scholarly journals POS1021 THE PsABio STUDY IN ITALY: A REAL-WORLD COMPARISON OF THE PERSISTENCE, EFFECTIVENESS AND SAFETY OF USTEKINUMAB AND TUMOUR NECROSIS FACTOR INHIBITORS IN PATIENTS WITH PSORIATIC ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 778-779
Author(s):  
E. Gremese ◽  
F. Ciccia ◽  
C. Selmi ◽  
G. Cuomo ◽  
R. Foti ◽  
...  
Keyword(s):  
Adverse Event ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Research Support ◽  
Treatment Persistence ◽  
Low Disease Activity ◽  
Necrosis Factor

Background:There are still unmet needs in the treatment of psoriatic arthritis (PsA), including in terms of treatment persistence, which is a function of effectiveness, safety and patient satisfaction. Ustekinumab (UST) was the first new biologic drug to be developed for the treatment of PsA after tumour necrosis factor inhibitors (TNFi).Objectives:To compare treatment persistence, effectiveness and safety of UST and TNFi in Italian patients within the PsABio cohort.Methods:PsABio (NCT02627768) is an observational study of 1st/2nd/3rd-line UST or TNFi treatment in PsA in 8 European countries. The current analysis set includes 222 eligible patients treated in 15 Italian centres, followed to Month 12 (±3 months). Treatment persistence/risk of stopping was analysed using Kaplan−Meier (KM) and Cox regression analysis. Proportions of patients reaching minimal disease activity (MDA)/very low disease activity (VLDA) and clinical Disease Activity Index for PsA (cDAPSA) low disease activity (LDA)/remission were analysed using logistic regression, including propensity score (PS) adjustment for imbalanced baseline covariates, and non-response imputation of effectiveness endpoints if treatment was stopped/switched before 1 year. Last observation carried forward data are reported.Results:Of patients starting UST and TNFi, 75/101 (74.3%) and 77/121 (63.6%), respectively, persisted with treatment at 1 year. The observed mean persistence was 410 days for UST and 363 days for TNFi. KM curves and PS-adjusted hazard ratios confirmed significantly higher persistence (hazard ratio [95% confidence interval (CI)]) for UST versus TNFi overall (0.46 [0.26; 0.82]; Figure 1). Persistence was also higher for UST than TNFi in patients receiving monotherapy without methotrexate (0.31 [0.15; 0.63]), in females (0.41 [0.20; 0.83]), and in patients with body mass index (BMI) <25 kg/m2 (0.34 [0.14; 0.87]) or >30 kg/m2 (0.19 [0.06; 0.54]). There was no significant difference in persistence between treatments in patients with BMI 25−30 kg/m2. While patients receiving 1st- and 3rd-line UST or TNFi showed similar risk of discontinuation (0.60 [0.27; 1.29] and 0.36 [0.10; 1.25], respectively), patients receiving 2nd-line UST showed better persistence than those receiving 2nd-line TNFi (0.33 [0.13; 0.87]). Other factors added to the PS-adjusted Cox model did not show significant effects. In patients with available follow-up data, the mean (standard deviation) baseline cDAPSA was 26.3 (15.4) for UST and 23.5 (12.3) for TNFi; at 1-year follow-up, 43.5% of UST- and 43.6% of TNFi-treated patients reached cDAPSA LDA/remission. MDA was reached in 24.2% of UST- and 28.0% of TNFi-treated patients, and VLDA in 12.5% of UST- and 10.2% of TNFi-treated patients. After