Utilization Trends of Tumor Necrosis Factor Inhibitors Among Patients with Rheumatoid Arthritis in a United States Observational Cohort Study

2009 ◽  
Vol 36 (8) ◽  
pp. 1611-1617 ◽  
Author(s):  
SUSAN J. LEE ◽  
HONG CHANG ◽  
YUSUF YAZICI ◽  
JEFFREY D. GREENBERG ◽  
JOEL M. KREMER ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Tumor Necrosis Factor ◽  
Disease Activity ◽  
Tumor Necrosis ◽  
Tnf Inhibitors ◽  
Tnf Inhibitor ◽  
Early Ra ◽  
The Mean ◽  
Necrosis Factor ◽  
Over Time

Objective.Studies have suggested that early institution of tumor necrosis factor (TNF) inhibitors improves functional status and slows radiographic progression among patients with rheumatoid arthritis (RA). To determine whether these findings have altered practice patterns, we used the Consortium of Rheumatology Researchers of North America (CORRONA) registry to assess the pattern of TNF inhibitor utilization in the US over time.Methods.Demographics and disease activity data were collected for patients with RA. The trend of TNF inhibitor use during 2002–06 was evaluated prospectively using linear and logistic regression models.Results.Of the 11,397 patients with RA, 66% and 34% had established RA and early RA (disease duration < 3 yrs), respectively. The majority of patients were female and Caucasian. Despite comparable levels of disease activity, more of the patients with established RA were taking TNF inhibitors than those with early RA (40% vs 25%; p < 0.0001). The majority of patients (70%) taking TNF inhibitors were also receiving disease modifying antirheumatic drugs. The use of TNF inhibitors increased at a rate of 2.8% per year in established RA and 1.2% per year in early RA. The mean Clinical Disease Activity Index at the start of TNF inhibitors decreased at a rate of −0.233 per quarter (p = 0.006), while the mean Disease Activity Score decreased at a rate of −0.04 per quarter (p = 0.022).Conclusion.Utilization of TNF inhibitors in this multicenter, observational US cohort is increasing in both early and established RA, although it is more prominent among patients with established RA. The level of disease activity at which TNF inhibitors were initiated decreased over time in patients with both established and early RA.

scholarly journals Changing Patterns of Tumor Necrosis Factor Inhibitor Use in 9074 Patients with Rheumatoid Arthritis

2009 ◽  
Vol 36 (5) ◽  
pp. 907-913 ◽  
Author(s):  
YUSUF YAZICI ◽  
SVETLANA KRASNOKUTSKY ◽  
JAIME P. BARNES ◽  
PATRICIA L. HINES ◽  
JASON WANG ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Tumor Necrosis Factor ◽  
Dose Escalation ◽  
Tumor Necrosis ◽  
Randomized Clinical Trials ◽  
Tnf Inhibitors ◽  
Tnf Inhibitor ◽  
Insurance Claims ◽  
Claims Database ◽  
Necrosis Factor

Objective.Patients with rheumatoid arthritis (RA) commonly switch between tumor necrosis factor (TNF) inhibitors after failing to control disease activity. Much of the clinical data that support switching to a second TNF agent when one agent fails to work has come from small, short-term studies. We utilized a US insurance claims database to determine patterns of use such as dose escalation, time to discontinuation, and switching between TNF inhibitors in patients with RA.Methods.A retrospective analysis was performed using an insurance claims database in the US from 2000 to 2005. TNF inhibitor use, time to switch, dose escalation, and continuation times were analyzed in patients with RA.Results.Nine thousand seventy-four patients with RA started TNF inhibitors during the period 2000 to 2005. Etanercept was the most commonly used TNF inhibitor; infliximab had the highest duration of continuation, about 50% at 2 years. In addition, infliximab showed higher rates of dose escalation compared to etanercept and adalimumab. For all TNF inhibitors, time to switching decreased from 2000 to 2005.Conclusion.TNF inhibitor use patterns changed from 2000 to 2005, with more frequent changes among the different TNF inhibitors and a shorter duration of treatment before the change. Only about 50% of TNF inhibitors are still continued at 2 years, reflecting the difference between randomized clinical trials and real-world experience.

