other biologics like certolizumab-pegol or abatacept.
Study details: This post hoc analysis of the phase 4 NORD-STAR trial included 812 treatment-naive patients with early RA who were randomly assigned to receive methotrexate in combination with ACT, certolizumab-pegol, abatacept, or tocilizumab.
Disclosures: This study did not receive any specific funding. Some authors declared receiving grants, contracts, payments, honoraria, or consulting fees from or having other ties with various sources.
Source: Lend K et al. Methotrexate safety and efficacy in combination therapies in patients with early rheumatoid arthritis: A post-hoc analysis of a randomized controlled trial (NORD-STAR). Arthritis Rheumatol. 2023 (Oct 17). doi: 10.1002/art.42730
Sustained remission tied to better outcomes than sustained LDA in early RA
Key clinical point: Patients with early rheumatoid arthritis (RA) who achieved disease remission and sustained it for 10 years had significantly lower structural progression and functional impairment than those who continued to have low disease activity (LDA).
Major finding: Patients with sustained remission vs sustained LDA had significantly lower mean 10-year structural progression (van der Heijde-modified Total Sharp Score 4.06 vs 14.59; P < .001) and 10-year functional impairment (Health Assessment Questionnaire Disability Index 0.14 vs 0.53; P < .001) scores.
Study details: This study analyzed the data of 252 patients with early RA from the ESPOIR cohort, of whom 48 patients were in sustained remission and 135 patients had sustained LDA.
Disclosures: The ESPOIR cohort was supported by grants from Merck Sharp & Dohme and other sources. The authors declared no conflicts of interest.
Source: Ruyssen-Witrand A et al. Ten-year radiographic and functional outcomes in rheumatoid arthritis patients in remission compared to patients in low disease activity. Arthritis Res Ther. 2023;25:207 (Oct 20). doi: 10.1186/s13075-023-03176-7
Key clinical point: Patients with early rheumatoid arthritis (RA) who achieved disease remission and sustained it for 10 years had significantly lower structural progression and functional impairment than those who continued to have low disease activity (LDA).
Major finding: Patients with sustained remission vs sustained LDA had significantly lower mean 10-year structural progression (van der Heijde-modified Total Sharp Score 4.06 vs 14.59; P < .001) and 10-year functional impairment (Health Assessment Questionnaire Disability Index 0.14 vs 0.53; P < .001) scores.
Study details: This study analyzed the data of 252 patients with early RA from the ESPOIR cohort, of whom 48 patients were in sustained remission and 135 patients had sustained LDA.
Disclosures: The ESPOIR cohort was supported by grants from Merck Sharp & Dohme and other sources. The authors declared no conflicts of interest.
Source: Ruyssen-Witrand A et al. Ten-year radiographic and functional outcomes in rheumatoid arthritis patients in remission compared to patients in low disease activity. Arthritis Res Ther. 2023;25:207 (Oct 20). doi: 10.1186/s13075-023-03176-7
Key clinical point: Patients with early rheumatoid arthritis (RA) who achieved disease remission and sustained it for 10 years had significantly lower structural progression and functional impairment than those who continued to have low disease activity (LDA).
Major finding: Patients with sustained remission vs sustained LDA had significantly lower mean 10-year structural progression (van der Heijde-modified Total Sharp Score 4.06 vs 14.59; P < .001) and 10-year functional impairment (Health Assessment Questionnaire Disability Index 0.14 vs 0.53; P < .001) scores.
Study details: This study analyzed the data of 252 patients with early RA from the ESPOIR cohort, of whom 48 patients were in sustained remission and 135 patients had sustained LDA.
Disclosures: The ESPOIR cohort was supported by grants from Merck Sharp & Dohme and other sources. The authors declared no conflicts of interest.
Source: Ruyssen-Witrand A et al. Ten-year radiographic and functional outcomes in rheumatoid arthritis patients in remission compared to patients in low disease activity. Arthritis Res Ther. 2023;25:207 (Oct 20). doi: 10.1186/s13075-023-03176-7
Four-fold higher risk for interstitial lung abnormalities in RA patients with a history of smoking
Key clinical point: Rheumatoid arthritis (RA) increased the prevalence of interstitial lung abnormalities (ILA) in participants with a history of smoking, which in turn led to a significant increase in the mortality rate.
Major finding: ILA were ~4 times more prevalent in individuals with a history of smoking who did vs did not have RA (adjusted odds ratio 4.15; 95% CI 2.17-7.97). Among patients with RA and a record of smoking, mortality risk was ~3 times higher in those with ILA or indeterminate ILA findings vs those without ILA (adjusted hazard ratio 2.86; 95% CI 1.33-6.16).
