Two dosing regimens of certolizumab pegol in patients with active rheumatoid arthritis

Arthritis Care and Research

Volumn 67, Issue 2, 2015, Pages 151-160

  Furst, D E ^a   Shaikh, S A ^b   Greenwald, M ^c   Bennett, B ^d,e   Davies, O ^d   Luijtens, K ^d   Staelens, F ^d   Koetse, W ^d   Bertin, P ^f  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b MCMASTER UNIVERSITY   (Canada)

^c Desert Medical Advances   (United States)

^d UCB PHARMA   (Belgium)

^e BABennett Consulting   (United States)

^f DUPUYTREN UNIVERSITY HOSPITAL   (France)

Author keywords

[No Author keywords available]

Indexed keywords

CERTOLIZUMAB PEGOL; METHOTREXATE; PLACEBO; ANTIRHEUMATIC AGENT; IMMUNOGLOBULIN F(AB) FRAGMENT; IMMUNOSUPPRESSIVE AGENT; MACROGOL DERIVATIVE; MONOCLONAL ANTIBODY;

ADULT; ARTHRALGIA; ARTICLE; BACKACHE; CONNECTIVE TISSUE DISEASE; CONTROLLED STUDY; COUGHING; DISEASE ACTIVITY SCORE; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; EAR INFECTION; ERYTHROCYTE SEDIMENTATION RATE; FEMALE; FEVER; GASTROINTESTINAL DISEASE; HEADACHE; HEALTH ASSESSMENT QUESTIONNAIRE; HEART DISEASE; HUMAN; LEG PAIN; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; MIDDLE AGED; MUSCULOSKELETAL DISEASE; NAUSEA; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RASH; REMISSION; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SINUSITIS; SKIN DISEASE; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; AGED; ARTHRITIS, RHEUMATOID; CLINICAL TRIAL; COMBINATION DRUG THERAPY; DOSE RESPONSE; MULTICENTER STUDY; TREATMENT OUTCOME;

ADULT; AGED; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; CERTOLIZUMAB PEGOL; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; IMMUNOGLOBULIN FAB FRAGMENTS; IMMUNOSUPPRESSIVE AGENTS; MALE; METHOTREXATE; MIDDLE AGED; POLYETHYLENE GLYCOLS; TREATMENT OUTCOME;

EID: 84922024416     PISSN: 2151464X     EISSN: 21514658     Source Type: Journal    
DOI: 10.1002/acr.22496     Document Type: Article

References (39)

