Clinical Outcomes of Golimumab As Second Line TNF Inhibitor Treatment in Patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS) – Subanalysis of a Non-Interventional Study in Germany

Klaus Krüger¹, Gerd R. Burmester², Siegfried Wassenberg³, Astrid Thiele⁴ and Matthias H. Thomas⁵, ¹Medical Centre of Rheumatology, Munich, Germany, ²Rheumatology and Clinical Immunology, Charité-University Medicine Berlin, Berlin, Germany, ³Rheumazentrum Ratingen, Ratingen, Germany, ⁴Krankenhaus St. Josef Wuppertal, Wuppertal, Germany, ⁵Medical Affairs, MSD Sharp & Dohme GmbH, Bünde, Germany

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: Ankylosing spondylitis (AS), Biologics, observation, psoriatic arthritis and rheumatoid arthritis (RA)

Session Information

Date: Sunday, October 21, 2018

Title: Rheumatoid Arthritis – Treatments Poster I: Strategy and Epidemiology

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: Golimumab (GLM) has demonstrated efficacy and safety in patients (pts.) with active RA after treatment with at least one TNFi in a RCT. However, data on effectiveness and patient-reported outcomes (PROs) under daily clinical practice conditions are required.
The aim is to assess the effectiveness of GLM as second line bDMARD therapy in patients with established RA, PsA or AS who had received TNFi pretreatment.

Methods: Subanalysis of the non-interv., prospective, 24-month (24 mo) study GO-NICE in pts. with established RA, PsA or AS starting with GLM 50mg SC once monthly as second line TNFi after one previous TNFi in a real life setting in Germany (158 sites). Disease activity was assessed with DAS28, PsARC and BASDAI. PROs included QoL (EQ-5D-3L), functionality (FFbH), and fatigue (FACIT-F).

Results: 358 pts. were eligible. They had previously received ADA (177), CZP (3), ETA (119), or IFX (59). 147 pts. (41.1%) completed the study until month 24.

RA pts. (n=98): Mean age 55.6 yrs., 73 (74.5%) patients were female, 67 (68.4%) were rheumatoid factor (RF) positive, and 71 (74.0%) had anti ccp-antibodies at BL. DAS28 score at BL dropped significantly from 5.0 to 4.2 after 3 months (m3) to 2.8 points (m24) (p<0.0001 vs. BL), (in bDMARD-naïve patients: 5.0, 3.6 to 2.9). After 3m of treatment, 47.4% of pts. had LDA or were in remission (DAS28 ≤3.2), after 24 mo 62.5%.

PsA pts. (n=134): Mean age 50.8 yrs., 68 (50.7%) were males, 120 pts. (89.6%) had extra-articular manifestations at BL. The proportion of pts. achieving a response (PsARC) was 51.3% at m3, and 52.1% at m24, respectively, (bDMARD-naïve: 64,0%, and 77,7%).

AS-pts. (n=126): Mean age 45.2 yrs., 79 (62.7%) were males, 101 (80.2%) were HLAB27+, 44 pts. (35.5%) had extra articular manifestations at BL. The BASDAI dropped significantly from 4.9 at BL to 3.1 (m3) to 2.9 within 24 months (p<0.0001 vs. BL), (bDMARD-naïve: 5.0, 2.5 to 2.0).

An improvement of quality of life (QoL) was seen after 6 months and was maintained over 24 months: The pts.’ health status (EQ VAS) improved significantly (p<0.001 vs. BL) from 48.4 to 64.4 (RA), from 47.8 to 62.9 (PsA) and from 45.5 to 60.8 (AS). The functional ability (FFbH) improved significantly (p<0.05 vs. BL) from 63.4 to 73.5 points (RA), and from 67.4 to 76.2 (AS), changes at m24 vs. BL in pts. with PsA were n.s. The mean fatigue score (FACIT–F) increased significantly (p<0.003 vs. BL) from 30.8 to 38.2 points (RA), and from 28.8 to 34.4 points (AS), changes at m24 vs. BL in pts. with PsA were n.s. No new safety signals were detected.

Difference BL to m24

[STD] p

RA: DAS28

AS: BASDAI

(2^nd line, after one TNFi)

-2.23 ±0.30
[-2.82,-1.64] <.0001

-2.02 ±0.32
[-2.65,-1.39] <.0001

(bDMARD-naïve)

-2.10 ±0.15
[-2.39,-1.81] <.0001

-2.89 ±0.20
[-3.29,-2.49] <.0001

Conclusion: GLM 50 mg SC once monthly as second-line TNFi in pts. with RA, PsA or AS who had previously received pretreatment with another TNFi was also effective and showed remarkable improvements in clinical parameters, patient-reported quality of life, functionality, and fatigue parameters within 3 (and 6) months. These effects were maintained over 24 mo. Overall results were consistent with those in patient who received GLM as first TNFi.

Disclosure: K. Krüger, MSD Sharp Dohme GmbH, 9,AbbVie Inc., 9,BMS, 9,Celgene Corporation, 9,Janssen, 9,Lilly, 9,Pfizer, Inc., 9,Sanofi-Aventis, 9,UCB, Inc., 9; G. R. Burmester, AbbVie, BMS, Lilly, MSD, Pfizer, Roche, 5; S. Wassenberg, AbbVie, Chugai, Janssen Biologics, MSD, Novartis, Pfizer, Roche, and UCB, 5; A. Thiele, MSD Sharp Dohme GmbH, 9,Biogen, 9,Celgene Corporation, 9,Chugai, 9,Hexal, 9,Janssen, 9,Lilly, 9,Novartis, 9,Pfizer, Inc., 9,UCB, Inc., 9; M. H. Thomas, MSD Sharp & Dohme GmbH Germany, 3.

To cite this abstract in AMA style:

Krüger K, Burmester GR, Wassenberg S, Thiele A, Thomas MH. Clinical Outcomes of Golimumab As Second Line TNF Inhibitor Treatment in Patients with Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA) or Ankylosing Spondylitis (AS) – Subanalysis of a Non-Interventional Study in Germany [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/clinical-outcomes-of-golimumab-as-second-line-tnf-inhibitor-treatment-in-patients-with-rheumatoid-arthritis-ra-psoriatic-arthritis-psa-or-ankylosing-spondylitis-as-subanalysis-of-a-no/. Accessed .

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