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Safety and effectiveness of upadacitinib or adalimumab plus methotrexate in patients with rheumatoid arthritis over 48 weeks with switch to alternate therapy in patients with insufficient response.

Fleischmann RM, Genovese MC, Enejosa JV, Mysler E, Bessette L, Peterfy C, Durez P, Ostor A, Li Y, Song IH.

Ann Rheum Dis. 2019 Jul 30. pii: annrheumdis-2019-215764. doi: 10.1136/annrheumdis-2019-215764. [Epub ahead of print]


A Phase II Trial of Lutikizumab, an Anti-Interleukin-1α/β Dual Variable Domain Immunoglobulin, in Knee Osteoarthritis Patients With Synovitis.

Fleischmann RM, Bliddal H, Blanco FJ, Schnitzer TJ, Peterfy C, Chen S, Wang L, Feng S, Conaghan PG, Berenbaum F, Pelletier JP, Martel-Pelletier J, Vaeterlein O, Kaeley GS, Liu W, Kosloski MP, Levy G, Zhang L, Medema JK, Levesque MC.

Arthritis Rheumatol. 2019 Jul;71(7):1056-1069. doi: 10.1002/art.40840. Epub 2019 Jun 7.


Phase IIa, placebo-controlled, randomised study of lutikizumab, an anti-interleukin-1α and anti-interleukin-1β dual variable domain immunoglobulin, in patients with erosive hand osteoarthritis.

Kloppenburg M, Peterfy C, Haugen IK, Kroon F, Chen S, Wang L, Liu W, Levy G, Fleischmann RM, Berenbaum F, van der Heijde D, Bansal P, Wittoek R, Feng S, Fang Y, Saltarelli M, Medema JK, Levesque MC.

Ann Rheum Dis. 2019 Mar;78(3):413-420. doi: 10.1136/annrheumdis-2018-213336. Epub 2018 Dec 14.


A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira®) in the treatment of active rheumatoid arthritis.

Fleischmann RM, Alten R, Pileckyte M, Lobello K, Hua SY, Cronenberger C, Alvarez D, Bock AE, Sewell KL.

Arthritis Res Ther. 2018 Aug 15;20(1):178. doi: 10.1186/s13075-018-1676-y.


Safety, Tolerability, and Pharmacodynamics of ABT-122, a Tumor Necrosis Factor- and Interleukin-17-Targeted Dual Variable Domain Immunoglobulin, in Patients With Rheumatoid Arthritis.

Fleischmann RM, Wagner F, Kivitz AJ, Mansikka HT, Khan N, Othman AA, Khatri A, Hong F, Jiang P, Ruzek M, Padley RJ.

Arthritis Rheumatol. 2017 Dec;69(12):2283-2291. doi: 10.1002/art.40319. Epub 2017 Nov 8.


Cutting Edge: Selective Oral ROCK2 Inhibitor Reduces Clinical Scores in Patients with Psoriasis Vulgaris and Normalizes Skin Pathology via Concurrent Regulation of IL-17 and IL-10.

Zanin-Zhorov A, Weiss JM, Trzeciak A, Chen W, Zhang J, Nyuydzefe MS, Arencibia C, Polimera S, Schueller O, Fuentes-Duculan J, Bonifacio KM, Kunjravia N, Cueto I, Soung J, Fleischmann RM, Kivitz A, Lebwohl M, Nunez M, Woodson J, Smith SL, West RF, Berger M, Krueger JG, Ryan JL, Waksal SD.

J Immunol. 2017 May 15;198(10):3809-3814. doi: 10.4049/jimmunol.1602142. Epub 2017 Apr 7.


DAS28-CRP and DAS28-ESR cut-offs for high disease activity in rheumatoid arthritis are not interchangeable.

Fleischmann RM, van der Heijde D, Gardiner PV, Szumski A, Marshall L, Bananis E.

