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2019 Brought Impressive Results for TNF Inhibitors, Research Into Monotherapy, Interest in CBD

Laura Joszt
This year has been an exciting time for rheumatologists with impressive clinical trial results and promising outcomes for patients, said Susan Manzi, MD, MPH, codirector of the Lupus Center of Excellence and chair of the Department of Medicine of West Penn Allegheny Health System, during a session at the American College of Rheumatology annual meeting in Atlanta, Georgia.
This is an exciting time in rheumatology with impressive clinical trial results and promising outcomes for patients, explained Susan Manzi, MD, MPH, codirector of the Lupus Center of Excellence and chair of the Department of Medicine of West Penn Allegheny Health System, during a look back at the year during a session at the American College of Rheumatology annual meeting in Atlanta, Georgia.

Psoriatic Arthritis and Psoriasis
She started with psoriatic arthritis (PsA), which has had aggressive first-line tumor necrosis factor (TNF) treatments and impressive outcomes for interleukin (IL)-17 and IL-23 medications.

Research in Annals of Rheumatic Diseases found that golimumab, a TNF inhibitor, plus methotrexate was superior to methotrexate alone in treating PsA.1 By the end of week 22, 81% of patients taking golimumab plus methotrexate had achieved Disease Activity Score remission compared with 42% of patients taking placebo plus methotrexate.

“You can see these separations as early as 8 weeks, which is pretty impressive,” Manzi said.

In addition to the improvements in remission, there was no difference in adverse events (AEs) or treatment-emergent AEs.

However, the IL-17 and IL-23 targets are the real highlight, Manzi said, adding that “these drugs have made a huge impact on the world of psoriasis and psoriatic arthritis.”

Risankizumab was successful in phase 2 trials in PsA, but it is also having an impact on psoriasis. In a trial published in The Lancet, risankizumab was superior to adalimumab in moderate to severe plaque psoriasis.2 At 16 weeks, 72% of patients on risankizumab versus 47% on adalimumab achieved at least a 90% reduction in the Psoriasis Area and Severity Index (PASI 90). In addition, patients taking risankizumab were far more likely than patients taking adalimumab (84% vs 60%) to be almost clear of diseases based on the static Physician’s Global Assessment score at week 16.

“But what’s interesting is in those that had only an intermediate response to adalimumab and were rerandomized to either stay on adalimumab or go to risankizumab, you see even more impressive results,” Manzi said.

When looking at the PASI 90 and Physician’s Global Assessment, patients who were rerandomized had “an impressive improvement in what we would consider fairly refractor to adalimumab psoriasis patients.”

In addition, there were no safety concerns with risankizumab and the quality of life was superior to adalimumab, she explained. As a result, she recommended everyone stay tuned to phase 3 trials for PsA.

“We keep raising the bar of what we’re seeing in terms of the primary outcomes” for PsA, Manzi said. “PASI 75 was always the target before…it’s now the PASI 90 and 100.”

JAK Inhibitors
In rheumatoid arthritis (RA) there have been some changing paradigms in clinical trials. The Janus kinase (JAK) inhibitors have been in the spotlight, more so looking at refractory patients who have failed previously on biologic disease-modifying antirheumatic drugs (bDMARDs). Another area being explored in RA is the idea of monotherapy where background therapy can actually be discontinued.

Research on the FINCH 2 phase 3 trials published in JAMA found that, compared with placebo, more patients with moderate to severe RA on filgotinib who had tried at least 3 previous bDMARDs achieved a clinical response in 12 weeks.3

In addition, there was a rapid onset, which is pretty typical of JAK inhibitors, Manzi said, and responses were maintained or improved over 24 weeks.

As these agents become more effective, the idea of monotherapy is being raised, she noted, referencing a paper in The Lancet that looked at upadacitinib.4 The study found that upadacitinib, another JAK inhibitor, used as a monotherapy in active RA in patients who had an inadequate response to methotrexate had more patients who achieved a 20% improvement in the American College of Rheumatology criteria (ACR 20). By week 14, 68% of patients on upadacitinib 15 mg and 71% of patients taking upadacitinib 30 mg achieved ACR 20 compared with just 41% of patients who continued with methotrexate.



 
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