Study details: This cross-sectional prospective study included participants with a current or past history of smoking from the COPDGene cohort, of whom 83 participants had RA and were compared with 8725 individuals without RA.
Disclosures: COPDGene was supported by the US National Heart, Lung, and Blood Institute and others. Several authors declared receiving consulting fees, grant support, research support, or having other ties with various sources.
Source: McDermott GC et al. Prevalence and mortality associations of interstitial lung abnormalities in rheumatoid arthritis within a multicentre prospective cohort of smokers. Rheumatology (Oxford). 2023;62(SI3):SI286-SI295 (Oct 23). doi: 10.1093/rheumatology/kead277
Key clinical point: Rheumatoid arthritis (RA) increased the prevalence of interstitial lung abnormalities (ILA) in participants with a history of smoking, which in turn led to a significant increase in the mortality rate.
Major finding: ILA were ~4 times more prevalent in individuals with a history of smoking who did vs did not have RA (adjusted odds ratio 4.15; 95% CI 2.17-7.97). Among patients with RA and a record of smoking, mortality risk was ~3 times higher in those with ILA or indeterminate ILA findings vs those without ILA (adjusted hazard ratio 2.86; 95% CI 1.33-6.16).
Study details: This cross-sectional prospective study included participants with a current or past history of smoking from the COPDGene cohort, of whom 83 participants had RA and were compared with 8725 individuals without RA.
Disclosures: COPDGene was supported by the US National Heart, Lung, and Blood Institute and others. Several authors declared receiving consulting fees, grant support, research support, or having other ties with various sources.
Source: McDermott GC et al. Prevalence and mortality associations of interstitial lung abnormalities in rheumatoid arthritis within a multicentre prospective cohort of smokers. Rheumatology (Oxford). 2023;62(SI3):SI286-SI295 (Oct 23). doi: 10.1093/rheumatology/kead277
Key clinical point: Rheumatoid arthritis (RA) increased the prevalence of interstitial lung abnormalities (ILA) in participants with a history of smoking, which in turn led to a significant increase in the mortality rate.
Major finding: ILA were ~4 times more prevalent in individuals with a history of smoking who did vs did not have RA (adjusted odds ratio 4.15; 95% CI 2.17-7.97). Among patients with RA and a record of smoking, mortality risk was ~3 times higher in those with ILA or indeterminate ILA findings vs those without ILA (adjusted hazard ratio 2.86; 95% CI 1.33-6.16).
Study details: This cross-sectional prospective study included participants with a current or past history of smoking from the COPDGene cohort, of whom 83 participants had RA and were compared with 8725 individuals without RA.
Disclosures: COPDGene was supported by the US National Heart, Lung, and Blood Institute and others. Several authors declared receiving consulting fees, grant support, research support, or having other ties with various sources.
Source: McDermott GC et al. Prevalence and mortality associations of interstitial lung abnormalities in rheumatoid arthritis within a multicentre prospective cohort of smokers. Rheumatology (Oxford). 2023;62(SI3):SI286-SI295 (Oct 23). doi: 10.1093/rheumatology/kead277
Meta-analysis assesses hepatitis B reactivation risk in anti-IL-6-treated RA
Key clinical point: The risk for hepatitis B virus (HBV) reactivation was substantially high in patients with rheumatoid arthritis (RA) and chronic HBV infection who were treated with anti-interleukin-6 (anti-IL-6), with the risk being ~5 times higher in the absence of antiviral prophylaxis.
Major finding: The HBV reactivation rate was 6.7% in patients with chronic HBV infection, with the value further increasing to 31% in patients without antiviral prophylaxis. In patients with resolved HBV infection, the HBV reactivation rate remained ~0% irrespective of antiviral prophylaxis administration.
Study details: This meta-analysis of 19 studies included 372 anti-IL-6-treated patients with RA who had chronic (n = 41) or resolved (n = 279) HBV infection, of whom 19 patients received antiviral prophylaxis.
Disclosures: This study did not receive any funding. Two authors declared receiving honoraria, speaker fees, or research grants from or participating in advisory boards of various sources.
Source: Katelani S et al. HBV reactivation in patients with rheumatoid arthritis treated with anti-interleukin-6: A systematic review and meta-analysis. Rheumatology (Oxford). 2023;62(SI3):SI252-SI259 (Oct 23). doi: 10.1093/rheumatology/kead243
Key clinical point: The risk for hepatitis B virus (HBV) reactivation was substantially high in patients with rheumatoid arthritis (RA) and chronic HBV infection who were treated with anti-interleukin-6 (anti-IL-6), with the risk being ~5 times higher in the absence of antiviral prophylaxis.
Major finding: The HBV reactivation rate was 6.7% in patients with chronic HBV infection, with the value further increasing to 31% in patients without antiviral prophylaxis. In patients with resolved HBV infection, the HBV reactivation rate remained ~0% irrespective of antiviral prophylaxis administration.
