JANSSEN
TREMFYA
Janssen has presented new data from two Phase 3 clinical trials, DISCOVER-1 and DISCOVER-2 of Tremfya (guselkumab), in adult patients with active psoriatic arthritis (PsA). The drug has demonstrated improvement in joint symptoms, skin symptoms, soft tissue inflammation, physical function, and reduction in radiographic progression at week 52.
DISCOVER-1 included treatment naïve patients, and DISCOVER-2 included biological naïve patients. The patients were administered with TREMFYA 100 mg every four weeks (q4w) or every eight weeks (q8w) for one year. 73% of patients administered the drug every four weeks, and 60% who were administered every eight weeks achieved ACR20. 54% of patients administered the drug every four weeks, and 39% who were administered every eight weeks achieved ACR50.
In the DISCOVER-2 study, 71% of patients administered with the drug every four weeks, and 75% who were administered every eight weeks achieved ACR20. 46% of patients who were administered with Tremfya every four weeks and 48% who were administered every eight weeks achieved ACR50.
NOVARTIS
COSENTYX
Novartis has presented PREVENT study details in patients with non-radiographic axial spondyloarthritis. Novartis has already received approval for non-radiographic axial spondyloarthritis in Europe.
PREVENT is a two-year randomized, double-blind, placebo-controlled Phase III study. The study included 555 patients, out of which 501 patients were biologically naïve. The primary endpoint considered was ASAS40 at week 16 and week 52. 41.5% of patients showed improvement in ASAS40 compared to 29.2% in the placebo arm.
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GILEAD
FILGOTINIB
Gilead presented Phase 3 FINCH 1 and FINCH 3 studies of filgotinib. The drug has demonstrated sustained safety and efficacy across all rheumatoid arthritis patients.
FINCH-1 study evaluated filgotinib versus placebo and adalimumab. The company announced that filgotinib met both the primary and secondary endpoints. Further, the drug achieved low disease activity (DAS28(CRP) ≤3.2) and clinical remission compared to adalimumab.
FINCH-3 study evaluated in treatment naïve patients. More patients who were administered with filgotinib achieved the primary endpoints compared to the adalimumab arm.
BMS
ORENCIA
BMS has submitted a trial demonstrating the durable response of Orencia in moderate-to-severe early rheumatoid arthritis. The company has presented an Early AMPLE study, a Phase IV exploratory biomarker study. The study assessed the efficacy of Orencia versus adalimumab.
In the trial, patients are randomized 1:1 to SC Orencia 125 mg weekly or SC adalimumab 40 mg every two weeks. After 28 weeks, patients who were on adalimumab arm were switched to open-label Orencia, followed by a 6-week washout period. Efficacy was assessed at week 24 and week 48. ACR 20/50/70 responders and DAS28 (CRP) remitters were assessed.
At week 24, ACR 20/50/70 responses in patients on Orencia arm were 83,73, and 50, whereas in patients on adalimumab arm were 63, 45, and 30, respectively.
ACR 20/50/70 responses in patients who were continuously administered with Orencia were 78, 63, and 50, respectively.
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UCB
UCB has presented the new data of Cimzia (certolizumab pegol), Evenity (romosozumab), and investigational IL-17A and IL-17F inhibitor, bimekizumab.
CIMZIA
UCB has presented the Phase 3b C-OPTIMISE study of certolizumab pegol in patients with axSpA who achieved sustained clinical remission. The trial is conducted in patients who achieved sustained clinical remission. The drug was administered as a continuous dose and intermittent dose. The data showed a reduction in the dose of Cimzia is suitable for patients with axSpA who achieve sustained remission after 48 weeks of treatment with Cimzia.
83.7% of patients who were on the full dose and 79% of patients who were on reduced maintenance dose remained flare-free. In comparison to this, only 20.2% of patients who were on placebo remained flare-free.
BIMEKIZUMAB
UCB has presented the Phase 2b BE AGILE study of bimekizumab in ankylosing spondylitis. The company announced that there is an improvement in spinal pain, fatigue, morning stiffness, sleep, disease activity, and quality of life compared to placebo.
The drug has not been approved for any indications.
EVENITY (ROMOSOZUMAB)
The company has submitted the Phase 3 ARCH and FRAME studies, which evaluated the drug in postmenopausal women with osteoporosis and with mild to moderate renal insufficiency.
In the ARCH study, the drug is compared with alendronate at month 12. 3.3 percent of patients on romosozumab showed improvement compared to 7.3 percent in patients who were on alendronate arm.
ABBVIE
RINVOQ (upadacitinib)
AbbVie has presented the data of Rinvoq (upadacitinib) in patients with rheumatoid arthritis. The company presented the data of SELECT-MONOTHERAPY and SELECT-COMPARE studies.
In SELECT-COMPARE study, patients who were on upadacitinib showed that upadacitinib in combination with methotrexate had higher levels of clinical response, including remission when compared to upadacitinib.
In SELECT-MONOTHERAPY, patients who were on methotrexate were shifted to upadacitinib after 14 weeks.
ACR 20
cMTX to upadacitinib 15 mg: 86%
cMTX to upadacitinib 30 mg: 90%
Continuous upadacitinib 15 mg: 88%
Continuous upadacitinib 30 mg: 96%
ACR 50
cMTX to upadacitinib 15 mg: 71%
cMTX to upadacitinib 30 mg: 68%
Continuous upadacitinib 15 mg: 71%
Continuous upadacitinib 30 mg: 78%
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