Median time to pain improvement and the impact of baseline pain severity on pain response in patients with psoriatic arthritis treated with tofacitinib

Abstract

Background: Pain is a core domain of psoriatic arthritis (PsA). This post hoc analysis evaluated time to pain improvement and the impact of baseline pain severity on pain response in patients with PsA receiving tofacitinib.

Methods: Data from two trials (NCT01877668; NCT01882439) in patients receiving tofacitinib 5 mg twice daily, placebo switching to tofacitinib 5 mg twice daily at month 3 (placebo-to-tofacitinib) or adalimumab (NCT01877668 only) were included. Improvement in pain (≥30%/≥50% decrease from baseline in Visual Analogue Scale pain score) was assessed; median time to initial (first post-baseline visit)/continued (first two consecutive post-baseline visits) pain improvement was estimated (Kaplan-Meier) for all treatment arms. A parametric model was used to determine the relationship between baseline pain severity and time to pain response in patients receiving tofacitinib.

Results: At month 3, more patients experienced pain improvements with tofacitinib/adalimumab versus placebo. Median days (95% CI) to initial/continued pain improvements of ≥30% and ≥50%, respectively, were 55 (29-57)/60 (57-85) and 85 (57-92)/171 (90-not estimable (NE)) for tofacitinib, versus 106 (64-115)/126 (113-173) and 169 (120-189)/NE (247-NE) for placebo-to-tofacitinib. Pain improvements were also experienced more quickly for adalimumab versus placebo. Predicted time to ≥30%/≥50% pain improvement was shorter in patients with higher baseline pain versus lower baseline pain (tofacitinib arm only).

Conclusions: In patients with PsA, pain improvements were experienced by more patients, and more rapidly, with tofacitinib and adalimumab versus placebo. In those receiving tofacitinib, higher baseline pain was associated with faster pain improvements.

Keywords: antirheumatic agents; patient-reported outcome measures; psoriatic arthritis.

Conflict of interest statement

Competing interests: KdV is a consultant for Lilly and Pfizer Inc. AO has served as a consultant for AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Corrona, Gilead, Janssen, Lilly, Novartis, Pfizer Inc, Takeda and UCB, and has received grant/research support from Amgen, Novartis and Pfizer Inc. AO’s husband has received royalties from Novartis. RF is a consultant for AbbVie, Acea, Amgen, Bristol-Myers Squibb, Celltrion, Genentech, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer Inc, Sanofi-Aventis and UCB, and has received grant/research support from AbbVie, Acea, Amgen, AstraZeneca, Bristol-Myers Squibb, Celltrion, Genentech, GSK, Janssen, Lilly, Novartis, Pfizer Inc, Sanofi-Aventis and UCB. PCT is a consultant for AbbVie, Biogen, Bristol-Myers Squibb, Fresenius, Galapagos, Gilead, Janssen, Lilly, Pfizer Inc, Roche, Sanofi-Aventis and UCB, and has received grant/research support from Celgene, Galapagos, Gilead and Lilly. VA is a consultant for AbbVie, Merck-Serono, Novartis and Pfizer Inc, and has received grant/research support from AbbVie, Lilly, Genentech, GSK, Pfizer Inc and UCB. PJM is a consultant for AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Corrona, Janssen, Lilly, Merck, Novartis, Pfizer Inc, Sun, UCB and Zynerba, and has received grant/research support from AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Novartis, Pfizer Inc, Sun and UCB. AGB, JCC, LF and JW are employees and shareholders of Pfizer Inc.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Proportion of patients with PsA receiving tofacitinib 5 mg BID, placebo-to-tofacitinib 5 mg BID (OPAL Broaden and OPAL Beyond) or adalimumab 40 mg Q2W (OPAL Broaden only) reporting (A) ≥30% and (B) ≥50% improvements in pain from baseline at each study visit. The vertical line represents the point at which patients receiving placebo switched to tofacitinib 5 mg BID (month 3). BID, twice daily; N, number of patients evaluable at the timepoint; PsA, psoriatic arthritis; Q2W, once every 2 weeks.

Figure 2

Probability of patients with PsA not experiencing (A) an initial and (B) continued ≥30% pain improvement, and (C) an initial and (D) continued ≥50% pain improvement, from baseline, with tofacitinib 5 mg BID or placebo-to-tofacitinib 5 mg BID (pooled across OPAL Broaden and OPAL Beyond). Tick marks indicate censored patients. BID, twice daily; PsA, psoriatic arthritis.

Figure 3

Probability of patients with PsA not experiencing (A) an initial and (B) continued ≥30% pain improvement, and (C) an initial and (D) continued ≥50% pain improvement, from baseline, with tofacitinib 5 mg BID or placebo-to-tofacitinib 5 mg BID; and (E) an initial and (F) continued ≥30% pain improvement, and (G) an initial and (H) continued ≥50% pain improvement, from baseline, with adalimumab 40 mg Q2W or placebo-to-tofacitinib 5 mg BID (OPAL Broaden only). Tick marks indicate censored patients. BID, twice daily; PsA, psoriatic arthritis; Q2W, once every 2 weeks.

Figure 4

Predicted median (95% CI) time (days) to pain improvement as a function of baseline pain severity in patients with PsA receiving tofacitinib 5 mg twice daily. Results from the parametric model (final selected model (log-normal distribution) with the smallest AIC). AIC, Akaike information criterion; PsA, psoriatic arthritis.