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Research paper thumbnail of Durability of Response to Tocilizumab Therapy in Rheumatoid Arthritis: Data from the US-Based Corrona Rheumatoid Arthritis Registry

Rheumatology and Therapy, 2021

Introduction: Understanding the durability of response to treatment and factors associated with f... more Introduction: Understanding the durability of response to treatment and factors associated with failure to maintain response in a real-world setting can inform treatment decisions for patients with rheumatoid arthritis (RA). The aim of this study was to analyze durability of response to tocilizumab (TCZ) and factors associated with durability among US patients with RA in routine clinical practice. Methods: TCZ initiators in the Corrona RA Registry were included. Durability of response was defined as maintaining continuous TCZ treatment and either an improvement of at least minimum clinically important difference (MCID) in Clinical Disease Activity Index (CDAI) score or low disease activity (LDA). Secondary analyses included patients treated with intravenous (IV) TCZ and excluded those who discontinued TCZ without reporting reasons for discontinuation. Durability was calculated with Kaplan-Meier survival analysis. Cox proportional hazards modeling identified factors associated with durability. Results: Among 1789 TCZ initiators, 466, 272, and 162 were persistent (with or without durable response) with follow-up visits at 1, 2, and 3 years, respectively. Median MCID durability of response in CDAI was [ 50% after 36 months overall, 26 months for TCZ-IV, and [ 50% after 36 months for those with known reasons for discontinuation; longer durability was associated with increased duration of RA and higher baseline CDAI score and shorter durability with history of malignancy and history of diabetes. Median LDA durability of response was 13.0 months overall, for TCZ-IV, and for those with known reasons for discontinuation; shorter durability was associated with history of malignancy, history of diabetes, and higher baseline CDAI score. Conclusions: Median durability of response to TCZ in RA was [ 3 years when defined as maintenance of MCID in CDAI score and [ 1 year with the more stringent criteria of maintenance of LDA.

Research paper thumbnail of Comparative effectiveness of first-line tumour necrosis factor inhibitor versus non-tumour necrosis factor inhibitor biologics and targeted synthetic agents in patients with rheumatoid arthritis: results from a large US registry study

Annals of the Rheumatic Diseases, 2020

ObjectivesThis study evaluated the comparative effectiveness of a tumour necrosis factor inhibito... more ObjectivesThis study evaluated the comparative effectiveness of a tumour necrosis factor inhibitor (TNFi) versus a non-TNFi (biological disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs)) as the first-line treatment following conventional synthetic DMARDs, as well as potential modifiers of response, observed in US clinical practice.MethodsData were from a large US healthcare registry (Consortium of Rheumatology Researchers of North America Rheumatoid Arthritis Registry). The analysis included patients (aged ≥18 years) with a documented diagnosis of rheumatoid arthritis (RA), a valid baseline Clinical Disease Activity Index (CDAI) score of >2.8 and no prior bDMARD or tsDMARD use. Outcomes were captured at 1-year postinitiation of a TNFi (adalimumab, etanercept, certolizumab pegol, golimumab or infliximab) or a non-TNFi (abatacept, tocilizumab, rituximab, anakinra or tofacitinib) and included CDAI, 28-Joint Modified Disease Activity Score, pati...

Research paper thumbnail of Methotrexate Discontinuation and Dose Decreases After Therapy With Tocilizumab: Results From the Corrona Rheumatoid Arthritis Registry

Rheumatology and Therapy, 2020

Introduction: Similar outcomes have been observed between patients with rheumatoid arthritis (RA)... more Introduction: Similar outcomes have been observed between patients with rheumatoid arthritis (RA) responding to tocilizumab (TCZ) with methotrexate (MTX) who discontinued vs. continued MTX and between patients receiving MTX who added TCZ vs. switched to TCZ monotherapy. This study examined MTX discontinuation and dose decreases in patients with RA initiating TCZ in a real-world setting. Methods: TCZ-naïve patients enrolled in the Corrona RA registry who initiated TCZ in combination with MTX and had a 6-month followup visit without TCZ discontinuation were included. Patients were grouped by MTX dose at the time of TCZ initiation (B 10 mg, [ 10 to B 15 mg, [ 15 to B 20 mg, [ 20 mg). The primary outcome was the proportion of patients with changes in MTX use at 6 months, with a secondary analysis at 12 months. Changes in disease activity [Clinical Disease Activity Index (CDAI)] and patient-reported outcomes (PROs) at 6 and 12 months were summarized descriptively. Results: Of 444 included patients, 82.7% were female and 83.7% white, with mean (SD) disease duration of 11.6 (9.3) years, baseline CDAI score of 24.0 (15.4), and baseline MTX dose of 17.7 (5.8) mg. At 6 months, 139 patients (31.3%) discontinued or decreased their MTX dose. All MTX dose groups and patients who discontinued, decreased, maintained, or increased their MTX dose displayed improvements in CDAI scores and PROs at 6 months. Similar patterns and results were observed at 12 months. Conclusions: A considerable proportion of patients initiating TCZ discontinued or decreased their MTX dose after TCZ initiation. Improvements in disease activity and functionality were observed in patients who decreased or stopped MTX. This real-world study confirmed prior observations that discontinuing or decreasing MTX may be a treatment strategy for patients initiating TCZ combination therapy. Trial Registration: ClinicalTrials.gov identifier, NCT01402661.