Which Factors Influence Radiographic Progression During Treatment with Tumor Necrosis Factor Inhibitors in Clinical Practice? Results from 930 Patients with Rheumatoid Arthritis in the Nationwide Danish DANBIO Registry

2014 ◽  
Vol 41 (12) ◽  
pp. 2352-2360 ◽  
Author(s):  
Lykke Midtbøll Ørnbjerg ◽  
Mikkel Østergaard ◽  
Pernille Bøyesen ◽  
Niels Steen Krogh ◽  
Anja Thormann ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Regression Analysis ◽  
Clinical Practice ◽  
Tumor Necrosis Factor ◽  
Disease Activity ◽  
Tumor Necrosis ◽  
Radiographic Progression ◽  
Tnf Inhibitor ◽  
Baseline Characteristics ◽  
Necrosis Factor

Objective.To investigate baseline characteristics associated with radiographic progression and the effect of disease activity, drug, switching, and withdrawal on radiographic progression in tumor necrosis factor (TNF) inhibitor-naive patients with rheumatoid arthritis (RA) followed for about 2 years after anti-TNF initiation in clinical practice.Methods.DANBIO-registered patients with RA who had available radiographs (anti-TNF initiation and ∼2 yrs followup) were included. Radiographs were scored, blinded to chronology with the Sharp/van der Heijde method and linked with DANBIO data. Baseline characteristics were investigated with univariate regression and significant variables included in a multivariable logistic regression analysis with ± radiographic progression [Δ total Sharp score (TSS) > 0] as dependent variable. Effect of time-averaged C-reactive protein (CRP), 28-joint Disease Activity Score with CRP (DAS28-CRP), and treatment status at followup were investigated with univariate regression analysis.Results.The study included 930 patients. They were 75% women, 79% positive for IgM-rheumatoid factor (IgM-RF), median age was 57 yrs (range 19–88), disease duration 9 yrs (1–59), DAS28-CRP 5.0 (1.4–7.8), TSS median 15 [3–45 interquartile range (IQR)] and mean 31 (SD 40). Patients started treatment with infliximab (59%), etanercept (18%), or adalimumab (23%). At followup (median 526 days, IQR 392–735), 61% were treated with the initial anti-TNF, 29% had switched TNF inhibitor, and 10% had withdrawn. Twenty-seven percent of patients had progressed radiographically. ΔTSS was median 0.0 [0.0–0.5 IQR/mean 0.6 (SD 2.4)] units/year. Higher TSS, older age, positive IgM-RF, and concomitant prednisolone at baseline were associated with radiographic progression. Time-averaged DAS28-CRP and time-averaged CRP, but not type of TNF inhibitor, were associated with radiographic progression. Patients who stopped/switched during followup progressed more than patients who continued treatment.Conclusion.High TSS, older age, IgM-RF positivity, and concomitant prednisolone were associated with radiographic progression during 2 years of followup of 930 anti-TNF–treated patients with RA in clinical practice. High disease activity and switching/stopping anti-TNF treatment were associated with radiographic progression.

scholarly journals SAT0118 COMPARATIVE EFFECTIVENESS OF TOCILIZUMAB IN COMBINATION WITH METHOTREXATE VERSUS TUMOR NECROSIS FACTOR INHIBITORS (TNFIS) IN COMBINATION WITH METHOTREXATE IN PATIENTS WITH RHEUMATOID ARTHRITIS WITH PRIOR EXPOSURE TO TNFIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 993.2-993
Author(s):  
D. A. Pappas ◽  
T. Blachley ◽  
S. Zlotnick ◽  
J. H. Best ◽  
K. Emeanuru ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Tumor Necrosis Factor ◽  
Disease Activity ◽  
Tumor Necrosis ◽  
Prior Exposure ◽  
World Population ◽  
Inadequate Response ◽  
Tumor Necrosis Factor Inhibitors ◽  
The Mean ◽  
Necrosis Factor

