axSpA patients stayed longest on TNF inhibitor golimumab: Study

Researchers collected real-world medical data on 552 patients

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by Steve Bryson PhD |

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Adults with axial spondyloarthritis (axSpA) remained on golimumab longer than any other TNF inhibitor, according to a real-world analysis of medical records.

Although adalimumab (marketed as Humira and biosimilars) was the most commonly prescribed first- and second-line TNF inhibitor, patients stayed with golimumab (marketed as Simponi and Simponi Aria) as a first-line therapy significantly longer.

Male sex, absence of peripheral disease affecting the outer parts of the body, less disease severity at the start of treatment, and early line of prescription were associated with longer TNF inhibitor retention, according to “Retention rate of subcutaneous TNF inhibitors in axial spondyloarthritis in a multicentre study from the RIC-FRANCE network,” which was published in Scientific Reports.

TNF inhibitors are a class of injectable medications designed to suppress the activity of TNF, a pro-inflammatory immune signaling protein found at elevated levels in the joints of people with various forms of arthritis.

Several of these medications, referred to as biological disease-modifying antirheumatic drugs (bDMARDs), are approved to treat axSpA, a form of arthritis that affects the joints of the pelvis, spine, and chest. Ankylosing spondylitis (AS) is a subtype of axSpA marked by inflammation of the sacroiliac joints, where the pelvis meets the base of the spine.

Approved TNF inhibitors administered as an injection under the skin, include golimumab, adalimumab, etanercept (sold as Enbrel and biosimilars), and Cimzia (certolizumab pegol). Switching to another therapy is often recommended if one of these medications doesn’t reduce inflammation sufficiently and provide benefits.

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A man in coveralls weighs two different treatments, one in each hand.

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TNF inhibitors in real-world settings

Here, scientists in France investigated the retention of subcutaneous TNF inhibitors in real-world settings, meaning how long patients remained on a treatment before switching. Data were collected from the medical records of 552 axSpA patients (54.5% men) who received subcutaneous TNF inhibitor treatment. Among those screened, 73.4% were positive for HLA-B27, a well-established genetic risk factor for AS.

“Data from real-world studies can provide information for rheumatologists that is precious on account of its being closer to clinical practice,” the researchers wrote.

Of the 824 prescriptions filled, adalimumab was the most commonly prescribed first- and second-line treatment, while golimumab was the most common third-line therapy.

Overall, golimumab had the longest median retention time at 59 months, or about five years, followed by adalimumab at 34 months, almost three years. Etanercept was retained for 22 months, nearly two years, and Cimzia was retained for 18 months. Golimumab had a significantly longer retention time than the other three therapies. All other comparisons were not significant.

First-, second-, and third-line therapies

As a first-line therapy, golimumab has a significantly higher retention rate than adalimumab and etanercept. Etanercept had a significantly lower rate than adalimumab and Cimzia. Similar findings were observed after one and two years of treatment.

Adalimumab had the longest median retention length as a second-line therapy at 57 months, or almost five years, then 44 months for etanercept (more than 3.5 years), 26 months for golimumab, and 13 months for Cimzia. There were no differences in retention rates among second-line treatments overall and after one and two years.

As a third-line therapy, the retention rate for etanercept and golimumab was significantly higher than Cimzia, at one and two years. After a year, golimumab’s retention rate was higher than adalimumab’s.

Median retention lengths for first-line treatments were significantly longer (48 months) than second- (23 months) and third-line treatments (29 months). Also, retention rates were significantly higher for men than women (54 vs. 25 months) and for patients with HLA-B27 versus those without (36 vs. 22 months).

Of the 824 medications prescribed, 385 were interrupted, mostly due to primary ineffectiveness (35.3%), defined as a lack of response in the first six months. Other reasons included secondary ineffectiveness (31.7%), that is, if a lack of response occurred after six months of initial response, then side effects (21.6%), and others (8.6%).

Factors that predicted treatment interruption included female sex, disease severity at the beginning, as assessed by the Bath Ankylosing Spondylitis Disease Activity Index, the line of treatment, and the disease affecting the outer parts of the body (peripheral). Treatment with golimumab using adalimumab as a comparison, was also a significant predictive factor for retention.

No predictive factors were identified for stopping golimumab, while being female predicted stopping adalimumab and worse disease severity at the start of treatment predicted stopping etanercept. Early treatment with Cimzia also predicted treatment interruption.

Female sex and peripheral disease predicted stopping first-line therapy, but no factors were identified that predicted second- or third-line treatment interruptions.

“Tailoring and prioritizing bDMARD prescription in axSpA could lead to improved patient management,” the researchers said.