RMD Open. 2017 Jan 30;3(1):e000382. doi: 10.1136/rmdopen-2016-000382. eCollection 2017.


Blood-Borne RNA Correlates with Disease Activity and IFN-Stimulated Gene Expression in Systemic Lupus Erythematosus.

Doedens JR, Jones WD, Hill K, Mason MJ, Gersuk VH, Mease PJ, Dall'Era M, Aranow C, Martin RW, Cohen SB, Fleischmann RM, Kivitz AJ, Burge DJ, Chaussabel D, Elkon KB, Posada JA.

J Immunol. 2016 Oct 1;197(7):2854-63. doi: 10.4049/jimmunol.1601142. Epub 2016 Aug 17.


Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis.

Fleischmann RM, Huizinga TW, Kavanaugh AF, Wilkinson B, Kwok K, DeMasi R, van Vollenhoven RF.

RMD Open. 2016 Jul 26;2(2):e000262. doi: 10.1136/rmdopen-2016-000262. eCollection 2016.


A Phase III, Randomized, Controlled Trial of Apremilast in Patients with Psoriatic Arthritis: Results of the PALACE 2 Trial.

Cutolo M, Myerson GE, Fleischmann RM, Lioté F, Díaz-González F, Van den Bosch F, Marzo-Ortega H, Feist E, Shah K, Hu C, Stevens RM, Poder A.

J Rheumatol. 2016 Sep;43(9):1724-34. doi: 10.3899/jrheum.151376. Epub 2016 Jul 15.


Effects of the oral Janus kinase inhibitor tofacitinib on patient-reported outcomes in patients with active rheumatoid arthritis: results of two Phase 2 randomised controlled trials.

Wallenstein GV, Kanik KS, Wilkinson B, Cohen S, Cutolo M, Fleischmann RM, Genovese MC, Gomez Reino J, Gruben D, Kremer J, Krishnaswami S, Lee EB, Pascual-Ramos V, Strand V, Zwillich SH.

Clin Exp Rheumatol. 2016 May-Jun;34(3):430-42. Epub 2016 Apr 28.


Clinical efficacy and safety maintained up to 5 years in patients with rheumatoid arthritis treated with tocilizumab in a randomised trial.

Kremer JM, Blanco R, Halland AM, Brzosko M, Burgos-Vargas R, Mela CM, Rowell L, Fleischmann RM.

Clin Exp Rheumatol. 2016 Jul-Aug;34(4):625-33. Epub 2016 Apr 15.


Impact of certolizumab pegol on patient-reported outcomes in rheumatoid arthritis and correlation with clinical measures of disease activity.

Pope J, Bingham CO 3rd, Fleischmann RM, Dougados M, Massarotti EM, Wollenhaupt J, Duncan B, Coteur G, Weinblatt ME.

Arthritis Res Ther. 2015 Nov 27;17:343. doi: 10.1186/s13075-015-0849-1.


Efficacy and Safety of Subcutaneous Golimumab in Methotrexate-Naive Patients With Rheumatoid Arthritis: Five-Year Results of a Randomized Clinical Trial.

Emery P, Fleischmann RM, Strusberg I, Durez P, Nash P, Amante EJ, Churchill M, Park W, Pons-Estel B, Han C, Gathany TA, Xu S, Zhou Y, Leu JH, Hsia EC.

Arthritis Care Res (Hoboken). 2016 Jun;68(6):744-52. doi: 10.1002/acr.22759.


Longterm Safety of Rituximab: Final Report of the Rheumatoid Arthritis Global Clinical Trial Program over 11 Years.

van Vollenhoven RF, Fleischmann RM, Furst DE, Lacey S, Lehane PB.

J Rheumatol. 2015 Oct;42(10):1761-6. doi: 10.3899/jrheum.150051. Epub 2015 Aug 15.


Rheumatoid arthritis: Developing new oral targeted therapies for RA can be challenging.

Fleischmann RM.

