In the Journals

Apremilast effective among biological-naive patients with PsA

Among patients with psoriatic arthritis who are biological-naive, apremilast monotherapy improved a variety of disease symptoms, including swollen, tender joints and morning stiffness, with no new safety concerns, according to findings from a phase 3b study published in the Annals of the Rheumatic Diseases.

“The efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, were demonstrated in patients with active PsA in four phase 3, placebo-controlled studies as part of the Psoriatic Arthritis Long-term Assessment of Clinical Efficacy (PALACE) clinical trial program,” Peter Nash, MD, of the University of Queensland, in Brisbane, Australia, and colleagues wrote. “The PALACE 1, 2 and 3 studies evaluated apremilast in patients with prior exposure to [conventional synthetic disease-modifying antirheumatic drugs] and/or biologicals and allowed concomitant [conventional synthetic disease-modifying antirheumatic drug] use.”

According to the researchers, the Assessing Apremilast Monotherapy in a Clinical Trial of BIologic-NaiVE Patients with Psoriatic Arthritis (ACTIVE) study sought to determine the effect and efficacy of apremilast (Otezla, Celgene) monotherapy, beginning at week 2, among patients with PsA who were biological-naive and may have had one prior conventional synthetic disease-modifying antirheumatic drug. In the ACTIVE phase 3b study, the researchers reported apremilast’s early and overall efficacy and safety through week 52.

Researchers included 219 participants aged 18 years and older who had a diagnosis of PsA for at least 3 months, of whom 110 were randomly selected to receive apremilast, while the remaining patients received placebo. The primary outcome was significantly greater response, as determined by the ACR20, at week 16. Those with swollen or tender joints that failed to improve by at least 10% at week 16 were given the opportunity to leave the study. By week 24, and throughout week 52, all participants were receiving apremilast.

According to the researchers, 38.2% of patients who received apremilast experienced a significantly greater ACR20 response at week 16, compared with 20.2% in the placebo group (P = .004). The response rate at week 2 among the apremilast group was 16.4%, compared with 6.4% in those who received a placebo (P =.025). At week 16, apremilast significantly reduced PsA disease activity vs. placebo, with changes in Disease Activity Score, as measured using C-reactive protein, (P < .0001), as well as the Health Assessment Questionnaire-Disability Index (P = .023) and the Gladman Enthesitis Index (P = .001), the researchers wrote. The treatment maintained these improvements through week 52.

In addition, apremilast’s safety throughout the 52 weeks was consistent with prior phase 3 studies in psoriasis and PsA.

“ACTIVE was the first randomized controlled study to assess the onset of response to apremilast monotherapy in biological-naive patients with active PsA,” Nash and colleagues wrote. “... These results support the use of apremilast monotherapy in biological-naive patients with PsA.” – by Jason Laday

Disclosure: The researchers report funding from the Celgene Corporation. Nash reports grant and research funding from the Celgene Foundation. See the full study for additional authors’ disclosures.

Among patients with psoriatic arthritis who are biological-naive, apremilast monotherapy improved a variety of disease symptoms, including swollen, tender joints and morning stiffness, with no new safety concerns, according to findings from a phase 3b study published in the Annals of the Rheumatic Diseases.

“The efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, were demonstrated in patients with active PsA in four phase 3, placebo-controlled studies as part of the Psoriatic Arthritis Long-term Assessment of Clinical Efficacy (PALACE) clinical trial program,” Peter Nash, MD, of the University of Queensland, in Brisbane, Australia, and colleagues wrote. “The PALACE 1, 2 and 3 studies evaluated apremilast in patients with prior exposure to [conventional synthetic disease-modifying antirheumatic drugs] and/or biologicals and allowed concomitant [conventional synthetic disease-modifying antirheumatic drug] use.”

According to the researchers, the Assessing Apremilast Monotherapy in a Clinical Trial of BIologic-NaiVE Patients with Psoriatic Arthritis (ACTIVE) study sought to determine the effect and efficacy of apremilast (Otezla, Celgene) monotherapy, beginning at week 2, among patients with PsA who were biological-naive and may have had one prior conventional synthetic disease-modifying antirheumatic drug. In the ACTIVE phase 3b study, the researchers reported apremilast’s early and overall efficacy and safety through week 52.

Researchers included 219 participants aged 18 years and older who had a diagnosis of PsA for at least 3 months, of whom 110 were randomly selected to receive apremilast, while the remaining patients received placebo. The primary outcome was significantly greater response, as determined by the ACR20, at week 16. Those with swollen or tender joints that failed to improve by at least 10% at week 16 were given the opportunity to leave the study. By week 24, and throughout week 52, all participants were receiving apremilast.

According to the researchers, 38.2% of patients who received apremilast experienced a significantly greater ACR20 response at week 16, compared with 20.2% in the placebo group (P = .004). The response rate at week 2 among the apremilast group was 16.4%, compared with 6.4% in those who received a placebo (P =.025). At week 16, apremilast significantly reduced PsA disease activity vs. placebo, with changes in Disease Activity Score, as measured using C-reactive protein, (P < .0001), as well as the Health Assessment Questionnaire-Disability Index (P = .023) and the Gladman Enthesitis Index (P = .001), the researchers wrote. The treatment maintained these improvements through week 52.

In addition, apremilast’s safety throughout the 52 weeks was consistent with prior phase 3 studies in psoriasis and PsA.

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“ACTIVE was the first randomized controlled study to assess the onset of response to apremilast monotherapy in biological-naive patients with active PsA,” Nash and colleagues wrote. “... These results support the use of apremilast monotherapy in biological-naive patients with PsA.” – by Jason Laday

Disclosure: The researchers report funding from the Celgene Corporation. Nash reports grant and research funding from the Celgene Foundation. See the full study for additional authors’ disclosures.