REMICADE®
CLINICAL INFORMATION

For adults with moderately to severely active rheumatoid arthritis

REMICADE®
CLINICAL INFORMATION

For adults with moderately to severely active rheumatoid arthritis

REMICADE® is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate (MTX)1

CLINICAL DATA

Improvement in JOINT symptoms as early as week 2
ATTRACT

ATTRACT (primary endpoint)

At Week 30, more patients receiving REMICADE® 3 mg/kg IV q8 weeks + MTX (n=86) or REMICADE® (combined)* + MTX (n=340) achieved ACR20 response vs patients receiving placebo + MTX (n=88), 50% and 52%, respectively, vs 20% (P0.001 and P<0.001, respectively).5

ACR20 RESPONSE RATES AT WEEK 2 IN MODERATELY TO SEVERELY ACTIVE RA1,5

clinic_chart_ra_n1

*Combined group includes patients receiving REMICADE® 3 mg/kg IV q8 weeks + MTX, patients receiving REMICADE® 3 mg/kg IV q4 weeks + MTX, patients receiving REMICADE® 10 mg/kg IV q8 weeks + MTX, and patients receiving REMICADE® 10 mg/kg IV q4 weeks + MTX.1,5


JOINT SYMPTOMS RESPONSE AT MULTIPLE TIMEPOINTS

ACR20 RESPONSE RATES AT WEEK 30
(PRIMARY ENDPOINT)1,5

clinic_chart_ra_nb1

ACR20 RESPONSE RATES AT WEEK 541,5

clinic_chart_ra_nb1_b

†Combined group includes patients receiving REMICADE® 3 mg/kg IV q8 weeks + MTX, patients receiving REMICADE® 3 mg/kg IV q4 weeks + MTX, patients receiving REMICADE® 10 mg/kg IV q8 weeks + MTX, and patients receiving REMICADE® 10 mg/kg IV q4 weeks + MTX.1,5


INHIBITION OF THE PROGRESSION of structural damage

Greater inhibition of the progression of structural damage was seen at Week 54 and maintained through Week 102 in patients with moderately to severely active RA receiving REMICADE® + MTX vs placebo + MTX.1,5,6

INHIBITION OF PROGRESSION OF STRUCTURAL DAMAGE AT 2 YEARS IN MTX-REFRACTORY ESTABLISHED RA1,5,6

clinic_chart_ra_nc1

*vdH-S=van der Heijde Modified Sharp score. The total modified vdH-S score (0-440) is a composite score of structural damage measuring the number and size of joint erosions and the degree of joint space narrowing in the hands and feet.

‡Combined group includes patients receiving REMICADE® 3 mg/kg IV q8 weeks + MTX, patients receiving REMICADE® 3 mg/kg IV q4 weeks + MTX, patients receiving REMICADE® 10 mg/kg IV q8 weeks + MTX, and patients receiving REMICADE® 10 mg/kg IV q4 weeks + MTX.1


IMPROVEMENT IN PHYSICAL FUNCTION

Median PERCENT improvement in HAQ-DI score1,5*

clinic_chart_ra_nd1

*Health Assessment Questionnaire, measurement of 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities (0=best, 3=worst).5

†Any patient who discontinued study follow-up, had 2 or more consecutive visits with missing data, started to receive a prohibited medication, or had surgery for RA, had the last observation prior to that event carried forward for this analysis.

Combined group includes patients receiving REMICADE® 3 mg/kg IV q8 weeks + MTX, patients receiving REMICADE® 3 mg/kg IV q4 weeks + MTX, patients receiving REMICADE® 10 mg/kg IV q8 weeks + MTX, and patients receiving REMICADE® 10 mg/kg IV q4 weeks + MTX.


References: 1. REMICADE® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. FDA approves Inflectra, a biosimilar to Remicade [news release]. Silver Spring, MD: US Food and Drug Administration; April 5, 2016. https://www.fda.gov/news-events/press-announcements/fda-approves-inflectra-biosimilar-remicade. Accessed August 2, 2019. 3. Biologics License Application approval for Renflexis [approval letter]. Silver Spring, MD; US Food and Drug Administration; April 21, 2017. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761054Orig1s000ltr.pdf. Accessed August 2, 2019. 4. Biologics License Application (BLA) clinical review for Renflexis. Silver Spring, MD; US Food and Drug Administration; March 21, 2016. 5. Data on file. Janssen Biotech, Inc. 6. Maini RN, Breedveld FC, Kalden JR, et al; for the Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. Sustained improvement over two years in physical function, structural damage, and signs and symptoms among patients with rheumatoid arthritis treated with infliximab and methotrexate. Arthritis Rheum. 2004;50(4):1051-1065.



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