Research paper thumbnail of Effectiveness of Tocilizumab in Patients with Rheumatoid Arthritis Is Unaffected by Comorbidity Burden or Obesity: Data from a US Registry

The Journal of Rheumatology, 2020

ObjectiveComorbidity burden and obesity may affect treatment response in patients with rheumatoid... more ObjectiveComorbidity burden and obesity may affect treatment response in patients with rheumatoid arthritis (RA). Few real-world studies have evaluated the effect of comorbidity burden or obesity on the effectiveness of tocilizumab (TCZ). This study evaluated TCZ effectiveness in treating RA patients with high versus low comorbidity burden and obesity versus nonobesity in US clinical practice.MethodsPatients in the Corrona RA registry who initiated TCZ were stratified by low or high comorbidity burden using a modified Charlson Comorbidity Index (mCCI) and by obese or nonobese status using body mass index (BMI). Improvements in disease activity and functionality after TCZ initiation were compared for the above strata of patients at 6 and 12 months after adjusting for statistically significant differences in baseline characteristics.ResultsWe identified patients with high (mCCI ≥ 2; n = 195) and low (mCCI < 2; n = 575) comorbidity burden and patients categorized as obese (BMI ≥ 30;...

Research paper thumbnail of SAT0156 METHOTREXATE Discontinuation and Dose Decreases After Therapy with Tocilizumab: Results from the Corrona Rheumatoid Arthritis Registry

SATURDAY, 15 JUNE 2019, 2019

Continuance rete of TNFi (IFX and ADA) treatment was significantly lower in ADrA-positive patient... more Continuance rete of TNFi (IFX and ADA) treatment was significantly lower in ADrA-positive patients than in those negative (p=0.0066 and p=0.0127, respectively). In IFX group, patients with ANA titers of !160 before treatment and those with ANA titers of ! 320 after treatment positive showed worse EULAR treatment response (p=0.037 and p=0.033, respectively). In ADA group, 7 of 9 ANA-negative patients before treatment showed moderate or good EULAR response, but positive ANA both before and after treatment was not connected with to the clinical response. Conclusion: The presence of ANA before IFX or ADA is a risk factor for the appearance of ADrA, while ADrA did not appeared in any patient negative for ANA before treatment. ANA of high titers before and after IFX treatment predicted existence of ADrA and possibly leading to the treatment failure.

Research paper thumbnail of THU0177 Durability of Response Among Patients with Rheumatoid Arthritis Initiating Tocilizumab: Data from the Us-Based Corrona Rheumatoid Arthritis Registry

Annals of the Rheumatic Diseases, 2020

Background: Understanding the durability of response to biologics and factors associated with fai... more Background: Understanding the durability of response to biologics and factors associated with failure to maintain response in a real-world setting can inform treatment decisions for patients with rheumatoid arthritis (RA). Objectives: To evaluate the durability of response and identify factors associated with decreased durability in US patients with RA initiating tocilizumab (TCZ) in routine clinical practice. Methods: TCZ-naive patients enrolled in the Corrona RA registry who initiated TCZ (subcutaneous [SC] or intravenous [IV]) after January 1, 2010 and had ≥1 follow-up visit were included. Durability of response was defined as maintaining continuous TCZ and: (a) a minimum clinically important difference (MCID) in clinical disease activity index (CDAI) (defined as an improvement in CDAI compared to baseline of: ≥2 if baseline CDAI ≤10; ≥6 if baseline >10 to ≤22; ≥11 if baseline >22) or (b) low disease activity (LDA; CDAI ≤10). Patient response was no longer durable upon the ...

