Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 Trials
Abstract Introduction We assessed tofacitinib efficacy and safety in ankylosing spondylitis (AS) by body mass index (BMI) category. Methods Data were pooled from phase 2/3 trials; analyses included patients with active AS randomized (1:1) to tofacitinib 5 mg twice daily or placebo, who were stratifi...
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Adis, Springer Healthcare
2024-12-01
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| Series: | Rheumatology and Therapy |
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| Online Access: | https://doi.org/10.1007/s40744-024-00726-6 |
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| author | Hillary Norton Paula Sliwinska-Stanczyk Tomas Hala Bassel El-Zorkany Lori Stockert Rajiv Mundayat Lisy Wang Christopher T. Ritchlin |
| author_facet | Hillary Norton Paula Sliwinska-Stanczyk Tomas Hala Bassel El-Zorkany Lori Stockert Rajiv Mundayat Lisy Wang Christopher T. Ritchlin |
| author_sort | Hillary Norton |
| collection | DOAJ |
| description | Abstract Introduction We assessed tofacitinib efficacy and safety in ankylosing spondylitis (AS) by body mass index (BMI) category. Methods Data were pooled from phase 2/3 trials; analyses included patients with active AS randomized (1:1) to tofacitinib 5 mg twice daily or placebo, who were stratified by baseline BMI into < 25, ≥ 25 to < 30, and ≥ 30 kg/m2 categories. Efficacy was assessed at week 12 and safety to week 16. Results Of 370 patients, 153, 131, and 86 had a baseline BMI of < 25, ≥ 25 to < 30, and ≥ 30 kg/m2, respectively. At baseline, patients with BMI < 25 kg/m2 were younger and more likely to be current smokers/Asian, and patients with BMI ≥ 30 kg/m2 had higher mean waist circumference/swollen joint count (SJC) and were more likely to have enthesitis, high-sensitivity C-reactive protein (hsCRP) > 5 mg/L, an inadequate response to tumor necrosis factor inhibitors (TNFi), and prior biologic disease-modifying anti-rheumatic drug (bDMARD) use versus other categories. Across categories, tofacitinib responses/improvements were greater than with placebo, except for ≥ 40% Assessment of SpondyloArthritis international Society improvement (ASAS40), ASAS partial remission, 50% improvement from baseline in the Bath Ankylosing Spondylitis Disease Activity Index score (BASDAI50), and Ankylosing Spondylitis Disease Activity Score using C-reactive protein (ASDAS-CRP) inactive disease rates, which were similar for tofacitinib and placebo in the BMI ≥ 30 kg/m2 category. Treatment effects were similar across categories, except for BASDAI50, which was smaller in the BMI ≥ 30 category versus the < 25 kg/m2 category. More adverse events (AEs) and serious adverse events (SAEs) with tofacitinib were reported in the BMI < 25 kg/m2 category, which had a higher proportion of current smokers versus other categories. Conclusions Regardless of baseline BMI category, efficacy was greater with tofacitinib versus placebo in patients with AS, and no treatment effect differences between categories were observed, with exceptions for BMI ≥ 30 kg/m2 (more active/treatment-refractory disease and a smaller sample size). Overall, tofacitinib safety was generally comparable across categories; however, AE/SAE rates with tofacitinib were higher in the BMI < 25 kg/m2 category (which had more current smokers). This post hoc analysis demonstrates that tofacitinib can be considered as a treatment option for AS, regardless of baseline BMI category; however, interpretation was limited by small sample sizes and differences in sample sizes and baseline characteristics across categories. Trial Registration ClinicalTrials.gov identifiers, NCT01786668 and NCT03502616. |
| format | Article |
| id | doaj-art-8e6148d139f84f588d4aa5cf50bb6d0e |
| institution | Kabale University |
| issn | 2198-6576 2198-6584 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Adis, Springer Healthcare |
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| series | Rheumatology and Therapy |
