Categories
Change Password!
Reset Password!
A study explored the potential influence of background methotrexate dose (≤ 15 or >15 mg per week) on safety and effectiveness of tofacitinib (an oral Janus kinase inhibitor) for the management of psoriatic arthritis.
Regardless of the methotrexate
dose, the efficacy of tofacitinib was numerically greater than placebo in adult
patients with active psoriatic arthritis.
A study explored the potential
influence of background methotrexate dose (≤ 15 or >15 mg per week) on
safety and effectiveness of tofacitinib (an oral Janus kinase inhibitor) for
the management of psoriatic arthritis.
This study pooled data from two phase 3, double-blind clinical studies (OPAL Beyond, OPAL Broaden) and recruited people receiving tofacitinib (five or ten mg twice daily [BID]), or placebo, with stable methotrexate.
In this post hoc exploratory
analysis, the efficacy endpoints at third month stratified by methotrexate
dosage were: (i) Health Assessment Questionnaire-Disability Index (HAQ-DI),
(ii) Physician's global assessment of psoriatic arthritis (PGA-psoriatic
arthritis-visual analog scale [VAS]), (iii) American College of Rheumatology
(ACR)20/50/70, (iv) Dactylitis Severity Score (DSS), (v) alteration from
baseline in HAQ-DI, (vi) Leeds Enthesitis Index (LEI), (vii) Psoriasis Area and
Severity Index (PASI) 50/75; and (viii) patient's global joint and skin
assessment (PGJS-VAS). Laboratory parameters and noxious events were the safety
assessments incorporated.
556 participants received tofacitinib 5 mg BID (n = 186), 10 mg BID (n = 178), or placebo (n = 192), plus methotrexate (371 received ≤15 mg per week, 185 received >15 mg per week). Tofacitinib showed higher effectiveness compared to placebo in the third month. People treated with 5 mg BID tofacitinib displayed greater numerical improvements in efficacy endpoints at third month with methotrexate > 15 mg per week vs methotrexate ≤ 15 mg per week.
On the other hand, people treated
with 10 mg BID tofacitinib showed the opposite. The safety profile showed
consistency between the study groups. Headache was a common noxious event
linked with the higher methotrexate dose (> 15 mg per week). Reduced
hemoglobin levels were noted in people treated with tofacitinib 10 mg BID and
background methotrexate ≤ 15 mg per week.
For the majority of dermatologic
and rheumatologic outcomes evaluated, 5 mg tofacitinib BID, in combination with
a greater dose of background methotrexate, was more effective than a lower dose
of background methotrexate. However, the opposite was noted for people treated
with 10 mg tofacitinib BID.
Clinical Rheumatology
Efficacy and safety of tofacitinib by background methotrexate dose in psoriatic arthritis: post hoc exploratory analysis from two phase III trials
Alan J Kivitz et al.
Comments (0)