Golimumab is effective and safe for the treatment of patients with Psoriatic Arthritis (PsA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) irrespective of any pretreatment with biologic agents.

The efficacy and tolerability of the TNF inhibitor (TNFi) golimumab (GLM) has been established in the randomized clinical trials (RCT) and their 5-year open-label extension studies. However, these trials were limited to patients with RA, PsA and AS who did not receive any prior treatment with a biologic agent before GLM.

Reduction in signs and symptoms of RA has been reported with subcutaneous GLM in patients with inadequate response to at least one TNFi in a recent placebo-controlled RCT GO-AFTER study. Extension study of this trial has also demonstrated the efficacy and safety of GLM treatment for about 5 years in some patients.

According to the EULAR guidelines, the RA patient who has an inadequate response with one TNFi therapy should receive an agent with a different mode of action or another TNFi. The updated EULAR guidelines also recommend switching to another anti-IL-17 or TNFi, if axial spondyloarthritis patients failed to achieve treatment response with TNFi therapy. Similarly, EULAR guidelines for the management of PsA recommends the use of another TNFi or biologic DMARD in patients with inadequate response to a biologic DMARD. Similar recommendations were provided by the US guidelines for PsA and AS.

GO-NICE study was chosen for the real-world analysis of GLM. The safety and efficacy of GLM 50 mg SC has been confirmed in patients with RA, PsA, and AS in this 2-year study. Significant improvements in clinical response, disease activity, functional capacity, patient-reported quality of life and fatigue were reported in patients with RA, PsA, and AS at 3 months and throughout the 24-month observation period. These findings were in agreement with previous clinical studies.

Rationale behind research

Real-life data on the consecutive administration of one TNFi after another and comparison of biologic-naïve and experienced patients is limited. Also, the data on the efficacy of golimumab from biologic experienced patients is scarce. Therefore, this study was conducted.

Objective

The present study was conducted to determine the efficacy and safety of GLM as a first, second, or at third-line in patients with RA, PsA, and AS in a real-world experience.

Study outcomes

The study outcomes included the evaluation of:

• Disease severity in RA patients using the Disease Activity Score-28 for Rheumatoid Arthritis with ESR (DAS28-ESR)
• Clinical response in PsA patients using Psoriatic Arthritis Response Criteria (PsARC)
• Drug efficacy in SA patients using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Outcomes

Baseline: There were no significant differences reported at baseline

Study outcomes

• There was a significant reduction in the DAS28 score in all groups from baseline to 24 months of treatment. Clinical remission was achieved after 3 months of treatment. (Fig.2)
• The clinical response rates as evaluated by PsARC was achieved in 76.4%, 51.0%, and 50.0% of the patients at 24 months in the first, second, and third-line use of GLM respectively
• A significant reduction in mean BASDAI scores was found in SA patients in all treatment groups after 24 months of treatment

Fig. 2: Disease activity (DAS28) in RA patients during treatment with golimumab as the first-, second-, or at least third-line biologic agent

The findings of the present study demonstrated the effectiveness of GLM therapy in patients with RA, PsA, and AS, GLM with notable improvements in DAS28, PsARC, and BASDAI scores. The treatment outcomes were better in biologic-naïve patients, especially in PsA patients as compared to those administered with GLM as a second-line and third-line therapy. These findings were in line with various observational and retrospective studies that evaluated the efficacy of second-line GLM therapy in various indications.

A retrospective study showed a high 3-year long-term survival rate of GLM in patients with various inflammatory arthritis with lower rates of treatment discontinuation and adverse events.  The survival rate of GLM was found to be 68% and 62%  at 2 and 3 years respectively in 328 patients with RA, PsA, and AS. No significant differences were found in survival on the drug between biologic-experienced and biologic-naïve patients, and between GLM monotherapy-treated and non-biologic-cotreated patients.

Another LORHEN multicentric registry study showed enhanced efficacy of second-line GLM over time, with an added advantage over etanercept and adalimumab. The 2-year retention rate was significantly lower for adalimumab (31.2%) and etanercept (39.8%) compared to GLM (53.4%) in RA patients who had an inadequate treatment with TNFi.

Real-life data recommended switching to a second TNFi in RA patients with inadequate response to first-line TNFi treatment, especially when the both second TNFi and synthetic DMARDs are used in combination.

A retrospective study of 845 patients reported a high persistence with second-line GLM compared to adalimumab, etanercept and certolizumab pegol in patients with immune-mediated rheumatic diseases. A recent systematic review of 12 real-world studies also showed a better or equal persistence of  GLM than its comparators in the treatment of immune-mediated rheumatic diseases. Overall persistence of GLM at 24 months was 50% with a reduced persistence in AS patients (43%) compared to PsA and RA patients.

The long term follow of 24 months is informative in context with the duration of the effect on work outcomes and other parameters. Mean regression should be considered as a cause of improvement due to the absence of a control group in this study because patients may initiate treatment with biologics after a flare of the disease. Great caution should be exercised while extrapolating these results to countries other than Germany due to existing heterogeneity between treatment patterns, health care systems, societal effects and legislation among countries.