Background/Purpose:

Golimumab (GLM) has demonstrated efficacy and safety in several randomized clinical trials with biologic-naïve patients (pts.).

However, more data regarding the effectiveness and patient-reported outcomes (PROs) parameters in daily clinical practice in Germany are required and helpful.
The aim of this subanalysis is to assess Golimumab on the effectiveness and PROs in biologic-naïve pts. with established RA, PsA or AS.

Methods:

Subanalysis of the non-interventional, prospective, 24-month study GO-NICE with biologic-naïve pts. with established RA, PsA or AS starting with GLM 50mg SC once monthly in a real life setting in Germany. Endpoint measures: disease activity DAS28, PsARC and BASDAI. PROs included QoL (EQ-5D-3L), functionality (FFbH), and fatigue (FACIT-F). Safety data were also collected.

Results:

RA-pts. (n=265): Mean age 54.5 yr, 82.1% of the pts. were female, 77.3% (n=204) were rheumatoid factor (RF) positive, and 76.4% (n=201) had anti ccp-antibodies at BL. The DAS28 score at BL was 5.0 and dropped significantly to 2.9 within 24 months (p<0.0001 v. BL). After 3 months of treatment, 45.2% of pts. had LDA (DAS28 ≤3.2). The amount of pts. increased to 50.8% after 6 month and 64.9% after 24 months.
PsA-pts. (n=247): Mean age 49.7 yr, 53.8% of the pts. were female, 42.1% (n=104) had a nail involvement, 25.5% (n=63) dactylitis and 13.8% (n=34) enthesitis at BL. The proportion of pts. achieving a response (mod PsARC) was 64%, 72.2% and 77.7% at 3,6 and 24 months, respectively.
AS-pts. (n=246): Mean age 41.9 yr, 70.7% of the pts. were male, 80.5% (n=198) were HLAB27 positiv. Most common extra-articular manifestations were: enthesitis (12.6%), iritis (12.2%), IBD (3.7%), and dactylitis (2.8%) at BL.
The BASDAI at BL was 5.0 and dropped significantly to 2.0 within 24 months (p<0.0001 vs. BL). The proportion of pts. achieving a response (BASDAI 50) was 62.2%, 66.9% and 76.9% at 3, 6 and 24 months, respectively. An improvement of quality of life (QoL) by EQ-5D-3L was seen after 6 months and was maintained over 24 months. The pts.’ health state today (EQ VAS) improved from 52.3 at BL to 64.9 (RA), from 49.0 to 66.3 (PsA) and from 49.2 to 70.6 (AS). The functional ability (FFbH) improved significantly (p<0.0001 vs. BL) from 73.1 to 80.4 points (RA), from 73.0 to 82.2 (PsA), and from 72.8 to 81.2 (AS). The mean Fatigue score (FACIT-F) increased from BL to visit 9 (month 24) 33.3 to 39.5 points (RA), from 31.6 to 38.4 points (PsA), and from 31.6 to 40.2 points (AS) (each p<0.001 vs BL).
No new safety signals were detected.

Conclusion:

Across the three rheumatic diseases (RA, PsA, AS) in biologic-naive pts. GLM SC once monthly showed remarkable improvements in clinical effectiveness, patient-reported quality of life, functionality, and fatigue parameters within 3 months.
These effects were maintained over 24 months: 64.9% of RA-pts. achieved LDA status, 77.7% of PsA-pts. a positive PsARC response and 76.9% of AS-pts. BASDAI 50. No new safety signals were detected.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/golimumab-in-biologic-naive-patients-with-rheumatoid-arthritis-ra-psoriatic-arthritis-psa-or-ankylosing-spondylitis-as-subanalysis-from-a-non-interventional-evaluation-in-germany/