Study details: This meta-analysis of 19 studies included 372 anti-IL-6-treated patients with RA who had chronic (n = 41) or resolved (n = 279) HBV infection, of whom 19 patients received antiviral prophylaxis.
Disclosures: This study did not receive any funding. Two authors declared receiving honoraria, speaker fees, or research grants from or participating in advisory boards of various sources.
Source: Katelani S et al. HBV reactivation in patients with rheumatoid arthritis treated with anti-interleukin-6: A systematic review and meta-analysis. Rheumatology (Oxford). 2023;62(SI3):SI252-SI259 (Oct 23). doi: 10.1093/rheumatology/kead243
Key clinical point: The risk for hepatitis B virus (HBV) reactivation was substantially high in patients with rheumatoid arthritis (RA) and chronic HBV infection who were treated with anti-interleukin-6 (anti-IL-6), with the risk being ~5 times higher in the absence of antiviral prophylaxis.
Major finding: The HBV reactivation rate was 6.7% in patients with chronic HBV infection, with the value further increasing to 31% in patients without antiviral prophylaxis. In patients with resolved HBV infection, the HBV reactivation rate remained ~0% irrespective of antiviral prophylaxis administration.
Study details: This meta-analysis of 19 studies included 372 anti-IL-6-treated patients with RA who had chronic (n = 41) or resolved (n = 279) HBV infection, of whom 19 patients received antiviral prophylaxis.
Disclosures: This study did not receive any funding. Two authors declared receiving honoraria, speaker fees, or research grants from or participating in advisory boards of various sources.
Source: Katelani S et al. HBV reactivation in patients with rheumatoid arthritis treated with anti-interleukin-6: A systematic review and meta-analysis. Rheumatology (Oxford). 2023;62(SI3):SI252-SI259 (Oct 23). doi: 10.1093/rheumatology/kead243
Two-fold higher risk for serious infections with tofacitinib vs bDMARD in older RA patients
Key clinical point: Compared with biological disease-modifying anti-rheumatic drugs (bDMARD), tofacitinib increased the risk for serious infections (SI) in older patients with rheumatoid arthritis (RA; age ≥ 69 years).
Major finding: The risk for non-fatal SI in the tofacitinib vs bDMARD treatment group was ~2 times higher in patients age 69 years (hazard ratio [HR] ~2.00; 95% CI ~1.02 to ~4.00) and ~2.8 times higher in those age ≥ 76 years (HR ~2.8; 95% CI 1.3 to ~6.4).
Study details: This observational cohort study included 1687 patients with RA enrolled in 2238 different treatment courses (TC), of which 345 and 1893 TC involved tofacitinib and bDMARD, respectively.
Disclosures: This study was supported by Pfizer. Several authors declared receiving speaker fees, consulting fees, research grants, or conference expenditures from or having other ties with various sources, including Pfizer.
Source: Riek M et al. Serious infection risk of tofacitinib compared to biologics in patients with rheumatoid arthritis treated in routine clinical care. Sci Rep. 2023;13:17776 (Oct 18). doi: 10.1038/s41598-023-44841-w
Key clinical point: Compared with biological disease-modifying anti-rheumatic drugs (bDMARD), tofacitinib increased the risk for serious infections (SI) in older patients with rheumatoid arthritis (RA; age ≥ 69 years).
Major finding: The risk for non-fatal SI in the tofacitinib vs bDMARD treatment group was ~2 times higher in patients age 69 years (hazard ratio [HR] ~2.00; 95% CI ~1.02 to ~4.00) and ~2.8 times higher in those age ≥ 76 years (HR ~2.8; 95% CI 1.3 to ~6.4).
Study details: This observational cohort study included 1687 patients with RA enrolled in 2238 different treatment courses (TC), of which 345 and 1893 TC involved tofacitinib and bDMARD, respectively.
Disclosures: This study was supported by Pfizer. Several authors declared receiving speaker fees, consulting fees, research grants, or conference expenditures from or having other ties with various sources, including Pfizer.
Source: Riek M et al. Serious infection risk of tofacitinib compared to biologics in patients with rheumatoid arthritis treated in routine clinical care. Sci Rep. 2023;13:17776 (Oct 18). doi: 10.1038/s41598-023-44841-w
Key clinical point: Compared with biological disease-modifying anti-rheumatic drugs (bDMARD), tofacitinib increased the risk for serious infections (SI) in older patients with rheumatoid arthritis (RA; age ≥ 69 years).
