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The efficacy evaluation of golimumab is crucial for patients with psoriatic arthritis, particularly for treating skin manifestations and psoriasis symptoms.
Golimumab (GLM) was shown to be a safe and effective long-term treatment for patients with psoriatic arthritis, according to a study published in Springer.1 Factors such as gender, smoking habits, BMI, comorbidities, and lines of treatment did not significantly impact results.
“Treatment recommendations underline the relevance of the burden of skin psoriasis (PsO) in patients affected by PsA and skin manifestations need to be a relevant part of the decision-making process for PsA therapeutic approach,” investigators explained. “However, the effectiveness evaluation of GLM in a real-life setting is a crucial issue, in particular for skin manifestation.”
In this retrospective, observational study, data from patients with moderate-to-severe psoriatic arthritis being treated with GLM between August 2011 and December 2020 were collected and compared at baseline and 6 (T6), 12 (T12), 24 (T24), 36, (T36), and 48 (T48) months. The primary endpoints were to determine the safety of a 4-year follow-up of patients treated with GLM, as well as the efficacy on both joint and skin manifestations in this patient population. Eligible patients were aged > 18 years, had a clinical diagnosis of PsA, concomitant and PsO according to the Psoriasis Area Severity Index (PASI), peripheral arthritis in at least 1 active joint, and were receiving GLM treatment. Previous use of biologic disease-modifying antirheumatic drugs (bDMARDs), concurrent conventional synthetic DMARDs (csDMARDs), non-steroidal anti-inflammatory drugs (NSAIDs), and corticosteroid therapy were recorded at both baseline and follow-ups.
Safety was determined by analyzing the number of adverse events and retention rate was estimated at each follow-up. Patients were evaluated using the Bath Ankylosing Spondylitis disease activity index (BASDAI), a Disease Activity in Psoriatic Arthritis (DAPSA) score, and a Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) score. The presence of dactylitis, enthesitis, and a tender and swollen joint count were collected. PASI was assessed by a dermatologist.
Of 105 patients with moderate-to-severe PsA, 80% exhibited psoriasis (PsO), 78% had enthesitis, 63,8% had peripheral arthritis, and 35.5% presented axial arthritis at baseline. The most common comorbidities were cardiovascular disease (33.14%) and metabolic syndrome (MetS) (19%). A total of 31.4% of patients were smokers, 37.1% were overweight, and 19% were classified as obese.
ASDAS-CRP and BASDAI (p < 0.0001) levels were reduced at each of the follow-up visits. Dactylitis was reduced from 8.6% at T6 to 0% at T48. Enthesitis decreased from 49.5% at T6 to 1.9% at T48. PASI (p < 0.01) significantly improved throughout the study.
Decreased CRP levels were seen at all subsequent follow-ups (T6, T12, T24 [p < 0.0001]; T36 [p = 0.0009]; and T48 [p = 0.0007]). GH and pain were reduced, (p < 0.0001), and disability improved (T6 [p < 0.0001], T12 [p < 0.0001], T24 [p < 0.0001], T36 [p = 0.0005], and T48 [p = 0.0002]). DAPSA ( p < 0.0001) was seen in 62.1% at T6, 63.6% at T12, 55.4% at T24, 61.5% at T36, and 61.5% at T48. Further, remission was achieved in 12.6% at T6, 20,8% at T12, 26.2% at T24, 36.8% at T36, and 36.8% at T48.
Interestingly, thyroid disease lowered the likelihood of treatment persistence (p = 0.030), although there was no correlation between MetS and therapy persistence (p = 0.238). There was no significant difference between patients who had taken other biologicals and those who were biological naïve (p = 0.208).
The retention rate was 82.8% at 6 months, 73.4% at 12 months, 62% at 24 months, and 54.4% at 38 months. Gender, BMI, smoking status, and comorbidities did not impact results. Reasons for discontinuation were primary inefficacy (n = 13), secondary inefficacy (n = 21), lost at follow-up (n = 5), mild infection (n = 5), and surgery unrelated to GLM (n = 1).
Limitations included the retrospective nature of the study, low cutaneous disease activity at baseline, the lack of imaging in follow-up visits, and the small sample size.
“Treatment efficacy was supported by a good drug persistence of GLM regardless of the presence of comorbidities and patients’ characteristics,” investigators concluded. “Our results were consistent with no differences in terms of clinical response and efficacy between males and females, smokers and no-smokers, obese and normal-weight patients, and lines of treatment, confirming GLM efficacy and safety in a long-term real-life setting.”
Chimenti MS, Conigliaro P, Caso F, et al. Long-term effectiveness and drug survival of golimumab in patients affected by psoriatic arthritis with cutaneous involvement [published online ahead of print, 2021 Aug 19]. Clin Rheumatol. 2021;10.1007/s10067-021-05874-6. doi:10.1007/s10067-021-05874-6