1. Keystone EC, Kavanaugh AF, Sharp JT, Tannenbaum H, Hua Y, Teoh LS, et al. Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti- tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomized, placebo-controlled, 52-week trial. Arthritis Rheum 2004;50:1400-11.
2. Maini R, St.Clair EW, Breedveld F, Furst D, Kalden J, Weisman M, et al. Infliximab (chimeric anti-tumor necrosis factor α monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group. Lancet 1999;354:1932-9.
3. Weinblatt ME, Kremer JM, Bankhurst AD, Bulpitt KJ, Fleischmann RM, Fox RI, et al. A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate. N Engl J Med 1999;340:253-9.
4. Williams EL, Edwards CJ. Patient preferences in choosing anti- TNF therapies-R1. Rheumatology (Oxford) 2006;45:1575-6.
5. Scarpato S, Antivalle M, Favalli EG, Nacci F, Frigelli S, Bartoli F, et al. Patient preferences in the choice of anti-TNF therapies in rheumatoid arthritis: results from a questionnaire survey (RIVIERA study). Rheumatology (Oxford) 2010;49:289-94.
6. Feldmann M. Development of anti-TNF therapy for rheumatoid arthritis. Nat Rev Immunol 2002;2:364-71.
7. Keystone E, van der Heijde D, Mason D Jr, Landewe R, van Vollenhoven R, Combe B, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, doubleblind, placebo-controlled, parallel-group study. Arthritis Rheum 2008;58:3319-29.
8. Smolen JS, Han C, van der Heijde DM, Emery P, Bathon JM, Keystone E, et al. Radiographic changes in rheumatoid arthritis patients attaining different disease activity states with methotrexate monotherapy and infliximab plus methotrexate: the impacts of remission and tumor necrosis factor blockade. Ann Rheum Dis 2009;68:823-7.
9. Smolen J, Landewe RB, Mease P, Brzezicki J, Mason D, Luijtens K, et al. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis 2009;68:797-804.
10. Choy E, McKenna F, Vencovsky J, Valente R, Goel N, Vanlunen B, et al. Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX. Rheumatology (Oxford) 2012;51:1226-34.
11. Fleischmann R, Vencovsky J, van Vollenhoven RF, Borenstein D, Box J, Coteur G, et al. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis 2009;68:805-11.
12. Rubbert-Roth A, Finckh A. Treatment options in patients with rheumatoid arthritis failing initial TNF inhibitor therapy: a critical review. Arthritis Res Ther 2009;11 Suppl 1:S1.
13. American College of Rheumatology Committee to Reevaluate Improvement Criteria. A proposed revision to the ACR20: the hybrid measure of American College of Rheumatology response. Arthritis Rheum 2007;57:193-202.
14. Felson DT, Smolen JS, Wells G, Zhang B, van Tuyl LH, Funovits J, et al. American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. Arthritis Rheum 2011;63:573-86.
15. Lipsky PE, van der Heijde DM, St.Clair EW, Furst DE, Breedveld FC, Kalden JR, et al. Infliximab and methotrexate in the treatment of rheumatoid arthritis: Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. N Engl J Med 2000;343:1594-602.
16. Van Vollenhoven RF, Klareskog L. Infliximab dosage and infusion frequency in clinical practice: experiences in the Stockholm biologics registry STURE. Scand J Rheumatol 2007;36:418-23.
17. Karpouzas GA, Moran R, Khanna D, Louie J, Paulus H, Furst D, et al. Adalimumab dose escalation improves clinical responses in patients with rheumatoid arthritis (RA) [abstract]. Arthritis Rheum 2008;58:S537.
18. Claxton A, Cramer J, Pierce C. A systematic review of the associations between dose regimens and medication compliance. Clin Ther 2001;23:1296-310.
19. Dezii CM, Kawabata H, Tran M. Effects of once-daily and twice-daily dosing on adherence with prescribed glipizide oral therapy for type 2 diabetes. South Med J 2002;95:68-71.
20. Laliberte F, Nelson WW, Lefebvre P, Schein JR, Rondeau- Leclaire J, Duh MS. Impact of daily dosing frequency on adherence to chronic medications among nonvalvular atrial fibrillation patients. Adv Ther 2012;29:675-90.
21. Weinblatt ME, Fleischmann R, Huizinga TW, Emery P, Pope J, Massarotti EM, et al. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology (Oxford) 2012;51:2204-14.
22. Schiff M. Can rheumatoid arthritis (RA) incomplete secondary responders to TNF-α attain an efficacious and safe response by switching to certolizumab pegol? [abstract]. Ann Rheum Dis 2012;71 Suppl 3:520.
