Patients with moderate PsA disease more likely to meet treatment targets with apremilast
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Patients with psoriatic arthritis are more likely to achieve treatment targets, such as remission or low disease activity, with apremilast if they demonstrate moderate, compared with high, disease activity at baseline, according to data published in Arthritis Care & Research.
“A fundamental question that remains is how to identify the most appropriate instruments to monitor disease activity in patients with PsA who may have multiple manifestations in clinical practice,” Philip J. Mease, MD, of the Swedish Medical Center and the University of Washington School of Medicine, and colleagues wrote. “In this regard, treat-to-target and American College of Rheumatology recommendations for PsA support the use of the Disease Activity Index for Psoriatic Arthritis (DAPSA) as a valid instrument to monitor the achievement of treatment targets, among other treatment targets.”
“A related measure, the Clinical DAPSA (cDAPSA), which excludes the CRP measurement, has been used in clinical practice,” they added. “Because the cDAPSA mainly focuses on articular manifestations, it remains to be determined whether patients who achieve these disease targets with apremilast could achieve comprehensive disease control across a wider range of disease manifestations that are not included in this measure, such as skin involvement, enthesitis or dactylitis.”
To examine the likelihood of achieving cDAPSA treatment targets — remission or low disease activity — for PsA with apremilast (Otezla, Celgene) based on baseline disease activity, Mease and colleagues pooled analyses from the PALACE 1, 2 and 3 studies. According to the researchers, these were phase 3, multicenter, double-blind, clinical trials in which adults with PsA were randomized 1:1:1 to receive either 30 mg of apremilast, 20 mg of apremilast or placebo twice daily.
Participants receiving placebo whose swollen or tender joint counts did not improve at least 20% at week 16 were rerandomized to one of the two apremilast groups. All remaining patients receiving placebo at week 24 were rerandomized to apremilast, with treatments continuing to week 52. For their study, Mease and colleagues analyzed pooled data regarding 494 participants treated with 30 mg of apremilast at baseline with available cDAPSA information. The researchers performed probability analyses using multiple imputation for discontinuations and missing values. They also conducted longitudinal analyses for participants grouped by cDAPSA category at week 52.
According to the researchers, among the analyzed patients, 46.9% of those with moderate disease activity at baseline achieved either remission or low disease activity by week 52, compared with 24.9% among those who demonstrated high disease activity at baseline. Among patients with moderate disease activity at baseline, small improvements — defined as cDAPSA reductions of at least 30% — by week 16 were associated with achieving treatment targets. In addition, participants who achieved remission or low disease activity by week 16 had a high likelihood of remaining at treatment targets at week 52.
Among the 375 analyzed participants with cDAPSA data available at week 52, achieving treatment targets with apremilast was associated with continuous disease activity improvements, with no or mild arthritis and other PsA symptoms.
“Our findings indicate that patients with moderate disease activity at baseline have a higher likelihood of achieving optimal outcomes with apremilast compared with those in HDA at baseline,” Mease and colleagues wrote. “Early and partial responses by Week 16 were associated with achieving long-term treatment targets. Finally, the results support the use of the cDAPSA to monitor patients treated with apremilast given that domains not captured by the cDAPSA traveled in the same direction as the cDAPSA. At a population level, patients who achieved cDAPSA [remission] or [low disease activity] also had no or mild musculoskeletal and non-musculoskeletal disease manifestations.” – by Jason Laday
Disclosure: Mease reports research grants from AbbVie, Amgen, Bristol-Myers Squibb, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical and UCB; consulting fees from Novartis, AbbVie, Amgen, Bristol-Myers Squibb, Celgene Corporation, Corrona, Eli Lilly, Galapagos, Genentech, Gilead, Janssen, Merck, Pfizer, Sun Pharmaceutical and UCB; and speaking fees from AbbVie, Amgen, Bristol-Myers Squibb, Celgene Corporation, Genentech, Janssen, Novartis, Pfizer and UCB. Please see the study for all other authors’ relevant financial disclosures.
Perspective
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Barbara Kienzle, BSN, RN
Psoriatic arthritis is often difficult to diagnosis and treat largely due to the wide range of presenting symptoms, lack of a single validated assessment tool of disease activity and the growing pool of approved medication options for adults. There are several take-home points from the information Mease and colleagues gleaned from digging deeper into the data from the PALACE 1-3 studies of apremilast as a treatment for PsA.
First, the study identifies a specific group of PsA patients: Those with moderate disease activity, who achieved and/or sustained remission or low disease activity (LDA) with a specific medication – apremilast. Data from cDAPSA at baseline, 16 weeks and end point (52 weeks) showed a progression of improved disease activity and the patient’s ability to achieve and/or maintain remission or LDA over time with continued use of apremilast. Second, clinical improvement was identified across other PsA domains (enthesitis, dactylitis, skin and physical functioning) not simply swollen/tender joints. Finally, this study takes a step forward in validating the cDAPSA as a practical tool for assessing disease activity in a day to day clinical setting.
Taken as a whole, the information compiled by Mease and colleagues on the effectiveness of apremilast for treating PsA has implications for the both clinician and patient. Rheumatology clinicians can use this information, along with their past experiences treating PsA, and other relevant research when formulating an individual patient’s treatment regime.
Sharing this information with PsA patients during discussions on treatment options is vital to their understanding of the risk/benefits of apremilast and that remission or LDA is not only possible but likely sustainable over time. The more education we can provide to our patients aids them in making informed decisions, leading to better compliance and better outcomes.
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Mease PJ, et al. Arthritis Care Res. 2019;doi:10.1002/acr.24134.
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