Laura Joszt

 for patients with inflammatory arthritis, such as rheumatoid arthritis (RA), and a 

 can have on patients with RA, psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA).

Danish researchers used a questionnaire-based cross-sectional survey to collect patient characteristics from patients in Denmark with RA, PsA, and axSpA.

“Fatigue is considered a multidimensional and complex phenomenon and is found to be associated with pain, sleep problems and low physical activity,” the authors explained. “Also, severe fatigue has been found to predict depression, low physical activity and quality of life, and more healthcare utilization. On the other hand, depression, reduced illness beliefs, psychological distress and low self-efficacy have been found to contribute to fatigue.”

Data was collected on 487 patients over a 6-month period from January 2017 to June 2017. The majority (60%) of patients had RA (n = 292), 23% had axSpA (n = 110), and 17% had PsA (n = 85).

Patients completed a questionnaire that asked about their disease history, type of household, education, employment, and household income. The researchers also used respondents’ medical journals to gather information about type of diagnosis, age, gender, treatment, treatment changes, and disease activity score. For the disease activity score, Disease Activity Score 28 (DAS28) was used for RA and PsA, Bath Ankylosing Spondylitis Disease Activity Index for axSpA, and Bath Ankylosing Spondylitis Functional Index for PsA and axSpA.

Fatigue did not differ significantly between the disease groups. The Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale has a range of 0 to 52, with higher scores indicating lower levels of fatigue. The FACIT-Fatigue score was 34.9 for RA, 31.8 for PsA, and 34.8 for axSpA. In comparison, the general population has a mean fatigue score of 44.0. While levels of fatigue were similar across the diseases, women, experienced patients, and patients who changed medication in the past 12 months all reported higher mean fatigue rate.

The socioeconomic characteristics that were correlated significantly with fatigue were education, employment, and income, with patients who had less education, were unemployed/retired, and had lower income showing a higher mean fatigue rate.

There was also a correlation between fatigue and work impairment, quality of life, pain, sleep problems, depression, and physical functioning.

The authors noted the limitations of their study included the fact that the cohort was slightly older and consisted of more women and the geographical scope was limited since the cohort was drawn from 2 clinics in the Capital Region of Denmark. They added that they cannot make conclusions concerning causality because they used a cross-sectional study.

“Fatigue cannot be seen as a single problem, but rather as a symptom that broadly affects the lives of people with [inflammatory arthritis],” the authors concluded.

Appel Esbensen B, Elkjær Stallknecht S, Elmegaard Madsen M, Hagelund L, Pilgaard T. Correlations of fatigue in Danish patients with rheumatoid arthritis, psoriatic arthritis and spondyloarthritis. 

. Published online August 3, 2020. doi:10.1371/journal.pone.0237117

Articles

A new study in PLOS ONE has highlighted the broad impact fatigue can have on patients with rheumatoid arthritis (RA), psoriatic arthritis, and axial spondyloarthritis.

Fatigue Broadly Impacts Patients With RA, Psoriatic Arthritis, Axial Spondyloarthritis

In the primary analysis of a phase 3 study, ruxolitinib, a 

, reduced spleen length and symptoms in patients with myelofibrosis (MF), according to results 

The JAK Inhibitor Ruxolitinib in Myelofibrosis Patients (JUMP) study was a global, single-arm, open-label, phase 3b, expanded-access trial. With 2233 patients, it is the largest and most expansive trial in patients with MF treated with ruxolitinib. In the study results, the authors presented the safety and efficacy results for all patients and a subgroup analysis (n = 138) of patients with low platelet counts (<100 x 109/1) at baseline.

The primary end point of JUMP was safety and tolerability or ruxolitinib by frequency, duration, and severity of adverse events (AEs).

The majority of patients were either intermediate-1 (37.4%) or intermediate-2 (33.8%) risk based on the dynamic International Prognostic Scoring System. The patients with low platelet counts at baseline had “disease characteristics that were consistent with more advanced disease,” based on hemoglobin levels and mean palpable spleen length, the authors noted.

More than half (57.5%) of all patients completed their treatment per protocol and the primary reason for 

 was AEs (18.1%), followed by disease progression (9.1%), and death (4.5%). The median exposure to ruxolitinib was 12.4 months; 51% of patients had more than 1 year of exposure and 30% and 13% of patients had greater than 2 and 3 years of exposure, respectively. However, patients in the low-platelet cohort had a lower median exposure (8.3 months).