Research paper thumbnail of Durability of Response to Tocilizumab Therapy in Rheumatoid Arthritis: Data from the US-Based Corrona Rheumatoid Arthritis Registry

Rheumatology and Therapy, 2021

Introduction: Understanding the durability of response to treatment and factors associated with f... more Introduction: Understanding the durability of response to treatment and factors associated with failure to maintain response in a real-world setting can inform treatment decisions for patients with rheumatoid arthritis (RA). The aim of this study was to analyze durability of response to tocilizumab (TCZ) and factors associated with durability among US patients with RA in routine clinical practice. Methods: TCZ initiators in the Corrona RA Registry were included. Durability of response was defined as maintaining continuous TCZ treatment and either an improvement of at least minimum clinically important difference (MCID) in Clinical Disease Activity Index (CDAI) score or low disease activity (LDA). Secondary analyses included patients treated with intravenous (IV) TCZ and excluded those who discontinued TCZ without reporting reasons for discontinuation. Durability was calculated with Kaplan-Meier survival analysis. Cox proportional hazards modeling identified factors associated with durability. Results: Among 1789 TCZ initiators, 466, 272, and 162 were persistent (with or without durable response) with follow-up visits at 1, 2, and 3 years, respectively. Median MCID durability of response in CDAI was [ 50% after 36 months overall, 26 months for TCZ-IV, and [ 50% after 36 months for those with known reasons for discontinuation; longer durability was associated with increased duration of RA and higher baseline CDAI score and shorter durability with history of malignancy and history of diabetes. Median LDA durability of response was 13.0 months overall, for TCZ-IV, and for those with known reasons for discontinuation; shorter durability was associated with history of malignancy, history of diabetes, and higher baseline CDAI score. Conclusions: Median durability of response to TCZ in RA was [ 3 years when defined as maintenance of MCID in CDAI score and [ 1 year with the more stringent criteria of maintenance of LDA.

Research paper thumbnail of Comparative effectiveness of first-line tumour necrosis factor inhibitor versus non-tumour necrosis factor inhibitor biologics and targeted synthetic agents in patients with rheumatoid arthritis: results from a large US registry study

Annals of the Rheumatic Diseases, 2020

ObjectivesThis study evaluated the comparative effectiveness of a tumour necrosis factor inhibito... more ObjectivesThis study evaluated the comparative effectiveness of a tumour necrosis factor inhibitor (TNFi) versus a non-TNFi (biological disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic DMARDs (tsDMARDs)) as the first-line treatment following conventional synthetic DMARDs, as well as potential modifiers of response, observed in US clinical practice.MethodsData were from a large US healthcare registry (Consortium of Rheumatology Researchers of North America Rheumatoid Arthritis Registry). The analysis included patients (aged ≥18 years) with a documented diagnosis of rheumatoid arthritis (RA), a valid baseline Clinical Disease Activity Index (CDAI) score of >2.8 and no prior bDMARD or tsDMARD use. Outcomes were captured at 1-year postinitiation of a TNFi (adalimumab, etanercept, certolizumab pegol, golimumab or infliximab) or a non-TNFi (abatacept, tocilizumab, rituximab, anakinra or tofacitinib) and included CDAI, 28-Joint Modified Disease Activity Score, pati...

Research paper thumbnail of Methotrexate Discontinuation and Dose Decreases After Therapy With Tocilizumab: Results From the Corrona Rheumatoid Arthritis Registry

Rheumatology and Therapy, 2020

Introduction: Similar outcomes have been observed between patients with rheumatoid arthritis (RA)... more Introduction: Similar outcomes have been observed between patients with rheumatoid arthritis (RA) responding to tocilizumab (TCZ) with methotrexate (MTX) who discontinued vs. continued MTX and between patients receiving MTX who added TCZ vs. switched to TCZ monotherapy. This study examined MTX discontinuation and dose decreases in patients with RA initiating TCZ in a real-world setting. Methods: TCZ-naïve patients enrolled in the Corrona RA registry who initiated TCZ in combination with MTX and had a 6-month followup visit without TCZ discontinuation were included. Patients were grouped by MTX dose at the time of TCZ initiation (B 10 mg, [ 10 to B 15 mg, [ 15 to B 20 mg, [ 20 mg). The primary outcome was the proportion of patients with changes in MTX use at 6 months, with a secondary analysis at 12 months. Changes in disease activity [Clinical Disease Activity Index (CDAI)] and patient-reported outcomes (PROs) at 6 and 12 months were summarized descriptively. Results: Of 444 included patients, 82.7% were female and 83.7% white, with mean (SD) disease duration of 11.6 (9.3) years, baseline CDAI score of 24.0 (15.4), and baseline MTX dose of 17.7 (5.8) mg. At 6 months, 139 patients (31.3%) discontinued or decreased their MTX dose. All MTX dose groups and patients who discontinued, decreased, maintained, or increased their MTX dose displayed improvements in CDAI scores and PROs at 6 months. Similar patterns and results were observed at 12 months. Conclusions: A considerable proportion of patients initiating TCZ discontinued or decreased their MTX dose after TCZ initiation. Improvements in disease activity and functionality were observed in patients who decreased or stopped MTX. This real-world study confirmed prior observations that discontinuing or decreasing MTX may be a treatment strategy for patients initiating TCZ combination therapy. Trial Registration: ClinicalTrials.gov identifier, NCT01402661.