| spelling | doaj-art-8e6148d139f84f588d4aa5cf50bb6d0e2025-01-26T12:52:06ZengAdis, Springer HealthcareRheumatology and Therapy2198-65762198-65842024-12-01121678410.1007/s40744-024-00726-6Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 TrialsHillary Norton0Paula Sliwinska-Stanczyk1Tomas Hala2Bassel El-Zorkany3Lori Stockert4Rajiv Mundayat5Lisy Wang6Christopher T. Ritchlin7Inspire Sante Fe Medical GroupReumatika Centrum ReumatologiiCenter for Clinical and Basic ResearchDepartment of Rheumatology, Cairo UniversityPfizer Inc.Pfizer Inc.Pfizer Inc.Allergy, Immunology and Rheumatology Division, University of Rochester Medical SchoolAbstract Introduction We assessed tofacitinib efficacy and safety in ankylosing spondylitis (AS) by body mass index (BMI) category. Methods Data were pooled from phase 2/3 trials; analyses included patients with active AS randomized (1:1) to tofacitinib 5 mg twice daily or placebo, who were stratified by baseline BMI into < 25, ≥ 25 to < 30, and ≥ 30 kg/m2 categories. Efficacy was assessed at week 12 and safety to week 16. Results Of 370 patients, 153, 131, and 86 had a baseline BMI of < 25, ≥ 25 to < 30, and ≥ 30 kg/m2, respectively. At baseline, patients with BMI < 25 kg/m2 were younger and more likely to be current smokers/Asian, and patients with BMI ≥ 30 kg/m2 had higher mean waist circumference/swollen joint count (SJC) and were more likely to have enthesitis, high-sensitivity C-reactive protein (hsCRP) > 5 mg/L, an inadequate response to tumor necrosis factor inhibitors (TNFi), and prior biologic disease-modifying anti-rheumatic drug (bDMARD) use versus other categories. Across categories, tofacitinib responses/improvements were greater than with placebo, except for ≥ 40% Assessment of SpondyloArthritis international Society improvement (ASAS40), ASAS partial remission, 50% improvement from baseline in the Bath Ankylosing Spondylitis Disease Activity Index score (BASDAI50), and Ankylosing Spondylitis Disease Activity Score using C-reactive protein (ASDAS-CRP) inactive disease rates, which were similar for tofacitinib and placebo in the BMI ≥ 30 kg/m2 category. Treatment effects were similar across categories, except for BASDAI50, which was smaller in the BMI ≥ 30 category versus the < 25 kg/m2 category. More adverse events (AEs) and serious adverse events (SAEs) with tofacitinib were reported in the BMI < 25 kg/m2 category, which had a higher proportion of current smokers versus other categories. Conclusions Regardless of baseline BMI category, efficacy was greater with tofacitinib versus placebo in patients with AS, and no treatment effect differences between categories were observed, with exceptions for BMI ≥ 30 kg/m2 (more active/treatment-refractory disease and a smaller sample size). Overall, tofacitinib safety was generally comparable across categories; however, AE/SAE rates with tofacitinib were higher in the BMI < 25 kg/m2 category (which had more current smokers). This post hoc analysis demonstrates that tofacitinib can be considered as a treatment option for AS, regardless of baseline BMI category; however, interpretation was limited by small sample sizes and differences in sample sizes and baseline characteristics across categories. Trial Registration ClinicalTrials.gov identifiers, NCT01786668 and NCT03502616.https://doi.org/10.1007/s40744-024-00726-6Body mass indexRandomized controlled trialRheumatologyTherapeutics |
| spellingShingle | Hillary Norton Paula Sliwinska-Stanczyk Tomas Hala Bassel El-Zorkany Lori Stockert Rajiv Mundayat Lisy Wang Christopher T. Ritchlin Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 Trials Rheumatology and Therapy Body mass index Randomized controlled trial Rheumatology Therapeutics |
| title | Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 Trials |
| title_full | Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 Trials |
| title_fullStr | Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 Trials |
| title_full_unstemmed | Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 Trials |
| title_short | Tofacitinib Efficacy/Safety in Patients with Ankylosing Spondylitis by Baseline Body Mass Index: A Post Hoc Analysis of Phase 2/3 Trials |
| title_sort | tofacitinib efficacy safety in patients with ankylosing spondylitis by baseline body mass index a post hoc analysis of phase 2 3 trials |
| topic | Body mass index Randomized controlled trial Rheumatology Therapeutics |
| url | https://doi.org/10.1007/s40744-024-00726-6 |
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