Major finding: The risk for non-fatal SI in the tofacitinib vs bDMARD treatment group was ~2 times higher in patients age 69 years (hazard ratio [HR] ~2.00; 95% CI ~1.02 to ~4.00) and ~2.8 times higher in those age ≥ 76 years (HR ~2.8; 95% CI 1.3 to ~6.4).
Study details: This observational cohort study included 1687 patients with RA enrolled in 2238 different treatment courses (TC), of which 345 and 1893 TC involved tofacitinib and bDMARD, respectively.
Disclosures: This study was supported by Pfizer. Several authors declared receiving speaker fees, consulting fees, research grants, or conference expenditures from or having other ties with various sources, including Pfizer.
Source: Riek M et al. Serious infection risk of tofacitinib compared to biologics in patients with rheumatoid arthritis treated in routine clinical care. Sci Rep. 2023;13:17776 (Oct 18). doi: 10.1038/s41598-023-44841-w
Real-world study demonstrates cons of tapering DMARD in well-controlled RA
Key clinical point: Tapering biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) or both b/tsDMARD and conventional synthetic (cs) DMARD increased the risk for disease flares in patients with well-controlled rheumatoid arthritis (RA).
Major finding: Compared with patients whose medication was not tapered, the risk for flares was 31 times higher in the b/tsDMARD taper group (hazard ratio [HR] 31.43; P < .0001) and 18 times higher in the b/tsDMARD and csDMARD taper group (HR 18.45; P = .0039).
Study details: This 2-year prospective cohort study included 131 patients with RA who were on stable b/tsDMARD with or without csDMARD and achieved remission or low disease activity, of whom 39.7% underwent a DMARD taper.
Disclosures: This study was supported by the Autoimmune Association - Young Investigator Grant Award. The authors declared no conflicts of interest.
Source: Tageldin M et al. A real-world 2-year prospective study of medication tapering in patients with well-controlled rheumatoid arthritis within the rheumatoid arthritis medication tapering (RHEUMTAP) cohort. Rheumatology (Oxford). 2023;62(Suppl 4):iv8-iv13 (Oct 19). doi: 10.1093/rheumatology/kead430
Key clinical point: Tapering biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) or both b/tsDMARD and conventional synthetic (cs) DMARD increased the risk for disease flares in patients with well-controlled rheumatoid arthritis (RA).
Major finding: Compared with patients whose medication was not tapered, the risk for flares was 31 times higher in the b/tsDMARD taper group (hazard ratio [HR] 31.43; P < .0001) and 18 times higher in the b/tsDMARD and csDMARD taper group (HR 18.45; P = .0039).
Study details: This 2-year prospective cohort study included 131 patients with RA who were on stable b/tsDMARD with or without csDMARD and achieved remission or low disease activity, of whom 39.7% underwent a DMARD taper.
Disclosures: This study was supported by the Autoimmune Association - Young Investigator Grant Award. The authors declared no conflicts of interest.
Source: Tageldin M et al. A real-world 2-year prospective study of medication tapering in patients with well-controlled rheumatoid arthritis within the rheumatoid arthritis medication tapering (RHEUMTAP) cohort. Rheumatology (Oxford). 2023;62(Suppl 4):iv8-iv13 (Oct 19). doi: 10.1093/rheumatology/kead430
Key clinical point: Tapering biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD) or both b/tsDMARD and conventional synthetic (cs) DMARD increased the risk for disease flares in patients with well-controlled rheumatoid arthritis (RA).
Major finding: Compared with patients whose medication was not tapered, the risk for flares was 31 times higher in the b/tsDMARD taper group (hazard ratio [HR] 31.43; P < .0001) and 18 times higher in the b/tsDMARD and csDMARD taper group (HR 18.45; P = .0039).
Study details: This 2-year prospective cohort study included 131 patients with RA who were on stable b/tsDMARD with or without csDMARD and achieved remission or low disease activity, of whom 39.7% underwent a DMARD taper.
Disclosures: This study was supported by the Autoimmune Association - Young Investigator Grant Award. The authors declared no conflicts of interest.
Source: Tageldin M et al. A real-world 2-year prospective study of medication tapering in patients with well-controlled rheumatoid arthritis within the rheumatoid arthritis medication tapering (RHEUMTAP) cohort. Rheumatology (Oxford). 2023;62(Suppl 4):iv8-iv13 (Oct 19). doi: 10.1093/rheumatology/kead430
Herpes zoster subunit vaccine can be recommended in JAKi-treated RA
Key clinical point: In a vulnerable population of individuals with rheumatoid arthritis (RA) receiving Janus kinase inhibitors (JAKi), the herpes zoster subunit (HZ/su) vaccine elicited a serological immune response in most patients and had an acceptable safety profile.