PS adjustment (stoppers/switchers as non-responders), odds ratios (95% CI) at 1 year did not differ significantly between UST and TNFi groups for reaching cDAPSA LDA/remission (1.08 [0.54; 2.15]), MDA (0.96 [0.45; 2.05]) or VLDA (0.98 [0.35; 2.76]). In total, 23 (20.4%) patients reported ≥1 treatment emergent adverse event with UST and 30 (22.2%) with TNFi; 6 (5.3%) and 10 (7.4%) patients, respectively, discontinued treatment because of an adverse event.Conclusion:In the Italian PsABio cohort, UST had better overall persistence compared with TNFi, as well as in specific subgroups: females, patients on monotherapy without methotrexate, with BMI <25 or >30 kg/m2, and patients receiving UST as 2nd-line treatment. At 1 year, both treatments showed similar effectiveness, as measured by cDAPSA responses and MDA/VLDA achievement.Acknowledgements:This study was funded by Janssen. Contributing author: Prof. Piercarlo Sarzi-Puttini, ASST Fatebenefratelli-Sacco, University of Milan, ItalyDisclosure of Interests:Elisa Gremese: None declared, Francesco Ciccia Speakers bureau: AbbVie, Abiogen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer, Roche, Consultant of: Celgene, Janssen, Lilly, Novartis, Pfizer, Roche, Grant/research support from: Celgene, Janssen, Novartis, Pfizer, Roche, Carlo Selmi Speakers bureau: AbbVie, Alfa-Wassermann, Amgen, Biogen, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, Sanofi-Genzyme, Consultant of: AbbVie, Alfa-Wassermann, Amgen, Biogen, Celgene, Eli Lilly, Gilead, Janssen, MSD, Novartis, Pfizer, Sanofi-Genzyme, Grant/research support from: AbbVie, Amgen, Janssen, Pfizer, Giovanna CUOMO: None declared, Rosario Foti Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Janssen, Roche, Sanofi, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Janssen, Roche, Sanofi, Marco Matucci Cerinic Speakers bureau: Actelion, Biogen, Janssen, Lilly, Consultant of: Chemomab, Grant/research support from: MSD, Fabrizio Conti Consultant of: AbbVie, Bristol-Myers Squibb, Galapagos, Lilly, Pfizer, Enrico Fusaro Speakers bureau: AbbVie, Amgen, Lilly, Grant/research support from: AbbVie, Pfizer, Giuliana Guggino Speakers bureau: AbbVie, Celgene, Novartis, Pfizer, Sandoz, Grant/research support from: Celgene, Pfizer, Florenzo Iannone Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Novartis, Pfizer, Sanofi, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Lilly, MSD, Novartis, Pfizer, Sanofi, UCB, Andrea Delle Sedie: None declared, Roberto Perricone: None declared, Luca Idolazzi Speakers bureau: AbbVie, Eli Lilly, Janssen, MSD, Novartis, Sandoz, Paolo Moscato: None declared, Elke Theander Employee of: Janssen, Wim Noel Employee of: Janssen, Paul Bergmans Shareholder of: Johnson & Johnson, Employee of: Janssen, Silvia Marelli Employee of: Janssen, Laure Gossec Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Biogen, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, UCB, Grant/research support from: Amgen, Galapagos, Janssen, Lilly, Pfizer, Sandoz, Sanofi, Josef S. Smolen Speakers bureau: AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO, Janssen, Lilly, MSD, Novartis- Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB, Grant/research support from: AbbVie, AstraZeneca, Lilly, Novartis, Roche.

