Use of a risk characterisation approach to contextualise the safety profile of new rheumatoid arthritis treatments: a case study using tofacitinib

Clinical Rheumatology

Volumn 36, Issue 3, 2017, Pages 683-688

  Curtis, Jeffrey R ^a   Zhang, Richard ^b   Krishnaswami, Sriram ^b   Anisfeld, Andrew ^b   Chen, Yan ^b   Strengholt, Sander ^b   Chen, Connie ^b   Geier, Jamie ^b  

^a UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^b PFIZER INC   (United States)

Author keywords

Exposure; Rheumatoid arthritis; Safety; Tofacitinib; Tumour necrosis factor inhibitors

Indexed keywords

TOFACITINIB; ANTIRHEUMATIC AGENT; PIPERIDINE DERIVATIVE; PYRIMIDINE DERIVATIVE; PYRROLE DERIVATIVE;

ARTICLE; CARDIOVASCULAR DISEASE; DIGESTIVE SYSTEM PERFORATION; DRUG EXPOSURE; DRUG MECHANISM; DRUG SAFETY; DRUG SCREENING; FOLLOW UP; HUMAN; LYMPHOMA; MAJOR CLINICAL STUDY; OPPORTUNISTIC INFECTION; OUTCOME ASSESSMENT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RHEUMATOID ARTHRITIS; TREATMENT DURATION; ARTHRITIS, RHEUMATOID; NEOPLASMS; OPPORTUNISTIC INFECTIONS; RISK ASSESSMENT;

ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; HUMANS; NEOPLASMS; OPPORTUNISTIC INFECTIONS; PIPERIDINES; PYRIMIDINES; PYRROLES; RISK ASSESSMENT;

EID: 84980034336     PISSN: 07703198     EISSN: 14349949     Source Type: Journal    
DOI: 10.1007/s10067-016-3359-x     Document Type: Article

References (23)