Major finding: The geometric mean concentration of vaccine-specific antibody levels increased from 2317 ng/mL prevaccination to 26,916 ng/mL postvaccination (P < .0001) in patients with RA, with 80.5% of patients showing a ≥4-fold increase in antibody levels. After vaccination, only 6.5% of patients reported an increase in RA disease activity, and adverse events were mostly mild or moderate.
Study details: Findings are from a phase 4 trial including 82 patients with RA treated using JAKi and 51 control individuals without rheumatic diseases, all of whom received two doses of the HZ/su vaccine.
Disclosures: Two authors declared receiving support or research funds for the present study from various sources. T Bergström declared receiving payments or honoraria from GlaxoSmithKline. The other authors declared no conflicts of interest.
Source: Källmark H et al. Serologic immunogenicity and safety of herpes zoster subunit vaccine in patients with rheumatoid arthritis receiving Janus kinase inhibitors. Rheumatology (Oxford). 2023 (Oct 18). Doi: 10.1093/rheumatology/kead552.
Key clinical point: In a vulnerable population of individuals with rheumatoid arthritis (RA) receiving Janus kinase inhibitors (JAKi), the herpes zoster subunit (HZ/su) vaccine elicited a serological immune response in most patients and had an acceptable safety profile.
Major finding: The geometric mean concentration of vaccine-specific antibody levels increased from 2317 ng/mL prevaccination to 26,916 ng/mL postvaccination (P < .0001) in patients with RA, with 80.5% of patients showing a ≥4-fold increase in antibody levels. After vaccination, only 6.5% of patients reported an increase in RA disease activity, and adverse events were mostly mild or moderate.
Study details: Findings are from a phase 4 trial including 82 patients with RA treated using JAKi and 51 control individuals without rheumatic diseases, all of whom received two doses of the HZ/su vaccine.
Disclosures: Two authors declared receiving support or research funds for the present study from various sources. T Bergström declared receiving payments or honoraria from GlaxoSmithKline. The other authors declared no conflicts of interest.
Source: Källmark H et al. Serologic immunogenicity and safety of herpes zoster subunit vaccine in patients with rheumatoid arthritis receiving Janus kinase inhibitors. Rheumatology (Oxford). 2023 (Oct 18). Doi: 10.1093/rheumatology/kead552.
Key clinical point: In a vulnerable population of individuals with rheumatoid arthritis (RA) receiving Janus kinase inhibitors (JAKi), the herpes zoster subunit (HZ/su) vaccine elicited a serological immune response in most patients and had an acceptable safety profile.
Major finding: The geometric mean concentration of vaccine-specific antibody levels increased from 2317 ng/mL prevaccination to 26,916 ng/mL postvaccination (P < .0001) in patients with RA, with 80.5% of patients showing a ≥4-fold increase in antibody levels. After vaccination, only 6.5% of patients reported an increase in RA disease activity, and adverse events were mostly mild or moderate.
Study details: Findings are from a phase 4 trial including 82 patients with RA treated using JAKi and 51 control individuals without rheumatic diseases, all of whom received two doses of the HZ/su vaccine.
Disclosures: Two authors declared receiving support or research funds for the present study from various sources. T Bergström declared receiving payments or honoraria from GlaxoSmithKline. The other authors declared no conflicts of interest.
Source: Källmark H et al. Serologic immunogenicity and safety of herpes zoster subunit vaccine in patients with rheumatoid arthritis receiving Janus kinase inhibitors. Rheumatology (Oxford). 2023 (Oct 18). Doi: 10.1093/rheumatology/kead552.
Elevated risk for cancer in RA patients treated with DMARD
Key clinical point: Compared with the general population, the risk for cancer was significantly higher in patients with rheumatoid arthritis (RA) treated with disease-modifying antirheumatic drugs (DMARD).
Major finding: The all-cancer risk was 20% higher in patients with RA than in the general population (standardized incidence ratio [SIR] 1.20; 95% CI 1.17-1.23). The risk was particularly higher for solid cancers like bladder cancer (SIR 2.38; 95% CI 2.25-2.51), cervical cancer (SIR 1.80; 95% CI 1.62-2.01), and lung cancer (SIR 1.41; 95% CI 1.36-1.46) and for hematological malignancies like Hodgkin’s lymphoma (SIR 2.73; 95% CI 2.31-3.23).
Study details: This population-based observational study included 257,074 patients with RA and without a history of cancer, who received DMARD and were compared with the general population.
Disclosures: This study was supported by unrestricted grants from the French National Cancer Institute and the Assistance Publique des Hôpitaux de Paris. Four authors declared receiving research grants, consulting fees, or support for meetings or travel from various sources.