Background:Clinical studies have demonstrated the efficacy of tocilizumab (TCZ) administered with methotrexate (MTX) in improving rheumatoid arthritis (RA) disease activity in patients who have had an inadequate response to tumor necrosis factor inhibitors (TNFis).Objectives:To compare the effectiveness of TCZ + MTX with that of TNFis + MTX in patients with RA who had prior exposure to TNFis in routine clinical practice.Methods:Eligible participants were TCZ-naïve patients from the Corrona RA registry who initiated TCZ + MTX or a TNFi + MTX after January 1, 2010 and had a 6-month follow-up visit. Patients in both groups must have used ≥ 1 TNFi, had a Clinical Disease Activity Index (CDAI) score available at initiation (baseline) and 6 months and had a CDAI score > 10 at baseline. The primary outcome was mean change in CDAI from baseline to 6 months. Secondary outcomes included achievement of low disease activity (LDA; CDAI ≤ 10) and mean change in modified Health Assessment Questionnaire (mHAQ) at 6 months. Patients were grouped by baseline MTX dose (≤ 10 mg; > 10 to ≤ 15 mg; > 15 to ≤ 20 mg; > 20 mg); outcomes were compared between patients initiating TCZ and those initiating a TNFi overall and within each MTX dose group using propensity score (PS)-trimmed populations. As a sensitivity analysis, TCZ and TNFi initiators in each group were PS-matched 1:1 and outcomes were assessed in the matched populations. Linear and logistic regression models were estimated in the trimmed and matched populations, adjusting for covariates not balanced after PS trimming or matching, respectively.Results:A total of 415 TCZ + MTX initiators and 725 TNFi + MTX initiators met the inclusion criteria prior to PS trimming or matching. The overall trimmed population included 402 TCZ + MTX initiators and 703 TNFi + MTX initiators. In the trimmed population, patient demographics were generally comparable between TCZ + MTX and TNFi + MTX initiators; the mean age was 57.1 years in the TCZ + MTX group and 57.7 years in the TNFi + MTX group, the majority of patients in both groups were female (≥ 80%) and white (≥ 82%) and the mean duration of RA was 11.8 and 10.5 years in the TCZ + MTX and TNFi + MTX groups, respectively. Higher proportions of patients initiating TCZ had received ≥ 2 prior biologics (66.0% to 76.3%) compared with those initiating a TNFi (33.2% to 42.2%) across all MTX dose groups. Patients initiating TCZ had higher mean baseline CDAI scores (26.5 to 29.3) than those initiating a TNFi (24.7 to 27.5). Patients in both cohorts had improvements in CDAI and mHAQ scores and achieved LDA in similar proportions at 6 months regardless of baseline MTX dose (Fig 1). Results were comparable between TCZ and TNFi initiators across all MTX groups in the trimmed population after adjustment for potential confounding variables. Similar results were observed in the PS-matched cohorts.Conclusion:In this real-world population of US patients with RA who had prior TNFi exposure, there was no statistically significant or clinically meaningful difference in the effectiveness of therapy in patients who initiated TCZ + MTX compared with TNFi + MTX.Acknowledgments :This study was sponsored by Corrona, LLC. Corrona is supported through contracted subscriptions with multiple pharmaceutical companies. The abstract was a collaborative effort between Corrona and Genentech, Inc., with financial support provided by Genentech, Inc.Disclosure of Interests: :Dimitrios A Pappas: None declared, Taylor Blachley Employee of: Corrona, LLC, Steve Zlotnick Shareholder of: Genentech, Inc., Employee of: Genentech, Inc., Jennie H. Best Shareholder of: Genentech, Inc., Employee of: Genentech, Inc., Kelechi Emeanuru Employee of: Corrona, LLC – employment, Joel M Kremer Shareholder of: May own stocks and opinions, Grant/research support from: Research and consulting fees from AbbVie Inc., Consultant of: AbbVie, Amgen, BMS, Genentech, Inc., Gilead, GSK, Lilly, Pfizer, Regeneron and Sanofi, Employee of: Corrona, LLC employee

