The results from an analysis of patients from 12 rheumatology centers treated with secukinumab for psoriatic arthritis were in line with earlier pivotal trials, the researchers said.
A recent study of patients in Italy with psoriatic arthritis (PsA) treated with secukinumab paints a strong picture of the biologic, finding that over 24 months, effectiveness and safety as well as drug retention rate performed well in a real-life setting.
In addition, the study examined differences between patients who were biologic-naïve patients and those who had failed other biologics. Overall, the results were in line with what was seen in pivotal late-stage randomized clinical trials.
In Italy, secukinumab, which blocks interleukin (IL)-17A, is approved for use as a subcutaneous injection for the treatment of moderate-to-severe psoriasis, PsA and ankylosing spondylitis (AS).
The prospective study was carried out at 12 rheumatology centers in patients with moderate to severe disease who were treated with secukinumab between September 2016 to March 2020.
Concomitant use of conventional synthetic disease-modifying anti-rheumatic drugs (methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, and ciclosporin) was allowed if the dosage had been stable over the previous 3-month period; patients were allowed to reduce or end those medications but were not allowed to increase them. NSAIDs and low-dose corticosteroids were also allowed but intra-articular corticosteroid injections were not.
Researchers collected information on comorbidities, concomitant therapies, previous biologics, use of csDMARDs, corticosteroid therapy, or NSAIDs at baseline and throughout the study. Disease activity, functional, clinimetric scores, and biochemical values were recorded at baseline, 6, 12, and 24 months.
The study enrolled 608 patients (41.28% male) with a mean age of 52.78 (11.33). Secukinumab was prescribed as first-line biological therapy in 227 (37.34%) patients and as a second (or more) biological treatment in 381 (62.66%) patients.
The patients were subdivided into 2 groups: those naïve to any biologic drug (group A) and patients who had failed anti-tumor necrosis factor therapies (aTNF) or anti-IL12/23 therapies (group B). Patients self-injected secukinumab at a dosage of 150 or 300 mg at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter.
Researchers used descriptive statistics to determine effectiveness and multivariate Cox and logistic regression models for drug discontinuation and minimal disease activity (MDA) at 6 months.
More than 75% of patients were able to achieve MDA at 6 months, and most stayed on treatment after 24 months. At 6, 12, and 24 months, secukinumab reduced all the clinical and inflammatory indexes as well as patient-reported outcomes.
Of the entire group of 608 patients, 68.75% had active psoriasis at baseline; by 24 months just 15.12% had signs of active psoriasis, with a significantly reduction in the Psoriasis Area Severity Index (PASI) (P <.01). The improvement was more pronounced in the biologic-naïve group than the group receiving it as a second or later therapy (0.23 vs 1.14, respectively).
At 24 months, group A showed lower PASI (P =.04); erythrocyte sedimentation rate (P = .03); C-reactive protein (P = .05); and joint count (P = .03) compared with group B.
In addition, the Ankylosing Spondylitis Disease Activity Score decreased from 3.26 (0.88) to 1.60 (0.69) at 24 months, (P = .02) and theDisease Activity Index for Psoriatic Arthritis (DAPSA) fell from 25.29 (11.14) to 7.69 (4.51) at 24 months, (P <.01).
At 24 months, MDA was reached in 75.71% of group A and 70.37% of group B; male sex was a predictor of achieving MDA by month 6 as well as with drug persistence. But a higher baseline DAPSA and the use of csDMARDs were negatively linked with achieving MDA by 6 months.
Treatment was discontinued in 123 (20.23%) patients, mainly due to primary/secondary loss of effectiveness; 22 patients discontinued due to adverse events. Higher body mass index was associated with drug discontinuation.
The drug retention rate was similar in both groups and was 71% at month 24 in the entire cohort, with some difference depending on the dosage (P = .004) and gender (P =.05).
Variants of psoriasis, including nail, scalp and palmoplantar pustolosis, could also be treated with the biologic.
One study limitation was the lack of imaging follow-up, the researchers said, although they noted that imaging was often used to confirm the diagnosis at baseline.
Overall, they noted, providers might consider secukinumab for both first and later treatment lines, as well as in patients who are unsuitable for csDMARDs or glucocorticoids.
Ramonda R, Lorenzin M, Carriero A, et al. Effectiveness and safety of secukinumab in 608 patients with psoriatic arthritis in real life: A 24-month prospective, multicentre study. RMD Open. 2021 Feb;7(1):e001519. doi: 10.1136/rmdopen-2020-001519.