Nat Rev Rheumatol. 2015 Jan;11(1):4-6. doi: 10.1038/nrrheum.2014.187. Epub 2014 Nov 11. No abstract available.


A randomized, double-blind, placebo-controlled, twelve-week, dose-ranging study of decernotinib, an oral selective JAK-3 inhibitor, as monotherapy in patients with active rheumatoid arthritis.

Fleischmann RM, Damjanov NS, Kivitz AJ, Legedza A, Hoock T, Kinnman N.

Arthritis Rheumatol. 2015 Feb;67(2):334-43. doi: 10.1002/art.38949.


Efficacy of golimumab plus methotrexate in methotrexate-naïve patients with severe active rheumatoid arthritis.

Emery P, Fleischmann RM, Hsia EC, Xu S, Zhou Y, Baker D.

Clin Rheumatol. 2014 Sep;33(9):1239-46. doi: 10.1007/s10067-014-2731-y. Epub 2014 Jul 9.


Response to H Zeidler's comments on the CONCERTO study.

Burmester GR, Kivitz A, Kupper H, Arulmani U, Florentinus S, Goss SL, Rathmann SS, Fleischmann RM.

Ann Rheum Dis. 2014 Aug;73(8):e51. doi: 10.1136/annrheumdis-2014-205704. Epub 2014 Jun 9. No abstract available.


Efficacy and safety of ascending methotrexate dose in combination with adalimumab: the randomised CONCERTO trial.

Burmester GR, Kivitz AJ, Kupper H, Arulmani U, Florentinus S, Goss SL, Rathmann SS, Fleischmann RM.

Ann Rheum Dis. 2015 Jun;74(6):1037-44. doi: 10.1136/annrheumdis-2013-204769. Epub 2014 Feb 18.


Sarilumab, a fully human monoclonal antibody against IL-6Rα in patients with rheumatoid arthritis and an inadequate response to methotrexate: efficacy and safety results from the randomised SARIL-RA-MOBILITY Part A trial.

Huizinga TW, Fleischmann RM, Jasson M, Radin AR, van Adelsberg J, Fiore S, Huang X, Yancopoulos GD, Stahl N, Genovese MC.

Ann Rheum Dis. 2014 Sep;73(9):1626-34. doi: 10.1136/annrheumdis-2013-204405. Epub 2013 Dec 2.


Evaluation of serum biomarkers associated with radiographic progression in methotrexate-naive rheumatoid arthritis patients treated with methotrexate or golimumab.

Wagner C, Chen D, Fan H, Hsia EC, Mack M, Emery P, Fleischmann RM.

J Rheumatol. 2013 May;40(5):590-8. doi: 10.3899/jrheum.120889. Epub 2013 Mar 1.


Tocilizumab inhibits structural joint damage and improves physical function in patients with rheumatoid arthritis and inadequate responses to methotrexate: LITHE study 2-year results.

Fleischmann RM, Halland AM, Brzosko M, Burgos-Vargas R, Mela C, Vernon E, Kremer JM.

J Rheumatol. 2013 Feb;40(2):113-26. doi: 10.3899/jrheum.120447. Epub 2013 Jan 15.


Effects of golimumab, an anti-tumour necrosis factor-α human monoclonal antibody, on lipids and markers of inflammation.

Kirkham BW, Wasko MC, Hsia EC, Fleischmann RM, Genovese MC, Matteson EL, Liu H, Rahman MU.

Ann Rheum Dis. 2014 Jan;73(1):161-9. doi: 10.1136/annrheumdis-2012-202089. Epub 2013 Jan 7.


Tabalumab, an anti-BAFF monoclonal antibody, in patients with active rheumatoid arthritis with an inadequate response to TNF inhibitors.

Genovese MC, Fleischmann RM, Greenwald M, Satterwhite J, Veenhuizen M, Xie L, Berclaz PY, Myers S, Benichou O.

Ann Rheum Dis. 2013 Sep 1;72(9):1461-8. doi: 10.1136/annrheumdis-2012-202775. Epub 2012 Dec 25.