Source: Beydon M et al. Risk of cancer for patients with rheumatoid arthritis versus general population: A national claims database cohort study. Lancet Reg Health Eur. 2023;35:100768 (Oct 29). doi: 10.1016/j.lanepe.2023.100768
Key clinical point: Compared with the general population, the risk for cancer was significantly higher in patients with rheumatoid arthritis (RA) treated with disease-modifying antirheumatic drugs (DMARD).
Major finding: The all-cancer risk was 20% higher in patients with RA than in the general population (standardized incidence ratio [SIR] 1.20; 95% CI 1.17-1.23). The risk was particularly higher for solid cancers like bladder cancer (SIR 2.38; 95% CI 2.25-2.51), cervical cancer (SIR 1.80; 95% CI 1.62-2.01), and lung cancer (SIR 1.41; 95% CI 1.36-1.46) and for hematological malignancies like Hodgkin’s lymphoma (SIR 2.73; 95% CI 2.31-3.23).
Study details: This population-based observational study included 257,074 patients with RA and without a history of cancer, who received DMARD and were compared with the general population.
Disclosures: This study was supported by unrestricted grants from the French National Cancer Institute and the Assistance Publique des Hôpitaux de Paris. Four authors declared receiving research grants, consulting fees, or support for meetings or travel from various sources.
Source: Beydon M et al. Risk of cancer for patients with rheumatoid arthritis versus general population: A national claims database cohort study. Lancet Reg Health Eur. 2023;35:100768 (Oct 29). doi: 10.1016/j.lanepe.2023.100768
Key clinical point: Compared with the general population, the risk for cancer was significantly higher in patients with rheumatoid arthritis (RA) treated with disease-modifying antirheumatic drugs (DMARD).
Major finding: The all-cancer risk was 20% higher in patients with RA than in the general population (standardized incidence ratio [SIR] 1.20; 95% CI 1.17-1.23). The risk was particularly higher for solid cancers like bladder cancer (SIR 2.38; 95% CI 2.25-2.51), cervical cancer (SIR 1.80; 95% CI 1.62-2.01), and lung cancer (SIR 1.41; 95% CI 1.36-1.46) and for hematological malignancies like Hodgkin’s lymphoma (SIR 2.73; 95% CI 2.31-3.23).
Study details: This population-based observational study included 257,074 patients with RA and without a history of cancer, who received DMARD and were compared with the general population.
Disclosures: This study was supported by unrestricted grants from the French National Cancer Institute and the Assistance Publique des Hôpitaux de Paris. Four authors declared receiving research grants, consulting fees, or support for meetings or travel from various sources.
Source: Beydon M et al. Risk of cancer for patients with rheumatoid arthritis versus general population: A national claims database cohort study. Lancet Reg Health Eur. 2023;35:100768 (Oct 29). doi: 10.1016/j.lanepe.2023.100768
Real-world study confirms efficacy of all JAK inhibitors in RA
Key clinical point: Janus kinase inhibitors (JAKi) like tofacitinib, baricitinib, peficitinib, and upadacitinib showed comparable efficacy, and all of these drugs had impressive remission rates in patients with rheumatoid arthritis (RA).
Major finding: At 6 months of treatment with JAKi, the average Clinical Disease Activity Index (CDAI) scores improved significantly (P < .001), with 1 out of 3 patients achieving CDAI-remission and ≥82% of patients achieving CDAI-low disease activity (LDA). The achievement rates of CDAI-remission and CDAI-LDA were comparable across the four treatment groups.
Study details: Findings are from analysis of a retrospective study including 361 patients with RA from the ANSWER cohort who received tofacitinib (n = 127), baricitinib (n = 153), peficitinib (n = 29), or upadacitinib (n = 52).
Disclosures: This study did not receive any specific funding. Some authors declared receiving research grants, payments for lectures, or speaking or consulting fees from various sources.
Source: Hayashi S et al. Real-world comparative study of the efficacy of Janus kinase inhibitors in patients with rheumatoid arthritis: The ANSWER cohort study. Rheumatology (Oxford). 2023 (Nov 1). doi: 10.1093/rheumatology/kead543
Key clinical point: Janus kinase inhibitors (JAKi) like tofacitinib, baricitinib, peficitinib, and upadacitinib showed comparable efficacy, and all of these drugs had impressive remission rates in patients with rheumatoid arthritis (RA).
Major finding: At 6 months of treatment with JAKi, the average Clinical Disease Activity Index (CDAI) scores improved significantly (P < .001), with 1 out of 3 patients achieving CDAI-remission and ≥82% of patients achieving CDAI-low disease activity (LDA). The achievement rates of CDAI-remission and CDAI-LDA were comparable across the four treatment groups.
Study details: Findings are from analysis of a retrospective study including 361 patients with RA from the ANSWER cohort who received tofacitinib (n = 127), baricitinib (n = 153), peficitinib (n = 29), or upadacitinib (n = 52).