The most common hematologic AEs were anemia (59.5%) and thrombocytopenia (53.5%). However, these AEs were manageable, since only 2.0% of patients with anemia and 3.4% of patients with thrombocytopenia discontinued treatment due to these AEs. Serious AEs included pneumonia (5.5%), anemia (4.2%), pyrexia (3.5%), cardiac failure (1.9%), dyspnea (1.6%), respiratory failure (1.2%), thrombocytopenia (1.1%), and urinary tract infection (1.0%).

More than half (56.5%) of patients with splenomegaly achieved a 50% or greater reduction from baseline to week 24 in palpable spleen length. By week 48, 61.4% had achieved a response and by week 96, 66.5% had achieved a response. Approximately a quarter (24.7%) of patients had a resolution of splenomegaly.

Overall survival probability was estimated at 94% (95% CI, 92%-95%) at 48 weeks and 87% (95% CI, 85%-89%) at 96 weeks. In addition, there were 205 deaths (9.2%) either on treatment or reported up to 28 days after the end of treatment.

The authors concluded that the findings from JUMP confirm the findings from the phase 3 COMFORT studies, while providing additional efficacy and safety evidence. They also noted that continued analysis is needed to determine the long-term efficacy of ruxolitinib.

“However, it is important to interpret our findings with caution given the limitations associated with a single-arm study and the small number of patients in the [intermediate-1]–risk and low-platelet cohorts; additionally, because comparisons of patient subgroups were conducted as a post-hoc analysis, no statistical testing was performed,” they explained.

Al-Ali HK, Greisshammer M, Foltz L, et al. Primary analysis of JUMP, a phase 3b, expanded-access study evaluating the safety and efficacy of ruxolitinib in patients with myelofibrosis, including those with low platelet counts. 

. 2020;189(5):888-903. doi:10.1111/bjh.16462

In the primary analysis of a phase 3 study, ruxolitinib reduced spleen length and symptoms in patients with myelofibrosis, according to results published in British Journal of Haemotology.

JUMP Provides Additional Safety, Efficacy Data on Ruxolitinib in Myelofibrosis

Just like in clinical trials, a real-world analysis of patients with psoriatic arthritis (PsA) who were treated with secukinumab achieved minimal disease activity (MDA), as well as other improvements, according to an abstract presented at the European League Against Rheumatism’s annual meeting.

The researchers analyzed 100 patients with PsA enrolled in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry who initiated and maintained secukinumab for 6 months. The patients had initiated the treatment after April 1, 2017, and had a follow-up visit in the 6 months after treatment initiation.

The primary outcome was MDA, which was defined as meeting 5 criteria out of 7 total: tender joint count (TJC) ≤1; swollen joint count (SJC) ≤1; psoriasis affected body surface area (BSA) <3%; patient assessment of pain on visual analog scale (VAS) ≤15; patient global assessment VAS ≤20; Health Assessment Questionnaire Disability Index (HAQ-DI) ≤ 0.5; and tender entheseal points ≤ 1 using the Leeds Enthesitis Index (LEI).

The mean age of patients was 51.6 years and the mean symptom and disease duration were 10.8 and 7.0 years, respectively. Thirty percent of patients initiated secukinumab at the 150 mg dose and the remaining 70% initiated it at 300 mg. Only 17 of the patients were initiating secukinumab as their first biologic—34 patients started it as their second biologic, 26 as their third, and 23 as their fourth or greater.

At the time of initiation, 75 of 90 patients were not in MDA and 36.6% of those with follow-up data had achieved MDA at 6 months. In addition, 28 patients (41.2%) with TJC ≥1, 24 patients (44.4%) with SJC ≥1, and 17 patients (60.7%) with enthesitis achieved resolution at 6 months.

According to the researchers, at 6 months, there were improvements in clinical outcomes and patient-reported outcomes (PROs) not only in the overall population, but also in patients who were initiating the treatment as a fourth-line or greater biologic.

“Consistent with clinical trials, real-world patients treated with secukinumab achieved MDA as well as improvement in clinical manifestations, PROs, and work productivity,” the authors concluded.

