Long-term drug survival of biological agents in patients with rheumatoid arthritis in clinical practice

León, Leticia; Rodríguez‐Rodríguez, Luis; Rosales, Zulema; Gómez, Alejandro Gómez; Lamas, José Ramón; Pato, Esperanza; Jover, Juan A.; Abásolo, Lydia

doi:10.3109/03009742.2016.1141979

Cited by 30 publications

(17 citation statements)

References 13 publications

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“…Patients with RA tend to discontinue treatment with bDMARDs mainly because of AEs and lack or loss of clinical efficacy , with a similar proportion of LTE patients discontinuing because of AEs and lack of efficacy . Discontinuations that are due to lack/loss of efficacy with tofacitinib were low (3.6%) compared with LTE studies of bDMARDs used in the treatment of RA (8%–23%) .…”

Section: Discussionmentioning

confidence: 94%

“…A systematic review of studies from clinical practice indicated that the persistence of golimumab therapy (2‐year drug survival rates ranging from 40% to 77%) may be higher than for other TNFis . In a longitudinal observational study of patients with RA receiving bDMARDs between 1999 and 2013, discontinuations were mainly due to AEs (45.8%) and lack of efficacy (40.8%) . Similarly, an analysis of registry data for patients with RA treated with rituximab, infliximab, or etanercept also identified inadequate response (IR) to treatment (41.4%) and occurrence of serious AEs (22.2%) as the main reasons for discontinuation of these treatments .…”

Section: Introductionmentioning

confidence: 99%

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Persistence of Tofacitinib in the Treatment of Rheumatoid Arthritis in Open‐Label, Long‐Term Extension Studies up to 9.5 Years

Pope

Keystone

Jamal

et al. 2019

ACR Open Rheumatology

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ObjectiveTofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This post hoc analysis evaluated tofacitinib persistence in patients with RA in long‐term extension (LTE) studies up to 9.5 years.MethodsData were pooled from two LTE studies: ORAL Sequel (NCT00413699) and Study A3921041 (NCT00661661). Patients received tofacitinib 5 or 10 mg twice daily (BID), as monotherapy or with background conventional synthetic disease‐modifying antirheumatic drugs. Kaplan‐Meier estimates for tofacitinib drug survival and reasons for discontinuation were evaluated. Baseline factors were analyzed as predictors of persistence.ResultsIn 4967 tofacitinib‐treated patients entering LTE studies, mean (maximum) treatment duration was 3.5 (9.4) years. Median drug survival (95% confidence interval) was 4.9 (4.7, 5.1) years. Estimated 2‐ and 5‐year drug survival rates were 75.5% and 49.4%, respectively. Median drug survival was similar between the tofacitinib 5 and 10 mg BID groups, and slightly higher for patients receiving tofacitinib monotherapy versus combination therapy. Overall, 50.7% of patients discontinued tofacitinib; of these, 47.2% were due to adverse events and 7.1% for lack/loss of efficacy. An increased risk of discontinuation was associated with baseline diabetes, hypertension, negative anticyclic citrullinated peptide (anti‐CCP), negative rheumatoid factor (RF), and inadequate response to tumor necrosis factor inhibitors (TNFi‐IR).ConclusionMedian drug survival of tofacitinib‐treated patients participating in LTE studies was approximately 5 years and was similar for tofacitinib dosed at 5 and 10 mg BID. Reduced drug survival was associated with negative anti‐CCP/RF status, TNFi‐IR, and certain comorbidities. These data support tofacitinib use for long‐term management of RA.

