scholarly journals Ixekizumab efficacy and safety with and without concomitant conventional disease-modifying antirheumatic drugs (cDMARDs) in biologic DMARD (bDMARD)-naïve patients with active psoriatic arthritis (PsA): results from SPIRIT-P1

RMD Open ◽  
2017 ◽  
Vol 3 (2) ◽  
pp. e000567 ◽  
Author(s):  
Laura C Coates ◽  
Mitsumasa Kishimoto ◽  
Alice Gottlieb ◽  
Catherine L Shuler ◽  
Chen-Yen Lin ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Efficacy And Safety ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Biologic Dmard ◽  
Disease Modifying

scholarly journals Biologic Disease-Modifying Antirheumatic Drugs and Risk of Multiple Myeloma

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1888-1888
Author(s):  
Gregory Sampang Calip ◽  
Karen Sweiss ◽  
Sruthi Adimadhyam ◽  
Alemseged Ayele Asfaw ◽  
Jifang Zhou ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Psoriatic Arthritis ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Biologic Dmards ◽  
Conventional Dmards ◽  
Oral Corticosteroids ◽  
Biologic Dmard ◽  
Disease Modifying

Abstract INTRODUCTION: Biologic disease-modifying antirheumatic drugs (DMARDs) are used more frequently and earlier in the course of rheumatologic conditions in a treat-to-target approach. These medications act on proteins and cytokines with potential pro- and anti-malignancy roles, including tumor necrosis factor-alpha (TNF), human interleukin (IL) receptors and B- and T-cell functions. There is concern for hematologic malignancy with some but not all biologic DMARDs. Little is known about possible associations between these medications and development of multiple myeloma (MM). Our purpose was to determine risk of MM in relation to biologic DMARD treatment, duration of use and by biologic target in a large cohort of patients with rheumatologic conditions. METHODS: We conducted a nested case-control study within a cohort of adults undergoing active treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Patients were sampled from a population of commercially-insured U.S. health plan enrollees in the Truven Health MarketScan Research Database between 2009 and 2015. MM cases were ascertained using validated algorithms for administrative data. Up to ten controls from the overall cohort were matched to each MM case on age, sex and rheumatologic indication using incidence density sampling with replacement. Index date was defined as the date of MM diagnosis for a case and corresponding time at-risk for matched controls. Exposure was defined as both treatment and duration of biologic DMARD use including TNF inhibitor (etanercept, infliximab, adalimumab, golimumab, certolizumab pegol), IL-6 receptor antagonist (tocilizumab), T-cell targeted (abatacept) and B-cell depleting (rituximab) agents and were determined from health claims and pharmacy dispensing data. Data on rheumatologic indication, comorbid conditions and treatment with prescription nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids and conventional synthetic DMARDs (hydroxychloroquine, sulfasalazine, methotrexate, leflunomide) were documented in the 12 month baseline period and during follow up as potential confounders. An exposure lag time of 365 days was used to minimize protopathic bias. Multivariable conditional logistic regression models were used to calculate adjusted odds ratios (OR) and 95% confidence intervals (CI) for risk of MM associated with biologic DMARDs. RESULTS: From a retrospective cohort of 56866 adult patients with rheumatologic conditions, 287 MM cases and 2760 matched controls were identified. Compared to controls, a higher proportion of cases had Charlson comorbidity scores of 2 or greater (24% vs 18%) and used oral corticosteroids during follow up (67% vs 61%). Cases and controls were similar with respect to use of prescription NSAIDs (56% vs 59%) and use of conventional DMARDs (63% vs 67%). Use of biologic DMARDs overall was similar between cases and controls (14% vs 15%), although cases had a slightly lower proportion of etanercept users (5% vs 7%) and a slightly higher proportion of tocilizumab users (1.4% vs 0.4%). Biologic DMARD users were younger, more likely to have psoriatic arthritis or ankylosing spondylitis, lower comorbidity and greater use of concomitant NSAIDs and oral corticosteroids. Risk of MM was neither associated with biologic DMARD use overall (OR 0.84; 95% CI 0.57, 1.26; P=0.40) nor with longer duration of biologic DMARD use (>2.5 years: OR 0.72; 95% CI 0.34, 1.52; P=0.39). However, compared to patients treated with only conventional DMARDs, those receiving concomitant conventional plus biologic DMARDs had a 48% lower risk of developing MM (OR 0.52; 95% CI 0.30, 0.88; P=0.02). Associations with MM appeared to differ by specific biologic DMARD agent with estimates suggesting a lowered risk of MM with use of etanercept (OR 0.55; 95% CI 0.30, 1.02; P=0.06) and greater risk with use of tocilizumab (OR 4.33; 95% CI 1.33, 14.19; P=0.02) that was statistically significant, although confidence intervals were wide. CONCLUSIONS: The potential influence of biologic DMARDs on multiple myeloma is complex. We found that immune suppression with conventional plus biologic DMARDs is inversely associated with MM risk in patients with rheumatologic conditions, but this association differed by biologic drug target. Further research is needed to understand the roles of DMARDs targeting TNF and IL-6 in relation to subsequent myeloma pathogenesis. Disclosures Patel: Celgene: Consultancy, Honoraria; Amgen: Consultancy, Honoraria; Janssen: Honoraria.