Mease PJ, Blachley T, Glynn M, et al. Secukinumab improves clinical and patient-reported outcomes at 6 months among patients with psoriatic arthritis in the US-based Corrona Psoriatic Arthritis/Spondyloarthritis (PsA/SpA) Registry. Presented at: EULAR 2020; June 3-6, 2020; Abstract SAT0429. https://ard.bmj.com/content/79/Suppl_1/1169.1

Just like in clinical trials, a real-world analysis of patients with psoriatic arthritis who were treated with secukinumab achieved minimal disease activity, as well as other improvements.

Real-World Analysis: Secukinumab Improves Psoriatic Arthritis Outcomes at 6 Months

Despite concerns, legislation to cap out-of-pocket payments for specialty drugs has not been shown to shift costs to health plans, thereby increasing insurance premiums, according to a study 

Researchers analyzed 27,161 people with rheumatoid arthritis, multiple sclerosis, hepatitis C, psoriasis, psoriatic arthritis, Crohn disease, or ulcerative colitis, who were under the age of 65 and in commercial health plans from 2011 to 2016. Since 2018, there have been 11 states that have introduced specialty drug spending-cap legislation, but there has been little evidence about the effect state-mandated cost-sharing caps have on patient and health plan spending.

“Addressing this gap will help to inform state and federal policies that aim to balance patient and plan spending for these important treatments,” the authors explained.

Specialty drugs are good candidates for generous coverage, they argued, because these therapies are usually clinically important and experience limited price sensitivity because they are so clinically important. Treatments for hepatitis C are curative, whereas treatments for multiple sclerosis, rheumatoid arthritis, or Crohn disease improve quality of life. Usually, there is a lack of appropriate substitutes for these treatments.

The study period included the 3 years before and 1 to 3 years after the specialty drug spending-cap legislation was enacted in Delaware (2014), Louisiana (2015), and Maryland (2016). All 3 states capped out-of-pocket payments for specialty drugs at $150 per prescription. These states were compared with neighboring states that did not enact caps: New Jersey as a control for Delaware, Arkansas as a control for Louisiana, and Virginia as a control for Maryland.

Among users in the 95th percentile of spending on specialty drugs, there was a 32% reduction in spending (–$351) per user per month (95% CI, –$554 to –$148). The caps were not associated with changes in other out-of-pocket spending, health plan spending, or, for the most part, specialty drug utilization. The only exception was that there was an increase in specialty drug utilization in Delaware in the third year post policy change. Delaware is the only state with 3 years of postpolicy observation.

As for the concern that specialty drug caps could increase health plan spending, the authors noted that the caps actually strengthen the risk-spreading function of insurance without increasing spending for the broader population.

There were a number of limitations that the authors noted, including that confounding is a possibility with any observational study and that the data set did not separate deductibles, which were not subject to the caps, from co-payments and coinsurance. Analyzing total out-of-pocket payments could have reduced the precision of the estimates, they explained. They also suggested evaluating the caps in the longer term.

“Many states and the federal government have considered out-of-pocket caps to reduce the spending burden on patients, but a concern is that these caps could increase insurance premiums,” the authors concluded. “The results we obtained with a quasi-experimental approach suggest that caps targeting out-of-pocket spending on specialty drugs can reduce the financial burden on the patients with the highest levels of spending without increasing spending on drugs or other care for the larger population.”

Yeung K, Barthold D, Dusetzina SB, Basu A. Patient and plan spending after state specialty-drug out-of-pocket spending caps. 

. 2020;383:558-66. doi:10.1056/NEJMsa1910366

Despite concerns, legislation to cap out-of-pocket payments for specialty drugs has not been shown to shift costs to health plans, thereby increasing insurance premiums, according to a study published in New England Journal of Medicine.

Author | Laura Joszt

Articles

Fatigue Broadly Impacts Patients With RA, Psoriatic Arthritis, Axial Spondyloarthritis

JUMP Provides Additional Safety, Efficacy Data on Ruxolitinib in Myelofibrosis

Real-World Analysis: Secukinumab Improves Psoriatic Arthritis Outcomes at 6 Months

Specialty Drug Spending After State-Mandated Out-of-Pocket Caps