THU0373 SECUKINUMAB DOSE ESCALATION ON ACR RESPONSES IN ANTI-TUMOUR NECROSIS FACTOR NAÏVE PATIENTS WITH PSORIATIC ARTHRITIS: 2-YEAR DATA FROM THE PHASE 3 FUTURE 4 AND FUTURE 5 STUDIES

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 418.1-419
Author(s):  
P. Emery ◽  
M. Ǿstergaard ◽  
L. C. Coates ◽  
A. Deodhar ◽  
E. Quebe-Fehling ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Tumour Necrosis Factor ◽  
Dose Escalation ◽  
Tumour Necrosis ◽  
Research Support ◽  
Phase 3 ◽  
Post Dose ◽  
Link Type ◽  
Necrosis Factor

Background:Secukinumab (SEC) 150 and 300 mg doses are approved for the treatment of psoriatic arthritis (PsA). SEC 300 mg is the recommended dose for patients (pts) with concomitant moderate-to-severe plaque psoriasis or who are anti-tumour necrosis factor (TNF) inadequate responders. An increase from 150 mg to 300 mg has been reported to be beneficial in some patients with a suboptimal response to SEC 150 mg.1Here, we present a post hoc analysis in anti-TNF naïve pts who escalated from SEC 150 to 300 mg dose in two Phase 3 studies, FUTURE 4 (NCT02294227) and FUTURE 5 (NCT02404350).Objectives:To evaluate the clinical efficacy on joints following dose escalation from SEC 150 to 300 mg on ACR responses in anti-TNF naïve pts with PsA.Methods:Study design, patient inclusion and exclusion criteria of the FUTURE 4 and FUTURE 5 studies have been reported previously.1–3In FUTURE 4, 341 pts were randomised in a 1:1:1 ratio to SEC 150 mg with loading dose (LD), SEC 150 mg without LD, or placebo. In FUTURE 5, 996 pts were randomised in a 2:2:2:3 ratio to SEC 300 mg with LD, SEC 150 mg with LD, SEC 150 mg without LD or placebo. Following a protocol amendment, pts were allowed to escalate from 150 mg to the 300 mg dose, in the event of suboptimal response based on investigator’s judgment, starting at Week 36 in FUTURE 4 and at Week 52 in FUTURE 5. ACR responses in anti-TNF naïve pts were evaluated pre- and up to 32 and 40 weeks post-escalation, in FUTURE 4 and FUTURE 5, respectively: pts were grouped into four ranges based on their response: no (< 20); low (≥ 20 to < 50); moderate (≥ 50 to < 70); high (≥ 70) ACR responses. Data presented are as observed in the Sankey-style overlay plot.Results:Dose escalation from SEC 150 to 300 mg occurred in 136 pts in FUTURE 4 and in 236 pts in FUTURE 5. The proportion of ACR responders increased and the proportion of non-responders decreased in anti-TNF naïve pts who escalated from SEC 150 to 300 mg in the two studies. The proportion of anti-TNF naïve pts with a response ≥ACR50 increased from 20% to 41% in FUTURE 4 and 28% to 46% in FUTURE 5, post dose escalation. The ACR responses in anti-TNF naïve pts up to 40 weeks after escalation from SEC 150 to 300 mg are presented in the Sankey-style overlay (Figure).Figure.ACR Response bar chart with Sankey-style overlays up to 40 weeks, after dose escalation from SEC 150 mg to 300 mg, in anti-TNF naïve pts in FUTURE 4 and 5Conclusion:The proportion of ACR responders increased within 12-16 weeks and was sustained up to 40 weeks following dose escalation in anti-TNF naïve pts with PsA. These results suggest that dose escalation from SEC 150 to 300 mg may be beneficial in anti-TNF naïve pts with a suboptimal response on SEC 150 mg.References:[1]Kivitz AJ, et al. Rheumatol Ther. 2019;6(3):393–407;[2]Mease PJ, et al. Ann Rheum Dis. 2018;77:890–7;[3]Mease, P.J., et al. ACR Open Rheumatology. 2019 [ePub ahead of print] doi:10.1002/acr2.11097.Disclosure of Interests:Paul Emery Grant/research support from: AbbVie, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer, Roche (all paid to employer), Consultant of: AbbVie (consultant, clinical trials, advisor), Bristol-Myers Squibb (consultant, clinical trials, advisor), Lilly (clinical trials, advisor), Merck Sharp & Dohme (consultant, clinical trials, advisor), Novartis (consultant, clinical trials, advisor), Pfizer (consultant, clinical trials, advisor), Roche (consultant, clinical trials, advisor), Samsung (clinical trials, advisor), Sandoz (clinical trials, advisor), UCB (consultant, clinical trials, advisor), Mikkel Ǿstergaard Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Merck, and Novartis, Consultant of: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Hospira, Janssen, Merck, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and UCB, Laura C Coates: None declared, Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Erhard Quebe-Fehling Shareholder of: Novartis, Employee of: Novartis, Pascale Pellet Shareholder of: Novartis, Employee of: Novartis, Luminita Pricop Shareholder of: Novartis, Employee of: Novartis, Corine Gaillez Shareholder of: Novartis, Employee of: Novartis, Filip van den Bosch Consultant of: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB, Speakers bureau: AbbVie, Celgene Corporation, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer, and UCB

scholarly journals Discontinuation and switching patterns of tumour necrosis factor inhibitors (TNFis) in TNFi-naive and TNFi-experienced patients with psoriatic arthritis: an observational study from the US-based Corrona registry