SAT0410 EFFICACY AND SAFETY OF IXEKIZUMAB IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS BASED ON CONCOMITANT CONVENTIONAL DISEASE-MODIFYING ANTIRHEUMATIC DRUGS (CDMARD) USE: RESULTS FROM SPIRIT-P1 AND SPIRIT-P2

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1157-1158
Author(s):  
L. C. Coates ◽  
A. Kronbergs ◽  
A. T. Sprabery ◽  
S. Y. Park ◽  
B. Combe ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Safety Profile ◽  
Response Rates ◽  
Efficacy And Safety ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Research Support ◽  
Disease Modifying ◽  
Post Hoc

Background:Biologic disease-modifying antirheumatic drugs such as ixekizumab (IXE), a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A, are commonly prescribed to patients with psoriatic arthritis (PsA) in combination with conventional synthetic disease-modifying antirheumatic drugs (cDMARDs). Previous studies have shown that, after 24 weeks of treatment, IXE is efficacious with or without concomitant cDMARD therapy in patients with active PsA.1,2However, there is limited evidence demonstrating efficacy and safety after 3 years of treatment.Objectives:To evaluate the long-term (3-year) efficacy and safety of IXE in patients with active PsA from SPIRIT-P1 (NCT01695239) and SPIRIT-P2 (NCT02349295) based on concomitant cDMARD use.Methods:Patients were subdivided into the following subgroups: 1) no cDMARD use for 3 years (ixekizumab monotherapy); 2) methotrexate (MTX) use without interruption (i.e., ≤14-day gap of not using MTX), but allowing a change of MTX dose; and 3) any cDMARD (MTX, sulfasalazine, leflunomide, ciclosporin, hydroxychloroquine) use during 3 years without interruption (i.e., ≤14-day gap of not using cDMARDs), but allowing a switch of cDMARD type and/or change of dose. The post-hoc integrated analysis assessed efficacy and safety up to 3 years by three subgroups. Efficacy outcomes included the American College of Rheumatology (ACR) 20/50/70, Psoriasis Area and Severity Index (PASI) 75/90/100, Health Assessment Questionnaire-Disability Index (HAQ-DI) ≥0.35-point improvement. Missing data were imputed using modified non-responder imputation. The IXE 80 mg every 4 weeks (IXEQ4W) dose data are reported here.Results:Overall, IXE-treated patients showed improvement in all efficacy outcomes over 156 weeks, regardless of concomitant cDMARD use. ACR response rates by concomitant cDMARD use at 156 weeks are highlighted in Figure 1. Patients treated with IXEQ4W in the no cDMARD use, MTX, and any cDMARD use subgroups had similar ACR20 (59.1%, 67.0%, and 66.1%, respectively), ACR50 (46.2%, 47.4%, and 46.8%, respectively), and ACR70 (30.7%, 28.4%, and 28.1%, respectively) response rates at 156 weeks. Patients treated with IXEQ4W in the three subgroups also had similar PASI75 (65.5%, 60.8%, and 59.8%, respectively), PASI90 (53.6%, 49.7%, and 48.0%, respectively), and PASI100 (42.2%, 46.2%, and 42.4%, respectively) response rates at 156 weeks. The proportion of patients achieving HAQ-DI improvement ≥0.35 in the three subgroups (51.9%, 45.0%, and 47.5%, respectively) was comparable. The safety profile of IXEQ4W was consistent with that previously reported.1,2A similar proportion of IXEQ4W-treated patients in the three subgroups reported ≥1 treatment-emergent adverse events (TEAEs) regardless of the addition of MTX or other cDMARDs (91.0%, 84.1%, and 83.2%, respectively), and the majority of TEAEs were mild or moderate in all three subgroups.Conclusion:IXEQ4W provided sustained improvements in the signs and symptoms of active PsA. While there are some numerical differences in ACR20/50/70 as well as PASI75/90/100, the overall responses with or without the addition of MTX or other cDMARDs were similar. In this post-hoc analysis, it appears that, for sustained responses over time, IXEQ4W does not require the addition of MTX or other cDMARDs. Addition of MTX or other cDMARDs to IXEQ4W did not negatively impact its favorable long-term safety profile.References:[1]Coates LC, Kishimoto M, Gottlieb A, et al. RMD Open 2017.[2]Nash P, Behrens F, Orbai A-M, et al. RMD Open 2018.Disclosure of Interests:Laura C Coates: None declared, Andris Kronbergs Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Aubrey Trevelin Sprabery Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, So Young Park Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Bernard Combe Grant/research support from: Novartis, Pfizer, Roche-Chugai, Consultant of: AbbVie; Gilead Sciences, Inc.; Janssen; Eli Lilly and Company; Pfizer; Roche-Chugai; Sanofi, Speakers bureau: Bristol-Myers Squibb; Gilead Sciences, Inc.; Eli Lilly and Company; Merck Sharp & Dohme; Pfizer; Roche-Chugai; UCB, 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

