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FOR ADULTS WITH ACTIVE PsA
FIRST
SIMPONI ARIA® IS THE FIRST ANTI-TNFα BIOLOGIC WITH FACIT-F IN THE LABEL1-6
ACR20 response at Week 14 (primary endpoint): 75% of patients receiving SIMPONI ARIA® +/- MTX achieved ACR20 response vs 22% of patients receiving placebo +/- MTX (P<0.001)1,7,8
FACIT-F measures a patient’s level of fatigue and tiredness over the last 7 days
through a questionnaire consisting of 13 questions.8
FACIT-F measures a patient’s level of fatigue and tiredness over the last 7 days
through a questionnaire consisting of 13 questions.8
Treatment with SIMPONI ARIA® resulted in improvement in fatigue as measured by FACIT-F1
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 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 PsA that supports a change of ≥4 points.
* Change from baseline in FACIT-F score is based on observed values.
† In rheumatology, a change of 4 points in FACIT-F score was considered meaningful and has been used as response definition in the PsA population.
‡ The same patients may not have responded at each time point.
§ Although not developed for PsA, FACIT-F has been used to assess fatigue in rheumatology, and its properties have been evaluated for the PsA population.
|| Improvement from baseline in FACIT-F score is based on observed values.
¶ After Week 24, selected sponsor personnel were unblinded to subject-level data which may have affected results.
ACR20=20% improvement in American College of Rheumatology criteria; FACIT-F=Functional Assessment of Chronic Illness Therapy–fatigue; MTX=methotrexate; PsA=psoriatic arthritis; TNFα=tumor necrosis factor alpha.
# “Efficient” is defined as the total amount of time required to administer SIMPONI ARIA®. For adult patients with RA, PsA, or AS, 2 mg/kg is administered once every 8 weeks, after starter doses at Weeks 0 and 4. For adult patients with moderately to severely active RA, SIMPONI ARIA® is given in combination with MTX.
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. Kavanaugh A, Husni ME, Harrison DD, et al. Safety and efficacy of intravenous golimumab in patients with active psoriatic arthritis: results through week twenty-four of the GO-VIBRANT study. Arthritis Rheumatol. 2017;69(11):2151-2161. doi: 10.1002/art.40226. 8. Data on file. Johnson & Johnson.