RMD Open ◽  
2019 ◽  
Vol 5 (1) ◽  
pp. e000880 ◽  
Author(s):  
Philip J Mease ◽  
Chitra Karki ◽  
Mei Liu ◽  
YouFu Li ◽  
Bernice Gershenson ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Patient Demographics ◽  
Switching Patterns ◽  
The Us ◽  
Factor Inhibitor ◽  
The Usa ◽  
Necrosis Factor

ObjectiveTo examine patterns of tumour necrosis factor inhibitor (TNFi) use in TNFi-naive and TNFi-experienced patients with psoriatic arthritis (PsA) in the USA.MethodsAll patients aged ≥18 years with PsA enrolled in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry who initiated a TNFi (index therapy) between March 2013 and January 2017 and had ≥1 follow-up visit were included. Times to and rates of discontinuation/switch of the index TNFi were compared between TNFi-naive and TNFi-experienced cohorts. Patient demographics and disease characteristics at the time of TNFi initiation (baseline) were compared between cohorts and between patients who continued versus discontinued their index TNFi by the first follow-up visit within each cohort.ResultsThis study included 171 TNFi-naive and 147 TNFi-experienced patients (total follow-up, 579.2 person-years). Overall, 75 of 171 TNFi-naive (43.9%) and 80 of 147 TNFi-experienced (54.4%) patients discontinued their index TNFi; 33 of 171 (19.3%) and 48 of 147 (32.7%), respectively, switched to a new biologic. TNFi-experienced patients had a shorter time to discontinuation (median, 20 vs 27 months) and were more likely to discontinue (p=0.03) or switch (p<0.01) compared with TNFi-naive patients. Among those who discontinued, 49 of 75 TNFi-naive (65.3%) and 59 of 80 TNFi-experienced (73.8%) patients discontinued by the first follow-up visit; such patients showed a trend towards higher baseline disease activity compared with those who continued.ConclusionsThe results of this real-world study can help inform treatment decisions when selecting later lines of therapy for patients with PsA.

Patients with rheumatoid arthritis treated with tumour necrosis factor antagonists increase their participation in the workforce: potential for significant long-term indirect cost gains (data from a population-based registry)

2009 ◽  
Vol 69 (01) ◽  
pp. 126-131 ◽  
Author(s):  
J Augustsson ◽  
M Neovius ◽  
C Cullinane-Carli ◽  
S Eksborg ◽  
R F van Vollenhoven
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Indirect Cost ◽  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Population Based ◽  
Hours Worked ◽  
Population Based Registry ◽  
Necrosis Factor

Objective:To investigate the effect of tumour necrosis factor (TNF) antagonist treatment on workforce participation in patients with rheumatoid arthritis (RA).Methods:Data from the Stockholm anti-TNFα follow-up registry (STURE) were used in this observational study. Patients with RA (n = 594) aged 18–55 years, (mean (SD) 40 (9) years) followed for up to 5 years were included with hours worked/week as the main outcome measure. Analyses were performed unadjusted and adjusted for baseline age, disease duration, Health Assessment Questionnaire (HAQ), 28-joint Disease Activity Score (DAS28) and pain score.Results:At baseline patients worked a mean 20 h/week (SD 18). In unadjusted analyses, significant improvements in hours worked/week could already be observed in patients at 6 months (mean, 95% CI) +2.4 h (1.3 to 3.5), with further increases compared to baseline at 1-year (+4.0 h, 2.4 to 5.6) and 2-year follow-up (+6.3 h, 4.2 to 8.4). The trajectory appeared to stabilise at the 3-year (+6.3 h, 3.6 to 8.9), 4-year (+5.3 h, 2.3 to 8.4) and 5-year follow-up (+6.6 h, 3.3 to 10.0). In a mixed piecewise linear regression model, adjusted for age, sex, baseline disease activity, function and pain, an improvement of +4.2 h/week was estimated for the first year followed by an added improvement of +0.5 h/week annually during the years thereafter. Over 5 years of treatment, the expected indirect cost gain corresponded to 40% of the annual anti-TNF drug cost in patients continuing treatment.Conclusion:Data from this population-based registry indicate that biological therapy is associated with increases in workforce participation in a group typically expected to experience progressively deteriorating ability to work. This could result in significant indirect cost benefits to society.

