Table 1.
Summary of studies specifically designed to assess the effectiveness of different biologic DMARDs in patients affected by psoriatic arthritis with axial involvement.
| Treatment | References | Definition of axial involvement | Type of study | N | Main findings |
|---|---|---|---|---|---|
| Secukinumab (SEC) | Baraliakos et al., 2020 | - Clinician-diagnosed axial involvement - Spinal pain VAS > 40/100 - BASDAI >4 (despite ≥2 NSAIDs) | Phase III double blind RCT (MAXIMASE) | 498 | •SEC 300 and 150 mg significantly improved ASAS20 response vs. PBO at week 12 (63% and 66 vs. 31%). •SEC 300 and 150 mg significantly improved ASAS40 response vs. PBO at week 12 (44% and 40 vs. 12%). •Least square means (LSM) of treatment difference of SEC 300 and 150 mg vs. PBO from baseline in total Berlin MRI score for the entire spine at week 12 was −0.4 (< 0.001) and −0.4 (p < 0.05). |
| Ixekizumab (IXE) | Deodhar et al., 2019a | - Self-reporting axial pain starting before the age of 45 years at baseline | Post-hoc integrated analysis of two phase III RCTs (SPIRIT-P1/P2) | 105 | •Pain and stiffness significantly improved at Weeks 16 and 24 in patients with PsA treated with IXEQ4W or IXEQ2W vs. PBO (p < 0.05). •Fatigue significantly improved at Week 16 in patients treated with IXEQ4W or IXEQ2W vs. PBO and at Week 24 with IXEQ2W vs. PBO (p < 0.05). •Total BASDAI scores significantly improved at Weeks 16 and 24 in patients treated with IXEQ4W or IXEQ2W vs. PBO (p < 0.01). •Physical function significantly improved at Weeks 16 and 24 in patients treated with IXEQ4W or IXEQ2W vs. PBO when assessed by HAQ-DI or SF-36 PCS (p < 0.05). |
| Ustekinumab (UST) | Kavanaugh et al., 2016 | - Clinician-diagnosed spondylitis | Post-hoc integrated analysis of two phase III RCTs (PSUMMIT-1 and 2) | 256 | •At week 24, significantly more patients achieved BASDAI20/50/70 responses (54.8/29.3/15.3% vs. 32.9/11.4/0%; p ≤ 0.002). •Higher improvement in BASDAI question 2 concerning axial pain in UST-treated vs. PBO 1.85 vs. 0.24 (p < 0.001) and mean per cent ASDAS-CRP improvements (27.8 vs. 3.9%; p < 0.001) for UST vs. PBO. |
| Guselkumab (GUS) | Helliwell et al., 2020 | - Imaging-confirmed sacroiliitis | Post-hoc integrated analysis of two phase III RCTs (SPIRIT-P1/P2) | 312 | •In GUS 100 mg q4w, q8w, and PBO groups, the LS mean change at 24w in BASDAI was −2.7, −2.7, −1.3 (p < 0.001); in modified BASDAI was −2.6, −2.7, −1.4 (p < 0.001), in spinal pain was −2.5, −2.7, −1.4 (p < 0.001); in ASDAS was −1.4, −1.4, −0.7 (p < 0.001). •The rate of BASDAI 50 achievement was 38, 40, 19% (p < 0.01). |
| Upadacitinib (UPA) | Deodhar et al., 2020a,c | - Clinician-diagnosed spondylitis | Post-hoc integrated analysis of two phase III RCTs (SELCET-PsA1-2) | 541–626 | •Mean delta-BASDAI at week 12: 1–75 and −2.22 in UPA 15 and 30 mg vs. PBO −0.56 (p < 0.001). •Mean delta-BASDAI at week 24: −2.61 and −2.71 in UPA 15 and 30 mg vs. PBO −1.00 (p < 0.001). |
PBO, placebo; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; ASAS, Assessment of Spondylarthritis International Society; ASDAS, Ankylosing Spondylitis Disease Activity Score.