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FOR ADULTS WITH MODERATELY TO SEVERELY ACTIVE RA, IN COMBINATION WITH MTX
SIMPONI ARIA® IS THE FIRST ANTI-TNFα BIOLOGIC WITH FACIT-F IN THE LABEL1-6
ACR20 response at Week 14 (primary endpoint): 59% of patients receiving SIMPONI ARIA® + MTX achieved ACR20 response vs 25% of patients receiving placebo + MTX (P<0.001)7,8
FACIT-F measures a patient's level of fatigue and tiredness over the last 7 days through a questionnaire consisting of 13 questions.7
Treatment with SIMPONI ARIA® resulted in improvement in fatigue as measured by FACIT-F 1,7
The FACIT-F endpoint was not adjusted for multiplicity. Therefore, statistical significance has not been established.
Patients with a ≥4-point improvement in fatigue as measured by FACIT-F 7,8
The FACIT-F endpoint was not adjusted for multiplicity. Therefore, statistical significance has not been established.
The threshold for clinically meaningful improvement when assessing fatigue using FACIT-F in clinical trials was based on literature in RA that supports a change of ≥4-point improvement.
*The randomized ITT population was used for these analyses.
†The same patients may not have responded at each time point.
‡Although not developed for patients with RA, FACIT-Fatigue has been used to assess fatigue in rheumatology, and its properties have been evaluated for the RA population.
§In rheumatology, a change of ≥4 points is considered meaningful and has been used as response definition in the RA population.
||After Week 24, all sponsor personnel were unblinded to subject-level data, which may have affected results. Additionally, 9 patients were inadvertently unblinded prior to Week 24, which may also have affected results.
ACR20=20% improvement in American College of Rheumatology criteria; FACIT-F=Functional Assessment of Chronic Illness Therapy–fatigue; ITT=intention-to-treat; MTX=methotrexate; RA=rheumatoid arthritis; RF=rheumatoid factor; TNF=tumor necrosis factor; TNFα=tumor necrosis factor alpha.
References: 1. SIMPONI ARIA® (golimumab) [Prescribing Information]. Horsham, PA: Johnson & Johnson. 2. SIMPONI® (golimumab) [Prescribing Information]. Horsham, PA: Johnson & Johnson. 3. REMICADE® (infliximab) [Prescribing Information]. Horsham, PA: Johnson & Johnson. 4. Enbrel® (etanercept) [Prescribing Information]. Thousand Oaks, CA: Immunex Corporation. 5. Humira® (adalimumab) [Prescribing Information]. North Chicago, IL: AbbVie Inc. 6. Cimzia® (certolizumab pegol) [Prescribing Information]. Smyrna, GA: UCB, Inc. 7. Data on file. Johnson & Johnson. 8. Bingham CO III, Mendelsohn AM, Kim L, et al. Maintenance of clinical and radiographic benefit with intravenous golimumab therapy in patients with active rheumatoid arthritis despite methotrexate therapy: week-112 efficacy and safety results of the open-label long-term extension of a phase III, double-blind, randomized, placebo-controlled trial. Arthritis Care Res (Hoboken). 2015;67(12):1627-1636.