Long-term safety of rituximab in rheumatoid arthritis: 9.5-year follow-up of the global clinical trial programme with a focus on adverse events of interest in RA patients.

van Vollenhoven RF, Emery P, Bingham CO 3rd, Keystone EC, Fleischmann RM, Furst DE, Tyson N, Collinson N, Lehane PB.

Ann Rheum Dis. 2013 Sep 1;72(9):1496-502. doi: 10.1136/annrheumdis-2012-201956. Epub 2012 Nov 7.


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.

Kavanaugh A, Fleischmann RM, Emery P, Kupper H, Redden L, Guerette B, Santra S, Smolen JS.

Ann Rheum Dis. 2013 Jan;72(1):64-71. doi: 10.1136/annrheumdis-2011-201247. Epub 2012 May 5.


Safety and efficacy of ocrelizumab in combination with methotrexate in MTX-naive subjects with rheumatoid arthritis: the phase III FILM trial.

Stohl W, Gomez-Reino J, Olech E, Dudler J, Fleischmann RM, Zerbini CA, Ashrafzadeh A, Grzeschik S, Bieraugel R, Green J, Francom S, Dummer W.

Ann Rheum Dis. 2012 Aug;71(8):1289-96. doi: 10.1136/annrheumdis-2011-200706. Epub 2012 Feb 2.


Rapid improvement in the signs and symptoms of rheumatoid arthritis following certolizumab pegol treatment predicts better longterm outcomes: post-hoc analysis of a randomized controlled trial.

Keystone EC, Curtis JR, Fleischmann RM, Furst DE, Khanna D, Smolen JS, Mease PJ, Schiff MH, Coteur G, Davies O, Combe B.

J Rheumatol. 2011 Jun;38(6):990-6. doi: 10.3899/jrheum.100935. Epub 2011 Mar 1.


Safety and efficacy of etanercept beyond 10 years of therapy in North American patients with early and longstanding rheumatoid arthritis.

Weinblatt ME, Bathon JM, Kremer JM, Fleischmann RM, Schiff MH, Martin RW, Baumgartner SW, Park GS, Mancini EL, Genovese MC.

Arthritis Care Res (Hoboken). 2011 Mar;63(3):373-82. doi: 10.1002/acr.20372. Epub 2010 Oct 18.


Progressive multifocal leukoencephalopathy following rituximab treatment in a patient with rheumatoid arthritis.

Fleischmann RM.

Arthritis Rheum. 2009 Nov;60(11):3225-8. doi: 10.1002/art.24906.


Golimumab, a human anti-tumor necrosis factor alpha monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naive patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomized, double-blind, placebo-controlled study of golimumab before methotrexate as first-line therapy for early-onset rheumatoid arthritis.

Emery P, Fleischmann RM, Moreland LW, Hsia EC, Strusberg I, Durez P, Nash P, Amante EJ, Churchill M, Park W, Pons-Estel BA, Doyle MK, Visvanathan S, Xu W, Rahman MU.

Arthritis Rheum. 2009 Aug;60(8):2272-83. doi: 10.1002/art.24638. Erratum in: Arthritis Rheum. 2010 Oct;62(10):3005.


Unresolved issues in identifying and overcoming inadequate response in rheumatoid arthritis: weighing the evidence.

Cohen SB, Cohen MD, Cush JJ, Fleischmann RM, Mease PJ, Schiff MH, Simon LS, Weaver AL.

J Rheumatol Suppl. 2008 Feb;81:4-30; quiz 31-4. Review.


Safety of biologic therapy in rheumatoid arthritis and other autoimmune diseases: focus on rituximab.

Fleischmann RM.

Semin Arthritis Rheum. 2009 Feb;38(4):265-80. doi: 10.1016/j.semarthrit.2008.01.001. Epub 2008 Mar 12. Review.