Disclosures: This study did not receive any specific funding. Some authors declared receiving research grants, payments for lectures, or speaking or consulting fees from various sources.
Source: Hayashi S et al. Real-world comparative study of the efficacy of Janus kinase inhibitors in patients with rheumatoid arthritis: The ANSWER cohort study. Rheumatology (Oxford). 2023 (Nov 1). doi: 10.1093/rheumatology/kead543
Key clinical point: Janus kinase inhibitors (JAKi) like tofacitinib, baricitinib, peficitinib, and upadacitinib showed comparable efficacy, and all of these drugs had impressive remission rates in patients with rheumatoid arthritis (RA).
Major finding: At 6 months of treatment with JAKi, the average Clinical Disease Activity Index (CDAI) scores improved significantly (P < .001), with 1 out of 3 patients achieving CDAI-remission and ≥82% of patients achieving CDAI-low disease activity (LDA). The achievement rates of CDAI-remission and CDAI-LDA were comparable across the four treatment groups.
Study details: Findings are from analysis of a retrospective study including 361 patients with RA from the ANSWER cohort who received tofacitinib (n = 127), baricitinib (n = 153), peficitinib (n = 29), or upadacitinib (n = 52).
Disclosures: This study did not receive any specific funding. Some authors declared receiving research grants, payments for lectures, or speaking or consulting fees from various sources.
Source: Hayashi S et al. Real-world comparative study of the efficacy of Janus kinase inhibitors in patients with rheumatoid arthritis: The ANSWER cohort study. Rheumatology (Oxford). 2023 (Nov 1). doi: 10.1093/rheumatology/kead543
Commentary: Examining DMARD Use in PsA, December 2023
Limiting radiographic progression is an important long-term goal of treatment of PsA. In a post hoc analysis that included 449 biologic-naive patients with PsA from the DISCOVER-2 trial who received 100 mg guselkumab every 4 or 8 weeks, Mease and colleagues demonstrated that a greater improvement in the Disease Activity Index for PsA (DAPSA) scores as early as week 8 and the achievement of DAPSA low disease activity at week 8 were associated with a significantly lower progression of radiographic joint damage (total PsA-modified van der Heijde-Sharp score) through week 100. Thus, patients who respond well early have better long-term outcomes.
The safety of targeted therapies is always of concern and is inadequately addressed by individual clinical trials. Meta-analyses may provide further insights. In a network meta-analysis of 94 randomized controlled trials that included a total of 54,369 patients with PsA or psoriasis who were treated with 14 biologics, five small molecules, or placebo, Chiu and colleagues found that for patients with psoriasis, infliximab, deucravacitinib, and bimekizumab had the highest risks for infection. In patients with PsA, bimekizumab, apremilast, and 30 mg upadacitinib led to a significantly higher risk for infection compared with placebo, and 30 mg upadacitinib also increasing the risk for serious infection compared with placebo. The risk for infection in patients with PsA did not increase with most bDMARD and targeted synthetic DMARD (tsDMARD), except bimekizumab, apremilast, and 30 mg upadacitinib.
There is increasing recognition of the difficulty in managing patients with refractory PsA. One approach to such difficult-to-treat disease is dual targeted therapy (DTT). However, the safety of these combinations is of major concern. There is currently an ongoing clinical trial comparing a combination of guselkumab and golimumab vs guselkumab alone for treatment-resistant PsA. In the meantime, Valero-Martinez and colleagues have reported results from an observational, retrospective, cross-sectional study that included patients with refractory PsA (n = 14) or spondyloarthritis (n = 22) who simultaneously received two bDMARD or tsDMARD with different therapeutic targets. The most commonly used combinations were a tumor necrosis factor (TNF) inhibitor plus an interleukin (IL)-12/23 pathway inhibitor, followed by a TNF inhibitor plus an IL-17 inhibitor. They found that at a median exposure of 14.86 months, the DTT retention rate in patients with PsA was 42.8%, with 40.0% and 53.3% of patients achieving remission or low activity and major clinical improvements, respectively. Treatment discontinuation due to adverse events was reported in one patient with PsA and multiple comorbidities. Thus, DTT led to satisfactory clinical improvements and no serious adverse events in patients with refractory PsA. The results of larger observational and randomized trials are awaited.
Limiting radiographic progression is an important long-term goal of treatment of PsA. In a post hoc analysis that included 449 biologic-naive patients with PsA from the DISCOVER-2 trial who received 100 mg guselkumab every 4 or 8 weeks, Mease and colleagues demonstrated that a greater improvement in the Disease Activity Index for PsA (DAPSA) scores as early as week 8 and the achievement of DAPSA low disease activity at week 8 were associated with a significantly lower progression of radiographic joint damage (total PsA-modified van der Heijde-Sharp score) through week 100. Thus, patients who respond well early have better long-term outcomes.