scholarly journals Ixekizumab is efficacious when used alone or when added to conventional synthetic disease-modifying antirheumatic drugs (cDMARDs) in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor inhibitors

RMD Open ◽  
2018 ◽  
Vol 4 (2) ◽  
pp. e000692 ◽  
Author(s):  
Peter Nash ◽  
Frank Behrens ◽  
Ana-Maria Orbai ◽  
Suchitrita S Rathmann ◽  
David H Adams ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Short Form ◽  
Joint Disease ◽  
Inadequate Response ◽  
Efficacy And Safety ◽  
Disease Modifying ◽  
Necrosis Factor

ObjectiveTo conduct subset analyses of SPIRIT-P2 (NCT02349295) to investigate the efficacy and safety of ixekizumab versus placebo in three subgroups of patients with active psoriatic arthritis (PsA) according to the concomitant conventional synthetic disease-modifying antirheumatic drug (cDMARD) received: any background cDMARDs (including methotrexate), background methotrexate only, or none.MethodsPatients were randomised to receive placebo, ixekizumab 80 mg every 4 weeks (IXEQ4W) or every 2 weeks (IXEQ2W). Efficacy and safety were assessed when patients were subdivided according to cDMARD use at baseline. Efficacy was evaluated versus placebo at week 24 by the American College of Rheumatology criteria (ACR20/50), achievement of minimal disease activity (MDA) state, Disease Activity Index for PsA (DAPSA), 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP), Health Assessment Questionnaire-Disability Index and the 36-item Short-Form health survey physical functioning domain.ResultsRegardless of background cDMARD status, ACR20, ACR50 and MDA response rates were significantly higher than placebo with IXEQ4W or IXEQ2W treatment. Similarly, significant improvements were observed relative to placebo for DAS28-CRP and DAPSA across subgroups. Physical function also significantly improved relative to placebo with IXEQ4W treatment regardless of background cDMARD status and with IXEQ2W alone. Percentages of reported treatment-emergent adverse events (AEs), serious AEs (including serious infections) and discontinuations due to AEs in each subgroup were comparable to the overall SPIRIT-P2 population.ConclusionIxekizumab was efficacious in patients with active PsA and previous tumour necrosis factor inhibitor (TNFi) inadequate response or TNFi intolerance treated with ixekizumab alone or when added to cDMARDs with subgroup safety profiles that were consistent with that observed in the overall SPIRIT-P2 population.

scholarly journals Effectiveness of IL-12/23 inhibition (ustekinumab) versus tumour necrosis factor inhibition in psoriatic arthritis: observational PsABio study results

2021 ◽  
pp. annrheumdis-2021-220263
Author(s):  
Josef S Smolen ◽  
Stefan Siebert ◽  
Tatiana V Korotaeva ◽  
Carlo Selmi ◽  
Paul Bergmans ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Tumour Necrosis Factor ◽  
Tumour Necrosis ◽  
Safety Data ◽  
Baseline Body Mass Index ◽  
Published Evidence ◽  
Study Results ◽  
Significant Difference ◽  
Necrosis Factor