23. Burmester B, Muller-Ladner U, Nusslein H, von Hinuber U, Edelmann E, Detert J, et al. Rapid achievement of remission with certolizumab pegol was maintained for one year: interim results from FaST, a German non-interventional study in rheumatoid arthritis real life patients [abstract]. Ann Rheum Dis 2012;71 Suppl 3:664.
24. Shaikh SA, Bensen WG, Chow A, Dixit S, Fortin I, Haraoui B, et al. Safety, effectiveness, work and household productivity of anti-TNF-α therapy with certolizumab pegol observed in adult rheumatoid arthritis patients in daily practice in Canada: first interim analysis of the non-interventional FasT CAN study [abstract]. Ann Rheum Dis 2013;72 Suppl 3:874-5.
25. Chatzidionysiou K, van Vollenhoven R. Treatment with certolizumab pegol in RA: data from the national registry ARTIS (Antirheumatic Therapies in Sweden) [abstract]. Ann Rheum Dis 2012; 71 Suppl 3:517.
26. Smolen JS, Kay J, Landewe RB, Matteson EL, Gaylis N, Wollenhaupt J, et al. Golimumab in patients with active rheumatoid arthritis who have previous experience with tumor necrosis factor inhibitors: results of a long-term extension of the randomised, double-blind, placebo-controlled GO-AFTER study through week 160. Ann Rheum Dis 2012;71:1671-9.
27. Bingham CO III, Ince A, Haraoui B, Keystone EC, Chon Y, Baumgartner S. Effectiveness and safety of etanercept in subjects with RA who have failed infliximab therapy: 16-week, open-label, observational study. Curr Med Res Opin 2009;25:1131-42.
28. Cohen SB, Emery P, Greenwald MW, Dougados M, Furie RA, Genovese MC, et al. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks. Arthritis Rheum 2006;54:2793-806.
29. Genovese MC, Becker JC, Schiff M, Luggen M, Sherrer Y, Kremer J, et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor α inhibition. N Engl J Med 2005;353:1114-23.
30. Nalysnyk L, Xu Y, Williams K, Sharma S, Villanueva I, Sallerin V, et al. Treatment of rheumatoid arthritis after failure of TNF antagonists: a systematic review and meta-analysis [abstract]. Ann Rheum Dis 2008;67 Suppl 3:326.
31. Karlsson JA, Kristensen LE, Kapetanovic MC, Gulfe A, Saxne T, Geborek P. Treatment response to a second or third TNF-inhibitor in RA: results from the South Swedish Arthritis Treatment Group Register. Rheumatology (Oxford) 2008;47:507-13.
32. Smolen JS, Landewe R, Breedveld FC, Buch M, Burmester G, Dougados M, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis 2014;73:492-509.
33. Smolen JS, Landewe R, Breedveld FC, Dougados M, Emery P, Gaujoux-Viala C, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis 2010;69:964-75.
34. Chatzidionysiou K, Turesson C, Teleman A, Knight A, Lindqvist E, Larsson P. A multicenter, randomized, controlled, open-label pilot study of the feasibility of discontinuation of adalimumab in rheumatoid arthritis patients in stable clinical remission [abstract]. Arthritis Rheum 2012;64;S336.
35. Smolen JS, Nash P, Durez P, Hall S, Ilivanova E, Irazoque- Palazuelos F, et al. Maintenance, reduction, or withdrawal of etanercept after treatment with etanercept and methotrexate in patients with moderate rheumatoid arthritis (PRESERVE): a randomised controlled trial. Lancet 2013;381:918-29.
36. Tanaka Y, Hirata S, Fukuyo S, Nawata M, Kubo S, Yamaoka K, et al. Discontinuation of adalimumab without functional and radiographic damage progression after achieving sustained remission in patients with rheumatoid arthritis (the HONOR study): 1-year results [abstract]. Arthritis Rheum 2012;64:S333.
37. Kavanaugh A, Fleischmann RM, Emery P, Kupper H, Redden L, Guerette B, et al. Clinical, functional and radiographic consequences of achieving stable low disease activity and remission with adalimumab plus methotrexate or methotrexate alone in early rheumatoid arthritis: 26-week results from the randomised, controlled OPTIMA study. Ann Rheum Dis 2012;72:64-71.
38. Smolen JS, Emery P, Ferraccioli G, Samborski W, Berenbaum F, Davies O, et al. Maintenance of remission in rheumatoid arthritis patients with low-moderate disease activity following withdrawal of certolizumab pegol treatment: week 52 results from the CERTAIN study [abstract]. Ann Rheum Dis 2012;71 Suppl 3:361.
39. Van der Heijde D, Klareskog L, Rodriguez-Valverde V, Codreanu C, Bolosiu H, Melo-Gomes J, et al. Comparison of etanercept and methotrexate, alone and combined, in the treatment of rheumatoid arthritis: two-year clinical and radiographic results from the TEMPO study, a double-blind, randomized trial. Arthritis Rheum 2006;54:1063-74