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Clinical Trial
. 2007 Apr;66(4):498-505.
doi: 10.1136/ard.2006.058339. Epub 2006 Nov 17.

Infliximab maintains a high degree of clinical response in patients with active psoriatic arthritis through 1 year of treatment: results from the IMPACT 2 trial

A Kavanaugh  1 , G G Krueger, A Beutler, C Guzzo, B Zhou, L T Dooley, P J Mease, D D Gladman, K de Vlam, P P Geusens, C Birbara, D G Halter, C Antoni; IMPACT 2 Study Group
Affiliations
Clinical Trial

Infliximab maintains a high degree of clinical response in patients with active psoriatic arthritis through 1 year of treatment: results from the IMPACT 2 trial

A Kavanaugh et al. Ann Rheum Dis. 2007 Apr.

Abstract

Objective: To evaluate the efficacy and safety of infliximab through 1 year in patients with psoriatic arthritis (PsA) enrolled in the IMPACT 2 trial.

Methods: In this double blind, placebo controlled, phase III study, 200 patients with active PsA were randomised to receive infusions of infliximab 5 mg/kg or placebo at weeks 0, 2, 6, and every 8 weeks thereafter through 1 year. Patients with persistent disease activity could enter early escape at week 16, and all remaining placebo patients crossed over to infliximab at week 24. Patients randomised to infliximab who had no response or who lost response could escalate their dose to 10 mg/kg starting at week 38. Clinical efficacy was assessed based on the proportion of patients achieving ACR 20 and PASI 75 responses. Major clinical response (that is, maintenance of ACR 70 response for 24 continuous weeks) was assessed for the first time in PsA.

Results: Through 1 year of treatment, 58.9% and 61.4% of patients in the randomised infliximab and placebo/infliximab groups, respectively, achieved ACR 20; corresponding figures for PASI 75 were 50.0% and 60.3%. At week 54, major clinical response was achieved by 12.1% of patients in the infliximab group. The safety profile of infliximab through week 54 was consistent with that seen through week 24. Two malignancies occurred: basal cell skin cancer (placebo) and stage I Hodgkin's lymphoma (infliximab).

Conclusion: Infliximab maintains a high degree of clinical efficacy and continues to be well tolerated in patients with PsA through 1 year of treatment.

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Conflict of interest statement

Competing interests: A Kavanaugh and DG Halter have received funds for research from Centocor, Inc and its competitors. GG Krueger and C Birbara have received speaking and consulting fees from Centocor, Inc and its competitors. PJ Mease has received research grants and consulting and speaking fees from Centocor, Inc and its competitors. DD Gladman has received consulting fees and research support from Centocor, Inc and Schering Canada. K de Vlam has received consulting fees and reimbursement for attending symposia from Schering‐Plough Corp PP Geusens has no competing interests to declare. C Antoni, who was affiliated with the Friedrich Alexander University of Erlangen‐Nurnberg, Erlangen, Germany, at the time the study was conducted, is now a full time employee of Schering‐Plough Corp, Kenilworth, New Jersey; he has received reimbursement for symposia and funds for research, consulting, speaking, and organising education from Centocor, Inc and its competitors. A Beutler, C Guzzo, B Zhou, and LT Dooley are employees of, and hold stock in, Centocor, Inc, Malvern, Pennsylvania, USA.

References

    1. Shbeeb M, Uramoto K M, Gibson L E, O'Fallon W M, Gabriel S E. The epidemiology of psoriatic arthritis in Olmsted County, Minnesota, USA, 1982–1991. J Rheumatol 2000271247–1250. - PubMed
    1. Leonard D G, O'Duffy J D, Rogers R S., III Prospective analysis of psoriatic arthritis in patients hospitalized for psoriasis. Mayo Clin Proc 197853511–518. - PubMed
    1. Gelfand J M, Gladman D D, Mease P J, Smith N, Margolis D J, Nijsten T.et al Epidemiology of psoriatic arthritis in the population of the United States. J Am Acad Dermatol 200553573–577. - PubMed
    1. Gladman D D, Antoni C, Mease P, Clegg D O, Nash P. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis 200564(suppl II)ii14–ii17. - PMC - PubMed
    1. Gladman D D, Shuckett R, Russell M L, Thorne J C, Schachter R K. Psoriatic arthritis (PSA)—an analysis of 220 patients. QJM 198762127–141. - PubMed

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