Research paper thumbnail of Effectiveness of Tocilizumab in Patients with Rheumatoid Arthritis Is Unaffected by Comorbidity Burden or Obesity: Data from a US Registry

The Journal of Rheumatology, 2020

ObjectiveComorbidity burden and obesity may affect treatment response in patients with rheumatoid... more ObjectiveComorbidity burden and obesity may affect treatment response in patients with rheumatoid arthritis (RA). Few real-world studies have evaluated the effect of comorbidity burden or obesity on the effectiveness of tocilizumab (TCZ). This study evaluated TCZ effectiveness in treating RA patients with high versus low comorbidity burden and obesity versus nonobesity in US clinical practice.MethodsPatients in the Corrona RA registry who initiated TCZ were stratified by low or high comorbidity burden using a modified Charlson Comorbidity Index (mCCI) and by obese or nonobese status using body mass index (BMI). Improvements in disease activity and functionality after TCZ initiation were compared for the above strata of patients at 6 and 12 months after adjusting for statistically significant differences in baseline characteristics.ResultsWe identified patients with high (mCCI ≥ 2; n = 195) and low (mCCI < 2; n = 575) comorbidity burden and patients categorized as obese (BMI ≥ 30;...

Research paper thumbnail of SAT0156 METHOTREXATE Discontinuation and Dose Decreases After Therapy with Tocilizumab: Results from the Corrona Rheumatoid Arthritis Registry

SATURDAY, 15 JUNE 2019, 2019

Continuance rete of TNFi (IFX and ADA) treatment was significantly lower in ADrA-positive patient... more Continuance rete of TNFi (IFX and ADA) treatment was significantly lower in ADrA-positive patients than in those negative (p=0.0066 and p=0.0127, respectively). In IFX group, patients with ANA titers of !160 before treatment and those with ANA titers of ! 320 after treatment positive showed worse EULAR treatment response (p=0.037 and p=0.033, respectively). In ADA group, 7 of 9 ANA-negative patients before treatment showed moderate or good EULAR response, but positive ANA both before and after treatment was not connected with to the clinical response. Conclusion: The presence of ANA before IFX or ADA is a risk factor for the appearance of ADrA, while ADrA did not appeared in any patient negative for ANA before treatment. ANA of high titers before and after IFX treatment predicted existence of ADrA and possibly leading to the treatment failure.

Research paper thumbnail of THU0177 Durability of Response Among Patients with Rheumatoid Arthritis Initiating Tocilizumab: Data from the Us-Based Corrona Rheumatoid Arthritis Registry

Annals of the Rheumatic Diseases, 2020

Background: Understanding the durability of response to biologics and factors associated with fai... more Background: Understanding the durability of response to biologics and factors associated with failure to maintain response in a real-world setting can inform treatment decisions for patients with rheumatoid arthritis (RA). Objectives: To evaluate the durability of response and identify factors associated with decreased durability in US patients with RA initiating tocilizumab (TCZ) in routine clinical practice. Methods: TCZ-naive patients enrolled in the Corrona RA registry who initiated TCZ (subcutaneous [SC] or intravenous [IV]) after January 1, 2010 and had ≥1 follow-up visit were included. Durability of response was defined as maintaining continuous TCZ and: (a) a minimum clinically important difference (MCID) in clinical disease activity index (CDAI) (defined as an improvement in CDAI compared to baseline of: ≥2 if baseline CDAI ≤10; ≥6 if baseline >10 to ≤22; ≥11 if baseline >22) or (b) low disease activity (LDA; CDAI ≤10). Patient response was no longer durable upon the ...