Golimumab as the First-, Second-, or at Least Third-Line Biologic Agent in Patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis: Post Hoc Analysis of a Noninterventional Study in Germany

Klaus Krüger, Gerd Rüdiger Burmester, Siegfried Wassenberg, Matthias H Thomas, Klaus Krüger, Gerd Rüdiger Burmester, Siegfried Wassenberg, Matthias H Thomas

Abstract

Introduction: While golimumab (GLM) has demonstrated efficacy in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS) in several randomized clinical trials with biologic-naïve patients, observational data from biologic-experienced patients are sparse. We aimed to assess the effectiveness of GLM used as the first-, second-, or at least third-line biologic agent in RA, PsA, and AS patients in a real-world setting.

Methods: Post hoc analysis of the noninterventional, prospective, 24-month GO-NICE study of RA, PsA, and AS patients who initiated GLM 50 mg subcutaneously once monthly in a real-world setting in Germany.

Results: In 1454 patients with RA, PsA, or AS, GLM was administered as the first-line (n = 305, 286, 292, respectively), second-line (n = 104, 136, 130, respectively), or at least third-line (n = 64, 79, 58, respectively) biologic agent. In RA patients (n = 473), the time since first diagnosis was 9.7, 10.1, and 14.3 years, respectively. The DAS28 score at BL was 5.0, 4.9, and 5.1 in patients using GLM as a first-, second-, and third-line biologic agent, respectively, and dropped significantly in all groups. After 3 months of treatment, 27.5%, 19.5%, and 14.5% of patients were in remission; the corresponding values after 24 months were 45.3%, 50.0%, and 33.3%, respectively. In PsA patients (n = 501), time since fist diagnosis was 12.4, 13.7, and 13.8 years, respectively. Based on PsARC, a response was achieved at 24 months in the first-, second-, and third-line use of GLM in 76.4%, 51.0%, and 50.0% of the patients. In AS patients (n = 480), the time since first diagnosis was 9.4, 9.8, and 12.4 years in patients using GLM as the first-, second-, and at least third-line biologic agent, respectively. After 24 months of treatment, the mean BASDAI scores decreased significantly (p < 0.001 vs. BL) to 2.1, 2.9, and 2.9 in the patients using GLM as the first-, second-, and at least third-line treatment, respectively.

Conclusions: Golimumab is an effective treatment in patients with RA, PsA, and AS, irrespective of any pretreatment with biologic agents.

Study registration: ClinicalTrials.gov NCT01313858.

Keywords: Ankylosing spondylitis; First-line/second-line/third-line treatment; Golimumab; Noninterventional study; Psoriatic arthritis; Real-world evidence; Rheumatoid arthritis.

Figures

Fig. 1
Fig. 1
Patient disposition
Fig. 2
Fig. 2
Disease activity (DAS28) in RA patients during treatment with golimumab as the first-, second-, or at least third-line biologic agent. BL, baseline; DAS28, Disease Activity Score, 28 joints; RA, rheumatoid arthritis. In patients with RA the 28-joint Disease Activity Score (DAS28) based on erythrocyte sedimentation rate was used to categorise disease activity
Fig. 3
Fig. 3
Percentages of RA patients with high disease activity (DAS28) or in remission during treatment with golimumab as the first-, second-, or at least third-line biologic agent. HDA: DAS28>5.1, remission: DAS28

Fig. 4

Percentages of PsA patients who…

Fig. 4

Percentages of PsA patients who responded (according to PsARC) to golimumab used as…

Fig. 4
Percentages of PsA patients who responded (according to PsARC) to golimumab used as a first-, second-, or at least third-line biologic agent. PsARC, Psoriatic Arthritis Response Criteria in Patients with PsA, the Psoriatic Arthritis Response Criteria (PsARC) index was used to assess joint and skin involvement

Fig. 5

Disease activity (BASDAI) in AS…

Fig. 5

Disease activity (BASDAI) in AS patients who used golimumab as first-, second-, or…

Fig. 5
Disease activity (BASDAI) in AS patients who used golimumab as first-, second-, or at least third-line biologic agent. AS, ankylosing spondylitis; BASDAI, Bath Ankylosing Spondylitis Disease Index; BL, baseline in patients with AS, the 10-point Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was used to categorise disease activity
Fig. 4
Fig. 4
Percentages of PsA patients who responded (according to PsARC) to golimumab used as a first-, second-, or at least third-line biologic agent. PsARC, Psoriatic Arthritis Response Criteria in Patients with PsA, the Psoriatic Arthritis Response Criteria (PsARC) index was used to assess joint and skin involvement
Fig. 5
Fig. 5
Disease activity (BASDAI) in AS patients who used golimumab as first-, second-, or at least third-line biologic agent. AS, ankylosing spondylitis; BASDAI, Bath Ankylosing Spondylitis Disease Index; BL, baseline in patients with AS, the 10-point Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was used to categorise disease activity

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