ObjectivesTo evaluate 6-month effectiveness of ustekinumab versus tumour necrosis factor inhibitor (TNFi), analysing predictors of low disease activity (LDA)/remission.MethodsPsABio is a prospective, observational cohort study of patients with psoriatic arthritis (PsA) at 92 sites in eight European countries, who received first-line to third-line ustekinumab or a TNFi. Comparative achievement at 6 months of clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) LDA/remission, and minimal disease activity (MDA)/very LDA using propensity score (PS)-adjusted multivariate logistic regression was assessed.ResultsIn the final analysis set of 868 participants with 6-month follow-up data (ustekinumab, n=426; TNFi, n=442), with long-standing disease and a high mean cDAPSA score (31.0 vs 29.8, respectively), proportions of patients in ustekinumab/TNFi treatment groups achieving cDAPSA LDA at 6 months were 45.7%/50.7%. cDAPSA remission was achieved in 14.9%/19.2%, and MDA in 26.4%/30.8% of patients. PS-adjusted odds ratios (OR; 95% confidence interval (CI)) of reaching cDAPSA LDA and MDA were 0.73 (0.46 to 1.15) and 0.87 (0.61 to 1.25) with ustekinumab versus TNFi, indicating no significant difference. High baseline body mass index or high cDAPSA were associated with a lower chance (OR (95% CI)) of reaching cDAPSA LDA with TNFi (0.94 (0.89 to 0.99) and 0.64 (0.52 to 0.79), respectively). Predictive factors were similar to previously published evidence, with cDAPSA and 12-item Psoriatic Arthritis Impact of Disease scores and chronic widespread pain at baseline appearing as new risk factors for unfavourable outcome. Safety data were similar between groups.ConclusionTreatment targets were reached similarly after 6 months of treatment with ustekinumab and TNFi.

Discontinuation of tumour necrosis factor inhibitors in patients with rheumatoid arthritis in low-disease activity: persistent benefits. Data from the Corrona registry

2014 ◽  
Vol 74 (6) ◽  
pp. 1150-1155 ◽  
Author(s):  
Arthur Kavanaugh ◽  
Susan J Lee ◽  
Jeffrey R Curtis ◽  
Jeffrey D Greenberg ◽  
Joel M Kremer ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Tumour Necrosis Factor ◽  
Clinical Benefit ◽  
Tumour Necrosis ◽  
Patient Characteristics ◽  
Low Disease Activity ◽  
Kaplan Meier ◽  
Factor Inhibitor ◽  
Necrosis Factor

BackgroundThere is increasing interest in discontinuing biological therapies for patients with rheumatoid arthritis (RA) achieving good clinical responses, provided patients maintain clinical benefit.MethodsWe assessed patients with RA from the Corrona registry who discontinued treatment with their first tumour necrosis factor inhibitor (TNFi) while in low-disease activity (LDA) or lower levels of disease activity. Patients were followed until they lost clinical benefit, defined as increased disease activity or change in RA medications. Duration of maintenance of clinical benefit was estimated using the Kaplan–Meier method. Cox proportional hazard models were assessed to identify factors related to maintenance of benefit.ResultsWe identified 717 eligible patients with RA from 35 656 in the Corrona registry. At discontinuation, patients had a median RA duration of 8 years, mean clinical disease activity score of 4.3±0.11; 41.8% were using TNFi as monotherapy. 73.4% of patients maintained benefit for >12 months after discontinuing therapy and 42.2% did so through 24 months. Factors predictive of maintaining clinical benefit in multivariate analysis included lower disease activity, less pain and better functional status at the time of TNFi discontinuation. Among 301 patients initiating their first TNFi within the registry, faster responders (ie, those who achieved LDA in 4 months or less) did better than slower responders (HR 1.54 (95% CI 1.17 to 2.04)). RA disease duration did not affect maintenance of clinical benefit.ConclusionsDiscontinuation of a first course of TNFi may be associated with persistent clinical benefit. Half of patients maintained response through 20 months. Several patient characteristics may help predict persistent benefit.

Sign in / Sign up

Export Citation Format

Share Document