1262 - A Profile of Rheumatoid Arthritis Patients Treated with Tocilizumab in a United States Registry Population

Monday, November 7, 2011: 9:00 AM-6:00 PM
Hall F2 - Poster Hall (McCormick Place West)
Dimitrios A. Pappas1, Alan Rathbun2, George Reed3, Joel M. Kremer4, Isidro Villanueva5, Jenny Devenport6, Sarika Ogale6, Ani John6 and Jeffrey D. Greenberg7, 1Columbia University, College of Physicians & Surge, New York, NY, 2UMASS Medical School, Worcester, MA, 3UMass Medical School, Worcester, MA, 4Albany Medical College and The Center for Rheumatology, Albany, NY, 5Viregen Macarena Hospital, Sevilla, Spain, 6Genentech, South San Francisco, CA, 7New York University School of Medicine, New York, NY
Presentation Number: 1262

Background/Purpose: Tocilizumab (TCZ), a humanized anti-IL-6 receptor monoclonal antibody has demonstrated safety and efficacy in the treatment of RA across numerous randomized clinical trials (RCTs). The purpose of this abstract is to describe characteristics of patients initiating TCZ in usual care settings using the US CORRONA registry and to assess treatment response.

Methods: The CORRONA registry is a network of more than 100 private and academic rheumatology practices across the U.S., with data on approximately 27,000 RA patients. Descriptive analysis of baseline characteristics was summarized for all patients initiating TCZ. Response to TCZ treatment (change from baseline to 6 months) was summarized for the subset of patients who had data available at baseline and continued treatment for 6 months. 

Results: In the CORRONA registry from August 23 2009 to May 2010, out of 2583 biologic initiations, 197 (7.6%) were treated with TCZ. Patients were predominately female, median age was 58 yrs (IQR 49-65), with median disease duration of 11 yrs (IQR 7-18) and baseline CDAI of 20.0 (IQR 12.1, 32.2).  Some commonly reported baseline comorbidities were Cardiovascular Disease 13 (6.6%), Hypertension 61 (31.0%), Diabetes 13 (6.6%), Liver Disorder 15 (8.7%), Peptic Ulcer disease 24 (12.2%), Cancer 21 (10.7%), and hospitalized infection in last 12 months 1 (0.5%). 77% of the patients starting TCZ had discontinued their previous therapy for efficacy reasons and 8.8% for safety reasons. Almost all TCZ patients reported prior biologic use; 62 (31.5%) had 1 previous TNF exposure, 60 (30.5%) had 2 previous TNF exposure, 66 (33.5%) had ≥ 3 previous TNF exposure and 6 (3.0%) reported no previous biologic exposure.

At Baseline, most patients (62.4%) were initiated on TCZ at 4 mg, 35% of them were treated as monotherapy. In the subset of patients with available data for change from baseline up to 6 months of TCZ treatment (77 patients) ; median CDAI scores improved from 20.3 (IQR: 13, 32) at BL to 14.5 (IQR: 9.5, 27) [Table 1]; Swollen Joint Count (28) improved from 6 (IQR: 2, 10) to 4 (IQR: 1, 10) and Tender Joint Count (28) from 6 (IQR: 3, 10) to  3.5  (IQR: 1, 10).

Conclusions: During the analysis period of 9 month, TCZ comprised 7.6% of all biologic initiations in the CORRONA registry.  TCZ was mostly used in patients with long standing disease duration, with moderate to severe disease and for patients who had failed to respond to one or more prior TNF treatment. The majority of TCZ initiators were on combination therapy; with most on 4 mg/kg dose and for a one-third of these patients TCZ was used as monotherapy. In this real-world setting, patients treated with TCZ for 6 months showed a decrease in RA disease activity.

 

Table 1: Response to Tocilizumab Treatment from Baseline to 6 month follow-up (N=77)

 

Baseline

6 month Follow Up

CDAI Disease Activity

Median (IQR)  20.3(13, 32)

Median (IQR)   4.5 (9.5, 27)

Remission

n = 2        2.6%

n = 8       10.4 %

Low

n = 11       14.3 %

n = 15       19.5 %

Moderate

n = 28       36.4 %

n = 28       36.4 %

Severe

n = 36       46.2 %

n = 26       33.8 %

 


Keywords: rheumatoid arthritis, treatment and tocilizumab

Disclosure: D. A. Pappas, None; A. Rathbun, None; G. Reed, Corrona, 5, Corrona, 9 ; J. M. Kremer, Roche Pharmaceuticals, 2, Roche Pharmaceuticals, 5 ; I. Villanueva, Genentech, Inc., 3 ; J. Devenport, Genentech, Inc., 3 ; S. Ogale, Genentech, Inc., 3 ; A. John, Genentech, Inc., 3 ; J. D. Greenberg, Corrona, 1, AstraZeneca Novartis, Pfizer, Corrona, 5 .