Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement

Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.


Long-Term Efficacy of Tocilizumab (TCZ) in Patients (Pts) with Rheumatoid Arthritis (RA) Treated up to 3.7 Years.

Khraishi3,  Majed, Alten8,  Rieke, Gomez-Reino2,  Juan J., Rizzo1,  Warren, Schechtman6,  Joy, Kahan4,  Andre, Vernon5,  Emma

Advanced Arthritis Care, Scottsdale, AZ
Hospital Clínico U. de Santiago, Santiago, Spain
Memorial University of Newfoundland, St. John's, NL, Canada
Paris Descartes University, Paris, France
Roche, Welwyn, UK
SunValley Arthritis Center, Peoria, AZ
University Clinic for Internal Medicine, Vienna, Austria
University of Berlin, Berlin, Germany

Background:

Efficacy and safety of TCZ have been shown in RA pts in phase 3 trials for up to 2 y. Efficacy data from ongoing extension studies for up to 3.7 y (wk 192) are presented for pts treated with TCZ ± MTX/other DMARDs.

Methods:

This analysis was in 2 populations from long-term extensions (GROWTH95, GROWTH96, open-label phase of LITHE) of phase 3 trials. One population comprised pts who were previous inadequate responders to DMARDs (DMARD-IR: OPTION, TOWARD, LITHE), and the other comprised pts who were never exposed to or who had never failed MTX (AMBITION). Pts received at least 1 dose of TCZ + DMARDs/MTX in the phase 3 or extension trials except pts in AMBITION, who received TCZ monotherapy. Pts from AMBITION with <50% reduction from baseline in tender and swollen joint counts (TJC, SJC) could receive DMARDs/MTX in the extension. Outcomes were assessed every 4 wks in the original studies and, in the extensions, every 8 (LITHE) or 12 (GROWTH95/96) wks from initial TCZ exposure to Aug 28, 2009; data were assigned to the nearest 12-wk point for pooling. Numbers of pts with assessments decreased over time because some pts had not yet reached later assessments or withdrew. Results include pts who had assessments at each visit; no imputation was performed for missing data. Data were included until <10% of the baseline pt number was reached.

Results:

The analysis was in 2904 DMARD-IR pts and 618 pts who were never exposed to or had never failed MTX. By the cutoff date, 27.7% of DMARD-IR pts and 24.6% of never exposed/never failed MTX pts had withdrawn. In DMARD-IR pts, TCZ efficacy was shown by continuously increasing absolute numbers achieving ACR50, LDA (DAS28 <=3.2), and DAS28 remission (DAS28 <=2.6) through wk 96 and ACR70 through wk 120 (Table). In never exposed/never failed MTX pts, efficacy was shown by sustained absolute numbers achieving ACR50/70, LDA, and DAS28 remission to wk 96 (Table). While proportions who achieved ACR50/70, LDA, and DAS28 remission were maintained to wks 168 and 192, data must be interpreted with caution due to lower absolute numbers reaching these visits in the extensions (Table). By wk 144, 20% (396/1980) of assessed DMARD-IR pts and 27% (105/390) of assessed never exposed/never failed MTX pts had achieved the major clinical response of ACR70 maintained for 24 consecutive wks. At wk 120, 52.3% (1118/2139) and 38.4% (821/2139) of assessed DMARD-IR pts and 59.5% (278/467) and 38.3% (179/467) of assessed never exposed/never failed MTX pts, respectively, had <=1 SJC and <=1 TJC; 38.4% (772/2008) of DMARD-IR pts and 48.4% (216/446) of never exposed/never failed MTX pts had HAQ-DI scores <=0.5.

Table.

Week024487296120144168192
DMARD-IR [n=2904], % (n/n)
ACR50N/A35 (929/2693)45 (1088/2439)50 (1162/2312)53 (1183/2227)56 (1154/2047)56 (1028/1825)61 (802/1323)66 (469/716)
ACR70N/A16 (423/2693)24 (581/2439)30 (692/2312)31 (698/2227)35 (714/2047)35 (638/1825)43 (562/1323)45 (325/716)
LDA2 (50/2889)43 (1137/2658)54 (1302/2396)62 (1403/2261)65 (1409/2158)68 (1352/1978)69 (1208/1755)70 (887/1268)73 (500/689)
DAS28 remission1 (22/2889)27 (722/2658)40 (962/2396)47 (1066/2261)50 (1083/2158)54 (1061/1978)54 (951/1755)57 (718/1268)61 (420/689)
Never exposed to or never failed MTX [n=618], % (n/n)
ACR50N/A40 (223/563)49 (256/521)53 (256/487)54 (257/477)58 (256/442)60 (208/348)62 (110/178)N/A
ACR70N/A22 (126/563)32 (164/521)31 (152/487)35 (169/477)38 (169/442)43 (151/348)45 (80/178)N/A
LDA5 (32/616)50 (277/556)62 (312/502)67 (314/471)67 (310/461)71 (298/421)73 (239/329)71 (120/170)N/A
DAS28 remission3 (20/616)37 (204/556)48 (243/502)52 (243/471)51 (236/461)55 (232/421)56 (184/329)57 (97/170)N/A
Baseline (wk 0) was first active TCZ dose. For pts randomly assigned to TCZ in initial studies, this was at core study baseline. For pts assigned to placebo, first active dose of TCZ was at initiation of rescue or at first dose received in the open-label or exclusion studies. Data points with <10% of original sample size are not presented. n/n = pts with response/evaluable pts. For TJC and SJC. LOCF was used for any missing individual joint; total joint count used data available at that time point No imputation for missing HAQ-DI score. CRP, ESR, or VAS assessment. CRP was used to calculate ACR response If missing, ESR was used. LDA=DAS28<=3.2; DAS28 remission=DAS28<2.6.

Conclusions:

Efficacy during long-term TCZ treatment was demonstrated by increasing numbers and/or proportions of pts achieving ACR50/70, LDA, and DAS28 remission until at least wk 96; for pts who reached wk 192, these benefits were maintained. These data support TCZ as an effective, long-term treatment for RA pts.

To cite this abstract, please use the following information:
Khraishi, Majed, Alten, Rieke, Gomez-Reino, Juan J., Rizzo, Warren, Schechtman, Joy, Kahan, Andre, et al; Long-Term Efficacy of Tocilizumab (TCZ) in Patients (Pts) with Rheumatoid Arthritis (RA) Treated up to 3.7 Years. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :1820
DOI: 10.1002/art.29585

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