scholarly journals Use of Disease-modifying Antirheumatic Drugs for Inflammatory Arthritis in US Veterans: Effect of Specialty Care and Geographic Distance

2017 ◽  
Vol 45 (3) ◽  
pp. 430-436 ◽  
Author(s):  
Jessica A. Walsh ◽  
Shaobo Pei ◽  
Zachary Burningham ◽  
Gopi Penmetsa ◽  
Grant W. Cannon ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Psoriatic Arthritis ◽  
Inflammatory Arthritis ◽  
Geographic Distance ◽  
Veterans Affairs ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Biologic Dmard ◽  
Disease Modifying ◽  
Us Veterans

Objective.To evaluate the effect of access to and distance from rheumatology care on the use of disease-modifying antirheumatic drugs (DMARD) in US veterans with inflammatory arthritis (IA).Methods.Provider encounters and DMARD dispensations for IA (rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis) were evaluated in national Veterans Affairs (VA) datasets between January 1, 2015, and December 31, 2015.Results.Among 12,589 veterans with IA, 23.5% saw a rheumatology provider. In the general IA population, 25.3% and 13.6% of veterans were exposed to a synthetic DMARD (sDMARD) and biologic DMARD (bDMARD), respectively. DMARD exposure was 2.6- to 3.4-fold higher in the subpopulation using rheumatology providers, compared to the general IA population. The distance between veterans’ homes and the closest VA rheumatology site was < 40 miles (Near) for 55.9%, 40–99 miles (Intermediate) for 31.7%, and ≥ 100 miles (Far) for 12.4%. Veterans in the Intermediate and Far groups were less likely to see a rheumatology provider than veterans in the Near group (RR = 0.72 and RR = 0.49, respectively). Exposure to bDMARD was 34% less frequent in the Far group than the Near group. In the subpopulation who used rheumatology care, the bDMARD exposure discrepancy did not persist between distance groups.Conclusion.Use of rheumatology care and DMARD was low for veterans with IA. DMARD exposure was strongly associated with rheumatology care use. Veterans in the general IA population living far from rheumatology sites accessed rheumatology care and bDMARD less frequently than veterans living close to rheumatology sites.

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