|Ahead of print publication
Apremilast generic for the treatment of active psoriatic arthritis: A single-center real-life experience from India
Sanjiv Amin1, Aneesa Kapadia1, Dhiraj Dhoot2, Hanmant Barkate2
1 Consultant at Private Clinic, Mumbai, Maharashtra, India
2 Department of Medical, Medical Services, Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, India
BD Sawant Marg, Chakala, Andheri (E), Mumbai, Maharashtra
Source of Support: None, Conflict of Interest: None
Introduction: Apremilast has been recently introduced in the treatment of adult psoriatic arthritis (PsA) patients in India. Its efficacy and safety have been established in the landmark clinical trials; however, there is still a dearth of its real-world experience in the management of PsA in India.
Materials and Methods: A retrospective cohort analysis of electronic medical records was conducted at our clinic, to study the effectiveness and tolerability of apremilast 30 mg twice a day in the management of PsA. A total of 86 patients were included in this report. Patients were classified as responders and nonresponders based on the overall physician judgment of clinical status, especially improvement of symptoms as per the disease activity in PsA (DAPSA) criteria.
Results: Of the 86 patients started on apremilast, 44 patients had at least 16 weeks of follow-up assessment. Of these 44 patients, 39 were of peripheral arthritis and five were of axial spondyloarthritis. Twenty-five of 39 (64%) patients were classified as responders and 14 (36%) as nonresponders based on the DAPSA criteria. On analyzing the DAPSA scores at baseline and subsequent follow-up, there was statistically significant improvement in mean DAPSA score. Remission was seen in three patients (7.7%) and low disease activity in 16 (41%) patients at 16 weeks. Only six patients developed one or more side effects. The most common side effects were gastrointestinal symptoms.
Conclusion: These results, from a real-world setting in India, confirm the effectiveness and tolerability of apremilast in PsA as seen in clinical trials.
Keywords: Apremilast, India, psoriatic ,arthritis, real world
|How to cite this URL:|
Amin S, Kapadia A, Dhoot D, Barkate H. Apremilast generic for the treatment of active psoriatic arthritis: A single-center real-life experience from India. Indian J Rheumatol [Epub ahead of print] [cited 2020 Apr 3]. Available from: http://www.indianjrheumatol.com/preprintarticle.asp?id=276550
| Introduction|| |
Apremilast, a small molecule and a competitive inhibitor of phosphodiesterase 4, has been recently introduced in the treatment of adult psoriatic arthritis (PsA) patients in India. Its efficacy and safety have been established in the landmark clinical trials; however, there is still a dearth of its real-world experience in the management of PsA.
| Materials and Methods|| |
After obtaining ethical approval, we did a retrospective cohort analysis of electronic medical records at our clinic, to study the effectiveness and tolerability of apremilast 30 mg twice a day in the management of PsA. We longitudinally collected data about patients who have been prescribed apremilast for PsA.
According to the patients' electronic clinical records, assessments were done at baseline and 16 weeks, using disease activity in PsA (DAPSA) scoring system and psoriasis area and severity index (PASI) responses. The data of those patients with peripheral arthritis, psoriasis-related axial spondyloarthritis, and skin psoriasis, who completed 16 weeks of treatment, were analyzed.
Patients were classified as responders and nonresponders based on the overall physician judgment of clinical status, especially improvement of symptoms as per the DAPSA criteria. We defined clinical response as percentage of patients achieving low (DAPSA ≤4) or minimal disease activity (DAPSA 5–14). For axial spondyloarthritis, ankylosing spondylitis disease activity score (ASDASC) C-reactive protein (CRP) was considered. Response was defined based on the follow-up assessment at 16 weeks as compared with the baseline evaluation.
Binomial variables were expressed as number and percentage and continuous variables as median (range) or mean (standard deviation [SD]) as appropriate. Paired t-test was used for comparisons between baseline and follow-up measurements. Significant differences between responders and nonresponders were defined as those at a level of P < 0.05 by unpaired t-test.
| Results|| |
A total of 86 patients were included in this report. Majority of the patients had prior exposure to optimal doses of disease-modifying anti-rheumatic drugs (DMARDs) and biologicals. Clinical characteristics are depicted in [Table 1]. Of the 86 patients started on apremilast, 44 patients had at least 16 weeks of follow-up assessment. Of these 44 patients, 39 were of peripheral arthritis and five were of axial spondyloarthritis. Remaining 42 patients either lost to follow-up (n = 32) or discontinued due to side effects (n = 10).
|Table 1: Baseline characteristics of psoriatic arthritis patients (n=86)|
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In case of psoriasis with peripheral arthritis, 25 of 39 (64%) patients were classified as responders and 14 (36%) as nonresponders based on the DAPSA criteria. On analyzing the DAPSA scores at baseline and subsequent follow-up (n = 39), there was statistically significant improvement (P < 0.01) in mean DAPSA score. Remission, i.e., DAPSA score ≤ 4, was seen in 3 patients (7.7%) and low disease activity, i.e., DAPSA score 5–14, was seen in 16 (41%) patients at 16 weeks. There was a statistically significant improvement in tender joint count (P = 0.02), but marginal difference was seen in swollen joint count (0.055).
On analyzing PASI responses, PASI ≥50 was seen in 13 patients. Of note, 6/13 patients achieved PASI 90 and above. However, there was a statistically nonsignificant improvement in ASDASC CRP (P = 0.37) for axial spondyloarthritis among five patients. All results are summarized in [Table 2].
|Table 2: Results of patients who have completed 16 weeks of treatment (n=44)|
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Striking feature in the present analysis was that shorter duration of disease was seen in responders as compared to nonresponders, which was statistically significant (9.57 [SD 6.75] vs. 13.8 [6.89] years; P = 0.04). Furthermore, responders were previously exposed to less amount of DMARDs and less duration of DMARDs (both conventional and synthetic) and biologics as compared to nonresponders. No other significant differences were found between the two groups (responders vs. nonresponders).
In our cohort analysis, only six patients developed one or more side effects who continued treatment for at least 16 weeks. The most common side effects were gastrointestinal symptoms, including gastritis (4/44) and diarrhea (3/44). One patient experienced headache.
| Conclusion|| |
To the best of our knowledge, the present study is the first real-world experience with use of apremilast in the management of PsA in India. The efficacy and favorable safety profile of apremilast generic in psoriasis and PsA is already established in randomized clinical trials published to date. On collating data of three phase 3 randomized controlled trials, 20% improvement in American College of Rheumatology (ACR) response was seen in 32.1%–41% of the patients, who were prescribed with apremilast 30 mg twice a day for PsA.,, These findings are corroborated in a recently published real-world experience of apremilast in PsA, by Abignano et al., who reported good efficacy in 60% of the patients. The only major shortcoming of the present study was small sample size being a single center.
Despite these limitations, it is noteworthy to point out that clinical response of apremilast was enhanced in patients with shorter duration of disease. This directs us to suggest that apremilast generic can be better placed in early part of the management algorithm of PsA. Needless to say, that this needs to be confirmed after larger clinical trials.
Our data are the first evidence of real-world experience of apremilast use in the management of active PsA in India, which positively depicts its short-term efficacy, and point to the assumption that its efficacy might be enhanced in the early stage of PsA. These findings enable us to view apremilast as valuable addition to armamentarium of drugs for the management of PsA. Larger observational cohort studies with health economic evaluations will help confirm the placing of apremilast in the treatment algorithm for PsA.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2]