scholarly journals AB0138 A MOLECULAR SIGNATURE RESPONSE CLASSIFIER STRATIFIES SEROPOSITIVE RHEUMATOID ARTHRITIS PATIENTS BASED ON THEIR LIKELIHOOD OF INADEQUATE RESPONSE TO TNF INHIBITOR THERAPIES

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1096.3-1097
Author(s):  
S. Cohen ◽  
V. Strand ◽  
E. Connolly-Strong ◽  
J. Withers ◽  
L. Zhang ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Targeted Therapy ◽  
Tumor Necrosis Factor ◽  
Tumor Necrosis ◽  
Molecular Signature ◽  
Inadequate Response ◽  
Tnf Inhibitor ◽  
Odds Ratios ◽  
Selection For ◽  
Necrosis Factor

Background:There is an urgent need for precision medicine in targeted therapy selection for the treatment of rheumatoid arthritis (RA). TNF inhibitor (TNFi) therapies are the most prescribed targeted therapy for RA patients, yet the majority of patients fail to achieve a clinically meaningful response using this medication class. A blood-based molecular signature test evaluates RNA and clinical metrics to stratify RA patients based on their likelihood of having an inadequate response to TNFi therapies.1 Patients unlikely to respond to TNFi therapies can be directed to a different treatment option such as a JAK inhibitor, thus reducing the time needed to identify an effective therapy, improving confidence in and adherence to treatment, and increasing the patients’ chance of reaching treat-to-target goals.Objectives:High-titers of anti-cyclic citrillunated protein (anti-CCP) have been independently associated with reduced response to TNFi therapy;2 thus, we evaluated the ability of a blood-based molecular signature response classifier (MSRC) test to stratify RA patients by their likelihood of inadequate response to TNFi therapies – regardless of their positive or negative anti-CCP status.Methods:A subset of patients enrolled in the Network-04 prospective observational trial evaluating the ability of a molecular signature response classifier to stratify patients were subdivided into two groups based upon whether they were positive (N = 72) or negative (N = 74) for anti-CCP. The odds of inadequate response to TNFi therapies were calculated based on whether or not a patient had a molecular signature of non-response to TNFi therapy at baseline before the start of treatment. Odds ratios and confidence intervals were calculated3,4 to represent the strength of association between detecting the molecular signature of non-response and the patient’s failure to achieve ACR50 at 6 months.Results:The odds that a patient with a molecular signature of non-response failed to meet ACR50 criteria at 6 months was approximately three times greater than among those patients who lacked the signal (Table 1). No significant difference in odds ratios was observed between patients who were positive or negative for anti-CCP.Table 1.The odds of patients with a molecular signature of non-response failing to achieve an ACR50 response 6 months after TNF inhibitor therapy initiationOdds ratio (95% confidence interval)Anti-CCP positive3.5 (1.3-9.7)Anti-CCP negative3.1 (1.2-8.3)Conclusion:The MSRC test evaluates RA disease biology and accurately stratifies patients based on their likelihood of having an inadequate response to TNFi therapies, regardless of being negative or positive for anti-CCP autoantibodies. Rheumatologists can use the results of the MSRC test to inform targeted therapy selection for RA patients, instead of their anti-CCP serostatus, eliminating the variability inherent to the anti-CCP measurement and its inability to consistently predict TNFi therapy incompatibility. With the MSRC test, providers can rely on a more predictable and accurate assessment of TNFi therapy success or failure when coordinating patient management.References:[1]Mellors, T. et al. Clinical Validation of a Blood-Based Predictive Test for Stratification of Response to Tumor Necrosis Factor Inhibitor Therapies in Rheumatoid Arthritis Patients. Network and Systems Medicine3, 91-104, doi:10.1089/nsm.2020.0007 (2020).[2]Braun-Moscovici, Y. et al. Anti-cyclic citrullinated protein antibodies as a predictor of response to anti-tumor necrosis factor-alpha therapy in patients with rheumatoid arthritis. J Rheumatol33, 497-500 (2006).[3]Szumilas, M. Explaining odds ratios. J Can Acad Child Adolesc Psychiatry19, 227-229 (2010).[4]Sperandei, S. Understanding logistic regression analysis. Biochem Med (Zagreb) 24, 12-18, doi:10.11613/BM.2014.003 (2014).Disclosure of Interests:Stanley Cohen: None declared, Vibeke Strand Consultant of: Abbvie, Amgen, Arena, BMS, Boehringer Ingelheim, Celltrion, Galapagos, Genentech/Roche, Gilead, GSK, Ichnos, Inmedix, Janssen,Kiniksa, Lilly,Merck, Novartis, Pfizer, Regeneron, Samsung, Sandoz, Sanofi, Setpoint, UCB, Erin Connolly-Strong Shareholder of: Scipher Medicine Corporation, Employee of: Scipher Medicine Corporation, Johanna Withers Shareholder of: Scipher Medicine Corporation, Employee of: Scipher Medicine Corporation, Lixia Zhang Shareholder of: Scipher Medicine Corporation, Employee of: Scipher Medicine Corporation, Ted Mellors Shareholder of: Scipher Medicine Corporation, Employee of: Scipher Medicine Corporation, Viatcheslav Akmaev Shareholder of: Scipher Medicine Corporation, Employee of: Scipher Medicine Corporation