The safety of targeted therapies is always of concern and is inadequately addressed by individual clinical trials. Meta-analyses may provide further insights. In a network meta-analysis of 94 randomized controlled trials that included a total of 54,369 patients with PsA or psoriasis who were treated with 14 biologics, five small molecules, or placebo, Chiu and colleagues found that for patients with psoriasis, infliximab, deucravacitinib, and bimekizumab had the highest risks for infection. In patients with PsA, bimekizumab, apremilast, and 30 mg upadacitinib led to a significantly higher risk for infection compared with placebo, and 30 mg upadacitinib also increasing the risk for serious infection compared with placebo. The risk for infection in patients with PsA did not increase with most bDMARD and targeted synthetic DMARD (tsDMARD), except bimekizumab, apremilast, and 30 mg upadacitinib.
There is increasing recognition of the difficulty in managing patients with refractory PsA. One approach to such difficult-to-treat disease is dual targeted therapy (DTT). However, the safety of these combinations is of major concern. There is currently an ongoing clinical trial comparing a combination of guselkumab and golimumab vs guselkumab alone for treatment-resistant PsA. In the meantime, Valero-Martinez and colleagues have reported results from an observational, retrospective, cross-sectional study that included patients with refractory PsA (n = 14) or spondyloarthritis (n = 22) who simultaneously received two bDMARD or tsDMARD with different therapeutic targets. The most commonly used combinations were a tumor necrosis factor (TNF) inhibitor plus an interleukin (IL)-12/23 pathway inhibitor, followed by a TNF inhibitor plus an IL-17 inhibitor. They found that at a median exposure of 14.86 months, the DTT retention rate in patients with PsA was 42.8%, with 40.0% and 53.3% of patients achieving remission or low activity and major clinical improvements, respectively. Treatment discontinuation due to adverse events was reported in one patient with PsA and multiple comorbidities. Thus, DTT led to satisfactory clinical improvements and no serious adverse events in patients with refractory PsA. The results of larger observational and randomized trials are awaited.
Limiting radiographic progression is an important long-term goal of treatment of PsA. In a post hoc analysis that included 449 biologic-naive patients with PsA from the DISCOVER-2 trial who received 100 mg guselkumab every 4 or 8 weeks, Mease and colleagues demonstrated that a greater improvement in the Disease Activity Index for PsA (DAPSA) scores as early as week 8 and the achievement of DAPSA low disease activity at week 8 were associated with a significantly lower progression of radiographic joint damage (total PsA-modified van der Heijde-Sharp score) through week 100. Thus, patients who respond well early have better long-term outcomes.
The safety of targeted therapies is always of concern and is inadequately addressed by individual clinical trials. Meta-analyses may provide further insights. In a network meta-analysis of 94 randomized controlled trials that included a total of 54,369 patients with PsA or psoriasis who were treated with 14 biologics, five small molecules, or placebo, Chiu and colleagues found that for patients with psoriasis, infliximab, deucravacitinib, and bimekizumab had the highest risks for infection. In patients with PsA, bimekizumab, apremilast, and 30 mg upadacitinib led to a significantly higher risk for infection compared with placebo, and 30 mg upadacitinib also increasing the risk for serious infection compared with placebo. The risk for infection in patients with PsA did not increase with most bDMARD and targeted synthetic DMARD (tsDMARD), except bimekizumab, apremilast, and 30 mg upadacitinib.
There is increasing recognition of the difficulty in managing patients with refractory PsA. One approach to such difficult-to-treat disease is dual targeted therapy (DTT). However, the safety of these combinations is of major concern. There is currently an ongoing clinical trial comparing a combination of guselkumab and golimumab vs guselkumab alone for treatment-resistant PsA. In the meantime, Valero-Martinez and colleagues have reported results from an observational, retrospective, cross-sectional study that included patients with refractory PsA (n = 14) or spondyloarthritis (n = 22) who simultaneously received two bDMARD or tsDMARD with different therapeutic targets. The most commonly used combinations were a tumor necrosis factor (TNF) inhibitor plus an interleukin (IL)-12/23 pathway inhibitor, followed by a TNF inhibitor plus an IL-17 inhibitor. They found that at a median exposure of 14.86 months, the DTT retention rate in patients with PsA was 42.8%, with 40.0% and 53.3% of patients achieving remission or low activity and major clinical improvements, respectively. Treatment discontinuation due to adverse events was reported in one patient with PsA and multiple comorbidities. Thus, DTT led to satisfactory clinical improvements and no serious adverse events in patients with refractory PsA. The results of larger observational and randomized trials are awaited.