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Section: Discussionmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 99%

Persistence of Tofacitinib in the Treatment of Rheumatoid Arthritis in Open‐Label, Long‐Term Extension Studies up to 9.5 Years

Pope

Keystone

Jamal

et al. 2019

ACR Open Rheumatology

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“…We have been interested in achieving clinical effects similar to those achieved with the TNF α biologicals, but with small molecules, to address issues of immunogenicity (12, 13), supply chain complexity (14), health economics, and other indications e.g., a TNF α inhibitor with an anti-amyloid β could slow the progression of Alzheimer’s disease (15). The opportunity to fine-tune TNF α biology with small molecules could also increase the therapeutic safety window over infection risk.…”

Section: Introductionmentioning

confidence: 99%

Natural Conformational Sampling of Human TNFα Visualized by Double Electron-Electron Resonance

Carrington

Myers

Horanyi

et al. 2017

Biophysical Journal

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Double electron-electron resonance in conjunction with site-directed spin labeling has been used to probe natural conformational sampling of the human tumor necrosis factor α trimer. We suggest a previously unreported, predeoligomerization conformation of the trimer that has been shown to be sampled at low frequency. A model of this trimeric state has been constructed based on crystal structures using the double-electron-electron-resonance distances. The model shows one of the protomers to be rotated and tilted outward at the tip end, leading to a breaking of the trimerous symmetry and distortion at a receptor-binding interface. The new structure offers opportunities to modulate the biological activity of tumor necrosis factor α through stabilization of the distorted trimer with small molecules.

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“…Of the 70 included studies, 19 were full-text articles, 7,[16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33] while 51 were conference abstracts. Study characteristics are described in Supplementary Table 6.…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Among the studies including patients with IA, 21 studies included some form of PRO, 18,20,21,23,24,27,[29][30][31]36,48,49,54,57,59,65,75,77,78,80,84 of which 10 studies reported PROs prior to the switch only and therefore did not provide any information on the patient experience of switching treatment. 20,21,23,24,[29][30][31]49,59,78 The PRO measurement tools used are summarized in Figure 3.…”

Section: Indirectly Reported Patient Experience Of Switchingmentioning

confidence: 99%

<p>Real-World Patient Experience of Switching Biologic Treatment in Inflammatory Arthritis and Ulcerative Colitis – A Systematic Literature Review</p>

Luttropp¹,

Dalén²,

Svedbom³

et al. 2020

PPA

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Purpose: To obtain an up-to-date overview of the measurement of patient experience of switching biologic treatment in patients with inflammatory arthritis (IA) or ulcerative colitis (UC). Secondary objectives included summarizing the types of patient-reported outcomes (PROs) used (if any), and related findings; and summarizing medical and non-medical reasons for treatment switch and/or discontinuation. Methods: A systematic literature review (SLR) was performed, searching Medline and Embase for relevant publications. Results: In total, 70 relevant publications were identified. While the majority of these reported reasons for switching and/or discontinuing treatment, only four provided information explicitly regarding patient-reported experience of switching biologic treatment. All four utilized ranking tools to assess patient experience of switching biologic treatment. The most common reason for switching and/or discontinuing treatment was loss of efficacy, while the least common reason was patient preference. Conclusion: Although the number of available treatments in IA and UC have increased, there is a sparsity of information regarding patient-reported experience of switching biologic treatment. Further research regarding patient preference and/or experience would benefit this therapeutic area and help guide treatment choices.

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Long-term drug survival of biological agents in patients with rheumatoid arthritis in clinical practice

Abstract: After several years of BA treatment in clinical practice, the survival rate was low, mainly as a result of ADRs and inefficacy. We also found differences between the discontinuation rates of BAs and other clinical factors that modify their survival.

Cited by 30 publications

References 13 publications

Persistence of Tofacitinib in the Treatment of Rheumatoid Arthritis in Open‐Label, Long‐Term Extension Studies up to 9.5 Years

Persistence of Tofacitinib in the Treatment of Rheumatoid Arthritis in Open‐Label, Long‐Term Extension Studies up to 9.5 Years

Natural Conformational Sampling of Human TNFα Visualized by Double Electron-Electron Resonance

<p>Real-World Patient Experience of Switching Biologic Treatment in Inflammatory Arthritis and Ulcerative Colitis – A Systematic Literature Review</p>

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