Efficacy and safety of up to 192 weeks of etanercept therapy in patients with ankylosing spondylitis.

Davis JC Jr, van der Heijde DM, Braun J, Dougados M, Clegg DO, Kivitz AJ, Fleischmann RM, Inman RD, Ni L, Lin SL, Tsuji WH.

Ann Rheum Dis. 2008 Mar;67(3):346-52. Epub 2007 Oct 29.


Comparison of the efficacy of biologic therapy for rheumatoid arthritis: can the clinical trials be accurately compared?

Fleischmann RM.

Rheum Dis Clin North Am. 2006 Dec;32 Suppl 1:21-8. Review. No abstract available.


Pharmacokinetics and safety of golimumab, a fully human anti-TNF-alpha monoclonal antibody, in subjects with rheumatoid arthritis.

Zhou H, Jang H, Fleischmann RM, Bouman-Thio E, Xu Z, Marini JC, Pendley C, Jiao Q, Shankar G, Marciniak SJ, Cohen SB, Rahman MU, Baker D, Mascelli MA, Davis HM, Everitt DE.

J Clin Pharmacol. 2007 Mar;47(3):383-96.


Treatment of early rheumatoid arthritis.

Fleischmann RM, Stern RL, Iqbal I.

Mod Rheumatol. 2005;15(3):153-62.


Safety and efficacy of etanercept treatment in elderly subjects with rheumatoid arthritis.

Bathon JM, Fleischmann RM, Van der Heijde D, Tesser JR, Peloso PM, Chon Y, White B.

J Rheumatol. 2006 Feb;33(2):234-43.


Safety of extended treatment with anakinra in patients with rheumatoid arthritis.

Fleischmann RM, Tesser J, Schiff MH, Schechtman J, Burmester GR, Bennett R, Modafferi D, Zhou L, Bell D, Appleton B.

Ann Rheum Dis. 2006 Aug;65(8):1006-12. Epub 2006 Jan 5.


Methotrexate dosage reduction in patients with rheumatoid arthritis beginning therapy with infliximab: the Infliximab Rheumatoid Arthritis Methotrexate Tapering (iRAMT) trial.

Fleischmann RM, Cohen SB, Moreland LW, Schiff M, Mease PJ, Smith DB, Keenan G, Kremer JM; iRAMT Study Group.

Curr Med Res Opin. 2005 Aug;21(8):1181-90.


Longterm safety, efficacy, and radiographic outcome with etanercept treatment in patients with early rheumatoid arthritis.

Genovese MC, Bathon JM, Fleischmann RM, Moreland LW, Martin RW, Whitmore JB, Tsuji WH, Leff JA.

J Rheumatol. 2005 Jul;32(7):1232-42.


Is there a need for new therapies for rheumatoid arthritis?

Fleischmann RM.

J Rheumatol Suppl. 2005 Feb;73:3-7; discussion 29-30. Review.


Considerations with the use of biological therapy in the treatment of rheumatoid arthritis.

Fleischmann RM, Iqbal I, Stern RL.

Expert Opin Drug Saf. 2004 Sep;3(5):391-403. Review.


Etanercept (Enbrel) in patients with rheumatoid arthritis with recent onset versus established disease: improvement in disability.

Baumgartner SW, Fleischmann RM, Moreland LW, Schiff MH, Markenson J, Whitmore JB.

J Rheumatol. 2004 Aug;31(8):1532-7.


Addressing the safety of anakinra in patients with rheumatoid arthritis.

Fleischmann RM.

Rheumatology (Oxford). 2003 May;42 Suppl 2:ii29-35. Review.


Etanercept added to background methotrexate therapy in patients with rheumatoid arthritis: continued observations.

Kremer JM, Weinblatt ME, Bankhurst AD, Bulpitt KJ, Fleischmann RM, Jackson CG, Atkins KM, Feng A, Burge DJ.

Arthritis Rheum. 2003 Jun;48(6):1493-9.

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