Determinants Associated with Work Participation in Patients with Established Rheumatoid Arthritis Taking Tumor Necrosis Factor Inhibitors

2014 ◽  
Vol 41 (7) ◽  
pp. 1263-1269 ◽  
Author(s):  
Sofie H.M. Manders ◽  
Wietske Kievit ◽  
Annemarie L.M.A. Braakman-Jansen ◽  
Herman L.M. Brus ◽  
Lidy Hendriks ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Tumor Necrosis Factor ◽  
Disease Activity ◽  
Functional Status ◽  
Tumor Necrosis ◽  
Work Participation ◽  
P Value ◽  
Retirement Pension ◽  
Patient Reported ◽  
Necrosis Factor

Objective.Reduced work participation (WP) is a common problem for patients with rheumatoid arthritis (RA) and generates high costs for society. Therefore, it is important to explore determinants of WP at the start of tumor necrosis factor inhibitor (TNFi) treatment, and for changes in WP after 2 years of TNFi treatment.Methods.Within the Dutch Rheumatoid Arthritis Monitoring (DREAM) biologic register, WP data were available from 508 patients with RA younger than 65 years and without an (early) retirement pension. WP was registered at start of TNFi treatment and after 2 years of followup and was measured by single patient-reported binary questions whether they had work, paid or voluntary, or had a disability allowance or a retirement pension. Determinants measured at baseline were age, sex, disease duration, functional status [through Health Assessment Questionnaire-Disability Index (HAQ-DI)], 28-joint Disease Activity Score (DAS28), rheumatoid factor, presence of erosions, number of previous disease-modifying antirheumatic drugs, and number of comorbidities. During the 2 years of followup, HAQ-DI response and European League Against Rheumatism response were measured. Univariate analyses (excluded if p value was > 0.2) and multivariate (excluded if p value was > 0.1) logistic regression analyses were used.Results.Determinants associated with WP at baseline were having a better HAQ-DI (OR 0.32, p = 0.000) and male sex (OR 0.65, p = 0.065). After 2 years of TNFi therapy, 11.8% (n = 60) started to work and 13.6% (n = 69) stopped working. Determinants associated with starting to work were better baseline HAQ-DI (OR 0.58), positive RF (OR 2.73), and young age (OR 0.96); and for stopping work, worse baseline HAQ-DI (OR 2.74), low HAQ-DI response (OR 0.31), and comorbidity (OR 2.67), all with p < 0.1.Conclusion.Young patients with RA and a high functional status without any comorbidity will have a better chance of working. This supports the main goal in the management of RA: to suppress disease activity as soon and as completely as possible to prevent irreversible destruction of the joints, and thus maintain a good functional status of the patient. Because of the low proportion of variance explained by the models in this study, other factors besides the ones studied are associated with WP.