1. Curtis JR, Perez-Gutthann S, Suissa S, Napalkov P, Singh N, Thompson L, Porter-Brown B (2015) Tocilizumab in rheumatoid arthritis: a case study of safety evaluations of a large postmarketing data set from multiple data sources. Semin Arthritis Rheum 44:381–388
2. Ruderman EM (2012) Overview of safety of non-biologic and biologic DMARDs. Rheumatology (Oxford) 51(Suppl 6):vi37–vi43
3. Burmester GR, Blanco R, Charles-Schoeman C, Wollenhaupt J, Zerbini C, Benda B, Gruben D, Wallenstein G, Krishnaswami S, Zwillich SH, Koncz T, Soma K, Bradley J, Mebus C, ORAL Step investigators (2013) Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial. Lancet 381:451–460
4. Fleischmann R, Kremer J, Cush J, Schulze-Koops H, Connell CA, Bradley JD, Gruben D, Wallenstein GV, Zwillich SH, Kanik KS, Solo Investigators ORAL (2012) Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med 367:495–507
5. Kremer J, Li ZG, Hall S, Fleischmann R, Genovese M, Martin-Mola E, Isaacs JD, Gruben D, Wallenstein G, Krishnaswami S, Zwillich SH, Koncz T, Riese R, Bradley J (2013) Tofacitinib in combination with nonbiologic disease-modifying antirheumatic drugs in patients with active rheumatoid arthritis: a randomized trial. Ann Intern Med 159:253–261
6. Lee EB, Fleischmann R, Hall S, Wilkinson B, Bradley J, Gruben D, Koncz T, Krishnaswami S, Wallenstein G, Zang C, Zwillich S, van Vollenhoven R, on behalf of the ORAL Start investigators (2014) Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med 370:2377–2386
7. van der Heijde D, Tanaka Y, Fleischmann R, Keystone E, Kremer J, Zerbini C, Cardiel MH, Cohen S, Nash P, Song YW, Tegzová D, Wyman BT, Gruben D, Benda B, Wallenstein G, Krishnaswami S, Zwillich SH, Bradley JD, Connell CA, ORAL Scan Investigators (2013) Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: twelve-month data from a twenty-four-month phase III randomized radiographic study. Arthritis Rheum 65:559–570
8. van Vollenhoven RF, Fleischmann R, Cohen S, Lee EB, García Meijide JA, Wagner S, Forejtova S, Zwillich SH, Gruben D, Koncz T, Wallenstein GV, Krishnaswami S, Bradley JD, Wilkinson B, Standard Investigators ORAL (2012) Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med 367:508–519
9. Wollenhaupt J, Silverfield J, Lee EB, Curtis JR, Wood SP, Soma K, Nduaka CI, Benda B, Gruben D, Nakamura H, Komuro Y, Zwillich SH, Wang L, Riese RJ (2014) Safety and efficacy of tofacitinib, an oral Janus kinase Inhibitor, for the treatment of rheumatoid arthritis in open-label, longterm extension studies. J Rheumatol 41:837–852
10. Wollenhaupt J, Silverfield J, Lee EB, Terry K, Kwok K, Lazariciu I, Nduaka C, Connell CA, DeMasi R, Wang L (2015) Tofacitinib, an oral Janus kinase inhibitor, in the treatment of rheumatoid arthritis: safety and clinical and radiographic efficacy in open-label, long-term extension studies over 7 years. Arthritis Rheumatol 67(Suppl 10):Abstract 1645
11. Food and Drug Administration (2015) BLA 125276/S049 Medical review(s). pp 1–75. http://www.accessdata.fda.gov/drugsatfda_docs/bla/2012/125276Orig1s049MedR.pdf
12. Strand V, Ahadieh S, French J, Geier J, Krishnaswami K, Menon S, Checchio T, Tensfeldt T, Hoffman E, Riese R, Boy M, Gómez-Reino J (2015) Systematic review and meta-analysis of serious infections with tofacitinib and biologic disease-modifying antirheumatic drug treatment in rheumatoid arthritis clinical trials. Arthritis Res Ther 17:362
13. Mariette X, Matucci-Cerinic M, Pavelka K, Taylor P, van Vollenhoven R, Heatley R, Walsh C, Lawson R, Reynolds A, Emery P (2011) Malignancies associated with tumour necrosis factor inhibitors in registries and prospective observational studies: a systematic review and meta-analysis. Ann Rheum Dis 70:1895–1904
14. Keystone EC, van der Heijde D, Kavanaugh A, Kupper H, Liu S, Guérette B, Mozaffarian N (2013) Clinical, functional, and radiographic benefits of longterm adalimumab plus methotrexate: final 10-year data in longstanding rheumatoid arthritis. J Rheumatol 40:1487–1497
15. Winthrop KL (2012) Infections and biologic therapy in rheumatoid arthritis: our changing understanding of risk and prevention. Rheum Dis Clin North Am 38:727–745
16. Gout T, Ostor AJ, Nisar MK (2011) Lower gastrointestinal perforation in rheumatoid arthritis patients treated with conventional DMARDs or tocilizumab: a systematic literature review. Clin Rheumatol 30:1471–1474
17. van Vollenhoven RF, Ronald F, Keystone E, Edward C, Furie R, Blesch A, Wang C, Curtis JR (2009) Gastrointestinal safety in patients with rheumatoid arthritis treated with tocilizumab: data from Roche clinical trials. Arthritis Rheum 60(Suppl 10):Abstract 1613
18. Strangfeld A, Richter A, Herzer P, Rockwitz K, Demary W, Aringer M, Zink A, Listing J (2015) Risk for lower intestinal perforations in RA patients treated with tocilizumab in comparison to treatment with TNF inhibitors, rituximab, abatacept or conventional synthetic DMARDs. Arthritis Rheum 67(Suppl 10):Abstract 2051
19. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (1994) The extent of population exposure to assess clinical safety for drugs intended for long-term treatment of non-life-threatening conditions: E1. pp. 1–3 http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E1/Step4/E1_Guideline.pdf
20. Charles-Schoeman C, Gonzalez-Gay MA, Kaplan I, Boy M, Geier J, Luo Z, Zuckerman A, Riese R (2016) Effects of tofacitinib and other DMARDs on lipid profiles in rheumatoid arthritis: implications for the rheumatologist. Semin Arthritis Rheum. doi:10.1016/j.semarthrit.2016.03.004
21. Isaacs JD, Zuckerman A, Krishnaswami S, Nduaka C, Lan S, Hutmacher MM, Boy MG, Kowalski K, Menon S, Riese R (2014) Changes in serum creatinine in patients with active rheumatoid arthritis treated with tofacitinib: results from clinical trials. Arthritis Res Ther 16:R158
22. Nyberg F, Askling J, Berglind N, Franzen S, Ho M, Holmqvist M, Horne L, Lampl K, Michaud K, Pappas DA, Reed G, Symmons D, Tanaka E, Tran TN, Verstappen SM, Wesby-van SE, Yamanaka H, Greenberg JD (2015) Using epidemiological registry data to provide background rates as context for adverse events in a rheumatoid arthritis drug development program: a coordinated approach. Pharmacoepidemiol Drug Saf 24:1121–1132
23. Verstappen SM, Askling J, Berglind N, Franzen S, Frisell T, Garwood C, Greenberg JD, Holmqvist M, Horne L, Lampl K, Michaud K, Nyberg F, Pappas DA, Reed G, Symmons DP, Tanaka E, Tran TN, Yamanaka H, Ho M (2015) Methodological challenges when comparing demographic and clinical characteristics of international observational registries. Arthritis Care Res (Hoboken) 67:1637–1645