scholarly journals Two Cases of Paradoxical Hidradenitis Suppurativa while on Adalimumab

2016 ◽  
Vol 10 (1) ◽  
pp. 92-98 ◽  
Author(s):  
Glenn Harvin ◽  
George Kasarala
Keyword(s):  
Tumor Necrosis Factor ◽  
Skin Disease ◽  
Hidradenitis Suppurativa ◽  
Tumor Necrosis ◽  
Tnf Inhibitors ◽  
Tnf Inhibitor ◽  
Inflammatory Skin Disease ◽  
Inflammatory Skin ◽  
Necrosis Factor ◽  
Inhibitor Treatment

Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disease characterized by recurring abscesses, nodules, and fistulas predominantly in the groin and axillae. The association between HS and Crohn’s disease (CD) has been well documented. Tumor necrosis factor (TNF) inhibitors have shown to be effective in treating both HS and CD. We report 2 patients who developed HS while on TNF inhibitor treatment for CD.

Effectiveness of a second biologic after failure of a non-tumor necrosis factor inhibitor as first biologic in rheumatoid arthritis

2021 ◽  
pp. jrheum.201467
Author(s):  
Katerina Chatzidionysiou ◽  
Merete Lund Hetland ◽  
Thomas Frisell ◽  
Daniela Di Giuseppe ◽  
Karin Hellgren ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Tumor Necrosis Factor ◽  
Disease Activity ◽  
Tumor Necrosis ◽  
Tumor Necrosis Factor Inhibitor ◽  
Primary Response ◽  
Low Disease Activity ◽  
Factor Inhibitor ◽  
Disease Modifying ◽  
Necrosis Factor

Objective In Rheumatoid Arthritis (RA), evidence regarding the effectiveness of a second biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in patients whose first ever bDMARD was a non-tumor-necrosis-factor-inhibitor (TNFi) bDMARD is limited. The objective of this study was therefore to assess the outcome of the second bDMARD (non-TNFi [rituximab, abatacept or tocilizumab, separately] and TNFi) after failure of a non-TNFi bDMARD as first bDMARD. Methods We identified RA patients from the five Nordic biologics registers started treatment with a non-TNFi as first ever bDMARD but switched to a second bDMARD. For the second bDMARD, we assessed survival-on-drug (at 6 and 12 months), and primary response (at 6 months). Results We included 620 patients starting a second bDMARD (ABA 86, RTX 40, TCZ 67 and TNFi 427) following failure of a first non-TNFI bDMARD. At 6 and 12 months after start of their second bDMARD, around 70% and 50%, respectively, remained on treatment, and at 6 months less than one third of patients were still on their second bDMARD and had reached low disease activity or remission according to DAS28. For those patients whose second bMDARD was a TNFI, the corresponding proportion was slightly higher (40%). Conclusion The survival-on-drug and primary response of a second bDMARD in RA patients switching due to failure of a non-TNFi bDMARD as first bDMARD is modest. Some patients may benefit from TNFi when used after failure of a non-TNFi as first bDMARD.

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